Intervention Review

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Theory-based interventions for contraception

  1. Laureen M Lopez1,*,
  2. Elizabeth E. Tolley2,
  3. David A Grimes3,
  4. Mario Chen4,
  5. Laurie L Stockton5

Editorial Group: Cochrane Fertility Regulation Group

Published Online: 7 AUG 2013

Assessed as up-to-date: 3 JUL 2013

DOI: 10.1002/14651858.CD007249.pub4


How to Cite

Lopez LM, Tolley EE, Grimes DA, Chen M, Stockton LL. Theory-based interventions for contraception. Cochrane Database of Systematic Reviews 2013, Issue 8. Art. No.: CD007249. DOI: 10.1002/14651858.CD007249.pub4.

Author Information

  1. 1

    FHI 360, Clinical Sciences, Research Triangle Park, North Carolina, USA

  2. 2

    FHI, Behavioral and Social Sciences, Research Triangle Park, North Carolina, USA

  3. 3

    University of North Carolina, School of Medicine, Obstetrics and Gynecology, Chapel Hill, North Carolina, USA

  4. 4

    FHI 360, Division of Biostatistics, Research Triangle Park, North Carolina, USA

  5. 5

    FHI360, Health Services Research, Research Triangle Park, North Carolina, USA

*Laureen M Lopez, Clinical Sciences, FHI 360, P.O. Box 13950, Research Triangle Park, North Carolina, 27709, USA. llopez@fhi360.org.

Publication History

  1. Publication Status: New search for studies and content updated (no change to conclusions)
  2. Published Online: 7 AUG 2013

SEARCH

 

Background

  1. Top of page
  2. Background
  3. Objectives
  4. Methods
  5. Results
  6. Discussion
  7. Authors' conclusions
  8. Acknowledgements
  9. Data and analyses
  10. Appendices
  11. What's new
  12. History
  13. Contributions of authors
  14. Declarations of interest
  15. Sources of support
  16. Index terms

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

  1. Top of page
  2. Background
  3. Objectives
  4. Methods
  5. Results
  6. Discussion
  7. Authors' conclusions
  8. Acknowledgements
  9. Data and analyses
  10. Appendices
  11. What's new
  12. History
  13. Contributions of authors
  14. Declarations of interest
  15. Sources of support
  16. Index terms

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

  1. Top of page
  2. Background
  3. Objectives
  4. Methods
  5. Results
  6. Discussion
  7. Authors' conclusions
  8. Acknowledgements
  9. Data and analyses
  10. Appendices
  11. What's new
  12. History
  13. Contributions of authors
  14. Declarations of interest
  15. Sources of support
  16. Index terms
 

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.

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

  1. Top of page
  2. Background
  3. Objectives
  4. Methods
  5. Results
  6. Discussion
  7. Authors' conclusions
  8. Acknowledgements
  9. Data and analyses
  10. Appendices
  11. What's new
  12. History
  13. Contributions of authors
  14. Declarations of interest
  15. Sources of support
  16. Index terms
 

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.

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).

    • 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).
    • 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).
  • 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).

 

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).

  • 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).

 

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).

 

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.

 

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).

  • 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

  1. Top of page
  2. Background
  3. Objectives
  4. Methods
  5. Results
  6. Discussion
  7. Authors' conclusions
  8. Acknowledgements
  9. Data and analyses
  10. Appendices
  11. What's new
  12. History
  13. Contributions of authors
  14. Declarations of interest
  15. Sources of support
  16. Index terms
 

Summary of main results

 

Outcome group

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

  • 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

  1. Top of page
  2. Background
  3. Objectives
  4. Methods
  5. Results
  6. Discussion
  7. Authors' conclusions
  8. Acknowledgements
  9. Data and analyses
  10. Appendices
  11. What's new
  12. History
  13. Contributions of authors
  14. Declarations of interest
  15. Sources of support
  16. Index terms

 

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

  1. Top of page
  2. Background
  3. Objectives
  4. Methods
  5. Results
  6. Discussion
  7. Authors' conclusions
  8. Acknowledgements
  9. Data and analyses
  10. Appendices
  11. What's new
  12. History
  13. Contributions of authors
  14. Declarations of interest
  15. Sources of support
  16. Index terms

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

  1. Top of page
  2. Background
  3. Objectives
  4. Methods
  5. Results
  6. Discussion
  7. Authors' conclusions
  8. Acknowledgements
  9. Data and analyses
  10. Appendices
  11. What's new
  12. History
  13. Contributions of authors
  14. Declarations of interest
  15. Sources of support
  16. Index terms
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]

 
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)1Odds Ratio (M-H, Fixed, 95% CI)Subtotals only

    1.1 Youth + parent programs versus youth program
1353Odds Ratio (M-H, Fixed, 95% CI)0.24 [0.10, 0.56]

    1.2 Youth + parent programs versus youth + parent programs + booster session
1295Odds Ratio (M-H, Fixed, 95% CI)0.27 [0.11, 0.66]

 2 Used contraception at last sex (at 24 months)1Odds Ratio (M-H, Fixed, 95% CI)Subtotals only

    2.1 Youth + parent programs versus youth programs
1337Odds Ratio (M-H, Fixed, 95% CI)1.35 [0.81, 2.25]

    2.2 Youth + parent programs versus youth + parent programs + booster session
1282Odds Ratio (M-H, Fixed, 95% CI)0.72 [0.43, 1.21]

