Behavioral interventions for improving condom use for dual protection

  • Review
  • Intervention

Authors


Abstract

Background

Unprotected sex is a major risk factor for disease, disability, and mortality in many areas of the world due to the prevalence and incidence of sexually transmitted infections (STI) including HIV. The male condom is one of the oldest contraceptive methods and the earliest method for preventing the spread of HIV. When used correctly and consistently, condoms can provide dual protection, i.e., against both pregnancy and HIV/STI.

Objectives

We examined comparative studies of behavioral interventions for improving condom use. We were interested in identifying interventions associated with effective condom use as measured with biological assessments, which can provide objective evidence of protection.

Search methods

Through September 2013, we searched computerized databases for comparative studies of behavioral interventions for improving condom use: MEDLINE, POPLINE, CENTRAL, EMBASE, LILACS, OpenGrey, COPAC, ClinicalTrials.gov, and ICTRP. We wrote to investigators for missing data.

Selection criteria

Studies could be either randomized or nonrandomized. They examined a behavioral intervention for improving condom use. The comparison could be another behavioral intervention, usual care, or no intervention. The experimental intervention had an educational or counseling component to encourage or improve condom use. It addressed preventing pregnancy as well as the transmission of HIV/STI. The focus could be on male or female condoms and targeted to individuals, couples, or communities. Potential participants included heterosexual women and heterosexual men.

Studies had to provide data from test results or records on a biological outcome: pregnancy, HIV/STI, or presence of semen as assessed with a biological marker, e.g., prostate-specific antigen. We did not include self-reported data on protected or unprotected sex, due to the limitations of recall and social desirability bias. Outcomes were measured at least three months after the behavioral intervention started.

Data collection and analysis

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

Main results

Seven studies met our eligibility criteria. All were randomized controlled trials; six assigned clusters and one randomized individuals. Sample sizes for the cluster-randomized trials ranged from 2157 to 15,614; the number of clusters ranged from 18 to 70. Four trials took place in African countries, two in the USA, and one in England. Three were based mainly in schools, two were in community settings, one took place during military training, and one was clinic-based.

Five studies provided data on pregnancy, either from pregnancy tests or national records of abortions and live births. Four trials assessed the incidence or prevalence of HIV and HSV-2. Three trials examined other STI. The trials showed or reported no significant difference between study groups for pregnancy or HIV, but favorable effects were evident for some STI. Two showed a lower incidence of HSV-2 for the behavioral-intervention group compared to the usual-care group, with reported adjusted rate ratios (ARR) of 0.65 (95% CI 0.43 to 0.97) and 0.67 (95% CI 0.47 to 0.97), while HIV did not differ significantly. One also reported lower syphilis incidence and gonorrhea prevalence for the behavioral intervention plus STI management compared to the usual-care group. The reported ARR were 0.58 (95% CI 0.35 to 0.96) and 0.28 (95% CI 0.11 to 0.70), respectively. Another study reported a negative effect on gonorrhea for young women in the intervention group versus the control group (ARR 1.93; 95% CI 1.01 to 3.71). The difference occurred among those with only one year of the intervention.

Authors' conclusions

We found few studies and little clinical evidence of effectiveness for interventions promoting condom use for dual protection. We did not find favorable results for pregnancy or HIV, and only found some for other STI. The overall quality of evidence was moderate to low; losses to follow up were high. Effective interventions for improving condom use are needed to prevent pregnancy and HIV/STI transmission. Interventions should be feasible for resource-limited settings and tested using valid and reliable outcome measures.

Résumé scientifique

Interventions comportementales destinées à améliorer l'utilisation de préservatifs pour une double protection

Contexte

Les rapports sexuels non protégés sont un facteur de risque majeur de maladies, invalidité et mortalité dans de nombreuses régions du monde en raison de la prévalence et l'incidence des maladies sexuellement transmissibles (MST), y compris le VIH. Le préservatif masculin est l'une des plus anciennes méthodes contraceptives et la méthode la plus ancienne pour prévenir la propagation du VIH. Dans le cas d'un usage correct, de manière constante, les préservatifs peuvent fournir une protection mixte, c’est à dire à la fois des grossesses et de VIH/MST.

Objectifs

Nous avons examiné les études comparatives des interventions comportementales pour améliorer l'utilisation de préservatifs. Nous étions intéressés par l'identification des interventions efficaces associées à l'utilisation de préservatifs mesurée par des évaluations biologiques, qui peuvent fournir des preuves objectives de protection.

Stratégie de recherche documentaire

Jusqu' à septembre 2013, nous avons effectué des recherches dans les bases de données informatisées pour trouver des études comparatives des interventions comportementales pour améliorer l'utilisation de préservatifs: MEDLINE, POPLINE, CENTRAL, EMBASE, LILACS, OpenGrey, COPAC, ClinicalTrials. gov et ICTRP. Nous avons écrit aux chercheurs pour obtenir des données manquantes.

Critères de sélection

Les études pouvaient être des essais randomisés ou non. Il s’agissait d’évaluer une intervention comportementale visant à améliorer l'utilisation de préservatifs. La comparaison pouvait être avec autre intervention comportementale, les soins habituels ou à l'absence d’intervention. Le groupe expérimental d’intervention avait une composante de conseil éducatif ou d’encouragement pour améliorer l'utilisation de préservatifs. Les études portaient sur la prévention des grossesses aussi bien que la transmission du VIH/MST. L'objectif pouvait être focalisé sur les préservatifs masculins ou féminins ou ciblés les individus, les couples, ou les communautés. Des participants potentiels étaient des femmes et des hommes hétérosexuels.

Les études devaient fournir les données de résultats d'examens ou des rapports sur un critère de jugement biologique: grossesse, VIH/MST, ou présence de sperme évaluée avec un marqueur biologique comme l’antigène prostatique spécifique. Nous n'avons pas inclus les données fournies par les intéressés concernant la protection lors des rapports, compte tenu des limitations de rappel et de biais souhaitées. Les critères de jugement étaient mesurés au moins trois mois après le début de l'intervention comportementale.

