Theory-based interventions for contraception

  • Review
  • Intervention

Authors


Abstract

Background

The explicit use of theory in research helps expand the knowledge base. Theories and models have been used extensively in HIV-prevention research and in interventions for preventing sexually transmitted infections (STIs). The health behavior field uses many theories or models of change. However, educational interventions addressing contraception often have no stated theoretical base.

Objectives

Review randomized controlled trials (RCTs) that tested a theoretical approach to inform contraceptive choice; encourage contraceptive use; or promote adherence to, or continuation of, a contraceptive regimen.

Search methods

Through June 2013, we searched computerized databases for trials that tested a theory-based intervention for improving contraceptive use (MEDLINE, POPLINE, CENTRAL, PsycINFO, ClinicalTrials.gov, and ICTRP). Previous searches also included EMBASE. For the initial review, we wrote to investigators to find other trials.

Selection criteria

Trials tested a theory-based intervention for improving contraceptive use. We excluded trials focused on high-risk groups and preventing sexually transmitted infections or HIV. Interventions addressed the use of one or more contraceptive methods for contraception. The reports provided evidence that the intervention was based on a specific theory or model. The primary outcomes were pregnancy, contraceptive choice or use, and contraceptive adherence or continuation.

Data collection and analysis

The primary author evaluated abstracts for eligibility. Two authors extracted data from included studies. For the dichotomous outcomes, the Mantel-Haenszel odds ratio (OR) with 95% CI was calculated using a fixed-effect model. Cluster randomized trials used various methods of accounting for the clustering, such as multilevel modeling. Most reports did not provide information to calculate the effective sample size. Therefore, we presented the results as reported by the investigators. No meta-analysis was conducted due to differences in interventions and outcome measures.

Main results

We included three new trials for a total of 17. Ten randomly assigned individuals and seven were cluster-randomized. Eight trials showed some intervention effect.

Two of 12 trials with pregnancy or birth data showed some effect. A theory-based group was less likely than the comparison group to have a second birth (OR 0.41; 95% CI 0.17 to 1.00) or to report a pregnancy (OR 0.24 (95% CI 0.10 to 0.56); OR 0.27 (95% CI 0.11 to 0.66)). The theoretical bases were social cognitive theory (SCT) and another social cognition model.

Of 12 trials with data on contraceptive use (non-condom), six showed some effect. A theory-based group was more likely to consistently use oral contraceptives (OR 1.41; 95% CI 1.06 to 1.87), hormonal contraceptives (reported relative risk (RR) 1.30; 95% CI 1.06 to 1.58) or dual methods (reported RR 1.36; 95% CI 1.01 to 1.85); to use an effective contraceptive method (reported effect size 1.76; OR 2.04 (95% CI 1.47 to 2.83)) or use more habitual contraception (reported P < 0.05); and were less likely to use ineffective contraception (OR 0.56; 95% CI 0.31 to 0.98). Theories and models included the Health Belief Model (HBM), SCT, SCT plus another theory, other social cognition, and motivational interviewing (MI).

For condom use, a theory-based group had favorable results in 5 of 11 trials. The main differences were reporting more consistent condom use (reported RR 1.57; 95% CI 1.28 to 1.94) and more condom use during last sex (reported results: risk ratio 1.47 (95% CI 1.12 to 1.93); effect size 1.68; OR 2.12 (95% CI 1.24 to 3.56); OR 1.45 (95% CI 1.03 to 2.03)). The theories were SCT, SCT plus another theory, and HBM.

Nearly all trials provided multiple sessions or contacts. SCT provided the basis for seven trials focused on adolescents, of which five reported some effectiveness. Two others based on other social cognition models had favorable results with adolescents. Of six trials including adult women, five provided individual sessions. Some effect was seen in two using MI and one using the HBM. Two based on the Transtheoretical Model did not show any effect.

Authors' conclusions

Eight trials provided evidence of high or moderate quality. Family planning researchers and practitioners could adapt the effective interventions, although most provided group sessions for adolescents. Three were conducted outside the USA. Clinics and low-resource settings need high-quality evidence on changing behavior. Thorough use of single theories would help in identifying what works, as would better reporting on research design and intervention implementation.

Plain language summary

Improving birth control use with programs based on theory

Theories and models help explain how behavior change occurs. HIV-prevention research has used theories and models. Programs to prevent sexually transmitted infections (STIs) are often based on behavioral science. The health field has used many theories and models of change. However, programs that address birth control often have no stated theory base.

Through June 2013, we did computer searches to find randomized controlled trials that tested a theory-based program to improve birth control use. We also wrote to investigators to find other trials.

Trials tested a theory-based program for improving birth control use. We excluded trials focused on high-risk groups and programs to prevent sexually transmitted infections or HIV. Programs addressed the use of one or more birth control methods. The reports showed that the theory or model was part of the program design. The comparison could be another program based on theory, usual care, or no intervention.

The main outcomes were pregnancy, choice of birth control method, change in birth control use, and continuing to use birth control. We did not combine any trials since the programs differed from each other.

We added three new trials in this update for a total of 17 studies. Nearly all provided several sessions or contacts. Twelve trials had pregnancy or birth data and two had better results for a theory-based group. Of 12 trials with data on birth control use (non-condom), six showed better use in a treatment group. For condom use, a theory-based group had better results in 5 of 11 trials. Social cognitive theory was the basis for seven trials focused on teenagers, and five showed some effect. Two based on other social cognition models had good results with teens. Of six trials with women older than teens, five had individual sessions. Some effect was shown in two using motivational interviewing and one using the health belief model.

Eight trials were rated as having good quality. Researchers and health care providers could use the programs that worked in their settings. Most focused on teenagers and had group sessions. We need good research on preventing pregnancy for clinics and places with low resources. Clearer use of one theory would help in seeing what works. Better reporting would help in knowing how the research was done and the program was provided.

Background

Theories and models help explain how behavior change occurs. The intentional or explicit testing of theory in research helps expand the knowledge base (Johnston 2008). Theories and models have been used extensively in HIV research (Fishbein 2000; Albarracín 2005) and in interventions for preventing sexually transmitted infections (STI) (Aral 2007). However, many health education interventions, including those addressing contraceptive use, often have no explicit theoretical premise (Bellg 2004; Borrelli 2005). The lack of guiding theory or principles for an educational or psychological intervention is akin to having no physiologic basis for a medical intervention. Knowledge about the use and effectiveness of theory-based interventions could help inform contraceptive research and practice.

Behavioral theory has been used for more than 60 years to explain health behavior and guide interventions (Glanz 2002). Most of the commonly used theories and models in health behavior are based on a social cognition approach (de Wit 2004; Conner 2005). These include the Health Belief Model (HBM), Social Cognitive Theory (SCT), the Theory of Reasoned Action (TRA) along with the later Theory of Planned Behavior (TPB), and Protection Motivation Theory. Underlying many of the social cognition models is expectancy-value theory (de Wit 2004; Conner 2005). While individuals make subjective assessments of probability (expectancy) and value (utility), those assessments are combined in a rational way for decision-making. Such principles may not be sufficient to explain how individuals make decisions (Conner 2005).

One of the most widely used theories, the Health Belief Model, posits that individuals will take some action to prevent illness if they believe they are susceptible, if the consequences of the illness are severe, and if the benefits of action outweigh the costs (Janz 2002). Like the HBM, the Theory of Reasoned Action (Ajzen 1980; Terry 1993) and the Theory of Planned Behavior (Montaño 2002) assume a rational approach to engaging in new behaviors. However, they emphasize understanding attitudes toward the new health behavior rather than attitude towards the illness itself. The Theories of Reasoned Action and of Planned Behavior focus on behavioral intention as the best predictor of the behavior. The Social Cognitive Theory states that current behaviors, thoughts and emotions, and environment all interact to affect new behavior (Bandura 1986; Baranowski 2002). The SCT contributed the construct of self-efficacy, that is, confidence in one’s ability to undertake a specific behavior. Self-efficacy has been incorporated into several theories and is sometimes used on its own. Having drawn on several theories, the Transtheoretical Model (Prochaska 1992) and the AIDS Risk Reduction Model (Catania 1990) suggest that individuals move through different stages before they can maintain complex health behaviors. These models suggest that tailoring interventions could help individuals move from thinking about a new behavior, to trying it, and eventually to adherence. The Information-Motivation-Behavior Skills Model (Fisher 1992) and the Theory of Reasoned Action include methods for eliciting information on theoretical constructs. The approaches themselves, such as motivational interviewing, have also been the basis of behavioral interventions.

Theories and models should be developed and tested formally. Too often, the published reports of intervention research have insufficient information to assess the relevance of the intervention to the problem and the adequacy of implementation (intensity and duration). Mayo-Wilson 2007 proposed the expansion of CONSORT guidelines include more intervention information. Borrelli 2011 developed a tool to assess the fidelity of health behavior interventions in clinical trials. The framework was intended for assessing current trials and can be useful in reviewing educational interventions. Domains of treatment fidelity include having a curriculum or treatment manual, specifying training of providers, assessing delivery of intervention, and assessing participants' receipt of treatment and ability to use the treatment skills.

This review of theory-based interventions updates a 2011 version. Prior to our original review in 2008, theory-based interventions for contraception had not been systematically examined. Halpern 2011 studied strategies to improve adherence to hormonal contraceptive regimens. Of trials that tested strategies for communicating contraceptive effectiveness, none had an explicit theoretical base (Lopez 2013). For interventions to reduce unintended pregnancies among adolescents, DiCenso 2002 abstracted the theoretical basis, but not all the strategies addressed specific contraceptive methods. In addition, O'Connor 2003 discussed the need for learning what types of health care decision aids work better with certain groups of people, but did not address any theoretical basis. This review focuses on randomized controlled trials that tested a theoretical approach to improve contraceptive use.

Objectives

We systematically reviewed randomized controlled trials that tested a theoretical approach to inform contraceptive choice; encourage contraceptive use; or promote adherence to, or continuation of, a contraceptive regimen. We examined the effect of theory-based interventions on contraceptive use. The comparison could be a different theory-based intervention or an intervention without a theoretical base.

Methods

Criteria for considering studies for this review

Types of studies

We included randomized controlled trials (RCTs) that tested an intervention with a theoretical basis for improving contraceptive use for contraception. RCTs were individually randomized or cluster randomized. The use of theories or models had to be explicit, that is, the theory or model had to be named in the report. In addition, the intervention description should have had some evidence of incorporating the theoretical basis, e.g., the constructs used to develop a counseling program.

We excluded trials that focused on preventing sexually transmitted infections (STI) or HIV (human immunodeficiency virus) without also addressing pregnancy prevention. The motivation to prevent disease may differ from that to prevent pregnancy, and consequently, the types of theories and models used could also differ. We had included such studies in the initial review, but decided to focus on the original intent in the first update.

Types of participants

We included the women in the trials who were users or potential users of the contraceptive methods.  We excluded trials that focused on women who are HIV-positive or high-risk groups, such as sex workers or women with a known psychiatric or substance abuse disorder.

Types of interventions

The intervention had to address the use of one or more contraceptive methods for contraception. Any hormonal or non-hormonal contraceptive could have been studied, such as oral contraceptives or intrauterine devices. Theoretical basis included, but was not limited to, theories or models of education, communication, or behavior change. A theory-based intervention could be compared to a different theory-based intervention, an intervention without an explicit theoretical base, or usual practice. Studies were excluded if the intervention focused on abstinence or postponing sexual intercourse for adolescents.

Types of outcome measures

Primary outcomes

Included trials had to report at least one of the primary outcomes, as the review focuses on affecting contraceptive use:

  • pregnancy (test or self-report)

  • contraceptive choice

  • initiation of, or change in, contraceptive use

  • adherence to contraceptive regimen

  • contraceptive continuation.

Secondary outcomes
  • knowledge of contraceptive effectiveness

  • attitude about contraception in general or about a specific contraceptive method.

Search methods for identification of studies

Electronic searches

Through June 2013, we searched MEDLINE via PubMed, Cochrane Central Register of Controlled Trials (CENTRAL), POPLINE, and PsycINFO for trials that tested an intervention with a theoretical basis for addressing contraceptive use. In addition, we searched for recent clinical trials through ClinicalTrials.gov and ICTRP. The strategies are given in Appendix 1. Previous searches also included EMBASE. Earlier strategies are shown in Appendix 2.

Searching other resources

We examined reference lists of relevant articles. We also wrote to investigators for information about other published or unpublished trials not discovered in our search.

Data collection and analysis

Selection of studies

We assessed for inclusion all titles and abstracts identified during the literature searches with no language limitations. One author reviewed the search results and identified reports for inclusion or exclusion. A second author also examined the reports identified for appropriate categorization.

Data extraction and management

One author extracted the data and entered the information into RevMan. This includes the Characteristics of included studies and the outcome data (Data and analyses; Additional tables). Another author conducted a second data extraction and verified correct data entry. Any discrepancies were resolved by discussion.

We extracted the theoretical basis of the experimental intervention, which could be derived from, e.g., the fields of education, communication, or behavioral change. The use of theory or models had to be explicit, that is, the theory or model had to be named in the report. In addition, the intervention description should have had some evidence of the theoretical basis, e.g., what principles or constructs were used to develop a counseling session. The identified theoretical basis can be found in Table 3, along with the constructs or principles reportedly used in the intervention design and implementation.

Table 3. Theoretical basis
StudyTheory or modelPrinciples or constructs
Barnet 2009Transtheoretical model; motivational interviewing; social cognitive theory (parenting curriculum from Black 2006)stage of change, intentions, behavior; risk, motivation, change
Berenson 2012Health belief modelcues, perceived risk, impact (consequences), benefits of action
Black 2006Social cognitive theoryskills, cultural norms, goal-setting, self-efficacy, modeling, family support and mentoring relationships
Boyer 2005Information Motivation Behavioral Skills Modelknowledge, attitudes, skills (communication and condom use), risks, decisions
Cowan 2010Social learning theory
Program for out-of-school youth reportedly based on stages of change model.
School curriculum from Ross 2007; societal norms, self-belief, risk, skill development, social support
Coyle 2001Social cognitive theory, social influence theory; models of school changeknowledge, self-efficacy, communicate, perceived risks and barriers, perceived peer norms;
school organization, staff development, school environment, parent education
Coyle 2006Social cognitive theory, theory of reasoned action, and theory of planned behaviorknowledge, attitudes, norms, self-efficacy, sense of vulnerability, risk, skills
Floyd 2007Motivational interviewing; Transtheoretical modelclient-centered, decisional balance, readiness to change, goal statements and change plans, personalized feedback, problem-solving, commitment to change
Ingersoll 2005Motivational interviewingrisk behavior; exercises (decisional balance, development of goal statements and change plans); feedback using "elicit-provide-elicit strategy."
Kirby 2010Motivational interviewingcareful and nonjudgmental listening, summarizing, expressing empathy; perceived advantages and disadvantages of behavior change, behavioral expectancies, perceived barriers, reinforcement
Peipert 2008Transtheoretical model of behavior changestages of change (contemplation, preparation, action, maintenance); decisional balance, self-efficacy, change processes
Petersen 2007Motivational interviewingempathy, self-efficacy, perceived barriers, motivation, stage of adopting, improving communication
Ross 2007Social learning theoryknowledge and beliefs about risks and behaviors, perceived susceptibility, perceived benefits of safer behavior, self-efficacy, social support, skills acquisition
Schinke 1981Cognitive and behavioral training; problem-solving schema (reportedly from Goldfried & Goldfried)decisions, worth and payoff of options, planning, communicate, coach, feedback, contracting
Sieving 2013Social cognitive theory; resilience paradigm (Resnick, 2000)environmental (relationships, involvement, norms), personal (expectations), behavioral (skills)
Stanton 2004Protection Motivation Theorythreat appraisal: extrinsic and intrinsic rewards, perceived severity and vulnerability; coping appraisal: self-efficacy, response efficacy, response cost
Wight 2002Social cognitive theory plus health education principles used by teachersself-efficacy, intentions, behavior planning, normative influence, social and communication skills, gender norms, power

To assess intervention fidelity, we used a framework intended for assessing current trials (Borrelli 2011). The domains of treatment fidelity are identified as study design, training of providers, delivery of treatment (intervention), receipt of treatment, and enactment of treatment skills. We selected five criteria for our review that were relevant to completed, rather than ongoing, interventions:

  • Study design - had a curriculum or treatment manual;

  • Provider credentials - were specified in report;

  • Training - providers had standardized training for the intervention;

  • Delivery - assessed providers' adherence to the protocol;

  • Receipt - assessed participants' understanding and skills regarding the intervention.