 3 Used condom at last sex (at 24 months)1Odds Ratio (M-H, Fixed, 95% CI)Subtotals only

    3.1 Youth + parent programs versus youth program
1334Odds Ratio (M-H, Fixed, 95% CI)1.25 [0.76, 2.04]

    3.2 Youth + parent programs versus youth + parent programs + booster session
1279Odds Ratio (M-H, Fixed, 95% CI)0.92 [0.53, 1.61]

 
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 use1Odds Ratio (M-H, Fixed, 95% CI)Subtotals only

    1.1 At 1 month
1199Odds Ratio (M-H, Fixed, 95% CI)0.49 [0.28, 0.87]

    1.2 At 4 months
1207Odds Ratio (M-H, Fixed, 95% CI)0.56 [0.31, 0.98]

 2 Effective contraceptive use (at 3 months)1Odds Ratio (M-H, Fixed, 95% CI)Subtotals only

    2.1 At 3 months
1665Odds Ratio (M-H, Fixed, 95% CI)2.12 [1.53, 2.92]

    2.2 At 9 months
1593Odds Ratio (M-H, Fixed, 95% CI)2.04 [1.47, 2.83]

 
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 improved1Odds Ratio (M-H, Fixed, 95% CI)Subtotals only

    1.1 At 2 months
1648Odds Ratio (M-H, Fixed, 95% CI)1.33 [0.95, 1.85]

    1.2 At 12 months
1664Odds 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]

 
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]

 
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 months1Odds Ratio (M-H, Fixed, 95% CI)Subtotals only

    1.1 CAMI+ versus CAMI
1167Odds Ratio (M-H, Fixed, 95% CI)0.77 [0.33, 1.78]

    1.2 CAMI versus usual care
1155Odds Ratio (M-H, Fixed, 95% CI)0.63 [0.29, 1.37]

 
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 counseling1Odds Ratio (M-H, Fixed, 95% CI)Subtotals only

    1.1 At 3 months
1767Odds Ratio (M-H, Fixed, 95% CI)1.41 [1.06, 1.87]

    1.2 At 12 months
1767Odds Ratio (M-H, Fixed, 95% CI)1.12 [0.78, 1.61]

 2 Consistent OC use: counseling versus standard care1Odds Ratio (M-H, Fixed, 95% CI)Subtotals only

    2.1 At 3 months
1771Odds Ratio (M-H, Fixed, 95% CI)0.81 [0.61, 1.07]

    2.2 At 12 months
1771Odds Ratio (M-H, Fixed, 95% CI)0.89 [0.62, 1.27]

 3 Dual-method use: counseling + phone versus counseling1Odds Ratio (M-H, Fixed, 95% CI)Subtotals only

    3.1 At 3 months
1767Odds Ratio (M-H, Fixed, 95% CI)1.38 [0.87, 2.18]

    3.2 At 12 months
1767Odds Ratio (M-H, Fixed, 95% CI)1.00 [0.51, 1.95]

 4 Dual-method use: counseling versus standard care1Odds Ratio (M-H, Fixed, 95% CI)Subtotals only

    4.1 At 3 months
1771Odds Ratio (M-H, Fixed, 95% CI)0.79 [0.50, 1.26]

    4.2 At 12 months
1771Odds Ratio (M-H, Fixed, 95% CI)0.75 [0.40, 1.40]

 5 Condom use at last sex: counseling + phone versus counseling1Odds Ratio (M-H, Fixed, 95% CI)Subtotals only

    5.1 At 3 months
1767Odds Ratio (M-H, Fixed, 95% CI)1.45 [1.03, 2.03]

    5.2 At 12 months
1767Odds Ratio (M-H, Fixed, 95% CI)0.93 [0.55, 1.57]

 6 Condom use at last sex: counseling versus standard care1Odds Ratio (M-H, Fixed, 95% CI)Subtotals only

    6.1 At 3 months
1771Odds Ratio (M-H, Fixed, 95% CI)0.91 [0.64, 1.29]

    6.2 At 12 months
1771Odds Ratio (M-H, Fixed, 95% CI)1.01 [0.60, 1.70]

 7 Pregnancy (by 12 months)1Odds Ratio (M-H, Fixed, 95% CI)Subtotals only

    7.1 Counseling + phone versus counseling
1767Odds Ratio (M-H, Fixed, 95% CI)0.80 [0.53, 1.18]

    7.2 Counseling versus standard care
1771Odds Ratio (M-H, Fixed, 95% CI)1.39 [0.93, 2.09]

 8 Would recommend OC use to a friend: counseling + phone versus counseling1Odds Ratio (M-H, Fixed, 95% CI)Subtotals only

    8.1 At 3 months
1623Odds Ratio (M-H, Fixed, 95% CI)1.52 [1.11, 2.09]

    8.2 At 12 months
1432Odds Ratio (M-H, Fixed, 95% CI)1.13 [0.75, 1.68]

 9 Would recommend OC use to a friend: counseling versus standard care1Odds Ratio (M-H, Fixed, 95% CI)Subtotals only

    9.1 At 3 months
1625Odds Ratio (M-H, Fixed, 95% CI)0.78 [0.57, 1.07]

    9.2 At 12 months
1427Odds Ratio (M-H, Fixed, 95% CI)0.82 [0.55, 1.23]

 

Appendices

  1. Top of page
  2. Background
  3. Objectives
  4. Methods
  5. Results
  6. Discussion
  7. Authors' conclusions
  8. Acknowledgements
  9. Data and analyses
  10. Appendices
  11. What's new
  12. History
  13. Contributions of authors
  14. Declarations of interest
  15. Sources of support
  16. Index terms
 

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

  1. Top of page
  2. Background
  3. Objectives
  4. Methods
  5. Results
  6. Discussion
  7. Authors' conclusions
  8. Acknowledgements
  9. Data and analyses
  10. Appendices
  11. What's new
  12. History
  13. Contributions of authors
  14. Declarations of interest
  15. Sources of support
  16. Index terms

Last assessed as up-to-date: 3 July 2013.