Recueil et analyse des données

Deux auteurs ont évalué l'éligibilité des résumés de manière indépendante et extrait les données issues des études incluses. Pour les résultats dichotomiques, le rapport de cotes de Mantel-Haenszel (RC) avec IC à 95% a été calculé en utilisant un modèle à effets fixes. Des essais randomisés en grappes utilisaient différentes méthodes de calcul pour les groupes d'individus come la modélisation à plusieurs niveaux. La plupart des rapports n'ont pas fourni d'informations pour calculer l'efficacité de la taille des grappes. Par conséquent, nous avons présenté les résultats rapportés par les investigateurs. Aucune méta-analyse n'a été effectuée en raison des différences dans les interventions et les mesures de résultats.

Résultats principaux

Sept études remplissaient nos critères d'éligibilité. Toutes étaient des essais contrôlés randomisés; six assignaient des grappes et un des individus. Les tailles des partitions de donnés dans les essais randomisés allaient de 2 157 à 15,614; le nombre de grappes allait de 18 à 70. Quatre essais ont été réalisés dans des pays africains, deux aux États-Unis, et un en Angleterre. Trois étaient faits principalement dans des écoles, deux étaient en milieu communautaire, un se déroulait au cours d’une formation militaire et un dans une clinique.

Cinq études ont fourni des données sur la grossesse, soit à partir de tests de grossesse ou de registres nationaux d'avortements et de naissances vivantes. Quatre essais ont évalué l'incidence ou la prévalence du VIH et de HSV-2. Trois essais ont examiné les autres MST. Les essais n’ont montré ou rapporté aucune différence significative entre les groupes d'étude pour la grossesse ou le VIH, mais des effets favorables ont été mis en évidence pour certaines MST. Deux ont montré une incidence plus faible en HSV-2 pour le groupe d’intervention comportementale par rapport au groupe de soins habituels, avec un rapport d'effets absolus (RAR) de 0,65(IC à 95%, de 0,43 à 0,97) et 0,67 (IC à 95% 0,47 à 0,97), tandis que le VIH n'était pas significativement différent. Un essai a également rapporté une plus faible incidence de syphilis et de prévalence de gonorrhée pour le groupe d'intervention comportementale plus de la prise en charge des MST par rapport au groupe de soins habituels. Des RAR rapportés étaient 0,58 (IC à 95%, entre 0,35 et 0,96) et 0,28 (IC à 95%, de 0,11 à 0,70), respectivement. Une autre étude rapportait un effet négatif concernant la gonorrhée des jeunes femmes dans le groupe d'intervention versus le groupe témoin (RAR 1,93; IC de à 95% 1,01 à 3,71). La différence était observée parmi ces patientes avec seulement un an de l'intervention.

Conclusions des auteurs

Nous avons trouvé peu d'études et peu de preuves d'efficacité clinique pour des interventions visant à promouvoir l'utilisation de préservatifs pour une double protection. Nous n'avons pas trouvé de résultats favorables pour la grossesse ou le VIH, et seulement quelques uns pour les autres MST. La qualité globale des preuves était de faible à modérée; les pertes de suivi étaient élevés. Des interventions efficaces pour améliorer l'utilisation de préservatifs sont nécessaires pour prévenir la grossesse et la transmission du VIH/MST. Ces interventions devraient être possibles pour les pays à ressources limitées et testées à l'aide de mesures de résultats valides et fiables.

Plain language summary

Programs for preventing pregnancy and disease through better condom use

Unprotected sex can result in disease and death in many areas of the world, due to sexually transmitted infections (STI) including HIV. The male condom is one of the oldest birth control methods and the earliest method that works to prevent HIV. When used correctly, condoms can provide dual protection against pregnancy and HIV/STI. We examined behavioral programs to improve condom use.

Through September 2013, we did computer searches for studies of programs to improve condom use. We wrote to researchers for missing data. The studies could have various designs. The education program addressed preventing pregnancy and HIV/STI. The intervention was compared with a different program, usual care, or no intervention. The studies had a clinical outcome such as pregnancy, HIV, or STI tests. We did not use self-reports of condom use.

We found seven randomized trials. Six assigned groups (clusters) and one randomized individuals. Four trials took place in African countries, two in the USA, and one in England. The studies were based in schools, community settings, a clinic, and a military training setting.

Five trials examined pregnancy, four studied HIV and HSV-2 (herpes), and three assessed other STI. We found no major differences between study groups for pregnancy or HIV. Some results were seen for STI outcomes. Two studies showed fewer HSV-2 cases with the behavioral program compared to the control group. One also reported fewer cases of syphilis and gonorrhea with the behavioral program plus STI management. Another study reported a higher gonorrhea rate for the intervention group. The researchers believed the result was due to a subgroup that did not have the full program.

We found little clinical effect of improving condom use. The studies provided moderate to low quality information. Losses to follow up were high. We need good programs on condom use to prevent pregnancy and HIV/STI. Programs should be useful for settings with few resources. Interventions should be tested with valid outcome measures.

Résumé simplifié

Des programmes de contraception et de prévention de maladies au moyen d'une meilleure utilisation des préservatifs

Des rapports sexuels non protégés peuvent entraîner des maladies et décès en nombreuses régions du monde, en raison de maladies sexuellement transmissibles (MST), y compris le VIH. Le préservatif masculin est l'une des plus anciennes des méthodes de contraception et le premier moyen de prévention utilisé efficacement dans la prévention du VIH. En cas d'utilisation correcte, l’usage de préservatifs peut fournir une protection contre grossesse et VIH/MST. Nous avons examiné les programmes comportementaux visant à améliorer l'utilisation de préservatifs.

Jusqu' à septembre 2013, nous avons effectué des recherches informatisées pour trouver des études de programmes d’amélioration de l'utilisation de préservatifs. Nous avons écrit aux chercheurs pour obtenir des données manquantes. Les études pourraient avoir divers types de planification. Le programme de formation portait sur la prévention de la grossesse et du VIH/MST. L'intervention était comparée à un programme différent, aux soins habituels ou à l'absence d'intervention. Les études présentaient des critères de jugement clinique tels que la grossesse, le VIH, ou des tests des IST. Nous n'avons pas utilisé les auto-évaluations concernant l'utilisation du préservatif.

Nous avons trouvé sept essais randomisés. Six assignaient de petits groupes et un des individus. Quatre essais ont été réalisés dans des pays africains, deux aux États-Unis et un au Royaume Uni. Les études étaient faites dans des écoles, des milieux communautaires, une clinique, et une dans un contexte de formation militaire.