We added intervention 'receipt' in 2013. Information on intervention fidelity was extracted from the primary articles and related design articles (Table 1).

Assessment of risk of bias in included studies

Studies were examined for methodological quality, according to recommended principles (Higgins 2011). Methodology considered included study design, randomization method, allocation concealment, blinding, and losses to follow up and early discontinuation. For individually randomized trials, adequate methods for allocation concealment include a centralized telephone system and the use of sequentially-numbered, opaque, sealed envelopes (Schulz 1995; Schulz 2002). In cluster randomized trials, clusters are usually randomized all at once, making allocation concealment less of an issue (Campbell 2012; Higgins 2011). However, selection bias may be introduced when individuals are approached for consent after the cluster has been randomized. In addition, high losses to follow up threaten validity (Strauss 2005). Limitations in design are presented in Risk of bias in included studies, and were considered when interpreting the results.

Measures of treatment effect

Outcomes listed in the Characteristics of included studies address the primary and secondary outcomes for this review. Trials reports may have included other outcomes of interest to the investigators. If a study had data collection at three or more follow-up visits, we used the first and last to measure short- and long-term changes.

For the dichotomous outcomes, the Mantel-Haenszel odds ratio (OR) with 95% CI was calculated using a fixed-effect model. An example is the proportion of women who initiated use of a particular contraceptive method. Analysis for cluster randomized trials is discussed below (Unit of analysis issues).

Unit of analysis issues

We included six cluster randomized trials for which the analysis appeared to account for the cluster effects (Coyle 2001; Wight 2002; Stanton 2004; Boyer 2005; Coyle 2006; Ross 2007).

Stanton 2004 reported the intraclass correlation coefficients for each outcome and the number of clusters. We calculated the design effects, and then effective sample sizes, according to the methods outlined in Higgins 2011, section 16.3.

The other cluster randomized trials used various methods of accounting for the clustering, such as multilevel modeling. The specific methods are given in the results for each trial. However, most reports did not provide sufficient information to calculate the effective sample size, so we did not analyze the data in this review. For those studies, we present the results as reported by the investigators.

Dealing with missing data

If reports were missing data needed for analysis, we wrote to the study investigators. Responses and any data provided are shown in Characteristics of included studies. We limited our data requests to studies less than 10 years old. Investigators are unlikely to have access to data for older studies.

Assessment of heterogeneity

We did not combine data from studies with different interventions. Therefore, we were not able to conduct any meta-analysis due to the variety of behavioral interventions. Heterogeneity is not an issue when a comparison has a single study.

Data synthesis

Following GRADE principles, we assessed the quality of evidence (Balshem 2011). When a meta-analysis is not viable due to varied interventions and outcome measures, a summary of findings table is not feasible. Therefore, we did not conduct a formal GRADE assessment, i.e., an evidence profile and summary of findings table (Guyatt 2011).

As noted earlier, we assessed each study for information on intervention fidelity. With the category for 'intervention receipt' added in 2013, the total possible 'score' was five. That sum is the number of criteria met by the study, according to information in the reports.

We summarized the quality of evidence for each study. In 2013, we added a category for randomization and allocation concealment. Quality could be high, moderate, low, or very low. RCTs were consider high quality then downgraded for each of the following: a) randomization sequence generation and allocation concealment: no information on either or one was inadequate; b) losses of 25% or more; c) all outcomes were self-reported; 4) intervention fidelity information was reported for three or fewer of our five categories.

Results

Description of studies

Results of the search

The 2013 search produced 589 citations: 540 references from the database searches, 5 from other sources, and 44 trials from searches of the clinical trials sites. Three new trials were included along with secondary articles from three previously included trials. We excluded nine studies after reviewing the full text. The remaining references were discarded after reviewing the titles and abstracts or trial summaries.

Included studies

Three new trials were included in 2013 (Berenson 2012; Cowan 2010; Sieving 2013) along with secondary articles from three previously included studies: Ingersoll 2005 (Ceperich & Ingersoll, 2011); Peipert 2008 (Peipert et al, 2011); Ross 2007 (Doyle et al, 2010). In addition, we included pregnancy data from Wight 2002 (Henderson et al, 2006) that came from health service records.

Of 17 trials, 10 randomly assigned individuals and 7 assigned groups (cluster randomized trials). Fourteen were conducted in the USA; the other three locations were Scotland (Wight 2002), Tanzania (Ross 2007), and Zimbabwe (Cowan 2010). Participants were generally recruited from primary care sites, family planning clinics, community-based organizations, and schools. The populations of focus included adolescents and adults; some studies focused on ethnic minorities.

Trial reports were published from 1999 to 2013, except for one from 1981. Sample sizes for the individually-randomized trials ranged from 36 to 1155. The cluster-randomized trials ranged from 817 to 9645 individuals, and the number of clusters ranged from 20 to 35. The effective sample sizes would be smaller due to the assignment of groups rather than individuals. Ten trials provided details on sample size calculations.

Sixteen trials provided multiple sessions or contacts with participants. Eight had group sessions, eight were focused on individuals, and one had both individual and group contact. Eleven studies targeted adolescents.

Intervention focus

The number of treatment contacts planned for each trial varied widely. Six studies had 1 to 7 sessions, five had 8 to 10, and six provided 14 or more sessions. Information on length of sessions can be found in the Characteristics of included studies. Follow up ranged from 1 to 36 months, but most often was 12 to 24 months. In addition, Ross 2007 conducted a cross-sectional survey at nine years.

Outcome measures available

Twelve trials assessed pregnancy or births. Eight of the 12 had objective measures: pregnancy test (Boyer 2005; Petersen 2007; Ross 2007; Peipert 2008; Cowan 2010), observation of a second child (Black 2006), or record review (Barnet 2009; Berenson 2012). The other three trials used self-report of pregnancy (Stanton 2004; Coyle 2006; Kirby 2010). One had self-reported pregnancy in the original report (Wight 2002), but a later article (Henderson et al, 2006) reported analysis data from national records on conceptions and abortions by age 20.

The other outcomes assessed included use of non-condom contraceptives (12 trials), condom use (11 trials), and dual-method use (3 trials).

Excluded studies

Reasons for excluding trials were the following:

  • Focused on

    • preventing STI or HIV without contraception component

    • high-risk group

  • Had no explicit theoretical base

  • Assignment was

    • not random

    • random by group (e.g., school classes) but the analysis did not appear to account for clustering effects.

  • Had no primary outcome for this review or outcome was not reported for both study arms.

In 2013, nine trials were excluded (Bachanas 2012; Brown 2011; Carneiro 2011; Ferrer 2011; Garbers 2012; Ingersoll 2013; Langston 2010; Lee 2011; Vogt 2012). Reasons are provided in Characteristics of excluded studies.

When we re-focused on contraception in 2010, 14 of the original trials were excluded due to focusing on STI or HIV prevention (Boekeloo 1999; DiClemente 2004; DiIorio 2006; Hoffman 2003; Jemmott 2005; Jemmott 2007; Kalichman 1999; Kiene 2006; Morrison-Beedy 2005; Peragallo 2005; Roye 2007; Shain 1999; Stanton 1996; Villarruel 2006).

Risk of bias in included studies

Allocation

Of the 17 included trials, 12 provided varying amounts of information on the randomization process, such as 'computer-generated' or the use of permuted blocks. For Cowan 2010, the design was changed to a cross-sectional survey due to out-migration of the cohort. Two provided no information on the randomization sequence generation (Ingersoll 2005; Schinke 1981). Five trials mentioned stratification (Black 2006; Ross 2007; Peipert 2008; Cowan 2010; Kirby 2010).

Of the 10 individually randomized trials, four reports mentioned allocation concealment of which three provided some detail (Ingersoll 2005; Floyd 2007; Petersen 2007), such as the use of sealed envelopes. Only Floyd 2007 had sufficient information to determine that concealment was adequate. Peipert 2008 referred to concealment but the information was limited. In addition, the investigator for Sieving 2013 communicated that they did not use any allocation concealment.

The cluster randomized trials identified the clusters prior to randomization; all individuals meeting the inclusion criteria were eligible. Allocation concealment was considered unclear if the report did not indicate whether the recruiters of individuals or the potential participants were aware of the cluster allocation prior to the consent process.

Blinding

Blinding was mentioned in six trials. The assessors or interviewers were masked to the participant's assignment (Schinke 1981; Wight 2002; Floyd 2007; Peipert 2008; Kirby 2010; Berenson 2012). No mention of blinding was found for nine trials. Double-blinding is often not feasible for participants or providers in educational interventions, but the assessors could have been blinded to study arm.

Incomplete outcome data

Losses to follow up were 25% or more for 10 trials by their last follow up. For five of those studies, losses were greater than 30%. The trials with high losses were Wight 2002 (31%), Stanton 2004 (40%), Boyer 2005 (38% to 55%), Coyle 2006 (44%), Floyd 2007 (29%), Ross 2007 (27%), Peipert 2008 (26%), Kirby 2010 (25%); Berenson 2012 (44%). High losses to follow up threaten validity (Strauss 2005).

For Cowan 2010, an interim survey showed nearly half of the cohort had migrated out of the area. Those remaining were determined to be lower risk. The investigators, with the data and safety monitoring board, changed the design to a cross-sectional survey.

Differential losses between treatment and control groups did not appear to be a major factor. Most trials had similar losses across treatment arms, and one reported the losses did not differ significantly. However, one trial did not provide information about losses by study group, yet had some positive results for the treatment group (Coyle 2001).

Selective reporting

In Black 2006, contraceptive use was presented by second birth rather than by randomized group. The authors presented combined percentages, but claimed there were no differences by second birth or not. However, mothers who did not have a second infant were slightly more likely to plan to use contraceptive at next sex.

Effects of interventions

The results are grouped according to the type of theory or model that guided the experimental intervention (Table 3). While several studies used the same theoretical basis for their experimental interventions, the actual programs differed in structure and emphasis, as noted in the Description of studies.

Social Cognitive Theory (SCT)

Seven trials were based on Social Cognitive Theory (Bandura 1986), two of which also included another theory or model.

Primarily based on SCT

The five trials based on Social Cognitive Theory examined a theory-based intervention versus usual care (or program). Two were individually randomized:

  • In Black 2006, the intervention group had multiple contacts over two years. The adolescents in the treatment group were less likely to have had a second birth within two years than the usual care group (OR 0.41; 95% CI 0.17 to 1.00) (Analysis 1.1). Second births were assessed during home visits.

  • For Sieving 2013, the 18-month intervention involved case management as well as a peer-leadership program. Principles of social connectedness were apparent, but no relevant guiding theory was mentioned. The investigators adjusted for baseline values and within-clinic similarities. As shown in Table 4, compared to the control group at 24 months, the intervention group was more likely to consistently use the following: condoms (reported relative risk 1.57; 95% CI 1.28 to 1.94); hormonal contraceptives (reported relative risk 1.30; 95% CI 1.06 to 1.58); and dual methods (OC and condoms) (reported relative risk 1.36; 95% CI 1.01 to 1.85). Similar effects were reported for the 12-month interim assessment (Table 4). The study groups were not significantly different for the attitude item.

    Table 4. Reduce pregnancy risk (Sieving 2013): case management + peer leadership versus usual clinic services
    1. 1Model adjusted for baseline measure and within-clinic similarities. Contraceptive use outcomes also adjusted for same sexual partner at baseline and 24 months; # months had sex with most recent partner.
      2Results as reported by researchers; insufficient data for analysis in this review.

    Outcome1,2TimeframeInterventionControlMeasure (95% CI)
    Adjusted mean scoreAdjusted relative risk
    Consistency of useCondoms12 months0.960.661.45 (1.26 to 1.67)
    24 months1.530.931.57 (1.28 to 1.94)
    Hormonal contraceptive12 months4.272.911.46 (1.13 to 1.89)
    24 months3.292.341.30 (1.06 to 1.58)
    Dual methods (hormonal + condoms)12 months0.830.531.58 (1.03 to 2.43)
    24 months0.650.421.36 (1.01 to 1.85)
     Adjusted %Adjusted OR
    AttitudeDesire to use contraception with partner
    (1 item)
    12 months64.553.61.62 (0.81 to 3.27)
    24 months51.144.31.17 (0.77 to 1.77)

Three cluster randomized trials used school-based curricula; two also had community-level activities:

  • Wight 2002 was based on social learning theory, but also incorporated methods that teachers were already using, to enhance acceptability. To account for the cluster effects in the analysis, the investigators used a randomization test based on the set of the 20,000 possible allocations providing the best balance of school level measures from which the final allocation was selected. Within gender, the study groups were not significantly for the outcomes of first intercourse without condom use, no condom use during last intercourse, use of oral contraception during last intercourse, and self-reported pregnancy (Table 5). Pregnancies by age 20, 4.5 years after the intervention, were examined by linking records from the National Health Service. The data included live births, stillbirths, abortions, and miscarriages. The investigators reported the groups did not differ significantly in conceptions or abortions (Table 5).

    Table 5. Sex education (Wight 2002): social-cognitive curriculum versus usual education
    1. 1Cluster randomized trial accounted for the cluster effects. Researchers used a randomization test based on the set of the 20,000 possible allocations providing the best balance.
      2Results as reported by researchers; insufficient data for analysis in this review.
      3CI of difference between arms from restricted randomization test, except for unwanted pregnancy (from random effects logistic regression adjusted for baseline characteristics).
      4From linked National Health Service records (Henderson et al, 2006). 'Any' abortion or conception reported due to some women having > 1. Conception includes live births, stillbirths, miscarriages, abortions.
      5Adjusted for school socioeconomic measure and individual measures of school leaver and social class.