DateEventDescription

3 July 2013New search has been performedSearches updated.

30 May 2013New citation required but conclusions have not changedThree 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.



 

History

  1. Top of page
  2. Background
  3. Objectives
  4. Methods
  5. Results
  6. Discussion
  7. Authors' conclusions
  8. Acknowledgements
  9. Data and analyses
  10. Appendices
  11. What's new
  12. History
  13. Contributions of authors
  14. Declarations of interest
  15. Sources of support
  16. Index terms

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

  1. Top of page
  2. Background
  3. Objectives
  4. Methods
  5. Results
  6. Discussion
  7. Authors' conclusions
  8. Acknowledgements
  9. Data and analyses
  10. Appendices
  11. What's new
  12. History
  13. Contributions of authors
  14. Declarations of interest
  15. Sources of support
  16. Index terms

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

  1. Top of page
  2. Background
  3. Objectives
  4. Methods
  5. Results
  6. Discussion
  7. Authors' conclusions
  8. Acknowledgements
  9. Data and analyses
  10. Appendices
  11. What's new
  12. History
  13. Contributions of authors
  14. Declarations of interest
  15. Sources of support
  16. Index terms

None

 

Sources of support

  1. Top of page
  2. Background
  3. Objectives
  4. Methods
  5. Results
  6. Discussion
  7. Authors' conclusions
  8. Acknowledgements
  9. Data and analyses
  10. Appendices
  11. What's new
  12. History
  13. Contributions of authors
  14. Declarations of interest
  15. Sources of support
  16. Index terms
 

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)