Cinq essais examinaient la grossesse, quatre avaient étudié le VIH et HSV-2 (herpès), et trois évaluaient les autres MST. Nous n'avons trouvé aucune différence majeure entre les groupes d'étude pour la grossesse ou le VIH. Certains résultats ont été observés pour les résultats des MST. Deux études ont montré une diminution des cas avec le programme comportemental par rapport au groupe témoin. Un essai a également rapporté moins de cas de syphilis et de gonorrhée avec le programme comportemental plus la prise en charge des MST. Une autre étude a rapporté un taux plus élevés de gonorrhée pour le groupe d'intervention. Les chercheurs pensent que le résultat était du à un sous-groupe qui n'avait pas eu le programme complet.

Nous avons trouvé très peu d'effet clinique d'amélioration pour l'usage de préservatifs. Les études ont fourni des informations de qualité faible à modérée. Les pertes de suivi étaient élevées. Nous avons besoin de programmes de bonne qualité sur l'utilisation de préservatifs pour la prévention des grossesses et VIH/MST. Les programmes devraient être utiles dans des conditions avec peu de ressources. Des interventions doivent être testées avec des mesures de résultats valides.

Notes de traduction

Traduit par: French Cochrane Centre 9th January, 2014
Traduction financée par: Financeurs pour le Canada : Instituts de Recherche en Sant� du Canada, Minist�re de la Sant� et des Services Sociaux du Qu�bec, Fonds de recherche du Qu�bec-Sant� et Institut National d'Excellence en Sant� et en Services Sociaux; pour la France : Minist�re en charge de la Sant�

Background

Description of the condition

Unprotected sex is a major risk factor for disease, disability, and mortality in many areas of the world due to the prevalence and incidence of sexually transmitted infections (STI) including HIV (Warner 2012). Millions of women also need protection against unintended pregnancy, especially in lower-resource areas (Thurman 2011). Multipurpose prevention technologies are being developed or improved to prevent HIV/STI and unplanned pregnancy (Friend 2010; Thurman 2011). Such technologies include physical and chemical barriers alone or in combination. Male and female condoms are existing physical barriers that can provide dual protection against both pregnancy and HIV/STI.

The male condom is one of the oldest contraceptive methods and the earliest method for preventing the spread of HIV (Crosby 2012). Condoms are inexpensive and widely available. In 'more developed' regions globally, the most prevalent forms of contraception, among women who are married or in a union, are condoms and contraceptive pills at 18% each (UN 2011). In 'less developed' areas, female sterilization leads at 21%, followed by use of an intrauterine device (IUD) (15%) and contraceptive pills (7%) (UN 2011). Only 6% of women report using male condoms in those regions. Use of the female condom has been low overall.

While use of two methods has been promoted for preventing pregnancy and disease, such 'dual-method use' has been relatively low. In the USA, rates may range from 7% to 23%, depending on age and life situation (Sales 2010; Brown 2011; Eisenberg 2012). In Europe, dual-method use is estimated to be higher, at 15% to 30% (Higgins 2012). Adherence to one contraceptive method is challenging for many people (Halpern 2011; Lopez 2013). Use of two methods can require multiple actions and the processing of multiple messages about risk, i.e., for pregnancy and HIV/STI (O'Leary 2011). Condoms alone may be used more frequently than dual methods, at least among adolescents. From urban clinics in the USA, African American adolescents reported condoms alone as the most frequently used contraceptive method (35%) Brown 2011. Across 24 countries in sub-Saharan Africa, the range for condom use varied widely for adolescents (Doyle 2012): 5% to 67% for females and 8% to 81% for males. Among never-married adolescent females, reported condom use at last sex averaged 22% in West Africa, 35% in East Africa, and 60% in Southern Africa. 

When used correctly and consistently, condoms can provide dual protection, i.e., against both pregnancy and disease (Steiner 1999; CDC 2010; O'Leary 2011). For the male condom, the estimated first-year pregnancy rate with typical use is 18% and the rate for perfect use is 2% (Trussell 2011). Typical use among experienced users may be much lower than 18%. Female sex workers in Nevada's legal brothels had very low rates for condom breakage and slippage (Albert 1995); such workers had regular state-mandated testing for HIV/STI. Educational interventions focused on reducing condom errors may reduce the typical failure rate. For the first version of the female condom approved in the USA (FC1) (FHC 2013), the estimated pregnancy rates were 21% and 5%, respectively (Trussell 2011). In 2009, a second version of this female condom (FC2) (FHC 2013) was approved in the USA, but corresponding effectiveness data are not available. Oral contraceptives (OCs) have first-year pregnancy rates of 9% with typical use and 0.3% with perfect use (Trussell 2011). Long-acting reversible contraception (LARC), i.e., IUDs and implants, do not require regular user action. A large cohort study reported pregnancy rates of 0.27 per 100 participant-years for LARC compared to 4.55 for those using pills, transdermal patch or intravaginal ring (Winner 2012).

Contraceptives that are more effective in typical use for preventing pregnancy do not protect against disease. Only condoms have that additional advantage. Consistent use of latex condoms can reduce risk of HIV transmission from an infected partner by 80% to 90% (USAID 2005). However, failure to use condoms correctly with every sex act can increase risk. Incorrect use includes donning the condom after starting the sex act and removing it before ejaculation (Warner 2012). Furthermore, users can experience condom malfunctioning, such as breakage or slippage. Condom problems appear common; 40% to 50% of users report at least one problem occurring over short time intervals (Hatherall 2007; Warner 2008). Consistent and correct use of condoms decreases the risk of STI, but inconsistent use provides little or no protection (USAID 2005). The female condom protects against both HIV/STI transmission and unintended pregnancy, but few studies have quantified the degree of efficacy (Beksinska 2011; Gallo 2012).

Description of the intervention

Use of condoms as the sole protection may be appropriate when exposure to infection is the primary concern due to the prevalence of HIV/STI or the individual's risk behavior (Cates 2002). If unplanned pregnancy is the major issue, then dual-method use could be more helpful, given the greater effectiveness of hormonal contraception for preventing pregnancy (Cates 2002). The use of two methods may not be necessary if condoms are used correctly and consistently. Conversely, if condoms are not used correctly for pregnancy prevention, they are unlikely to prevent the transmission of HIV/STI either.