    Outcome at 6 months1,2GenderIntervention
    (%)
    Control
    (%)
    Difference (95% CI)3
    Unwanted pregnancy (self-report)females4.03.81.0 (0.6 to 1.8)
    Oral contraception during last sexmales18.721.2-2.5 (-8.0 to 2.9)
    females30.428.02.4 (-4.1 to 8.9)
    First sex without condom after first yearmales5.25.7-0.5 (-2.5 to 1.5)
    females9.79.10.6 (-1.9 to 3.1)
    No condom during last sexmales33.634.9-1.3 (-5.9 to 3.3)
    females44.944.00.9 (-5.7 to 7.4)
    Outcome at 4.5 years (by age 20)1,2,4(rate/1000)(rate/1000)Difference (95% CI)5
    Abortionfemales126.6112.015.7 (-10.7 to 42.1)
    Conceptionfemales300.2273.831.9 (-16.1 to 79.9)
    Any abortionfemales108.9104.35.6 (-16.0 to 27.2)
    Any conceptionfemales222.6216.89.7 (-21.8 to 41.2)
  • Ross 2007

    • The intervention was primarily based on social cognitive theory. A random-effects model was used to account for the cluster effects in the analysis. At three years, the treatment group was more likely than the control group to first use a condom during follow up within the males (reported risk ratio 1.41; 95% CI 1.15 to 1.73) and the females (reported risk ratio 1.30; 95% CI 1.03 to 1.63) (Table 6). Condom use during last intercourse was more frequent for the intervention versus control males (reported risk ratio 1.47; 95% CI 1.12 to 1.93) but did not differ significantly for female groups. Pregnancy (tested or self-reported) did not differ significantly for the study arms. However, the secondary outcome, knowledge of pregnancy prevention, was greater for the treatment group than the control group among both males (reported risk ratio 1.66; 95% CI 1.55 to 1.78) and females (reported risk ratio 1.58; 95% CI 1.26 to 1.99).

      Table 6. Preventing HIV, STI, and pregnancy (Ross 2007): multi-component, sexual health intervention versus usual sex education activities
      1. 1Cluster randomized trial accounted for the cluster effects by using a random-effects model.
        2Results as reported by researchers; insufficient data for analysis in this review
        3Rate ratio adjusted for age group, stratum, tribe, and number of lifetime partners at baseline.

      Outcome at 3 years1,2GenderIntervention
      %
      Comparison
      %
      Adjusted
      rate ratio3 (95% CI)
      Pregnancy prevalence (tested)females19.218.01.09 (0.85 to 1.40)
      Pregnancy (self-report)females46.945.51.03 (0.89 to 1.20)
      Condom first used during follow upmales39281.41 (1.15 to 1.73)
      females38281.30 (1.03 to 1.63)
      Condom use during last sexmales29201.47 (1.12 to 1.93)
      females27221.12 (0.85 to 1.48)
      Knowledge of pregnancy prevention
      (composite of 3 questions)
      males84501.66 (1.55 to 1.78)
      females72461.58 (1.26 to 1.99)
    • A secondary paper presented data collected nine years after the intervention began (Doyle et al, 2011). Participants in the cross-sectional survey attended trial schools during the intervention period. From the adjusted models, the comparison groups were reportedly not significantly different for self-reported pregnancy, use of modern contraceptive, or condom use at last sex (Table 7). However, females from the intervention communities were reportedly more likely to have used a condom at last sex with a non-regular partner (reported prevalence ratio 1.34; 95% CI 1.07 to 1.69). For both males and females, knowledge of pregnancy prevention was more common among those from the intervention communities. The reported prevalence ratio for males was 1.19 (95% CI 1.12 to 1.26) and for females it was 1.17 (95% CI 1.06 to 1.30).

      Table 7. Preventing HIV, STI, and pregnancy (Ross 2007 (Doyle 2010)): multi-component, sexual health intervention versus usual sex education activities
      1. 1Data reportedly analyzed for stratified cluster-randomized trial. Survey participants attended trial schools during the intervention period (Doyle et al, 2010).
        2Results as reported by researchers; insufficient data for analysis in this review
        3Adjusted for age group, stratum, ethnic group.

      Cross-sectional survey at 9 years1,2GenderInterventionComparisonAdjusted prevalence
      ratio3 (95% CI)
      CategoryVariable
      Pregnancy (self-report) (%)> 2 lifetimefemale18190.96 (0.80 to 1.15)
      in primary schoolfemale331.16 (0.68 to 1.97)
      >= 1 unplannedfemale25241.03 (0.83 to 1.26)
      Use of modern contraceptive (%)evermales59551.09 (0.94 to 1.26)
      females48421.11 (0.95 to 1.30)
      last sexmales35291.21 (0.92 to 1.58)
      females22181.16 (0.91 to 1.47)
      Condom use in past 12 months (%)last sexmales34291.19 (0.91 to 1.54)
      females19151.27 (0.97 to 1.67)
      last sex with
      non-regular partner
      males50441.15 (0.97 to 1.36)
      females45311.34 (1.07 to 1.69)
      Knowledge of pregnancy prevention (%)
      (3 questions correct)
      males83691.19 (1.12 to 1.26)
      females71601.17 (1.06 to 1.30)
  • Cowan 2010 used social cognitive theory as the intervention basis. The study design was changed due to out-migration of the cohort. The investigators conducted a cross-sectional survey at four years rather than a cohort study. To adjust for clustering, generalized estimating equations were used with robust standard errors. The comparison groups reportedly did not differ significantly for pregnancy prevalence, reported unintended pregnancy, no condom use at last sex, and no pregnancy prevention with last partner (Table 8).

    Table 8. Preventing HIV, HSV-2, and pregnancy (Cowan 2010): multi-component intervention versus deferred intervention
    1. 1Cluster randomized trial accounted for the cluster effects. Investigators used generalized estimating equations
      with robust standard errors.
      2Results as reported by researchers; insufficient data for analysis in this review
      3Adjusted for age, strata, marital status, and education.
      4Attended trial school and lived in trial community for duration of intervention (40% of survey respondents).

    Outcomes at 4 years1,2Intervention
    %
    Comparison
    %
    Adjusted
    OR3 (95% CI)
    Pregnancy prevalence7.78.10.92 (0.70 to 1.19)
    Reported unintended pregnancy13.013.80.88 (0.69 to 1.12)
    No condom use at last sex41.240.10.93 (0.72 to 1.20)
    No pregnancy prevention with last partner54.153.01.04 (0.77 to 1.40)
    Subgroup analysis4
    Pregnancy prevalence5.35.90.83 (0.50 to 1.35)
SCT plus another theory or model

The interventions in two trials were based on social cognitive theory plus another theory or model:

  • The intervention in Coyle 2001 addressed prevention of HIV, STI, and pregnancy. The school-based curriculum incorporated social cognitive theory, social influence theory, and models of school change. The comparison group received the standard curriculum addressing the same issues. This cluster randomized trial accounted for the cluster effects in the analysis by using multilevel models. At the 7- and 31-month assessments, the intervention group reportedly had a lower frequency of sex without condom use in the past three months compared to the usual-program group (Table 9). The reported effect sizes (ES) were 0.50 and 0.63 (SE 0.23), respectively. Standard errors (SE) were only reported for the 31-month assessment. Further, the intervention group was reportedly more likely than the comparison group to have used a condom during last intercourse (reported ES 1.91 and 1.68 (SE 0.25)) and to have used an effective method of contraception (reported ES 1.62 and 1.76 (SE 0.29)). For the secondary outcomes, the intervention group had a higher mean for positive attitudes about condoms (reported ES 0.10 and 0.07 (SE 0.02) and a lower mean for barriers to condom use (reported ES -0.12 and -0.11 (SE 0.04)) (Table 9).

    Table 9. Preventing pregnancy, HIV, and STI (Coyle 2001): social-cognitive (+ other theories) curriculum versus usual education
    1. 1Cluster randomized trial accounted for the cluster effects by using multilevel models. Levels were measurement occasion, student, and school. Models included predictor variables, such as baseline responses on outcome, intervention group, geographic area, and 'outcome specific covariates.'
      2Results as reported by researchers; insufficient data for analysis in this review
      3Estimated from odds ratios for dichotomous outcomes or ratios of adjusted means (standard errors were only reported for 31-month assessment).
      * P <= 0.05 for both assessments reported by researchers.

    Outcome1,2Estimate effect size3
    7 months31 months
    Effective method of pregnancy prevention at last sex*1.621.76 (0.29)
    Frequency of sex without condom in past 3 months*0.500.63 (0.23)
    Condom use at first sex (initiators)0.681.44 (0.27)
    Condom use at last sex*1.911.68 (0.25)
    Attitudes toward condoms*0.100.07 (0.02)
    Barriers to condom use*-0.12-0.11 (0.04)
  • Coyle 2006 also focused on prevention of HIV, STI, and pregnancy. The school-based curriculum was based on Social Cognitive Theory and the Theory of Reasoned Action, as well as the related Theory of Planned Behavior. The intervention group was compared to a group receiving the usual prevention activities for HIV, STI, and pregnancy. This cluster randomized trial accounted for the cluster effects in the analysis by using multilevel models. At the six-month assessment, the intervention group had a lower frequency of sex without a condom in the past three months than the comparison group (reported mean difference (MD) -1.09 (SE 0.36), and was more likely to have used a condom during last intercourse (reported OR 2.12; 95% CI 1.24 to 3.56) (Table 10). At 18 months, the groups reportedly did not differ significantly for those outcomes, for reported pregnancy, or for effective method of pregnancy prevention at last sex (Table 10).

    Table 10. Preventing HIV, STI, and pregnancy (Coyle 2006): social-cognitive (+ other theories) curriculum versus usual activities
    1. 1Cluster randomized trial accounted for the cluster effects by using multilevel models. Levels were student and school; psychosocial outcomes also had survey measurement occasion. Predictor variables in the models were baseline responses on outcome, intervention group, and “outcome specific covariates.”
      2Results as reported by researchers; insufficient data for analysis in this review
      3SE = standard error
      *P < 0.05; reported by researchers

    Outcome1,2Group estimate
    6 months18 months
    OR (95% CI)Mean difference
    (SE)3
    OR (95% CI)Mean difference
    (SE)
    Reported pregnancy since baseline0.61 (0.33 to 1.12)---0.84 (---)---
    Effective method of pregnancy prevention at last sex1.15 (0.78 to 1.70)---0.77 (0.49 to 1.23)---
    Frequency of sex without condom
    in past 3 months
    ----1.09 (0.36)*---0.38 (0.39)
    Condom use at last sex2.12 (1.24 to 3.56)*---1.00 (0.49 to 2.02)---
    General attitudes toward condoms---0.086 (0.061)----0.044 (0.066)

Other social cognition models

Two trials were based on social cognition models (de Wit 2004; Conner 2005) other than Social Cognitive Theory:

  • The pregnancy prevention program of Schinke 1981 was based on cognitive and behavioral training, and used the problem-solving schema of Goldfried 1980. Contact included 14 sessions of 50 minutes each. The controls only had the assessments. The report provided results of t-tests. Details were not requested due to the age of the publication. Compared to the controls at the six-month follow up, the students who received the training reportedly used 'more habitual contraception' (reported t(32) = 2.38; P < 0.05), had 'greater protection at last intercourse' (reported t(32) = 3.26; P < 0.005), and had 'less reliance on inadequate birth control' (reported t(32) = 4.35; P < 0.001).

  • Stanton 2004 was based on Protection Motivation Theory (Rogers 1983), which includes components of the Health Belief Model as well as self-efficacy (Conner 2005). The study was cluster randomized trials that provided multiple intervention sessions. The three study groups were as follows: 1) an eight-week youth intervention (Y); 2) the youth program and a short parent program (Y+P); or 3) the youth and parent interventions plus booster sessions for the youth program (Y+P+B). We calculated the design effects and then the effective sample sizes with the intraclass correlation coefficients for each outcome and the number of clusters provided in the report. At the 24-month follow up, the Y+P group was less likely than the Y group to self-report having been pregnant or gotten someone pregnant (OR 0.24; 95% CI 0.10 to 0.56) (Analysis 2.1), as was the Y+P compared to the Y+P+B (OR 0.27; 95% CI 0.11 to 0.66) (Analysis 2.1). In contrast, the groups did not differ significantly in the proportions who self-reported use of contraception or condom during last sex.

Information-Motivation-Behavioral Skills Model (IMB) or motivational interviewing

IMB model

Boyer 2005 used the IMB model to address preventing STIs and unplanned pregnancy. Four group sessions were provided. This cluster randomized trial accounted for the cluster effects in the analysis; the investigators calculated robust standard errors using the Huber-White sandwich estimator in regression models assessing intervention effectiveness. No significant differences were found between the study groups in unplanned pregnancy (tested) or inconsistent condom use by 14 months (Table 11).

Table 11. Pregnancy and STI prevention (Boyer 2005): group risk reduction versus group health promotion
  1. 1Cluster randomized trial accounted for the cluster effects. Investigators calculated robust standard errors using the Huber-White sandwich estimator in regression models. Independent variables were intervention group, sexual history, and time between assessments.
    2Results as reported by researchers; insufficient data for analysis in this review

Outcome at 14 months1,2Experimental
%
Control
%
Unplanned pregnancy (tested)6.77.3
Inconsistent condom use72.876.5
Motivational interviewing

Four studies were based primarily on motivational interviewing (MI) (Miller 1991; Miller 2002):

    • Ingersoll 2005 had a single session lasting about an hour. The control group received a pamphlet on women's health. A secondary paper provided results for the four-month follow up as well as additional intervention information (Ceperich & Ingersoll, 2011). The treatment group was less likely than the control group to report using ineffective contraception at one month (OR 0.49; 95% CI 0.28 to 0.87) and at four months (OR 0.56; 95% CI 0.31 to 0.98) (Analysis 3.1).

    • Floyd 2007 incorporated elements of the Stages of Change into multiple sessions. The control group received pamphlets on alcohol use and women's health. The intervention group was more likely than the control to have used effective contraception during the three months prior to the follow-up interviews at three months (OR 2.12; 95% CI 1.53 to 2.92) (Analysis 3.2) and nine months (OR 2.04; 95% CI 1.47 to 2.83) (Analysis 3.2).

  • Petersen 2007 addressed prevention of pregnancy and STI with motivational interviewing in two sessions. The comparison group received brief general counseling on women's health. The primary outcome was improving level of contraceptive use or maintaining a high level of contraceptive use. The groups were not significantly different in contraceptive use at the 2-month and 12-month follow-up visits (Analysis 4.1). Pregnancy (tested) was not significantly different for the two groups at 12 months, either (Analysis 4.2).

  • The intervention in Kirby 2010 used motivational interviewing via phone calls to improve contraceptive use. Nine calls could be provided in 12 months: monthly for the first 6 months and then every other month. The comparison group had usual care from the reproductive health clinic, which only made calls to report abnormal results or respond to patients' inquiries. Outcomes included condom use and hormonal contraceptive use, pregnancy (self-report), and correct contraceptive use. Only 30% of calls were completed (mean of 2.7 per participant). Reportedly, the intervention and control groups did not differ significantly for the reported percentages that used condom at last sex: 53% and 60% respectively at 6 months; 58% and 55% respectively at 18 months (Table 12). The figures for hormonal contraceptives used at last sex were 44% for both groups at 6 months and 43% and 42% respectively at 18 months (Table 12). The investigators provided additional results. The original analysis involved multiple linear and logistic regression repeated measures, and included adjustments for differences between groups. Self-reported pregnancy did not differ significantly for the two groups at study end (27% treatment and 23% control), according to the investigators. Pregnancy rates from clinic charts were much lower, as participants did not necessarily use one clinic.