* Indicates the major publication for the study

References

References to studies included in this review

  1. Top of page
  2. Abstract
  3. Background
  4. Objectives
  5. Methods
  6. Results
  7. Discussion
  8. Authors' conclusions
  9. Acknowledgements
  10. Data and analyses
  11. Appendices
  12. What's new
  13. History
  14. Contributions of authors
  15. Declarations of interest
  16. Sources of support
  17. Characteristics of studies
  18. References to studies included in this review
  19. References to studies excluded from this review
  20. Additional references
  21. References to other published versions of this review
Barnet 2009 {published data only}
  • Barnet B, Liu J, DeVoe M, Duggan AK, Gold MA, Pecukonis E. Motivational intervention to reduce rapid subsequent births to adolescent mothers: a community-based randomized trial. Annals of Family Medicine 2009, issue 5:436-45.
Berenson 2012 {published data only}
  • Berenson A B, Rahman M. A randomized controlled study of two educational interventions on adherence with oral contraceptives and condoms. Contraception 2012;86(6):716-24.
Black 2006 {published data only (unpublished sought but not used)}
  • Black MM, Bentley ME, Papas MA, Oberlander S, Teti LO, McNary S, et al. Delaying second births among adolescent mothers: a randomized, controlled trial of a home-based mentoring program. Pediatrics 2006;118(4):e1087-99.
  • Black MM, Siegel EH, Abel Y, Bentley ME. Home and videotape intervention delays early complementary feeding among adolescent mothers. Pediatrics 2001;107(5):e67.
Boyer 2005 {published and unpublished data}
  • Boyer CB, Shafer MA, Shaffer RA, Brodine SK, Pollack LM, Betsinger K, et al. Evaluation of a cognitive-behavioral, group, randomized controlled intervention trial to prevent sexually transmitted infections and unintended pregnancies in young women. Preventive Medicine 2005;40(4):420-31.
Cowan 2010 {published data only}
  • Cowan F M, Pascoe S J, Langhaug L F, Dirawo J, Chidiya S, Jaffar S, et al. The Regai Dzive Shiri Project: a cluster randomised controlled trial to determine the effectiveness of a multi-component community-based HIV prevention intervention for rural youth in Zimbabwe--study design and baseline results. Tropical Medicine & International Health 2008;13(10):1235-44.
  • Cowan F M, Pascoe S J, Langhaug L F, Mavhu W, Chidiya S, Jaffar S, et al. The Regai Dzive Shiri project: results of a randomized trial of an HIV prevention intervention for youth. AIDS 2010;24(16):2541-52.
  • Hayes RJ, Changaluchab J, Ross DA, Gavyolec A, Todd J, Obasi AIN, et al. The MEMA kwa Vijana Project: Design of a community randomised trial of an innovative adolescent sexual health intervention in rural Tanzania. Contemporary Clinical Trials 2005;26(4):430-42.
  • Obasi AI, Cleophas B, Ross DA, Chima KL, Mmassy G, Gavyole A, et al. Rationale and design of the MEMA kwa Vijana adolescent sexual and reproductive health intervention in Mwanza Region, Tanzania. AIDS Care 2006;18(4):311-22.
Coyle 2001 {published data only}
  • Coyle K, Basen-Engquist K, Kirby D, Parcel G, Banspach S, Collins J, et al. Safer Choices: Reducing teen pregnancy, HIV, and STDs. Public Health Reports 2001;116(Suppl 1):82-93.
  • Coyle K, Basen-Engquist K, Kirby D, Parcel G, Banspach S, Harrist R, et al. Short-term impact of Safer Choices: a multicomponent, school-based HIV, other STD, and pregnancy prevention program. Journal of School Health 1999;69(5):181-8.
  • Kirby DB, Baumler E, Coyle KK, Basen-Engquist K, Parcel GS, Harrist R, et al. The "Safer Choices" intervention: its impact on the sexual behaviors of different subgroups of high school students. Journal of Adolescent Health 2004;35(6):442-52.
Coyle 2006 {published data only (unpublished sought but not used)}
  • Coyle KK, Kirby DB, Robin LE, Banspach SW, Baumler E, Glassman JR. All4You! A randomized trial of an HIV, other STDs, and pregnancy prevention intervention for alternative school students. AIDS Education and Prevention 2006;18(3):187-203.
Floyd 2007 {published data only}
  • Floyd RL, Sobell M, Velasquez MM, Ingersoll K, Nettleman M, Sobell L, et al. Preventing alcohol-exposed pregnancies. A randomized controlled trial. American Journal of Preventive Medicine 2007;32(1):1-10.
  • Ingersoll K, Floyd l, Sobell M, Velasquez MM, Project CHOICES Intervention Research Group. Reducing the risk of alcohol-exposed pregnancies: a study of a motivational intervention in community settings. Pediatrics 2003;111(5 Part 2):1131-5.
  • Velasquez MM, Ingersoll KS, Sobell MB, Floyd RL, Sobell LC, von Sternberg K. A dual-focus motivational intervention to reduce the risk of alcohol-exposed pregnancy. Cognitive and Behavioral Practice. 2010/05/18 2010; Vol. 17, issue 2:203-12.
Ingersoll 2005 {published and unpublished data}
  • Ceperich S D, Ingersoll K S. Motivational interviewing + feedback intervention to reduce alcohol-exposed pregnancy risk among college binge drinkers: determinants and patterns of response. J Behav Med 2011;34(5):381-95.