Encouraging effective condom use includes increasing use and promoting consistent and correct use (Warner 2012). Lack of use may still be the limiting factor for condoms (Steiner 1999; Warner 2012). Behavioral interventions to improve condom use often involve counseling, but may also include broader educational programs and communication campaigns. Programs targeted to individuals or couples may be based on direct oral communication and written materials. Social marketing can have greater reach than interventions directed to individuals or groups, and may increase awareness and promote use (Chapman 2012). However, interventions should address the advantages of condoms, barriers to use, and the challenges in using condoms correctly (Maticka-Tyndale 2012). Interpersonal interaction may help communicate such complex use information and help build skills. Projects may also utilize technology, such as computer-assisted interviews and mobile phone reminders, while others may engage community workers or peer educators. Identifying effective interventions can be challenging. Evaluations of condom promotion programs could benefit from using valid and reliable outcome measures rather than self-reports alone (Crosby 2012).

Why it is important to do this review

Reviews of condom interventions often focus on specific types of studies or programs. Carvalho 2011 included RCTs of condom promotion for women with HIV. Others have reviewed programs in less developed areas, e.g., voluntary counseling and testing program (Fonner 2012), social marketing of condoms (Sweat 2012), and peer education (Medley 2009). Some reviews focused on specific populations, i.e., young people 13 to 19 years old (Picot 2012), people who use drugs (Meader 2013), and heterosexual men (Townsend 2013). Many reviews consider biological outcomes such as incidence of HIV/STI, but also examine social, psychological, and behavioral outcomes. Moreover, they do not necessarily require addressing pregnancy prevention, as they often focus on prevention of HIV/STI transmission.

We aimed to identify behavioral interventions associated with improved condom use. Successful promotional or educational programs could be adapted for other groups or locations (Zou 2012). Most interventions to promote condom use focus on prevention of HIV/STI. The motivation for preventing transmission may differ from that for preventing pregnancy. In this review, the behavioral interventions must have addressed contraception as well as prevention of HIV/STI. Studies had to have a clinical (biological) assessment of unprotected sex, which provides a more reliable and valid measure than self-report. These measures include the incidence of pregnancy, HIV, or other STI and markers of semen exposure, e.g., prostate-specific antigen (Gallo 2013).

Objectives

We examined comparative studies of behavioral interventions for improving condom use for dual protection. We were interested in identifying interventions associated with effective condom use as measured with biological assessments, which can provide objective evidence of protection. 

Methods

Criteria for considering studies for this review

Types of studies

Studies were comparative and could be randomized or nonrandomized. They examined a behavioral intervention for improving condom use. The comparison could be another behavioral intervention, usual care, or no intervention.

Types of participants

Due to the focus on preventing pregnancy as well as HIV/STI transmission, participants could be heterosexual women or heterosexual men. Participants may have been at risk for pregnancy or HIV/STI and could be HIV-positive or HIV-negative.

Types of interventions

The behavioral intervention addressed the use of condoms specifically, that is, had an educational or counseling component to encourage or improve condom use. The focus could be on male or female condoms and targeted to individuals, couples, or communities. The intervention addressed preventing both pregnancy and the transmission of HIV/STI. We did not include behavioral interventions promoting dual-method use, e.g., use of a hormonal method plus condoms.

The report described the content or process of the condom promotion intervention. Condom counseling described as 'standard' or 'routine' was not sufficient nor was standard contraception counseling that covered a range of contraceptive methods without a specific condom component. Such interventions would not be informative about how to improve condom use. However, they were acceptable for the comparison or control condition.

Types of outcome measures

Primary outcomes

The studies had to provide data on one or more of the following:

  • Pregnancy (test result or birth record)

  • HIV (test result)

  • Sexually transmitted infection (test result)

  • Presence of semen as assessed with a biological marker, e.g., prostate-specific antigen (Gallo 2013).

Outcomes were measured three or more months after the behavioral intervention began, to provide evidence of protected sex over a minimum time period. We did not include self-reported data on protected or unprotected sex, due to the limitations of recall and social desirability bias.

Search methods for identification of studies

Electronic searches

Through September 2013, we conducted searches of MEDLINE via PubMed, Cochrane Central Register of Controlled Trials (CENTRAL), POPLINE, EMBASE, and LILACS. Further searches for unpublished reports involved OpenGrey and COPAC. We also searched ClinicalTrials.gov and ICTRP for current trials and trials with results or relevant articles. The search strategies are given in Appendix 1.

Searching other resources

We examined reference lists of pertinent papers, including review articles, for additional citations. In addition, we contacted investigators in the field for other relevant published or unpublished studies.

Data collection and analysis

Selection of studies

We assessed for inclusion all titles and abstracts identified during the literature search. Two authors independently examined the search results for potentially eligible studies. Any discrepancies were resolved by discussion. For studies that appeared to be eligible for this review, we obtained and examined the full-text articles.

Data extraction and management

Two authors extracted the data. One author entered the data into RevMan, and a second author checked accuracy. These data include the study characteristics, risk of bias (quality assessment), and outcomes. Any discrepancies were resolved by discussion.

Assessment of risk of bias in included studies

Intervention fidelity

We used the framework in Borrelli 2011 to assess the quality of the intervention reporting. Domains of treatment fidelity are study design, training of providers, delivery of treatment (intervention), receipt of treatment, and enactment of treatment skills. The framework was intended for assessing current trials. Criteria of interest for our review were as follows:

  1. Study design - had a curriculum or treatment manual.

  2. Training -

    1. specified provider credentials;

    2. provided standardized training for the intervention.

  3. Delivery - assessed adherence to the protocol.

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

Research design

For randomized controlled trials, we evaluated methodological quality according to recommended principles (Higgins 2011). That is, we examined the information on 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 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. Losses to follow up of 20% or more were considered high losses. Quality assessment also included the length of follow up. While three months was the minimum for inclusion in the review, a six-month follow up provides more meaningful outcome measures.

We did not find any nonrandomized studies that had biological outcomes and met our other criteria. Therefore, we did not use the Newcastle-Ottawa Scale (NOS) for nonrandomized studies (Wells 2013).