    Table 12. Improving contraceptive use (Kirby 2010): motivational phone calls versus usual care
    1. 1Results as reported by researchers; insufficient data for analysis in this review

    Outcome16 months18 months
    Intervention
    %
    Control
    %
    Intervention
    %
    Control
    %
    Pregnancy (self-report)------2723
    Used hormonal contraceptive
    at last sex
    44444342
    Used condom at last sex53605855
    Used condom or hormonal
    contraceptive at last sex
    82847978

Transtheoretical model

The interventions in two trials incorporated the Transtheoretical model.

  • For Peipert 2008, a tailored intervention based on the Transtheoretical model was compared with enhanced standard care. The computer-delivered intervention had three tailored sessions for the experimental group and one non-tailored session for the comparison group. At 24 months, the groups were not significantly different for any dual-method use (Analysis 5.1), consistent condom use (Analysis 5.2), or unplanned pregnancy (tested) (Analysis 5.3). The investigators had reported differences between the groups after adjusting for a propensity score that included covariates and two-way interactions. A secondary paper examined dual-method use with adjusted analyses (Peipert et al, 2011). By 24 months, the intervention group was no more likely than the comparison group to have initiated or sustained dual-method use (Table 13).

    Table 13. Preventing pregnancy and STI (Peipert 2008): computer-delivered; tailored versus non-tailored intervention
    1. 1Results as reported by researchers; insufficient data for analysis in this review.
      2Adjusted for education, substance use, contraceptive use at baseline, stages of change.
      3Reported at >= 2 follow-up interviews (Peipert et al, 2011).

    Outcome at 2 years1Intervention
    %
    Comparison
    %
    Adjusted relative
    risk2 (95% CI)
    Dual-method useinitiated82681.52 (0.96 to 2.41)
    sustained319240.89 (0.45 to 1.75)
  • Barnet 2009 used several theories or models. The computer-assisted motivational intervention (CAMI) was based on the Transtheoretical model (stages of change) (Prochaska 2005). The CAMI software used participants' responses to sexual and risk behavior questions to determine their stage of change. Then CAMI counselors used motivational interviewing for contraception counseling, which was matched to the participant's stage of change. Social Cognitive Theory was the basis of the parenting curriculum from Black 2006, which included contraception and was provided to the CAMI+ group. The groups were not significantly different for repeat births by 24 months from index birth (Analysis 6.1). Births were assessed through Vital Statistics; 100% of the index births were located. Abortion information was obtained at the follow-up interview. According to the investigators, the percentages for reported abortions did not differ significantly across the groups: CAMI+ 22%, CAMI-only 20%, and usual care 21%.

Health belief model

The intervention in Berenson 2012 was based on the health belief model. Individuals were assigned to special counseling about OCs plus follow-up phone calls (C+P), special clinic counseling about OC use, or usual clinic services. At 3 months, but not 12 months, the group with special counseling plus phone calls (C+P) was more likely than the special counseling group to report consistent OC use (OR 1.41; 95% CI 1.06 to 1.87) (Analysis 7.1) as well as condom use at last sex for inconsistent condom users (OR 1.45; 95% CI 1.03 to 2.03) (Analysis 7.5). Also at 3 months but not 12, women in the C+P group were more likely to report they would recommend OC use to a friend (OR 1.52; 95% CI 1.11 to 2.09). The group with counseling but no phone calls did not differ significantly from the group with standard care for any outcome. In addition, the study groups did not differ significantly for reported use of dual methods or for pregnancy (from medical records). When the investigators adjusted for age and race or ethnicity, the C+P group was reportedly more likely to report condom use at last sex (data not shown here). No other significant differences were reportedly found in those analyses.

Discussion

Summary of main results

Outcome group

The outcomes were summarized and sorted by theoretical base and evidence quality (Table 14).

Table 14. Outcome summary by theory base and evidence quality
  1. 1>= 50% of comparisons
    2From Table 2
    3 Information Motivation Behavioral Skills model
    4nd = no significant difference between study groups

StudyPregnancies
or births
Contraceptive use
(non-condom)
Condom use1Dual-method
use
Evidence of
intervention
effect
Evidence quality2
Motivational interviewing or IMB3
Petersen 2007ndnd--- ---High
Ingersoll 2005---Better------xModerate
Boyer 2005 3nd---nd------Low
Floyd 2007---Better------xLow
Kirby 2010nd4ndnd------Low
Social cognitive theory
Black 2006Fewer---------xHigh
Coyle 2001---BetterBetter---xModerate
Ross 2007nd---Better---xModerate
Wight 2002ndndnd------Moderate
Sieving 2013---BetterBetterBetterxLow
Cowan 2010ndndnd------Low
Coyle 2006ndndBetter---xLow
Other social cognition
Schinke 1981---Better------xVery low
Stanton 2004Fewerndnd---xVery low
Transtheoretical model
Barnet 2009nd------------High
Peipert 2008nd---ndnd---Moderate
Health belief model
Berenson 2012ndBetterBetterndxLow
  • Pregnancies or births: Two of 12 trials showed lower rates within the intervention group compared to the control group. Data came from observed second births in one trial and from self-reported pregnancies in the other study. The two trials had different theoretical bases and served different populations.

  • Contraceptive use (other than condoms): Six of the 12 trials with contraceptive use data showed more or better self-reported use in the intervention group than in a comparison group. The six trials had four different theoretical bases and served various populations. Further, three interventions were individually-focused and three were group interventions.

  • Condom use: Of 11 studies, five showed some positive results for an intervention group. Of the five, four were based on social cognitive theory and the fifth on the health belief model.

  • Dual-method use: The three studies did not show any significant difference between the study groups. They had different theoretical bases.

Theoretical basis for intervention

Motivational interviewing provided the basis for the interventions in four trials while a fifth was based on the actual Information-Motivation-Behavioral Skills (IMB) model. Two of the five showed a significant difference for relatively short time frames. Compared to a group with minimal information, the motivational interview group described less 'ineffective contraception' in Ingersoll 2005 and more 'effective contraception' in Floyd 2007. The study groups were not significantly different for the outcomes in the trial based on the IMB model.

Of seven trials based on Social Cognitive theory, five had some positive results for the experimental group. Compared to the usual care group, the treatment group had fewer second births (Black 2006), better contraceptive use (non-condom) (Coyle 2001; Sieving 2013), more reported condom use (Coyle 2001; Coyle 2006; Ross 2007; Sieving 2013), and more use of dual methods (Sieving 2013).

Two trials based on other social cognition models had some positive results. Compared to the usual care group, the treatment group in Schinke 1981 had more contraceptive use (non-condom). Stanton 2004 compared variations of a theory-based intervention. Fewer pregnancies were reported for youth and parent programs than for the youth program alone or for a combined program with booster sessions. The groups did not differ significantly in reported use of contraception or condoms. The interventions differed in theory base, settings, and target populations.

The two trials using the Transtheoretical model did not show any significant differences between the groups. One also included motivational interviewing and social cognitive theory.

The intervention for one study was based on the Health Belief Model (Berenson 2012). The enhanced intervention group was more likely to report consistent OC use and condom use in the short-term.

Overall completeness and applicability of evidence

Nearly half of the trials were conducted in community settings, schools, or both. The others were conducted in clinic settings. Most trials included pregnancy prevention as an objective and the majority focused on contraceptive use (non-condom). Of 17 trials, 16 provided multiple sessions or contacts. Only three trials took place outside the USA.

Eleven trials focused on adolescents; seven showed some evidence of effectiveness and were based on social cognitive theory or other social cognitive models. Five of those seven trials provided group sessions. The six studies that included other than adolescents had one to seven contacts. Five provided individual sessions, of which three showed some effect. Contraceptive investigators and health care providers might consider using the effective interventions most pertinent to their environment.

Applicability of the successful interventions to traditional contraceptive counseling may be limited. The shortest intervention was a single session of 60 to 75 minutes. Contraceptive counseling typically focuses on individual women. Contact time might be a few minutes within a clinic visit or a separate session of 10 to 15 minutes. In such situations, expectations for behavior change should be limited.

As noted earlier, theories and models have been used extensively in HIV and STI research. Comparable high-quality research on behavior change has been limited for reproductive health. A USA study explored attitudes and beliefs of clinicians about reproductive counseling. In-depth interviews indicated that most of the clinicians believed they influenced their patients through their medical authority and the presentation of information (Henderson 2011). The investigators noted that views were not consistent with current thinking about behavior change and patient-centered counseling. Effective interventions are needed, including some that can be adapted to clinical settings.

Quality of the evidence

The quality of evidence is based on the evidence from the included studies. Of 17 trials, eight provided evidence of high or moderate quality according to the criteria we used (Table 14), and were distributed across the various theory groups. Of the 10 trials with effective interventions, four were high or moderate quality. As noted earlier, losses to follow up were high in 10 trials, but the study arms had similar losses (Incomplete outcome data). Losses may be more likely with a focus on adolescents and a relatively long follow-up period.

Many reports did not provide sufficient information to fully assess trial quality, as design information was lacking. Within the studies with a priori sample size estimations, sample size was sufficient to detect differences in behavior. However, eight studies did not report a priori calculations. One individually randomized trial was reportedly powered to detect a difference in pregnancy.

The primary outcomes for our review were generally self-reported (contraceptive use). Because of social desirability and other types of information bias, self-reports are not the most reliable indicators of behavior. Pregnancy rates are preferable to self-reports, especially if the incidence is likely to be high enough to detect differences between groups. Seven trials used objective means to assess pregnancies: four conducted pregnancy tests, one observed the presence of second births, and two checked records for relevant births. Some types of contraceptive use can be assessed more objectively in clinical trials, e.g., on-time injections or electronic pill counts. However, such methods are less feasible when the intervention is a program rather than a drug or device; the participants may be using a wide range of contraceptives.

All studies provided information on the fidelity of implementation; we used five criteria from Borrelli 2011 that were relevant to completed interventions. The type and amount of information reported varied (Table 1). Thirteen trials met at least four of the five criteria we used.

Effectiveness may be limited when the theory or model is partially implemented. Some trials appeared to use parts of theories or models, i.e., specific principles or constructs, rather than the full theory. When trials combined models, we could not always determine what parts were used and what may have worked. For some trials, the emphasis was likely on the intervention rather than a particular theory or model, as most theories had been examined previously. We required the intervention to have evidence of incorporating constructs or principles from the theory or model. However, we could not always discern whether the theory drove the intervention development or if a theory or model were chosen to complement an intervention idea. The information was not sufficient in most cases to assess theory implementation, which might have been due to journal policy and space limitations.

Potential biases in the review process

We identified the primary theoretical basis and grouped the results accordingly. Other researchers may have synthesized the results differently. In addition, the main social cognition models have considerable overlap in their principles and constructs (Conner 2005). Rather than adding or modifying individual theories, a cumulative scientific approach could benefit the health behavior field (Johnston 2008) and may lead to an integrated model of health behavior (Conner 2005).

For some trials, certain intervention components may have been emphasized rather than the overall theory. Further inquiries to the investigators and review of intervention materials might have provided more information for analysis and interpretation. However, a full assessment of theory implementation was beyond the scope of this review. Response rates to inquiries for such information vary, as does the quantity and quality of information provided.

Authors' conclusions

Implications for practice

Interventions with a theoretical base help explain behavior change. Usual counseling often focuses on information transfer rather than how people learn, think, and behave. Nearly all the programs here provided multiple sessions or contacts. Half of those addressing contraceptive use (other than condoms) showed some effect. Those studies used several different theories: motivational interviewing (MI), SCT, other social cognition models, and the Health Belief Model (HBM). Seven trials were based on social cognitive theory (SCT) and most provided group sessions for adolescents; five had favorable results. Five studies that included adult women provided individual counseling; the three effective ones used MI or the HBM. Practitioners could adapt the effective and relevant interventions to improve contraceptive counseling within their own settings.

Implications for research

Most studies had pregnancy prevention as an objective, though sample size calculations, when available, were often based on contraceptive use or HIV/STI incidence. Interventions using social cognitive theory showed some effect with adolescents, although the extent of theory implementation could have been clearer in many reports. Identifying what worked was difficult when trials used parts of theories or combined various models. A minority of studies provided individual counseling; a few were effective and provided some detail on intervention content. Clinics and low-resource settings need more high-quality evidence on changing behavior.

Acknowledgements

From FHI 360, Carol Manion helped with the literature searches, and Kenneth Schulz provided consultation on methodological issues for the initial review.

Data and analyses

Download statistical data

Comparison 1. Prevent second births: home-based mentoring versus usual care
Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size
1 Second birth by 24 months1149Odds Ratio (M-H, Fixed, 95% CI)0.41 [0.17, 1.00]
Analysis 1.1.

Comparison 1 Prevent second births: home-based mentoring versus usual care, Outcome 1 Second birth by 24 months.

Comparison 2. Multiple risk reduction: group youth and parent programs
Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size
1 Been pregnant or gotten someone pregnant, self-reported (at 24 months)1 Odds Ratio (M-H, Fixed, 95% CI)Subtotals only
1.1 Youth + parent programs versus youth program1353Odds Ratio (M-H, Fixed, 95% CI)0.24 [0.10, 0.56]
1.2 Youth + parent programs versus youth + parent programs + booster session1295Odds Ratio (M-H, Fixed, 95% CI)0.27 [0.11, 0.66]
2 Used contraception at last sex (at 24 months)1 Odds Ratio (M-H, Fixed, 95% CI)Subtotals only
2.1 Youth + parent programs versus youth programs1337Odds Ratio (M-H, Fixed, 95% CI)1.35 [0.81, 2.25]
2.2 Youth + parent programs versus youth + parent programs + booster session1282Odds Ratio (M-H, Fixed, 95% CI)0.72 [0.43, 1.21]
3 Used condom at last sex (at 24 months)1 Odds Ratio (M-H, Fixed, 95% CI)Subtotals only
3.1 Youth + parent programs versus youth program1334Odds Ratio (M-H, Fixed, 95% CI)1.25 [0.76, 2.04]
3.2 Youth + parent programs versus youth + parent programs + booster session1279Odds Ratio (M-H, Fixed, 95% CI)0.92 [0.53, 1.61]
Analysis 2.1.

Comparison 2 Multiple risk reduction: group youth and parent programs, Outcome 1 Been pregnant or gotten someone pregnant, self-reported (at 24 months).

Analysis 2.2.

Comparison 2 Multiple risk reduction: group youth and parent programs, Outcome 2 Used contraception at last sex (at 24 months).

Analysis 2.3.

Comparison 2 Multiple risk reduction: group youth and parent programs, Outcome 3 Used condom at last sex (at 24 months).