  • Ingersoll KS, Ceperich SD, Nettleman MD, Karanda K, Brocksen S, Johnson BA. Reducing alcohol-exposed pregnancy risk in college women: initial outcomes of a clinical trial of a motivational intervention. Journal of Substance Abuse Treatment 2005;29(3):173-80.
Kirby 2010 {published data only}
  • Kirby D, Raine T, Thrush G, Yuen C, Sokoloff A, Potter SC. Impact of an intervention to improve contraceptive use through follow-up phone calls to female adolescent clinic patients. Perspectives on Sexual and Reproductive Health 2010;42(4):251-7. [: NCT00230880]
  • Raine TR. Young Woman's Reach Project: Trial of an Intervention to Impact Contraceptive Behavior, Unintended Pregnancy, and Sexually Transmitted Infections (STIs) Among Adolescent Females (REACH). http://clinicaltrials.gov/ct2/show/NCT00230880 (accessed 10 Dec 2010).
Peipert 2008 {published data only}
  • Peipert J F, Zhao Q, Meints L, Peipert B J, Redding C A, Allsworth J E. Adherence to dual-method contraceptive use. Contraception 2011;84(3):252-8.
  • Peipert J, Redding CA, Blume J, Allsworth JE, Iannuccillo K, Lozowski F, Mayer K, Morokoff PJ, Rossi JS. Design of a stage-matched intervention trial to increase dual method contraceptive use (Project PROTECT). Contemporary Clinical Trials 2007;28(5):626-37.
  • Peipert JF, Redding CA, Blume JD, Allsworth JE, Matteson KA, Lozowski F, et al. Tailored intervention to increase dual-contraceptive method use: a randomized trial to reduce unintended pregnancies and sexually transmitted infections. American Journal of Obstetrics & Gynecology 2008;198(6):630.e1-8.
Petersen 2007 {published and unpublished data}
Ross 2007 {published data only}
  • Doyle A M, Ross D A, Maganja K, Baisley K, Masesa C, Andreasen A, et al. Long-term biological and behavioural impact of an adolescent sexual health intervention in Tanzania: follow-up survey of the community-based MEMA kwa Vijana Trial. PLoS Med 2010;7(6):e1000287.
  • Hayes RJ, Changaluchab J, Ross DA, Gavyolec A, Todd J, Obasi AIN, et al. The MEMA kwa Vijana Project: Design of a community randomised trial of an innovative adolescent sexual health intervention in rural Tanzania. Contemporary Clinical Trials 2005;26(4):430-42.
  • Obasi AI, Cleophas B, Ross DA, Chima KL, Mmassy G, Gavyole A, et al. Rationale and design of the MEMA kwa Vijana adolescent sexual and reproductive health intervention in Mwanza Region, Tanzania. AIDS Care 2006;18(4):311-22.
  • Ross DA, Changaluchab J, Obasia AIN, Todd J, Plummer ML, Cleophas-Mazige B, et al. Biological and behavioural impact of an adolescent sexual health intervention in Tanzania: a community-randomized trial. AIDS 2007;21(14):1943-55.
Schinke 1981 {published data only (unpublished sought but not used)}
  • Schinke SP, Blythe BJ, Gilchrist LD. Cognitive-behavioral prevention of adolescent pregnancy. Journal of Counseling Psychology 1981;28(5):451-4.
  • Schinke SP, Gilchrist LD, Smith TE, Wong SE. Group interpersonal skills training in a natural setting: an experimental study. Behavior Research and Therapy 1979;17(2):149-54.
Sieving 2013 {published data only}
  • Sieving RE, McMorris BJ, Beckman KJ, Pettingell SL, Secor-Turner M, Kugler K, et al. Prime Time: 12-month sexual health outcomes of a clinic-based intervention to prevent pregnancy risk behaviors. Journal of Adolescent Health 2011;49(2):172-9.
  • Sieving RE, McRee AL, McMorris BJ, Beckman KJ, Pettingell SL, Bearinger LH, et al. Prime time: sexual health outcomes at 24 months for a clinic-linked intervention to prevent pregnancy risk behaviors. JAMA Pediatrics 2013;167(4):333-40.
  • Tanner AE, Secor-Turner M, Garwick A, Sieving R, Rush K. Engaging vulnerable adolescents in a pregnancy prevention program: perspectives of Prime Time staff. Journal of Pediatric Health Care 2010;26(4):254-65.
Stanton 2004 {published data only}
  • Stanton B, Cole M, Galbraith J, Li X, Pendleton S, Cottrel L, et al. Randomized trial of a parent intervention: parents can make a difference in long-term adolescent risk behaviors, perceptions, and knowledge. Archives of Pediatrics & Adolescent Medicine 2004;158(10):947-55.
  • Stanton BF, Li X, Galbraith J, Cornick G, Feigelman S, Kaljee L, et al. Parental underestimates of adolescent risk behavior: a randomized, controlled trial of a parental monitoring intervention. Journal of Adolescent Health 2000;26(1):18-26.
Wight 2002 {published data only}
  • Henderson M, Wight D, Raab GM, Abraham C, Parkes A, Scott S, et al. Impact of a theoretically based sex education programme (SHARE) delivered by teachers on NHS registered conceptions and terminations: final results of cluster randomised trial. British Medical Journal 2006;334(7585):133.
  • Wight D, Abraham C. From psycho­social theory to sustainable classroom practice: developing a research­based teacher­delivered sex education programme. Health Education Research 2000;15(1):25-38.
  • Wight D, Raab GM, Henderson M, Abraham C, Buston K, Hart G, et al. Limits of teacher delivered sex education: interim behavioural outcomes from randomised trial. British Medical Journal 2002;324(7351):1430.