Measures of treatment effect

Outcomes listed in the Characteristics of included studies address the primary outcomes for this review. Study 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 follow-up assessments to measure short- and long-term changes.

For RCTs with dichotomous outcomes, the Mantel-Haenszel odds ratio (OR) with 95% confidence interval (CI) was calculated using a fixed-effect model. An example is the incidence of a sexually transmitted infection. Fixed and random effects give the same result if no heterogeneity exists, as when a comparison includes only one study. For life-table rates for pregnancy, we had planned to use the rate difference as the effect measure. However, none of the included studies had life-table rates for pregnancy.

The cluster randomized trials used a variety of strategies to account for the clustering. When available, we used adjusted measures that the investigators considered as the primary effect measures. Odds ratio (OR) is an appropriate effect measure and is commonly provided when adjusted analyses are obtained using logistic regression models. However, if an appropriate adjusted OR was not available from the report, we considered other effect measures, e.g., rate ratio, hazard ratio, or incidence difference. Where multivariate models were used, we did not analyze the treatment effect as that would usually require individual participant data. Rather we presented the results from adjusted models as reported by the investigators.

Unit of analysis issues

If clustering was part of the design, we assessed whether the estimates were properly adjusted to account for clustering effects. The 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. Most reports did not provide sufficient information to calculate the effective sample size, so we did not analyze the data but presented the results as reported.

Dealing with missing data

If reports were missing data needed for analysis, we wrote to the study investigators. However, we limited our data requests to studies less than 10 years old. Researchers are unlikely to have access to data from older studies.

Assessment of heterogeneity

Given the diversity of design features and behavioral interventions, we did not conduct meta-analysis for pooled estimates. Behavioral interventions can vary widely in design and content. In such cases, we assessed sources of heterogeneity without pooling the data. We addressed heterogeneity due to differences in study design, analysis strategies, and confounding adjustment. To interpret the intervention results, we examined the intervention location, i.e., country and setting (clinic, school, community); participant characteristics; and the intervention content, implementation, and fidelity information.

Data synthesis

We applied principles from GRADE to assess the evidence quality and address confidence in the effect estimates (Balshem 2011). However, when a meta-analysis is not viable due to varied interventions, a summary of findings table is not feasible. Therefore, we did not conduct a formal GRADE assessment with an evidence profile and summary of findings table (Guyatt 2011).

Our assessment of the body of evidence was based on the quality of evidence from the included studies. We included our assessment of intervention fidelity in the overall quality assessment. Evidence quality could be high, moderate, low, or very low. RCTs were considered high quality initially, then downgraded a level for each of the following: a) randomization sequence generation and allocation concealment: no information on either, or one was inadequate; b) intervention fidelity information for three or fewer criteria; c) follow up less than 6 months; d) losses to follow up 20% or more.

Results

Description of studies

Results of the search

The database searches resulted in 5960 citations due to the broad nature of the search for educational interventions (Figure 1). A total of 1118 duplicates were removed (912 electronically and 206 by hand). This left 4842 items. We also identified 9 reports from other sources, such as reference lists. We discarded 4741 items based on the titles and abstracts. We reviewed the full text of 110 papers for eligibility as original studies or related articles. Many studies did not have an intervention, an appropriate study design, or a biological outcome. Our search also identified 96 unduplicated listings in ClinicalTrials.gov and ICTRP; no ongoing trials met our inclusion criteria.

Figure 1.

Study flow diagram.

Included studies

Seven studies met our Criteria for considering studies for this review, along with eight secondary articles (two of which were relevant for both Ross 2007 and Cowan 2010). We examined another six papers related to these studies, but did not extract any information from them. Four of the included trials had been included in our review of theory-based interventions (Lopez 2013). However, this review utilized different outcome data.

All seven studies were RCTs; six assigned clusters (platoons, villages, communities, schools) and one assigned individuals. Four cluster randomized trials were conducted in Africa: Uganda (Kamali 2003), Tanzania (Ross 2007), South Africa (Jewkes 2008), and Zimbabwe (Cowan 2010). The other two were conducted in the USA (Boyer 2005) and England (Stephenson 2008). The trial that randomized individuals was conducted in the USA (Petersen 2007). The settings varied: three were mainly based in schools with two also having community activities. Two others were conducted in community settings, one took place during training for military recruits, and one was clinic-based. The ages of the target populations included adolescents for three trials, young women for two trials, and wider age ranges for the remaining two studies. Two trials focused on women; another included both male and female participants, but the biological data came from women (abortions and live births).

The trials were published from 2003 to 2010. Sample sizes for the six cluster-randomized trials ranged from 2157 to 15,614; the number of clusters ranged from 18 to 70. Therefore, the effective sample sizes would be smaller due to the assignment of groups rather than individuals. The one individually-randomized trial had 764 participants. All trials provided details on sample size calculations.

For the intervention, six trials provided multiple sessions in a group format. The remaining trial had one individual session and a booster follow-up contact. Planned follow up ranged from 14 months to six years after baseline; the average was three years.

Comparisons

The interventions can be classed as follows:

Outcomes

Available outcome data are summarized below.

Biological outcomes reported by study
StudyPregnancy1HIV and HSV-2Other STI
Kamali 2003---xx
Boyer 2005x---x
Petersen 2007x---x
Ross 2007xxx
Jewkes 2008---x---
Stephenson 2008x------
Cowan 2010xx---
Total studies544

1Results of pregnancy tests, except Stephenson 2008 (linked records from national data on abortions and live births).

Excluded studies

We excluded 39 reports for which we examined the full text; these represented 25 studies and 14 related papers. Two were completed trials for which manuscripts were being prepared for publication. We obtained additional information from an investigator for one completed trial (Bachanas 2013) and from a conference presentation for the other (Grossman 2012). Some excluded studies did not provide a behavioral intervention focused on condom use that also addressed contraception. Others were not comparative or did not have the outcome data we sought. Specifics can be found in Characteristics of excluded studies.

Risk of bias in included studies

Intervention fidelity

The reported fidelity information is presented by study (Table 1).

Table 1. Intervention fidelity
  1. 1Assessed participants' understanding and skills regarding the intervention.