Comparison 3. Reducing risk for alcohol-exposed pregnancy: motivational interviewing versus pamphlet on women's health
Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size
1 Ineffective contraceptive use1 Odds Ratio (M-H, Fixed, 95% CI)Subtotals only
1.1 At 1 month1199Odds Ratio (M-H, Fixed, 95% CI)0.49 [0.28, 0.87]
1.2 At 4 months1207Odds Ratio (M-H, Fixed, 95% CI)0.56 [0.31, 0.98]
2 Effective contraceptive use (at 3 months)1 Odds Ratio (M-H, Fixed, 95% CI)Subtotals only
2.1 At 3 months1665Odds Ratio (M-H, Fixed, 95% CI)2.12 [1.53, 2.92]
2.2 At 9 months1593Odds Ratio (M-H, Fixed, 95% CI)2.04 [1.47, 2.83]
Analysis 3.1.

Comparison 3 Reducing risk for alcohol-exposed pregnancy: motivational interviewing versus pamphlet on women's health, Outcome 1 Ineffective contraceptive use.

Analysis 3.2.

Comparison 3 Reducing risk for alcohol-exposed pregnancy: motivational interviewing versus pamphlet on women's health, Outcome 2 Effective contraceptive use (at 3 months).

Comparison 4. Pregnancy and STI prevention: motivational interviewing versus general health counseling
Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size
1 Contraceptive use maintained at high level or improved1 Odds Ratio (M-H, Fixed, 95% CI)Subtotals only
1.1 At 2 months1648Odds Ratio (M-H, Fixed, 95% CI)1.33 [0.95, 1.85]
1.2 At 12 months1664Odds Ratio (M-H, Fixed, 95% CI)1.19 [0.87, 1.63]
2 Pregnancy (by 12 months)1737Odds Ratio (M-H, Fixed, 95% CI)0.88 [0.55, 1.42]
Analysis 4.1.

Comparison 4 Pregnancy and STI prevention: motivational interviewing versus general health counseling, Outcome 1 Contraceptive use maintained at high level or improved.

Analysis 4.2.

Comparison 4 Pregnancy and STI prevention: motivational interviewing versus general health counseling, Outcome 2 Pregnancy (by 12 months).

Comparison 5. Pregnancy and STI prevention: computer-delivered, tailored versus non-tailored intervention
Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size
1 Any dual-method use (at 24 months)1542Odds Ratio (M-H, Fixed, 95% CI)1.30 [0.89, 1.88]
2 Consistent condom use (at 24 months)1542Odds Ratio (M-H, Fixed, 95% CI)0.99 [0.70, 1.38]
3 Unplanned pregnancy (at 24 months)1542Odds Ratio (M-H, Fixed, 95% CI)0.95 [0.63, 1.42]
Analysis 5.1.

Comparison 5 Pregnancy and STI prevention: computer-delivered, tailored versus non-tailored intervention, Outcome 1 Any dual-method use (at 24 months).

Analysis 5.2.

Comparison 5 Pregnancy and STI prevention: computer-delivered, tailored versus non-tailored intervention, Outcome 2 Consistent condom use (at 24 months).

Analysis 5.3.

Comparison 5 Pregnancy and STI prevention: computer-delivered, tailored versus non-tailored intervention, Outcome 3 Unplanned pregnancy (at 24 months).

Comparison 6. Prevent repeat births: computer-assisted motivational interviewing (CAMI) + parenting curriculum versus CAMI versus usual care
Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size
1 Repeat birth by 24 months1 Odds Ratio (M-H, Fixed, 95% CI)Subtotals only
1.1 CAMI+ versus CAMI1167Odds Ratio (M-H, Fixed, 95% CI)0.77 [0.33, 1.78]
1.2 CAMI versus usual care1155Odds Ratio (M-H, Fixed, 95% CI)0.63 [0.29, 1.37]
Analysis 6.1.

Comparison 6 Prevent repeat births: computer-assisted motivational interviewing (CAMI) + parenting curriculum versus CAMI versus usual care, Outcome 1 Repeat birth by 24 months.

Comparison 7. Adherence to OCs and condom use: counseling + phone calls versus counseling versus standard care
Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size
1 Consistent OC use: counseling + phone versus counseling1 Odds Ratio (M-H, Fixed, 95% CI)Subtotals only
1.1 At 3 months1767Odds Ratio (M-H, Fixed, 95% CI)1.41 [1.06, 1.87]
1.2 At 12 months1767Odds Ratio (M-H, Fixed, 95% CI)1.12 [0.78, 1.61]
2 Consistent OC use: counseling versus standard care1 Odds Ratio (M-H, Fixed, 95% CI)Subtotals only
2.1 At 3 months1771Odds Ratio (M-H, Fixed, 95% CI)0.81 [0.61, 1.07]
2.2 At 12 months1771Odds Ratio (M-H, Fixed, 95% CI)0.89 [0.62, 1.27]
3 Dual-method use: counseling + phone versus counseling1 Odds Ratio (M-H, Fixed, 95% CI)Subtotals only
3.1 At 3 months1767Odds Ratio (M-H, Fixed, 95% CI)1.38 [0.87, 2.18]
3.2 At 12 months1767Odds Ratio (M-H, Fixed, 95% CI)1.00 [0.51, 1.95]
4 Dual-method use: counseling versus standard care1 Odds Ratio (M-H, Fixed, 95% CI)Subtotals only
4.1 At 3 months1771Odds Ratio (M-H, Fixed, 95% CI)0.79 [0.50, 1.26]
4.2 At 12 months1771Odds Ratio (M-H, Fixed, 95% CI)0.75 [0.40, 1.40]
5 Condom use at last sex: counseling + phone versus counseling1 Odds Ratio (M-H, Fixed, 95% CI)Subtotals only
5.1 At 3 months1767Odds Ratio (M-H, Fixed, 95% CI)1.45 [1.03, 2.03]
5.2 At 12 months1767Odds Ratio (M-H, Fixed, 95% CI)0.93 [0.55, 1.57]
6 Condom use at last sex: counseling versus standard care1 Odds Ratio (M-H, Fixed, 95% CI)Subtotals only
6.1 At 3 months1771Odds Ratio (M-H, Fixed, 95% CI)0.91 [0.64, 1.29]
6.2 At 12 months1771Odds Ratio (M-H, Fixed, 95% CI)1.01 [0.60, 1.70]
7 Pregnancy (by 12 months)1 Odds Ratio (M-H, Fixed, 95% CI)Subtotals only
7.1 Counseling + phone versus counseling1767Odds Ratio (M-H, Fixed, 95% CI)0.80 [0.53, 1.18]
7.2 Counseling versus standard care1771Odds Ratio (M-H, Fixed, 95% CI)1.39 [0.93, 2.09]
8 Would recommend OC use to a friend: counseling + phone versus counseling1 Odds Ratio (M-H, Fixed, 95% CI)Subtotals only
8.1 At 3 months1623Odds Ratio (M-H, Fixed, 95% CI)1.52 [1.11, 2.09]
8.2 At 12 months1432Odds Ratio (M-H, Fixed, 95% CI)1.13 [0.75, 1.68]
9 Would recommend OC use to a friend: counseling versus standard care1 Odds Ratio (M-H, Fixed, 95% CI)Subtotals only
9.1 At 3 months1625Odds Ratio (M-H, Fixed, 95% CI)0.78 [0.57, 1.07]
9.2 At 12 months1427Odds Ratio (M-H, Fixed, 95% CI)0.82 [0.55, 1.23]
Analysis 7.1.

Comparison 7 Adherence to OCs and condom use: counseling + phone calls versus counseling versus standard care, Outcome 1 Consistent OC use: counseling + phone versus counseling.

Analysis 7.2.

Comparison 7 Adherence to OCs and condom use: counseling + phone calls versus counseling versus standard care, Outcome 2 Consistent OC use: counseling versus standard care.

Analysis 7.3.

Comparison 7 Adherence to OCs and condom use: counseling + phone calls versus counseling versus standard care, Outcome 3 Dual-method use: counseling + phone versus counseling.

Analysis 7.4.

Comparison 7 Adherence to OCs and condom use: counseling + phone calls versus counseling versus standard care, Outcome 4 Dual-method use: counseling versus standard care.

Analysis 7.5.

Comparison 7 Adherence to OCs and condom use: counseling + phone calls versus counseling versus standard care, Outcome 5 Condom use at last sex: counseling + phone versus counseling.

Analysis 7.6.

Comparison 7 Adherence to OCs and condom use: counseling + phone calls versus counseling versus standard care, Outcome 6 Condom use at last sex: counseling versus standard care.

Analysis 7.7.

Comparison 7 Adherence to OCs and condom use: counseling + phone calls versus counseling versus standard care, Outcome 7 Pregnancy (by 12 months).

Analysis 7.8.

Comparison 7 Adherence to OCs and condom use: counseling + phone calls versus counseling versus standard care, Outcome 8 Would recommend OC use to a friend: counseling + phone versus counseling.

Analysis 7.9.

Comparison 7 Adherence to OCs and condom use: counseling + phone calls versus counseling versus standard care, Outcome 9 Would recommend OC use to a friend: counseling versus standard care.

Appendices

Appendix 1. Searches 2013

MEDLINE via PubMed (01 Jun 2010 to 03 Jul 2013)

("Contraception"[Mesh] OR "Contraception Behavior"[Mesh] OR "Contraceptive Agents"[Mesh] OR "Contraceptive Devices"[Mesh] OR condom*[tiab] OR protected[tiab] OR unprotected[tiab]) AND (theor* OR model* OR principle* OR construct* OR framework* OR behavioral OR psycho-social OR psychosocial) AND (educat* OR counsel* OR communicat* OR information disseminat* OR intervention* OR choice OR choose OR use OR continuation)
Limits Activated: Clinical Trial, Randomized Controlled Trial

CENTRAL (2010 to 27 May 2013)

contracept* in Title, Abstract or Keywords
AND (theory OR theories OR theoret* OR model* OR principle* OR construct* OR framework* OR behavioral OR psycho-social OR psychosocial) in Title, Abstract or Keywords
AND (counsel* OR communicat* OR educat* OR information disseminat* OR intervention OR choice OR choose OR use OR continuation) in Title, Abstract or Keywords
Limits Activated: Trials

POPLINE (2010 to 28 Mar 2013)

All Fields: (contraceptive methods chosen, contraceptive continuation, contraceptive usage determinants) AND
(behavioral, psycho-social, psychosocial, theor*, model*, principle*, construct*, framework*) AND
(educat*, counsel*, communicat*, information disseminat*, intervention*)

PsycINFO (01 Jun 2010 to 19 Mar 2013)

(contraception OR contraceptive OR contraceptives OR birth control) AND (theory OR theories OR theoret* OR model* OR principle* OR construct* OR framework* OR behavioral OR psycho-social OR psychosocial) AND (educat* OR counsel* OR communicat* OR information disseminat* OR intervention* OR choice OR choose OR use OR continuation)
Empirical study

ClinicalTrials.gov (01 Jun 2010 to 01 May 2013)

Search terms:  theor* OR model* OR principle* OR construct* OR framework* OR behavioral OR psycho-social OR psychosocial OR motivational
Study type: Interventional studies
Intervention:  Contracept* OR condom* OR protected OR unprotected
Outcomes: pregnancy OR pregnant* OR birth* OR condom OR contracept*

ICTRP (01 Jun 2010 to 28 Mar 2013)

1) Title: contracept* or 2) Condition: contracept*
Intervention: theor* OR model* OR principle* OR construct* OR framework* OR behavioral OR psycho-social OR psychosocial
Recruitment status: all

Appendix 2. Searches 2008 and 2010

MEDLINE via PubMed (through 08 Nov 2010)

("Contraception"[Mesh] OR "Contraception Behavior"[Mesh] OR "Contraceptive Agents"[Mesh] OR "Contraceptive Devices"[Mesh] OR condom*[tiab] OR protected[tiab] OR unprotected[tiab]) AND (theor* OR model* OR principle* OR construct* OR framework* OR behavioral OR psycho-social OR psychosocial) AND (educat* OR counsel* OR communicat* OR information disseminat* OR intervention* OR choice OR choose OR use OR continuation)
Limits Activated: Clinical Trial, Randomized Controlled Trial

CENTRAL (through 08 Nov 2010)

contracept* in Title, Abstract or Keywords
AND (theory OR theories OR theoret* OR model* OR principle* OR construct* OR framework* OR behavioral OR psycho-social OR psychosocial) in Title, Abstract or Keywords
AND (counsel* OR communicat* OR educat* OR information disseminat* OR intervention OR choice OR choose OR use OR continuation) in Title, Abstract or Keywords
Limits Activated: Trials

POPLINE (through 08 Nov 2010)

(contraceptive methods chosen, contraceptive continuation,  contraceptive usage determinants) & (behavioral/psycho-social/psychosocial/ theor*/ model*/ principle*/ construct*/ framework*) & (educat*/ counsel*/ communicat*/ information disseminat*/ intervention*)

EMBASE (through 08 Nov 2010)

contracept? AND (theory OR theories OR theoret? OR model? OR principle? OR construct? OR framework?) AND (behavioral OR psycho-social OR psychosocial) AND (educat? OR choice OR choos? OR counsel? OR communicat? OR information()disseminat? OR intervention? OR use OR continuation)

PsycINFO (through 08 Nov 2010)

(contraception OR contraceptive OR contraceptives OR birth control) AND (theory OR theories OR theoret* OR model* OR principle* OR construct* OR framework* OR behavioral OR psycho-social OR psychosocial) AND (educat* OR counsel* OR communicat* OR information disseminat* OR intervention* OR choice OR choose OR use OR continuation)

ClinicalTrials.gov (through 09 Nov 2010)

Search terms:  theor* OR model* OR principle* OR construct* OR framework* OR behavioral OR psycho-social OR psychosocial
Intervention:  Contracept* OR condom* OR protected OR unprotected
Outcomes: pregnancy OR pregnant* OR birth* OR condom OR contracept*
Study type: interventional studies

ICTRP (through 07 Feb 2011)

Title or Condition: contracept*
Intervention: theor* OR model* OR principle* OR construct* OR framework* OR behavioral OR psycho-social OR psychosocial

What's new

DateEventDescription
3 July 2013New search has been performedSearches updated.
30 May 2013New citation required but conclusions have not changed

Three new trials included (Berenson 2012; Cowan 2010; Sieving 2013).

Secondary papers from previously included trials added: Ceperich & Ingersoll, 2011 (Ingersoll 2005; Peipert et al, 2011 (Peipert 2008); Doyle et al, 2010 (Ross 2007); Henderson et al, 2006 (Wight 2002).

Intervention fidelity (Table 1): added criterion and ratings.

Evidence quality ratings (Table 2): included more design and fidelity information.

Table 1. Intervention fidelity
  1. 1Intervention information was assessed with 5 criteria from Borrelli 2011. Those criteria were relevant to completed, rather than ongoing, interventions. 2Number of criteria met by the study, according to information in the reports.