References to studies excluded from this review

  1. Top of page
  2. Abstract
  3. Background
  4. Objectives
  5. Methods
  6. Results
  7. Discussion
  8. Authors' conclusions
  9. Acknowledgements
  10. Data and analyses
  11. Appendices
  12. What's new
  13. History
  14. Contributions of authors
  15. Declarations of interest
  16. Sources of support
  17. Characteristics of studies
  18. References to studies included in this review
  19. References to studies excluded from this review
  20. Additional references
  21. References to other published versions of this review
Bachanas 2012 {published data only (unpublished sought but not used)}
  • Bachanas P. HIV Prevention for PLHIV: Evaluation of an Intervention Toolkit for HIV Care & Treatment Settings. http://clinicaltrials.gov/ct2/show/NCT01256463 (accessed 31 Jul 2012).
  • Kidder DP, Bachanas P, Medley A, Pals S, Nuwagaba-Biribonwoha H, Ackers M, et al. HIV prevention in care and treatment settings: baseline risk behaviors among HIV patients in Kenya, Namibia, and Tanzania. PloS one. 2013/03/06 2013; Vol. 8, issue 2:e57215.
Barnet 2007 {published data only}
  • Barnet B, Liu J, DeVoe M, Alperovitz-Bichell K, Duggan AK. Home visiting for adolescent mothers: effects on parenting, maternal life course, and primary care linkage. Annals of Family Medicine 2007;5:224-32.
Barth 1992 {published data only}
  • Barth RP, Fetro JV, Leland N, Volkan K. Preventing adolescent pregnancy with social and cognitive skills. Journal of Adolescent Research 1992;7:208-32.
  • Kirby D, Barth RP, Leland N, Fetro JV. Reducing the Risk: impact of a new curriculum on sexual risk-taking. Family Planning Perspectives 1991;23:253-63.
Boekeloo 1999 {published data only}
Brown 2011 {published data only}
Carneiro 2011 {published data only}
  • Carneiro Gomes Ferreira A L, Impieri Souza A, Evangelista Pessoa R, Braga C. The effectiveness of contraceptive counseling for women in the postabortion period: an intervention study. Contraception 2011;84(4):377-83.
Chung-Park 2008 {published data only}
DiClemente 2004 {published data only}
  • DiClemente RJ, Wingood GM, Harrington KF, Lang DL, Davies SL, Hook EW 3rd, et al. Efficacy of an HIV prevention intervention for African-American adolescent girls: a randomized controlled trial. Journal of the American Medical Association 2004;292(2):171-9.
  • Wingood GM, DiClemente RJ, Harrington KF, Lang DL, Davies SL, Hook EW 3rd, et al. Efficacy of an HIV prevention program among female adolescents experiencing gender-based violence. American Journal of Public Health 2006;96(6):1085-90.
  • Wingood GM, DiClemente RJ, Hubbard McCree D, Harrington K, Davies SL. Dating violence and the sexual health of Black adolescent females. Pediatrics 2001;107(5):e72.
DiIorio 2006 {published data only}
  • DiIorio C, Resnicow K, McCarty F, De AK, Dudley WN, Wang DT, et al. Keepin' it R.E.A.L.!: results of a mother-adolescent HIV prevention program. Nursing Research 2006;55(1):43-51.
  • DiIorio C, Resnicow K, Thomas S, Wang DT, Dudley WN, Van Marter DF, et al. Keepin' It R.E.A.L.!: program description and results of baseline assessment. Health Education & Behavior 2002;29(1):104-23.
Eisen 1990 {published data only}
  • Eisen M, Zellman GL, McAlister AL. A Health Belief Model-Social Learning Theory approach to adolescents' fertility control: findings from a controlled field trial. Health Education Quarterly 1992;19:249-62.
  • Eisen M, Zellman GL, McAlister AL. Evaluating the impact of a theory-based sexuality and contraceptive education program. Family Planning Perspectives 1990;22:261-71.
Ferrer 2011 {published data only}
  • Ferrer R A, Fisher J D, Buck R, Amico K R. Pilot test of an emotional education intervention component for sexual risk reduction. Health Psychol 2011;30(5):656-60.
Gallegos 2008 {published data only}
  • Gallegos EC, Villarruel AM, Loveland-Cherry C, Ronis DL, Yan Zhou M. [Intervention to reduce adolescents sexual risk behaviors: a randomized controlled trial]. Salud Pública de México 2008;50:59-66.
  • Villarruel AM, Zhou Y, Gallegos EC, Ronis DL. Examining long-term effects of Cuidate-a sexual risk reduction program in Mexican youth. Revista Panamericana de sSalud Pública. 2010/07/06 2010; Vol. 27, issue 5:345-51.
Garbers 2012 {published data only}
  • Garbers S, Meserve A, Kottke M, Hatcher R, Chiasson M A. Tailored health messaging improves contraceptive continuation and adherence: results from a randomized controlled trial. Contraception 2012;86(5):536-42.
  • Garbers S, Meserve A, Kottke M, Hatcher R, Ventura A, Chiasson M A. Randomized controlled trial of a computer-based module to improve contraceptive method choice. Contraception 2012;86(4):383-90.
Hanna 1993 {published data only}
  • Hanna KM. Effect of nurse-client transaction on female adolescents' oral contraceptive adherence. IMAGE: Journal of Nursing Scholarship 1993;25:285-290.
Hoffman 2003 {published data only}
  • Ehrhardt AA, Exner TM, Hoffman S, Silberman I, Leu C-S, Miller S, et al. A gender-specific HIV/STD risk reduction intervention for women in a health care setting: short- and long-term results of a randomized clinical trial. AIDS Care 2002;14(2):147-61.
  • Ehrhardt AA, Exner TM, Hoffman S, Silberman I, Yingling S, Adams-Skinner J, et al. HIV/STD risk and sexual strategies among women family planning clients in New York: Project FIO. AIDS and Behavior 2002;6(1):1-13.
  • Hoffman S, Exner TM, Leu CS, Ehrhardt AA, Stein Z. Female-condom use in a gender-specific family planning clinic trial. American Journal of Public Health 2003;93(11):1897-903.
  • Miller S, Exner TM, Williams SP, Ehrhardt AA. A gender-specific intervention for at-risk women in the USA. AIDS Care 2000;12(5):603-12.
Ingersoll 2013 {published data only}