StudyCurriculum or manualProvider credentialsTraining for intervention Assessed adherence
to protocol
Assessed intervention
receipt1
Fidelity
Petersen 2007No informationExperienced health educators trained for this project30 to 40 hoursRandom observation of sessions and feedback from the project manager'Booster session' focused on progress toward risk reduction and effective method use4
Ross 20073-year school curriculum with 10 to 15 lessons each school year

Teachers (T);

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

health workers (HW) from government health unit;

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

T: 1 week each year;
CPE: 2 days on dramas;
HW: 6 days on youth-friendly services;
CPD: 2 days
Supervision visits to intervention schools and clinics; observe in-class and clinic sessions and clubs; check exercise books for sessions taught; annual feedback to teachersNo information4
Jewkes 2008Manual with 13 core sessions and 3 meetings; content and activitiesSlightly older than participants; post-school qualification; open-mindedness and gender sensitivity3 weeks: course as participants, week of didactic; facilitated practice groups with manual, included observation and feedback Not specific:
1 day in-service training per month
3 meetings: treatment groups gather, present exercises, have dialogue4
Stephenson 20083 sessions with identified topics and activities. Peer-educators prepared lessons. Intervention 'standardized as far as possible'.

Peer educators: 11th-grade students.

Trainers: expertise in sexual health promotion.

2 days: sexual health information, participatory learning methods, classroom management and group facilitation.

Plus 3 sessions pre-training (needs assessment) and 1 follow up (lesson planning)

Not specific:

Observation for process data (not supervision).

Participatory sessions were interactive; involved practice.4
Cowan 2010Youth: 3-year school curriculum (from Ross 2007); year 4, 24-session program for out-of-school youth.
Clinic: 5-day training for nurses.
Parents and community: 22-session program

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

Community, carefully selected community facilitators

Youth program, 'trained';

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

Community facilitators 'trained'

Clinic: monthly visits, additional training as needed; assessed against standards

Team of social scientists regularly assessed delivery; feedback provided and modifications made as needed

No information3
Kamali 200316-topic guide for large group discussions

Not specific:

community educators (CE) self-selected then approved by local committee

CE: 1 week plus 2-day retraining 18 months later;

Drama groups: 2 days plus monthly visits

Not specific:
'regular supervision' and meetings to discuss progress and work plans
No information2
Boyer 20054 sessions with educational objectives and strategies; activities and materials Not specific:
research assistants

Not specific:

Trained

No informationLast session involved describing, practicing, discussing2
Studies meeting criteria64634 3.3 overall fidelity
  • Six studies specified how the intervention was standardized.

  • For training, four studies noted the qualifications of the providers and six mentioned specific training related to the study, though one did not specify the content or length.

  • Three studies had a means to assess delivery adherence.

  • Four had means to assess intervention receipt by participants.

Allocation

Of the seven included trials, all provided information on the randomization process, such as 'computer-generated' or the use of permuted blocks. Kamali 2003 used shuffled cards. For Cowan 2010, the design was changed to a cross-sectional survey due to out-migration of the cohort. Four trials mentioned stratification (Ross 2007; Jewkes 2008; Stephenson 2008; Cowan 2010).

The individually randomized trial used sealed envelopes for allocation concealment (Petersen 2007). The cluster randomized trials identified the clusters prior to randomization except Jewkes 2008; 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

Two trials used some blinding (Kamali 2003; Jewkes 2008). The evaluators or interviewers were masked to the participant's assignment. Two other studies noted the participants were not blinded to study arm and three trial reports did not mention blinding. 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 20% or more for five trials: Kamali 2003 (28% at 18 to 24 months; 39% at 36 to 48 months); Boyer 2005 (59% at 14 months); Ross 2007 (27% at 3 years); Jewkes 2008 (22% at 12 months; 25% at 24 months); and Stephenson 2008 (25% missing postal codes for matching national health records). In addition, 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.

High losses to follow up threaten validity (Strauss 2005). Differential losses between treatment and control groups did not appear to be a major factor in these studies. Losses did not differ substantially across treatment arms.

Effects of interventions

Pregnancy

Five studies provided data on pregnancy, either from pregnancy tests (Boyer 2005; Cowan 2010; Petersen 2007; Ross 2007) or from national records of abortions and live births (Stephenson 2008). No significant difference was reported between the study arms in these trials. In Petersen 2007, individuals were randomized to the study groups. Pregnancy rates were not significantly different at 12 months for the two groups (OR 0.88; 95% CI 0.55 to 1.42) (Analysis 1.1). The other four studies were cluster randomized trials:

  • For Boyer 2005, the investigators calculated robust standard errors using the Huber-White sandwich estimator in regression models assessing intervention effectiveness. Reportedly, no significant differences were found between the study groups in unplanned pregnancy by 14 months (Table 2).

    Table 2. Pregnancy and STI prevention (Boyer 2005): group risk reduction versus group health promotion
    1. 1Cluster randomized trial accounted for the cluster effects. Researchers calculated robust standard errors using the Huber-White sandwich estimator in regression models. Independent variables were intervention group, sexual history, and time between assessments.
      2Results as reported by researchers; insufficient data for analysis in this review.
      3STI included chlamydia, gonorrhea, and trichomonas.

    Outcomes by 14 months1,2ExperimentalControlOdds ratio (95% CI)
    Unplanned pregnancy or
    sexually transmitted infection3 (%)
    17.923.91.41 (1.01 to 1.98)
    Unplanned pregnancy (%)6.77.3not reported
  • In Ross 2007, a random-effects model was used to account for the cluster effects in the analysis. Reportedly, pregnancy was not significantly different between the study arms at three years (Table 3). A secondary paper (Doyle 2010) reported on a cross-sectional survey at nine years that did not include pregnancy tests.

    Table 3. Preventing HIV, STI, and pregnancy (Ross 2007): multi-component intervention versus usual sex education activities
    1. 1Cluster randomized trial accounted for the cluster effects by using a random-effects model.
      2Results as reported by researchers; insufficient data for analysis in this review.
      3Adjusted for age group, stratum, ethnic group, and number of lifetime partners at baseline.
      4NA = not applicable; reportedly, numbers were too small to justify comparison.