Study1Curriculum or
manual
Provider
credentials
Training for
intervention
Assessed adherence to protocolAssessed intervention receiptFidelity
information2
Barnet 2009CAMI was structured software developed for study; counseling was 20-minute stage-matched MI session; parenting curriculum (Black 2006)African American paraprofessional women from participants' communities; hired for empathetic qualities, rapport with adolescents, and knowledge of the community2.5 days on Transtheoretical model, motivational interviewing (MI), and computer-assisted motivational intervention (CAMI)First 4 months: counselors met biweekly with MI supervisor, who discussed audiotapes, provided feedback

Not specific:

stage-matched MI

4
Berenson 2012'Standardization of counseling techniques' (lower literacy handouts, key points, review instructions) Not specific:
Research assistants (RA)
Investigator trained RA in contraceptive counselingAudio record some sessions for each RA; review for key pointsDevelop cue for pill-taking, discuss risks and benefits of pill use, develop plan for side effects, practice condom application4
Black 2006Curriculum with 19 lessons; order could vary after 2 sessions2 Black women, college-educated, in their 20s, single mothers and living independentlyExtensive training provided

Not specific:

Weekly supervisory sessions

---4
Boyer 20054 sessions with educational objectives and strategies; activities and materials Not specific:
research assistants

Not specific:

Trained

---Last session involved describing, practicing, discussing2
Cowan 2010Youth: 3-year school curriculum (Ross 2007); year 4, 24 sessions for out-of-school youth.
Clinic: 5-day training for nurses.
Parents and community: 22 sessions

Not specific:
Youth program, carefully selected school-leavers before starting university;

community, carefully selected community facilitators

Youth program, 'trained';

Nurses trained for clinic intervention ran some youth and parent sessions;

Community facilitators 'trained'

Clinic: monthly visits, more training as needed, compare to standards.

Social scientists assess delivery, provide feedback; modify

---3
Coyle 200120 lessons; grades 9 and 10 (10 lessons each year)School teachers; in-class peer leaders for selected activitiesTeachers had initial training and ongoing technical support---In-class peer leaders for some activities, role playing; homework (student-parent, local resources)4
Coyle 200614-session curriculum; 9 class lessons and 5 units of service-learning; pilot-tested twiceExperienced health educatorsTrained to implement; practiced during pilot---Curriculum had experiential activities, e.g., creating posters, role playing, group discussion, guided skill practice.4
Floyd 2007Intervention had been tested in feasibility study21 counselors (master's level or above) and 6 contraceptive care providers (physicians and family planning nurse practitioners)---Counselors supervised by Project Research teamSessions involved participant in goals-setting, change plans, problem solving.4
Ingersoll 2005Intervention had semi-structured counseling manual, with activities and materials4 counselors (master's degree in psychology or social work); supervisors experienced in MI training and supervision.Training in motivational interviewing (MI) and counseling manual; reviewed, practiced MI twice per monthSessions audio-taped, used in supervision sessions; adjustments made if drifting notedSession involved participant in summarizing, self-assessment, readiness for change5
Kirby 2010Motivational interviewing (MI) guide and training materialsclinic staff with training on family planning methods, adolescent risk behavior, and counselingCall content plus 3 sessions on MI; observed >=4 callsCounselors were observed for >= 4 calls before conducting solo callsInterview methods engaged participant in decision-making5
Peipert 2008Computer-delivered; participants were counseled about computer useComputer-deliveredProgram based on prior system; extensively tested to provide intended feedbackPre-tested for delivery of feedback as intended---4
Petersen 2007---Experienced health educators trained for this project30 to 40 hoursRandom observation of sessions, feedback from project managerBooster session addressed progress and barriers to risk reduction4
Ross 200710 to 15 lessons each school year

Teachers (T);

class peer educators (CPE), selected by teachers and research staff;

health workers (HW) from government health unit;

condom promoters and deliverers (CPD), elected in village meetings

T: 1 week each year;
CPE: 2 days on dramas;
HW: 6 days on youth-friendly services;
CPD: 2 days
Supervision visits to intervention sites; observe sessions; check exercise books for sessions taught; annual feedback to teachersSome lessons had drama and role play; 'internalization exercises'5
Schinke 198114 group sessions (50-minute) for cognitive and behavioral trainingFemale and male graduate students, 3 to 4 years counseling experience, though not with teenagers regarding sex------Sessions involved problem solving, role play, rehearsal3
Sieving 2013

Case management: monthly core topics each 6 months.

Peer leadership: peer-educator training with 15-session curriculum, group teaching practicum;

service learning with standard curriculum.

Case managers, intervention coordinators: women, aged 22 to 50 years, diverse ethnic and racial backgrounds, bachelor's or master's degree in related field, experience with youth programs.

Not specific for intervention coordinators.

Case managers (CM) received training for program and in youth development.

Not specific for intervention coordinators.

CM had practice and feedback on strategies, coaching during first group.

CM: adolescent's needs guided specific topics covered.4
Stanton 2004Standard curricula for 3 components, with activities and materials---------Involves making decisions, setting goals; includes discussion, homework, role play.2
Wight 2002Resource pack of 20 lessons, piloted twice and revised; pilot-test included evaluation with teachers and students, and lesson observationClassroom teachers5 daysProcess evaluation: # and type of lessons covered; tracking who led sessionsInteraction on video with discussion; how to obtain condoms, practice use.5
Table 2. Summary of evidence quality
  1. 1Grades could be high (RCT), moderate, low, or very low. RCTs were downgraded (x) one level for each of the following: a) randomization sequence generation and allocation concealment: no information on either, or one was inadequate; b) losses >= 25%; c) all outcomes were self-reported; d) intervention fidelity information for <= 3 criteria.
    2Due to out-migration, cohort losses were >=25%. Design was changed to cross-sectional survey for final data collection.

StudyRandomization
and allocation
concealment
Outcomes
self-reported
Loss >= 25%Intervention
fidelity
Evidence quality1
Barnet 2009------------High
Black 2006------------High
Petersen 2007------------High
Coyle 2001---x------Moderate
Ingersoll 2005---x------Moderate
Peipert 2008------x---Moderate
Ross 2007------x---Moderate
Wight 2002------x---Moderate
Boyer 2005------xxLow
Cowan 2010------x2xLow
Coyle 2006---xx---Low
Floyd 2007---xx---Low
Kirby 2010---xx---Low
Berenson 2012x---x---Low
Sieving 2013xx------Low
Schinke 1981xx---xVery low
Stanton 2004---xxxVery low

History

Protocol first published: Issue 3, 2008
Review first published: Issue 1, 2009

DateEventDescription
10 December 2010New citation required and conclusions have changedRevised review to focus on interventions that had identified contraception content as well as outcome of pregnancy, repeat birth, or contraceptive use other than condoms. For specifics, see Criteria for considering studies for this review and Excluded studies. Two new trials were included (Barnet 2009; Kirby 2010).
9 November 2010New search has been performedSearches were updated
21 April 2008AmendedConverted to new review format.
17 April 2008New citation required and conclusions have changedSubstantive amendment

Contributions of authors

LM Lopez developed the idea, reviewed the search results, conducted the primary data extraction, and drafted the review. She led the 2010 and 2013 updates and revisions. EE Tolley provided expertise in behavioral science and reviewed the data extracted on theories and constructs. M Chen reviewed the cluster randomized trials for analytical methods, provided expertise on study design, and reviewed the data extracted on evidence quality. In 2008 and 2010, DA Grimes consulted on inclusion criteria and conducted the secondary data extraction for the outcomes. In 2013, LL Stockton reviewed search results and extracted and checked data. All authors reviewed and edited the manuscript.

Declarations of interest

None

Sources of support

Internal sources

  • No sources of support supplied

External sources

  • National Institute of Child Health and Human Development, USA.

    For conducting the review: LML, EET, MC (2008 to 2013); DAG (2008 to 2011); LLS (2013)

  • U.S. Agency for International Development, USA.

    For conducting the review: LML, EET, MC (2008 to 2013); DAG (2008 to 2011); LLS (2013)

Characteristics of studies

Characteristics of included studies [ordered by study ID]

Barnet 2009

MethodsLocation: Baltimore, MD (USA)
Sample size calculation (and outcome of focus): not specified (ns)
ParticipantsGeneral with N: 237 pregnant adolescents
Source: 5 prenatal care clinics serving low-income, mainly African American communities
Inclusion criteria: 12 to 18 years old, pregnancy >= 24 weeks gestation.
Exclusion criteria: pregnancy did not result in a live birth and withdrawn if the infant died in the neonatal period, since parenting was an intervention focus.
Interventions

Study focus: prevent rapid repeat births
Theory or model: Transtheoretical model for computer-assisted motivational intervention (CAMI); motivational interviewing on contraception by CAMI counselors; Social Cognitive Theory for parenting curriculum from Black 2006, which included contraception.
Treatment:

  • CAMI+: multi-component, home-visiting intervention (parent training and case management);

  • CAMI-only: single-component, home-based intervention

Comparison or control: usual care
Duration: from 6 weeks postpartum to 24 months postpartum with maximum of 9 quarterly sessions

OutcomesPrimary: Repeat birth by 24 months postpartum (assessed via Vital Statistics); abortion since index child's birth
Secondary: not applicable (na)
Additional data provided by investigator: losses by arm to help interpret abortion information obtained at 24-month interview
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskRandomly assigned, 'computer-generated permuted blocks'. In communications, investigator stated the ratio was 3:3:2; with 6 used for intervention groups and 4 for control. Block size of 16 would account for the ratio rather than block size of 6 that was reported in paper.
Allocation concealment (selection bias)Unclear risknot specified (ns)
Blinding (performance bias and detection bias)
All outcomes
Unclear riskns
Incomplete outcome data (attrition bias)
All outcomes
Low riskLosses to follow up: Investigator provided losses by study arm (counts and %) at 24 month-interview. Overall loss was 19%. Group losses were 17% CAMI+, 16% CAMI-only, 24% Usual care.
Exclusions after randomization: 1 participant with stillborn infant and 1 whose 2-month old infant died.
If participant became pregnant, CAMI was stopped because questions on contraception were no longer relevant and the program did not allow skipping.

Berenson 2012

Methods

Location: Southeast Texas (USA); enrollment from Jul 2006 to Jan 2010.

Sample size calculation (and outcome of focus): N=190 in each group (570 total) for 90% power to detect OR of 2.0 for oral contraceptive (OC) continuation after 12 months.

Participants

General with N: 1155 women, 16 to 24 years of age

Source: five public reproductive health clinics in Southeast Texas serving low income women

Inclusion criteria: sexually active, non-pregnant females, 16 to 24 years old, requesting OC initiation.

Exclusion criteria: desire to become pregnant in next year, medical contraindication to OC, current or prior (>1 month) OC use.

Interventions

Study focus: increasing contraceptive adherence as well as dual-method use to prevent STI and pregnancy.
Theory or model: health belief model
Treatment:

  • C: standard care (below) plus 45 minutes of contraceptive counseling from study staff;

  • C+P: C (above) plus phone calls by contraceptive counselor (weekly until initiation then monthly for 6 months) and access to 24-hour toll-free number (n=384);

Comparison or control: standard care from nurse practitioner with written protocol for new OC users.
Duration: 6-month intervention; telephone follow up at 3, 6 and 12 months

OutcomesOC adherence (consistent OC use), dual-method use (consistent OC use and consistent condom use), condom use at last sex (if inconsistent condom user), pregnancy (self-report and medical record review)
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskComputer-generated randomization scheme (PLAN procedure, SAS Institute)
Allocation concealment (selection bias)High riskWhen asked about concealment before assignment, investigator communicated that they did not conceal it from the researchers but did conceal it from the patient.
Blinding (performance bias and detection bias)
All outcomes
Unclear riskSingle-blinded study; staff who made assessment phone calls were blinded to intervention group.
Incomplete outcome data (attrition bias)
All outcomes
High risk

Losses to follow up by 12 months: 44% counseling, 43% counseling + phone, and 45% standard care.

Exclusions after randomization: none apparent

Black 2006

MethodsLocation: Baltimore, MD (USA)
Sample size calculation (and outcome of focus): ns
ParticipantsGeneral with N: 181 adolescents
Source: 3 urban hospitals
Inclusion criteria: low income (< 185% poverty level), < 18 years old, first-time delivery, black race, no indication of cocaine or heroin use in chart, no chronic illness that would interfere with parenting or adolescent development; infant was term (>= 37 weeks) and > 2500 g; infant had no congenital problem, chronic illness, or disability.
InterventionsStudy focus: delaying second births; parenting, contraception
Theory or model: primarily Social Cognitive Theory
Treatment: Home-based curriculum for adolescent mothers, maximum of 19 lessons; participants were seen twice per month until infant's first birthday. Intervention included information about access to birth control, and condoms were provided at each visit. After the first 2 visits, facilitators could vary the order of sessions, as well as combine or repeat them.
Comparison or control: usual care
Duration: maximum of 19 visits for intervention group at 2 per month; evaluation visits occurred at 6, 13, and 24 months for both groups.
OutcomesPrimary: Second birth (not pregnancy) by 24 months; contraceptive use was presented by second birth rather than by randomized group.
Secondary: na
Additional data provided by investigator: na; unsuccessful in contacting about contraceptive use by study arm
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear risk'Randomization procedure' stratified on maternal age and child's gender.
Allocation concealment (selection bias)Unclear riskns
Blinding (performance bias and detection bias)
All outcomes
Unclear riskns
Incomplete outcome data (attrition bias)
All outcomes
High riskLosses to follow up: overall, 18%; by group, intervention 20% (17/87); control 16% (15/94).
Exclusions after randomization: excluded from analysis the 32 mothers who did not have a 24-month evaluation (17 treatment and 15 control), purportedly because the intent was to assess second births. These young women may have had 6-month or 13-month evaluations.

Boyer 2005

MethodsLocation: most likely California and South Carolina (USA)
Sample size calculation (and outcome of focus): originally N=477 per group to assess decreasing STIs by 6%. Increased to 568 per group to address cluster effect, and then increased to 1000 per group since about half of participants would be stationed where STI and pregnancy screening would not be possible at follow up.
Cluster randomized trial: platoons were assigned to study groups. Number of platoons not specified (likely about 30, given 50 to 75 recruits in each platoon and overall sample size).
ParticipantsGeneral with N: 2157 female Marine recruits in training
Source: marine recruit training
Inclusion criteria: female Marine recruits in training
Exclusion criteria: ns
InterventionsStudy focus: preventing STIs and unplanned pregnancies
Theory or model: Information-motivation-behavioral (IMB) skills model
Treatment: four 2-hour group sessions at weeks 1, 2, 4, and 12 of 13-week recruit training
Comparison or control: same format; content addressed nutrition and physical performance, risk of sports or training injuries, risk and prevention of cervical and breast cancer.
Duration: 12 weeks for intervention; follow up at 14 months after baseline assessment
OutcomesPrimary: unplanned pregnancy (tested), frequency of condom use, frequency of contraceptive use
Secondary: na
Additional data provided by investigator: number of events and group size for pregnancy and condom use
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskComputer-generated random numbers table established before the study start
Allocation concealment (selection bias)Low riskPlatoons were identified prior to randomization. All female marine recruits in the platoons were eligible.
Blinding (performance bias and detection bias)
All outcomes
Unclear riskPlatoons were informed of their group assignment after enrollment and baseline assessment; no information on assessors.
Incomplete outcome data (attrition bias)
All outcomes
High riskLosses to follow up: 38% loss for questionnaire data and 59% loss for pregnancy data (due to deployments); study groups were similar.
Exclusions after randomization: none apparent

Cowan 2010

Methods

Location: southeastern Zimbabwe; baseline survey from Mar to Jun 2003.