  • Ingersoll K S, Ceperich S D, Hettema J E, Farrell-Carnahan L, Penberthy J K. Preconceptional motivational interviewing interventions to reduce alcohol-exposed pregnancy risk. J Subst Abuse Treat 2013;44(4):407-16.
Ito 2008 {published data only}
  • Ito KE, Kalyanaraman S, Ford CA, Brown JD, Miller WC. "Let's Talk About Sex": pilot study of an interactive CD-ROM to prevent HIV/STIs in female adolescents. AIDS Education and Prevention 2008;20:78-89.
James 2006 {published data only}
  • James S, Reddy P, Ruiter RA, McCauley A, van den Borne B. The Impact of an HIV and AIDS Life Skills Program on Secondary School Students in KwaZulu-Natal, South Africa. AIDS Education and Prevention 2006;18:281-94.
Jemmott 2005 {published data only}
  • Jemmott JB 3rd, Jemmott LS, Braverman PK, Fong GT. HIV/STD risk reduction interventions for African American and Latino adolescent girls at an adolescent medicine clinic: a randomized controlled trial. Archives of Pediatrics & Adolescent Medicine 2005;159(5):440-9.
Jemmott 2007 {published data only}
  • Jemmott LS, Jemmott JB 3rd, O'Leary A. Effects on sexual risk behavior and STD rate of brief HIV/STD prevention interventions for African American women in primary care settings. American Journal of Public Health 2007;97(6):1034-40.
  • O'Leary A, Jemmott LS, Jemmott JB. Mediation analysis of an effective sexual risk-reduction intervention for women: the importance of self-efficacy. Health Psychology 2008;27(2(Suppl)):S180-4.
Jewkes 2008 {published data only}
  • Jewkes R, Nduna M, Levin J, Jama N, Dunkle K, Khuzwayo N, et al. A cluster randomized-controlled trial to determine the effectiveness of Stepping Stones in preventing HIV infections and promoting safer sexual behaviour amongst youth in the rural Eastern Cape, South Africa: trial design, methods and baseline findings. Tropical Medicine and International Health 2006;11(1):3-16.
  • Jewkes R, Nduna M, Levin J, Jama N, Dunkle K, Puren A, et al. Impact of stepping stones on incidence of HIV and HSV-2 and sexual behaviour in rural South Africa: cluster randomised controlled trial. BMJ. 2008/08/09 2008; Vol. 337:a506.
  • Welbourn A. Stepping Stones: a positive force for change. Reproductive Health Matters 1996;4(7):177-8.
Kalichman 1999 {published data only}
  • Kalichman SC, Cherry C, Browne-Sperling F. Effectiveness of a video-based motivational skills-building HIV risk-reduction intervention for inner-city African American men. Journal of Consulting and Clinical Psychology 1999;67(6):959-66.
Kiene 2006 {published data only}
  • Kiene SM, Barta WD. A brief individualized computer-delivered sexual risk reduction intervention increases HIV/AIDS preventive behavior. Journal of Adolescent Health 2006;39(3):404-10.
Kirby 1997 {published data only}
  • Kirby D, Korpi M, Adivi C, Weissman J. An impact evaluation of Project SNAPP: an AIDS and pregnancy prevention middle school program. AIDS Education and Prevention 1997;9(Suppl A):44-61.
Kraft 2007 {published and unpublished data}
  • Kraft JM, Harvey SM, Thorburn S, Henderson JT, Posner SF, Galavotti C. Intervening with couples: assessing contraceptive outcomes in a randomized pregnancy and HIV/STD risk reduction intervention trial. Womens Health Issues 2007;17(1):52-60.
Langston 2010 {published data only}
  • Langston AM, Rosario L, Westhoff CL. Structured contraceptive counseling--a randomized controlled trial. Patient Education and Counseling. 2010/09/28 2010; Vol. 81, issue 3:362-7.
  • Westhoff C. Randomized controlled trial of structured contraceptive counseling in adult women. http://clinicaltrials.gov/ct2/show/NCT00746993 (accessed 25 Mar 2010). [: NCT00746993]
  • World Health Organization. Decision-making tool for family planning clients and providers. http://www.who.int/reproductivehealth/publications/family_planning/9241593229index/en/index.html (accessed 08 Jan 2012).
Lederman 2003 {published data only}
  • Lederman RP, Chan W, Roberts-Gray C. Parent-Adolescent Relationship Education (PARE): program delivery to reduce risks for adolescent pregnancy and STDs. Behavioral Medicine 2008;33(4):137-143.
  • Lederman RP, Chan W, Roberts-Gray C. Sexual risk attitudes and intentions of youth aged 12-14 years: survey comparisons of parent-teen prevention and control groups. Behavioral Medicine 2004;29(4):155-63.
  • Lederman RP, Mian TS. The Parent-Adolescent Relationship Education (PARE) Program: a curriculum for prevention of STDs and pregnancy in middle school youth. Behavioral Medicine 2003;29(1):33-41.
Lee 2007 {published data only}
Lee 2011 {published data only}
  • Lee J T, Tsai J L, Tsou T S, Chen M C. Effectiveness of a theory-based postpartum sexual health education program on women's contraceptive use: a randomized controlled trial. Contraception 2011;84(1):48-56.
Legardy 2005 {published data only}
  • Legardy JK, Macaluso M, Artz L, Brill I. Do participant characteristics influence the effectiveness of behavioral interventions? Promoting condom use to women. Sexually Transmitted Diseases 2005;32(11):665-71.
Melnick 2008 {published data only}
  • Melnick AL, Rdesinski RE, Creach ED, Choi D, Harvey SM. The influence of nurse home visits, including provision of 3 months of contraceptives and contraceptive counseling, on perceived barriers to contraceptive use and contraceptive use self-efficacy. Womens Health Issues. 2008/10/18 2008; Vol. 18, issue 6:471-81.
Moberg 1998 {published data only}
Morrison-Beedy 2005 {published and unpublished data}
Peragallo 2005 {published and unpublished data}
  • Peragallo N, Deforge B, O'Campo P, Lee SM, Kim YJ, Cianelli R, et al. A randomized clinical trial of an HIV-risk-reduction intervention among low-income Latina women. Nursing Research 2005;54(2):108-18.
Roberto 2007 {published data only}