    Outcomes at 3 years1,2GenderInterventionComparisonAdjusted
    rate ratio3 (95% CI)
    Pregnancy prevalence (%)females19.218.01.09 (0.85 to 1.40)

    HIV incidence

    (per 1000 person-years)

    females3.184.730.75 (0.34 to 1.66)
    males0.430.30NA4
    HSV-2 prevalence (%)females21.320.81.05 (0.83 to 1.32)
    males11.312.50.92 (0.69 to 1.22)
    Syphilis prevalence (%)females3.33.60.99 (0.67 to 1.46)
    males1.41.80.78 (0.46 to 1.30)
    Chlamydia prevalence (%)females4.93.61.37 (0.98 to 1.91)
    males0.50.51.14 (0.53 to 2.43)
    Gonorrhea prevalence (%)females2.41.21.93 (1.01 to 3.71)
    males0.40.1NA4
    Trichomonas prevalence (%)females28.625.81.13 (0.92 to 1.37)
  • The investigators in Stephenson 2008 used general estimating equations, accounting for correlation between schools, with robust standard errors. Reportedly, the study arms were not significantly different for the study's primary outcome of abortion by age 20 nor for live births by age 20.5 (Table 4).

    Table 4. Pregnancy and STI prevention (Stephenson 2008): peer-led versus teacher-led sex education
    1. 1Cluster randomized trial accounted for cluster effects. Investigators used general estimating equations, accounting for correlation between schools, with robust standard errors.
      2Results as reported by researchers; insufficient data for analysis in this review.
      3CI reportedly account for clustering by school.

    Outcomes by age 201,2Intervention
    % (95% CI)3
    Control
    % (95% CI)
    Adjusted odds ratio
    (95% CI)
    Abortion by age 205.0 (4.0 to 6.3)5.0 (4.0 to 6.4)1.07 (0.80 to 1.42)
    Live births by age 20.57.5 (5.9 to 9.6)10.6 (6.8 to 16.1)0.77 (0.51 to 1.15)
  • Cowan 2010 assessed pregnancy prevalence in a cross-sectional survey due to design change (Table 5). The investigators used generalized estimating equations with robust standard errors to account for the clustering. Reportedly, the comparison groups did not differ significantly for pregnancy prevalence in the main analysis nor in the subgroup analysis of respondents who attended a trial school during the study (Table 5).

    Table 5. Preventing HIV, HSV-2, and pregnancy (Cowan 2010): multi-component intervention versus deferred intervention
    1. 1Cluster randomized trial accounted for the cluster effects. Investigators used generalized estimating equations
      with robust standard errors.
      2Results as reported by researchers; insufficient data for analysis in this review.
      3Adjusted for age, strata, marital status, and education.
      4Attended trial school and lived in trial community for duration of intervention (40% of survey respondents).

    Outcomes at 4 years1,2GenderInterventionComparisonAdjusted odds
    ratio3 (95% CI)
    HIV prevalence (%)females8.17.21.15 (0.81 to 1.64)
    males1.71.31.20 (0.66 to 2.18)
    HSV-2 prevalence (%)females11.99.81.24 (0.93 to 1.65)
    males1.81.51.23 (0.69 to 2.18)
    Pregnancy prevalence (%)females7.78.10.92 (0.70 to 1.19)
    Subgroup analysis4
    HIV prevalence (%)females6.53.81.65 (0.90 to 3.03)
    males1.51.40.91 (0.35 to 3.24)
    HSV-2 prevalence (%)females7.55.91.21 (0.71 to 2.05)
    males1.40.81.34 (0.51 to 3.53)
    Pregnancy prevalence (%)females5.35.90.83 (0.50 to 1.35)

HIV and HSV-2

Four trials assessed the incidence or prevalence of HIV and HSV-2. The investigators reportedly did not find any significant difference in HIV outcomes between the study groups. Two trials reportedly showed lower rates for HSV-2 in the intervention group compared to the control group. In Kamali 2003, incident events and person-years at risk were combined across three rounds of data collection. Incidence rate ratios accounted for the matching of communities by comparing observed to expected (from a regression model). The incidence of HSV-2 was reportedly lower by four years in the behavioral intervention group compared to the control group (reported adjusted rate ratio 0.65; 95% CI 0.43 to 0.97) (Table 6). For Jewkes 2008, the investigators used general linear mixed models with clusters treated as random effect. Incidence was analyzed for HIV and HSV-2 by two years (Table 7). HSV-2 was reportedly lower for the intervention group compared to the control group (reported adjusted rate ratio 0.67; 95% CI 0.47 to 0.97). The addition of the STI program did not appear to make a significant difference.

Table 6. Preventing HIV (Kamali 2003): multi-component or multi-component + STI management versus standard activities
  1. 1Results as reported by researchers; insufficient data for analysis in this review.
    2Adjusted for age and sex. HIV, HSV-2, and syphilis adjusted for respective baseline prevalence. Gonorrhea and chlamydia data pooled from 2 follow-up assessments.

Outcomes at 4 years1Behavioral
intervention
Intervention
+ STI program
ControlAdjusted rate ratio2 (95% CI)
Intervention
versus Control
Intervention + STI program
versus Control

HIV incidence

(per 100 person-years)

0.610.810.800.92 (0.62 to 1.37)0.91 (0.56 to 1.47)

HSV-2 incidence

(per 100 person-years)

2.33.63.50.65 (0.43 to 0.97)1.02 (0.69 to 1.50)
Active syphilis incidence, any titre
(per 100 person-years)
2.92.12.91.13 (0.70 to 1.82)0.81 (0.64 to 1.04)
Active syphilis incidence, titre >= 1/8
(per 100 person-years)
0.50.30.61.13 (0.61 to 2.07)0.58 (0.35 to 0.96)
Gonorrhea prevalence (%)1.020.511.170.74 (0.30 to 1.82)0.28 (0.11 to 0.70)
Chlamydia prevalence (%)1.351.921.810.59 (0.20 to 1.72)0.99 (0.71 to 1.39)
Table 7. Preventing HIV and HSV-2 (Jewkes 2008): multi-component intervention versus standard program
  1. 1Cluster randomized trial accounted for the cluster effects. Investigators used general linear mixed models with clusters treated as random effect.
    2Results as reported by researchers; insufficient data for analysis in this review.
    3Adjusted for stratum, sex, participant’s age, and baseline cluster prevalence of HIV or HSV-2, respectively.