Original sample size calculation (and outcome of focus): 15 communities per arm (average 220 students enrolled) for 80% power to detect 40% reduction in HIV incidence in early intervention arm (assuming 4% in deferred intervention arm).

Interim survey showed 46% out-migration of cohort; those remaining were lower risk (HIV prevalence 1.2%). Investigators and data and safety monitoring board changed design to cross-sectional survey.

Revised sample size calculation (for cross-sectional survey): > 95% power to detect 40% reduction in HIV prevalence and 80% power to detect 30% reduction.

Cluster randomized trial: 30 communities randomized; 3 strata based on distance from tarred road. For cross-sectional survey, 6 enumeration areas from each trial community were purposively selected.

Participants

General with N: 30 rural communities; 7885 students in original cohort; 4684 individuals, 18 to 22 years old, for cross-sectional (final) survey.

Source: 7 districts in 3 provinces in southeastern Zimbabwe; communities defined as rural health clinic with catchment area.

Inclusion criteria (initial): communities with at least 250 students in ninth year of school and no HIV prevention targeting young people. Original cohort included all students in ninth year.

Final survey (cross-sectional): 18 to 22 years old and living in 180 enumeration areas purposively selected.

Exclusion criteria: not specified

Interventions

Study focus: reducing rates of HIV-1, HSV-2, and unintended pregnancy
Theory or model:

  • Social cognitive theory was basis for curriculum from Ross 2007 (below), and principles were apparent in report; investigators cited the predecessor of social learning theory.

  • Stages of change reportedly used for out-of-school youth program, but evidence lacking.

  • Investigators noted participatory and empowerment approaches for out-of-school youth and community programs; did not cite as guiding theory or model.

Treatment

  • Youth program

    • 3-year school curriculum from Ross 2007, sessions on self-belief and gender issues, materials from other organizations;

    • out-of-school youth: 24-sessions, 'highly participatory,' in year 4.

  • Clinic intervention: 5-day youth-friendly training for nurses;

  • Parents and community program: 22-sessions to improve knowledge about reproductive health and communication skills.

  • Comparison or control: no specific intervention during trial; deferred intervention provided in 2007 after final survey.

Standard HIV prevention conducted by various organizations in both arms.
Duration: 4 years

Outcomes

Pregnancy prevalence (cross-sectional) and reported unintended pregnancy, no condom use at last sex, no pregnancy prevention with last partner

Additional data provided by investigator: not applicable

Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear risk

Randomization restricted for equal number of schools per arm, balance across districts, and average N of 255 to 261 per community per arm. One allocation out of all possible allocations that met the criteria was randomly chosen at randomization meeting.

Design changed to cross-sectional survey; participants lived in trial communities but did not necessarily attend trial schools.

Allocation concealment (selection bias)Unclear riskCommunities identified prior to randomization.
Blinding (performance bias and detection bias)
All outcomes
Unclear riskns
Incomplete outcome data (attrition bias)
All outcomes
Unclear risk

Losses to follow up: see Methods above for design change.

Of 4822 eligible for cross-sectional survey, 97% participated; 5% were from original cohort; 40% attended trial school and lived in trial community for duration of intervention.
Exclusions after randomization: not applicable due to design change; 12 excluded from survey due to inability to confirm age.

Coyle 2001

MethodsLocation: Texas and California (USA)
Sample size calculation (and outcome of focus): ns
Cluster randomized trial: 20 schools were assigned to study groups.
ParticipantsGeneral with N: 3869 ninth-grade students
Source: public schools, 10 in southeast Texas and 10 in northern California
Inclusion criteria: school districts served diverse populations (ethnicity and socioeconomic status), were in areas with high HIV prevalence, and were close to research team.
Exclusion criteria: ns
InterventionsStudy focus: prevention of HIV, STI, and pregnancy for high school youth
Theory or model: Social Cognitive Theory plus social influence model, models of school change
Treatment: 10 lessons in each of the 9th and 10th grades, school organization activities, peer resource team, parent education, and school-community linkages
Comparison or control: standard 5-session knowledge-based curriculum plus varied other school activities
Duration: 2-year program; follow up at 7, 19, and 31 months
OutcomesData were not available for analysis in this review. The report provided the effect estimates but not the means or frequencies per study group. Since the study was conducted in the mid-1990s, we did not request data from the investigator.
Primary: frequency of unprotected sex, condom use during last sex, use of effective contraception during last sex (i.e., condom, birth control pills, or both)
Secondary: not addressed here, since the data could not be analyzed
Additional data supplied by investigator: na
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskRestricted randomization process to assign schools: schools were ranked on index of possible confounders, and adjacent schools in ranking were paired and randomly assigned to intervention or control
Allocation concealment (selection bias)Unclear riskSchools were identified prior to randomization. All students in the identified grades were eligible.
Blinding (performance bias and detection bias)
All outcomes
Unclear riskns
Incomplete outcome data (attrition bias)
All outcomes
Unclear riskLosses to follow up: 5% at 7 months and 21% at 31 months, group data not reported; loss was reportedly 17% at 19 months.
Exclusions after randomization: 346 students who left in the first year and did not enroll in the fall of the second year, and 95 who took the baseline survey but were in the 11th or 12th grade.

Coyle 2006

MethodsLocation: northern California (USA)
Sample size calculation (and outcome of focus): ns
Cluster randomized trial: schools were assigned to intervention or control
ParticipantsGeneral with N: 24 alternative day schools; 988 students
Source: 4 counties with ethnic diversity and in close proximity to investigators
Inclusion criteria: all enrolled students
Exclusion criteria: students on extended leave (e.g., maternity or medical), suspended or incarcerated at baseline, functionally dropped out of school.
InterventionsStudy focus: Prevention of HIV, STI, and pregnancy
Theory or model: Social Cognitive Theory plus Theory of Planned Behavior
Treatment: 2 or 3 times per week for 5 to 7 weeks
Comparison or control: usual activities related to prevention of HIV, STI, and pregnancy
Duration: follow up at 6, 12, and 18 months
OutcomesData were not available for analysis in this review. The report provided the effect estimates but not the means or frequencies per study group.
Primary: frequency of sex without condom in past 3 months, condom use with last sex, use of effective birth control, self-reported pregnancy
Secondary: not addressed here, since the data could not be analyzed
Additional data provided by investigator: na; unsuccessful in contacting about outcomes by group for use in analysis
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskRestricted randomization: schools put into matched sets, matched groups formed with set from each county, and matched groups randomized
Allocation concealment (selection bias)Unclear riskSchools were identified prior to randomization. All students in the schools were eligible.
Blinding (performance bias and detection bias)
All outcomes
Unclear riskns
Incomplete outcome data (attrition bias)
All outcomes
High riskLosses: 27% at 6 months, 44% at 18-months. Losses by group not reported; authors report no statistically significant differences between groups.
Exclusions: none apparent

Floyd 2007

MethodsLocation: Florida, Virginia, and Texas (USA)
Sample size calculation (and outcome of focus): N=60 in each group to detect 30% difference in reduction of problem drinking
ParticipantsGeneral with N: 830 women, aged 18 to 44 years, at risk for alcohol-exposed pregnancy
Source: primary care practices, jails, drug and alcohol treatment centers, hospital-based gynecology clinic, Medicaid health maintenance organization, and media-recruited sample.
Inclusion criteria: 18 to 44 years old, no condition causing infertility, not pregnant or planning to get pregnant in 9 months, had vaginal sex in past 3 months (or 3 months prior to jail) with non-sterile male and without using effective contraception, engaged in risky drinking, available for follow up.
Exclusion criteria: ns
InterventionsStudy focus: change one or both of the target behaviors, i.e., risky drinking and ineffective contraceptive use
Theory or model: motivational interviewing and Transtheoretical Model
Treatment: 4 motivational interviewing counseling sessions and 1 contraceptive counseling visit (each 45 to 60 minutes)
Comparison or control: brochures on alcohol use and women's health in general
Duration: 14 weeks with sessions 2 to 3 weeks apart; follow-up assessments at 3, 6, and 9 months
OutcomesPrimary: ineffective contraception use (vaginal sex without contraception or with ineffective contraception, i.e., reported deviation from published guidelines for method use)
Secondary: na
Additional data provided by investigator: na
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskData coordinating center used randomization program to generated unique IDs for each site; equal number in each study group
Allocation concealment (selection bias)Low riskSequentially-numbered, sealed, opaque envelopes
Blinding (performance bias and detection bias)
All outcomes
Low riskFollow-up interviews were conducted by staff blinded to group assignment
Incomplete outcome data (attrition bias)
All outcomes
High riskLosses to follow up: 29% overall; 30% treatment and 27% control
Exclusions after randomization: none apparent

Ingersoll 2005

MethodsLocation: Richmond VA (USA)
Sample size calculation (and outcome of focus): ns
ParticipantsGeneral with N: 228 female students
Source: urban university via mailings or posted flyers
Inclusion criteria: 18 to 24 years old; at risk for alcohol-exposed pregnancy: had sex with man in past 90 days, use contraception ineffectively (none, incorrect use of effective method, or use of ineffective method), and drinking at risk levels (>=5 drinks per occasion in past 90 days or >=8 drinks per week on average).
Exclusion criteria: ns
InterventionsStudy focus: reducing alcohol-exposed pregnancy risk
Theory or model: motivational interviewing
Treatment: single session with individual from 60 to 75 minutes; retrospective recording of risk behavior; exercises such as decisional balance and development of goal statements and change plans; feedback using 'elicit-provide-elicit strategy.'
Comparison or control: information pamphlet on women's health
Duration: single session or pamphlet with one-month follow up
Outcomes

Primary: ineffective contraceptive use

  • 1-month assessment (2005 report): no use, incorrect use of effective method, use of ineffective method only

  • 4-month assessment (2011 report): used method(s) effectively for part of 3 months; used method effectively but no back-up when needed, e.g., antibiotic use and oral contraceptives.

Secondary: na
Additional data provided by investigator: 'ineffective methods' included those with high pregnancy rates, such as withdrawal, 'natural family planning,' and spermicide only.

NotesLater report (Ceperich & Ingersoll, 2011) provided 4-month outcome data and additional information on the intervention and measures.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskns
Allocation concealment (selection bias)Low riskClosed envelope; after assessment, counselor opened envelope and provided the counseling intervention or information-only condition.
Blinding (performance bias and detection bias)
All outcomes
Unclear riskns
Incomplete outcome data (attrition bias)
All outcomes
Low riskLosses to follow up: 10% overall; by group, intervention 13% (13/114), control 8% (8/114)
Exclusions after randomization: none apparent

Kirby 2010

MethodsLocation: San Francisco, CA (USA)
Sample size calculation (and outcome of focus): 80% chance of finding 10-percentage-point difference in proportion of women who used hormonal contraception for 6 months or longer
ParticipantsGeneral with N: 805 females, 14 to 18 years old
Source: reproductive health clinic for adolescents and young adults
Inclusion criteria: not pregnant or trying to become pregnant, had sex in the last 3 months, no consistent hormonal contraception for 3 months and no IUD or contraceptive implant
Exclusion criteria: ns
InterventionsStudy focus: improve contraceptive use, reduce unintended pregnancy and STI
Theory or model: motivational interviewing, which investigators claimed was built on Health Belief Model
Treatment: Intense phone follow-up (9 calls planned)
Comparison or control: usual care
Duration: 12 months
OutcomesPrimary: hormonal contraceptive use at last sex, condom use at last sex, self-reported pregnancy
Secondary: na
Additional data provided by investigator: pregnancy rates by group; effect sizes and P values for outcomes without details in report. Analysis involved multiple linear and logistic regression repeated measures, and included adjustments for differences between groups.
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskRandom number generator; participants were stratified by age
Allocation concealment (selection bias)Unclear riskns
Blinding (performance bias and detection bias)
All outcomes
Low riskSingle blind (outcome assessor)
Incomplete outcome data (attrition bias)
All outcomes
High riskLosses: 22% at 6 months, 25% at 18 months; reportedly did not differ by group
Exclusions: ns
Report does not provide numbers per group at each assessment.

Peipert 2008

MethodsLocation: Rhode Island (USA)
Sample size calculation (and outcome of focus): N=250 in each group to detect two-fold increase in dual method use and 50% difference in unintended pregnancy
ParticipantsGeneral with N: 542 women
Source: primary care and family planning clinics
Inclusion criteria: 13 to 35 years old, sex with man in past 6 months, desire to avoid pregnancy for 24 months; if age 25 to 35 years, then high-risk history (unplanned pregnancy, STI, inconsistent contraception use, > 1 sex partner in past 6 months, drug or alcohol abuse)
Exclusion criteria: currently using dual methods of contraception consistently and correctly.
InterventionsStudy focus: STI and pregnancy prevention
Theory or model: Transtheoretical model
Treatment: 3 sessions over 80 days; individually-tailored, computer-delivered; designed to move toward action and maintenance for dual-method use and recycling through relapse.
Comparison or control: 1 session, computer-delivered, standard contraception and STI prevention information.
Duration: depended on study arm; follow up by phone at 6 and 18 months, return visits at 12 and 24 months.
OutcomesPrimary: dual-method use (hormonal + barrier; male condoms + female condoms; condoms + spermicide; intrauterine device + barrier); consistent condom use; unplanned pregnancy (tested)
Secondary: na
Additional data provided by investigator: na
NotesLater article (Peipert et al, 2011) reported on 'sustained' use of dual methods (reported use >= 2 follow-up interviews).
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskComputer program; stratified by site and contraceptive use
Allocation concealment (selection bias)Unclear riskComputer allocated women after collecting baseline information; separate from executor of assignment (phone interviewer and nurse doing exams)
Blinding (performance bias and detection bias)
All outcomes
Low riskFollow-up evaluators were 'masked' to allocation as far as possible
Incomplete outcome data (attrition bias)
All outcomes
High risk

Losses to follow up: 26% by 24 months (groups had similar losses)

2011 paper: N=463; 15% had no follow-up data
Exclusions after randomization: no; intent-to-treat analysis

Petersen 2007

MethodsLocation: North Carolina (USA)
Sample size calculation (and outcome of focus): N=1050 to measure improvements in level of contraceptive use (with 10% loss = 948)
ParticipantsGeneral with N: 764 women visiting clinics
Source: 3 primary care clinics serving "numerous" counties
Inclusion criteria: 16 to 44 years old, at risk of unintended pregnancy (not pregnant and not planning to get pregnant, not using an IUD, and neither the woman or her partner was sterilized)
Exclusion criteria: ns
InterventionsStudy focus: pregnancy and STI prevention counseling
Theory or model: motivational interviewing
Treatment: counseling session on reproductive health, based on motivational interviewing; explored discrepancy between pregnancy intention and contraceptive use and between STI risk and condom use, information shared with participants, promoted behaviors to reduce risk. Booster session provided to participants 2 months later - in person or by telephone.
Comparison or control: brief general counseling on preventive health care, excluding counseling on pregnancy and STI prevention
Duration: 2 sessions for treatment and 1 for control, with follow up assessments at 2, 8, and 12 months.
Outcomes

Primary: contraceptive use improved (nonuser shifted to high or low level, or woman at low level shifted to high), maintained at high level or improved to maintain highest level, decreased (shifted from high to low level, or shifted from low to nonuse, or maintained at low level or nonuse); consistent condom use.