  • Roberto AJ, Zimmerman RS, Carlyle KE, Abner EL. A computer-based approach to preventing pregnancy, STD, and HIV in rural adolescents. Journal of Health Communication 2007;12(1):53-76.
Roye 2007 {published and unpublished data}
  • Roye C, Perlmutter Silverman P, Krauss B. A brief, low-cost, theory-based intervention to promote dual method use by black and Latina female adolescents: a randomized clinical trial. Health Education & Behavior 2007;34(4):608-21.
  • Roye CF, Hudson M. Developing a culturally appropriate video to promote dual-method use by urban teens: rationale and methodology. AIDS Education and Prevention 2003;15(2):148-58.
Shain 1999 {published data only (unpublished sought but not used)}
  • Shain RN, Perdue ST, Piper JM, Holden AEC, Champion JD, Newton ER, et al. Behaviors changed by intervention are associated with reduced STD recurrence. Sexually Transmitted Diseases 2002;29(9):520-9.
  • Shain RN, Piper JM, Newton ER, Perdue ST, Ramos R, Champion JD, et al. A randomized, controlled trial of a behavioral intervention to prevent sexually transmitted disease among minority women. New England Journal of Medicine 1999;340(2):93-100.
  • Thurman AR, Holden AEC, Shain RN, Perdue S, Piper JM. Preventing recurrent sexually transmitted diseases in minority adolescents. Obstetrics and Gynecology 2008;111(6):1417-25.
Sieving 2012 {published data only}
  • Sieving RE, Bernat DH, Resnick MD, Oliphant J, Pettingell S, Plowman S, et al. A clinic-based youth development program to reduce sexual risk behaviors among adolescent girls: prime time pilot study. Health Promotion Practice. 2011/05/25 2012; Vol. 13, issue 4:462-71.
Stanton 1996 {published data only}
  • Stanton B, Fang X, Li X, Feigelman S, Galbraith J, Ricardo I. Evolution of risk behaviors over 2 years among a cohort of urban African American adolescents. Archives of Pediatrics & Adolescent Medicine 1997;151(4):398-406.
  • Stanton BF, Li X, Ricardo I, Galbraith J, Feigelman S, Kaljee L. A randomized, controlled effectiveness trial of an AIDS prevention program for low-income African-American youths. Archives of Pediatrics & Adolescent Medicine 1996;150(4):363-72.
Stanton 2005 {published data only}
  • Stanton B, Guo J, Cottrell L, Galbraith J, Li X, Gibson C, et al. The complex business of adapting effective interventions to new populations: an urban to rural transfer. Journal of Adolescent Health 2005;37(2):163.
  • Stanton B, Harris C, Cottrell L, Li X, Gibson C, Guo J, et al. Trial of an urban adolescent sexual risk-reduction for rural youth: a promising but imperfect fit. Journal of Adolescent Health 2006;38(1):25-36.
Stephenson 2004 {published data only}
  • Stephenson JM, Strange V, Forrest S, Oakley A, Copas A, Allen E, et al. Pupil-led sex education in England (RIPPLE study): cluster-randomised intervention trial. Lancet 2004;364(9431):338-46.
Thato 2008 {published data only}
  • Thato R, Jenkins RA, Dusitsin N. Effects of the culturally-sensitive comprehensive sex education programme among Thai secondary school students. J Adv Nurs. 2008/05/15 2008; Vol. 62, issue 4:457-69.
Tortolero 2008 {published data only}
  • Tortolero SR, Markham CM, Addy RC, Baumler ER, Escobar-Chaves SL, Basen-Engquist KM, et al. Safer choices 2: rationale, design issues, and baseline results in evaluating school-based health promotion for alternative school students. Contemporary Clinical Trials 2008;29:70-82.
Villarruel 2006 {published data only (unpublished sought but not used)}
  • Villarruel AM, Jemmott JB 3rd, Jemmott LS, Ronis DL. Predictors of sexual intercourse and condom use intentions among Spanish-dominant Latino youth: a test of the planned behavior theory. Nursing Research 2004;53(3):172-81.
  • Villarruel AM, Jemmott JB III, Jemmott LS. A randomized controlled trial testing an HIV prevention intervention for Latino youth. Archives of Pediatrics & Adolescent Medicine 2006;160(8):772-7.
  • Villarruel AM, Jemmott LS, Jemmott JB III. Designing a culturally based intervention to reduce HIV sexual risk for Latino adolescents. Journal of the Association of Nurses in AIDS Care 2005;16(2):23-31.
Vogt 2012 {published data only}
  • Vogt Claudia, Schaefer Marion. Knowledge matters — Impact of two types of information brochure on contraceptive knowledge, attitudes and intentions. The European Journal of Contraception and Reproductive Health Care 2012;17(2):135-43.
Weeks 1997 {published data only}
  • Levy SR, Perhats C, Weeks K, Handler AS, Zhu C, Flay BR. Impact of a school-based AIDS prevention program on risk and protective behavior for newly sexually active students. Journal of School Health 1995;65(4):145-51.
  • Weeks K, Levy SR, GOrdon AK, Handler A, Perhats C, Flay BR. Does parental involvement make a difference? The impact of parent interactive activities on students in a school-based AIDS prevention program. AIDS Education and Prevention 1997;9(Suppl A):90-106.
Winter 1993 {published data only}
Zimmerman 2008 {published data only}
  • Zimmerman RS, Cupp PK, Donohew L, Sionean CK, Feist-Price S, Helme D. Effects of a school-based, theory-driven HIV and pregnancy prevention curriculum. Perspectives on Sexual and Reproductive Health. 2008/03/06 2008; Vol. 40, issue 1:42-51.

Additional references

  1. Top of page
  2. Abstract
  3. Background
  4. Objectives
  5. Methods
  6. Results
  7. Discussion
  8. Authors' conclusions
  9. Acknowledgements
  10. Data and analyses
  11. Appendices
  12. What's new
  13. History
  14. Contributions of authors
  15. Declarations of interest
  16. Sources of support
  17. Characteristics of studies
  18. References to studies included in this review
  19. References to studies excluded from this review
  20. Additional references
  21. References to other published versions of this review
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