Pregnancy data (tested) were not provided, but reportedly did not differ significantly between the groups.
Secondary: na
Additional data provided by investigator: number that completed each follow up by study arm (flow diagram of trial participants); pregnancy data by study arm

Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskRandom-numbers table; permuted blocks of 100
Allocation concealment (selection bias)Unclear riskSealed envelopes (no other detail)
Blinding (performance bias and detection bias)
All outcomes
Unclear riskns
Incomplete outcome data (attrition bias)
All outcomes
Low riskLosses to follow up: overall 13% at 12 months (groups were the same)
Exclusions after randomization: none apparent; analysis reportedly included 737 with complete follow-up data.

Ross 2007

MethodsLocation: Mwanza Region, Tanzania
Sample size calculation (and outcome of focus): 10 to 11 communities per arm (with 500 per community) to detect 50% reduction in HIV incidence (from 1.6% to 0.8%)
Cluster randomized trial: communities were assigned to study groups.
ParticipantsGeneral with N: 20 rural, well-separated, communities; 9645 adolescents
Source: Mwanza Region
Inclusion criteria: rural communities, located in 1 of 4 districts; evaluation cohort limited to students born in 1984 or later (at least age 14 at start and age 16.75 at final follow up) - due to age-related differences in HIV prevalence.
Exclusion criteria: students who received intervention but were not within specified age limits
InterventionsStudy focus: reduce incidence of HIV, other STIs, and unwanted pregnancy among adolescents
Theory or model: primarily Social Cognitive Theory
Treatment: 3-year school curriculum (students received 1, 2, or 3 years depending on school level (grade) at project start), youth-friendly health services, community activities, and condom promotion and distribution
Comparison or control: usual activities
Duration: follow up at 18 and 36 months after baseline
Outcomes

Primary: pregnancy (tested and self-reported during follow up), condom use (first time and during last sex)
Secondary: knowledge of pregnancy prevention

Initial outcome data collected from 2001 to 2002 (at 3 years); reported in Ross 2007.
Additional data provided by investigator: na

NotesReported in Doyle et al, 2010: cross-sectional survey (at 9 years) from Jun 2007 to Jul 2008; N=13,814, 15 to 30 years old, attended trial schools during intervention (1999 to 2002). Sample size calculation for survey (and outcome of focus): 10 communities per arm; 14,520 participants for 85% power to detect 50% reduction in HIV prevalence in males and 79% power to detect 35% reduction in females.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskCommunities were grouped into 3 strata by HIV prevalence and geographical characteristics. Constrained randomization, via computer program, to allocate and ensure balance on important factors. One allocation that met the balance criteria was randomly chosen.
Allocation concealment (selection bias)Unclear riskCommunities were identified prior to randomization. All adolescents meeting the inclusion criteria were eligible.
Blinding (performance bias and detection bias)
All outcomes
Unclear riskns
Incomplete outcome data (attrition bias)
All outcomes
High riskLosses: 27% overall; 28% intervention and 26% comparison; no communities dropped out as a whole.
Exclusions after randomization: none

Schinke 1981

MethodsLocation: not specified; authors were based in Seattle, WA (USA)
Sample size calculation (and outcome of focus): ns
ParticipantsGeneral with N: 36 high school students (sophomores)
Source: public high school
Inclusion criteria: sophomore class students
Exclusion criteria: ns
InterventionsStudy focus: preventing adolescent pregnancy
Theory or model: Cognitive and behavioral training; problem-solving schema
Treatment: 1) pretest, training, and post-test; 2) training and post-test.
Comparison or control: 1) pretest and post-test; 2) post-test only.
Duration: 14 group sessions of 50 minutes each.
Follow up at 6 months.
OutcomesData were not available for analysis in this review. Due to the age of the study, we did not request data from the investigator.
Primary: 'habitual contraception,' 'greater protection at last intercourse,' 'less reliance on inadequate birth control'
Secondary: na
Additional data provided by investigator: clarification that the contraceptive outcomes were based on reported behavior.
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskns
Allocation concealment (selection bias)Unclear riskns
Blinding (performance bias and detection bias)
All outcomes
Low riskMeasures were scored by 2 assistants who were not aware of study conditions or hypotheses
Incomplete outcome data (attrition bias)
All outcomes
Unclear riskLosses to follow up: ns
Exclusions after randomization: ns

Sieving 2013

Methods

Location: Minneapolis and Saint Paul, MN (USA); recruitment from Apr 2007 to Oct 2008.

Sample size calculation (and outcome of focus): ns

Participants

General with N: 253 sexually active girls, 13 to 17 years old
Source: four school and community-based clinics

Inclusion: one or more of following: clinic visit with negative pregnancy test or treatment for STI, young age, high-risk sexual and contraceptive behavior, aggressive and violent behavior, and behavior indicating school disconnection. (Behavioral indicators from screening tool.)

Exclusion: did not understand consent material; married, pregnant, or had given birth.

Interventions

Study focus: reduce pregnancy risk (sexual risk behavior, involvement in violence, school disconnection)

Theory or model:

  • social cognitive theory and the resilience paradigm;

  • principles of social connectedness used, but not cited as guiding theory or model.

Treatment: usual clinic services plus combination of case management and peer leadership program (included contraceptive use skills)

Control: usual clinic services

Duration: 18-month intervention

Outcomes

Primary: contraceptive use consistency with most recent sex partner (condoms, hormonal, dual-method (hormonal plus condoms)). Consistency based on number of months method was reportedly used during sex (every time or most times); range 0 to 7 (past 6 months and current month).

ORs reportedly adjusted for baseline measure (of outcome measure) and within-clinic clustering; contraceptive use also adjusted for change in recent sex partner.

Secondary: desire to use contraception (1 item, later dichotomized)

Assessments after 12 and 18 months of intervention and at 24 months (6-month follow up).

NotesInvestigator provided further information on 1) randomization and allocation concealment; 2) 'clustering' meant the analysis included 'clinic’ variable to adjust for similarities of teens enrolled from any specific particular clinic; 3) 'beliefs about birth control' not reported with final outcomes due to space limits and being non-significant.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskInvestigator communicated that they generated a list of random numbers for each clinic. Teens were individually randomized within clinics.
Allocation concealment (selection bias)High riskNot used (investigator communication)
Blinding (performance bias and detection bias)
All outcomes
Unclear riskns
Incomplete outcome data (attrition bias)
All outcomes
Low risk

Losses: 6% overall; 8% intervention, 3% control

Exclusions after randomization:

Stanton 2004

MethodsLocation: Baltimore, MD (USA)
Sample size calculation (and outcome of focus): ns
Sites were assigned to treatment group. Report included intraclass correlation coefficients and number of clusters for use in calculating design effect.
Cluster randomized trial: communities were assigned to study groups; 35 sites.
ParticipantsGeneral with N: 817 youth, African Americans, 13 to 16 years old
Source: low-income housing developments, tenant associations and local recreation center staff
Inclusion criteria: youth living in low income communities
Exclusion criteria: ns
Interventions

Study focus: multiple risk reduction, including sexual risk
Theory or model: Protection Motivation Theory
Treatment:

  • Focus on Kids (FOK), 8 weekly group meetings at 1.5 hours each on risk reduction;

  • FOK plus parent program (ImPACT) on monitoring and communicating (20-minute video, role-play, and discussion);

  • FOK plus ImPACT plus booster session for FOK (90-minutes each at 7, 10, 13, 16 months after intervention).

Comparison or control: na
Duration: see treatment arms above; follow up assessments at 6, 12, 18, and 24 months after intervention.

OutcomesPrimary: in past 6 months - been pregnant or gotten a girl pregnant (self-reported), used birth control during last sex (specify a method), used condom during last sex; only 24-month data were reported
Secondary: na
Additional data provided by investigator: na
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskUse of a random numbers table
Allocation concealment (selection bias)Unclear riskRandomization of sites occurred after all youths in the selected sites were identified. All youths meeting the inclusion criteria were eligible.
Blinding (performance bias and detection bias)
All outcomes
Unclear riskns
Incomplete outcome data (attrition bias)
All outcomes
High riskLosses to follow up: 40%, groups ranged from 38% to 41%
Exclusions after randomization: ns

Wight 2002

  1. a

    Note: Primary and secondary outcomes refer to those selected for this review. These outcomes may not have had the same priority in the trial reports.
    N = number
    na = not applicable
    ns = not specified
    STI = sexually transmitted infection

MethodsLocation: Tayside and Lothian regions of Scotland
Sample size calculation (and outcome of focus): 80% power to detect 28% decrease in sex without condom use for each gender
Cluster randomized trial: schools were assigned to intervention or control
ParticipantsGeneral with N: 25 schools, 8430 participants, 13 to 15 years old
Source: schools
Inclusion criteria: non-Catholic state schools within 24 km of main cities in region; students were in third year of secondary school
Exclusion criteria: pilot schools; teachers excluded 3 students due to learning difficulties
InterventionsStudy focus: reduce unsafe sex behavior, unwanted pregnancies, and improve quality of sexual relationships
Theory or model: primarily Social Cognitive Theory plus 'orthodox' health education principles
Treatment: 20 sessions (10 in 3rd year and 10 in 4th year) (13 schools)
Comparison or control: usual sex education (12 schools)
Duration: 2 school years; follow up about 6 months after program completion
Outcomes

Primary: first sex without condom, condom use with last sex, oral contraception (pills) with last sex, unwanted pregnancy (self-reported)

Final pregnancy data at age 20 (linked National Health Service records), 4.5 years after intervention (reported in Henderson et al, 2006).
Secondary: na
Additional data provided by investigator: na

Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskBalanced randomization: assigned schools by selecting an allocation that provided good balance on all school-level measures.
Allocation concealment (selection bias)Unclear riskSchools were identified prior to randomization. All students meeting the inclusion criteria were eligible.
Blinding (performance bias and detection bias)
All outcomes
Low riskData analysis and checking was conducted while blind to study arm.
Incomplete outcome data (attrition bias)
All outcomes
High riskLosses: 32% treatment, 29% control
Exclusions: none apparent

Characteristics of excluded studies [ordered by study ID]

StudyReason for exclusion
Bachanas 2012Study focus: HIV prevention
Barnet 2007The experimental intervention (home visiting) focused on parenting and adolescent curricula. For contraception, the home-visitors "sought to connect adolescents with primary care." Hence, the theoretical basis did not apply to the contraceptive component.
Barth 1992Some classes were assigned randomly to study groups, while others were assigned based on group size.
Boekeloo 1999Intervention focused on STI and HIV prevention, emphasized condom use for protection and abstinence as the safest behavior.
Brown 2011Investigator communicated that study was not randomized. Materials for each condition were distributed ad hoc within each classroom or data collection setting.
Carneiro 2011No explicit behavioral theory or model
Chung-Park 2008Random assignment by group; analysis did not appear to account for clustering effects.
DiClemente 2004Study focus: HIV prevention among female adolescents; no mention of contraception.
DiIorio 2006Study focus: HIV prevention
Eisen 1990Random assignment by group; analysis did not appear to account for clustering effects.
Ferrer 2011Study focus: sexual risk reduction not contraception
Gallegos 2008Did not have any of the primary outcomes in this review. Study focused on intentions to use condoms and contraceptives, not behavior.
Garbers 2012No explicit behavioral theory or model
Hanna 1993Primary outcome of contraceptive adherence combined pill-taking and appointment-keeping.
Hoffman 2003Study focus: HIV and STI prevention
Ingersoll 2013No contraceptive counseling intervention, unlike Ingersoll 2005.
Ito 2008Did not have any of the primary outcomes in this review
James 2006No explicit behavioral theory or model
Jemmott 2005Study focus: HIV and STI risk reduction
Jemmott 2007Study focus: HIV and STI risk reduction
Jewkes 2008Focused on preventing HIV infections
Kalichman 1999Study focus: HIV prevention via condom use
Kiene 2006Study focus: HIV/AIDS risk reduction via condom use
Kirby 1997Classrooms were assigned to study group; analysis did not appear to account for clustering effects.
Kraft 2007No relevant outcome measure. Report notes that effective contraceptive use did not differ significantly between the study groups; data were not presented.
Langston 2010No explicit behavioral theory or model
Lederman 2003No behavioral data were reported, so no primary outcomes for this review were available. Later reports included attitudes and intentions.
Lee 2007Coin flip determined which rooms were assigned to program first. Even-numbered rooms were the experimental group and odd-numbered were the control group. Cluster assignment (by room) not addressed in the analysis.
Lee 2011Even-numbered rooms were control group (routine services). Odd-numbered rooms were experimental; divided into 2 groups (1 to 11; 13 to 23); coin flip determined which would receive the special intervention first (versus pamphlet). Rooms with double occupancy were assigned as a unit. Cluster assignment (by room) not addressed in the analysis.
Legardy 2005No explicit behavioral theory or model; some constructs were mentioned.
Melnick 2008Did not have any of the primary outcomes in this review. No explicit behavioral theory or model that might have guided the development of the intervention. Both groups had the same counseling; the 'intensive' intervention also included 3-month supply of contraceptives.
Moberg 1998Assignment was not completely random. Schools were randomized to either control or treatment, but the latter had a choice of 2 treatments. Curriculum objectives included not engaging in sex.
Morrison-Beedy 2005Study focus: HIV risk reduction
Peragallo 2005Study focus: HIV prevention
Roberto 2007Random assignment by group; only 2 schools were randomized so the analysis could not be adjusted for clustering effects.
Roye 2007Study focus: brief intervention to prevent HIV via condom use (in addition to current use of hormonal contraceptives)
Shain 1999Study focus: preventing STI among minority women
Sieving 2012Pilot study to refine intervention protocols and determine preliminary efficacy. Outcome analysis included participants randomized (phase 1) and nonrandomized (phase 2).
Stanton 1996Study focus: AIDS prevention
Stanton 2005Trial had 4 arms (3 program versions and 1 control). Investigators excluded the one group (with the interactive televised version) from the analysis. A secondary report (Stanton 2006) grouped the 3 intervention arms and compared them to the control. Adjustment for cluster effects was not apparent in the latter report.
Stephenson 2004No explicit behavioral theory or model
Thato 2008Curriculum emphasized abstinence (Thai values and culture toward premarital sex and maintaining virginity until marriage). Report did not include any of the primary outcomes for this review.
Tortolero 2008The investigator communicated that there was no intervention effect and they never published an outcome paper.
Villarruel 2006Study focus: HIV prevention for Latino youth
Vogt 2012No relevant outcome
Weeks 1997Random assignment by group; analysis did not appear to account for cluster effects.
Winter 1993No explicit behavioral theory or model. Did not have any of the primary outcomes in this review. 'Condom acceptance' was defined by the number of condoms taken at the end of the session rather than reported use.
Zimmerman 2008Curriculum emphasized abstinence.

Ancillary