Outcomes at 2 years1,2GenderInterventionControlAdjusted rate
ratio3 (95% CI)

HIV incidence

(per 100 person-years)

overall3.464.070.95 (0.67 to 1.35)
women5.656.95---
men1.401.29---

HSV-2 incidence

(per 100 person-years)

overall3.244.620.67 (0.47 to 0.97)
women5.357.71---
men1.462.04---

Two of the trials reported no significant differences in HIV or HSV-2 outcomes. Ross 2007 assessed incidence at three years (Table 3). A cross-sectional survey for this study examined prevalence at nine years (Table 8); respondents attended trial schools during the intervention period but did not necessarily participate in the study. For Cowan 2010, the investigators examined the prevalence in a cross-sectional survey due to design change. The study groups reportedly did not differ significantly for either measure at four years (Table 5).

Table 8. Preventing HIV, STI, and pregnancy (Ross 2007 (Doyle 2010)): multi-component intervention versus usual sex education activities
  1. 1Cross-sectional survey; reportedly analyzed for stratified cluster randomized trial. Survey participants attended trial schools during the intervention period.
    2Results as reported by researchers; insufficient data for analysis in this review.
    3Adjusted for age group, stratum, and ethnic group.

Outcomes at 9 years1,2GenderInterventionComparisonAdjusted prevalence
ratio3 (95% CI)
HIV prevalence (%)females3.94.21.07 (0.68 to 1.67)
males2.01.70.91 (0.50 to 1.65)
HSV-2 prevalence (%)females40.342.50.96 (0.87 to 1.06)
males25.026.70.94 (0.77 to 1.15)
Syphilis seroprevalence (%)females6.37.50.86 (0.62 to 1.21)
males5.85.31.06 (0.74 to 1.52)
Active syphilis prevalence (%)females4.55.20.91 (0.65 to 1.28)
males3.83.31.11 (0.72 to 1.72)
Chlamydia prevalence (%)females2.62.11.27 (0.87 to 1.86)
males2.12.11.24 (0.66 to 2.33)
Gonorrhea prevalence (%)females0.30.40.73 (0.20 to 2.63)
males0.30.40.71 (0.21 to 2.41)

Sexually transmitted infections

Three trials examined other STI. In Petersen 2007, chlamydia incidence reportedly was 1% overall and did not differ significantly between the study groups. The actual data were not reported. Two trials reported some intervention effect. Kamali 2003 assessed syphilis, gonorrhea, and chlamydia at four years (Table 6). While the behavioral intervention group reportedly did not differ significantly from the control, some effect was noted for the behavioral intervention plus STI program (Intervention-plus). The incidence of active syphilis (high-titer) was lower for the Intervention-plus compared to the control group (reported adjusted rate ratio 0.58; 95% CI 0.35 to 0.96). The prevalence of gonorrhea was also lower for the Intervention-plus versus the control group (reported adjusted rate ratio 0.28: 95% CI 0.11 to 0.70). For prevalence estimates, the investigators adjusted the standard errors in the logistic models using the Huber-White sandwich estimator. Ross 2007 analyzed the prevalence of syphilis, gonorrhea, chlamydia, and trichomonas at three years (Table 3). Among the young women, the prevalence of gonorrhea was reportedly higher for the intervention group compared to the control (adjusted rate ratio 1.93; 95% CI 1.01 to 3.71). The groups did not differ significantly for syphilis or chlamydia. The cross-sectional survey at 9 years also examined the prevalence of these STI among young people who attended trial schools during the intervention (Table 8). Reportedly, the comparison groups did not differ significantly.

Discussion

Summary of main results

Although we considered comparative studies of various designs, the only studies identified were randomized controlled trials. Our criteria for having a biological outcome likely limited the type of study. We summarized the outcome measures and evidence of effect (Table 9). As noted earlier (Unit of analysis issues), we were not able to analyze outcomes for the cluster randomized trials, so we presented them as reported by the investigators.

Table 9. Outcome summary
  1. ND = No significant difference between study groups
    I = Behavioral intervention
    I-plus = Behavioral intervention plus STI syndromic management
    C = Comparison
    1Abortions and live births
    2Chlamydia, gonorrhea, trichomonas (grouped)
    3High-titre syphilis only

StudyPregnancyHIVHSV-2SyphilisGonorrheaChlamydiaTrichomonasOther
Petersen 2007ND---------------------
Ross 2007NDNDNDNDFemales, I > CNDND---
Stephenson 2008ND1---------------------
Boyer 2005ND------------------ND2
Cowan 2010NDNDND---------------
Jewkes 2008---NDI < C---------------
Kamali 2003---NDI < CI-plus < C3I-plus < CND------
Studies with some
intervention effect
------212---------

The trials showed or reported no significant differences between study groups for pregnancy or HIV, but favorable effects were evident for STI in some studies. Two studies showed a lower incidence of HSV-2 in the intervention group, while HIV did not differ significantly (Kamali 2003; Jewkes 2008). One of those trials also reported lower syphilis incidence and gonorrhea prevalence for the group with the behavioral intervention plus STI management versus the usual-care group. Another study reported one difference in an STI and that was a negative effect (Ross 2007). Young women in the special intervention group had a higher prevalence of gonorrhea than the control group. The investigators' analysis by school year at baseline indicated the difference occurred among those who had only one year of the intervention.

Overall completeness and applicability of evidence

Study characteristics. The trials were conducted in community settings, schools, a clinic, and a military training setting. Ages of the target populations varied. Six of the seven trials provided multiple sessions in a group format, which is more common for public health programs such as HIV prevention than for clinic-based models of contraceptive counseling. Four trials took place in African countries, two in the USA, and one in England.

Applicability. Relevance of the few successful interventions to traditional contraceptive counseling may be limited. 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. Effective interventions are needed, including some that can be adapted to clinical settings.

Theory base. Nearly all of these trials had an identified theoretical or model basis, which is also more common in HIV and STI prevention than in contraception counseling. High-quality research on behavior change has been limited for reproductive health (Lopez 2013). A USA study explored attitudes and beliefs of clinicians about reproductive counseling. Most respondents believed they influenced their patients through their medical authority and the presentation of information (Henderson 2011). Those views are not consistent with current thinking about behavior change and patient-centered counseling.

Adverse effects. These studies did not report on adverse effects or events (AE) as clinical trials would. Because these were educational interventions and not drug trials, side effects like physical pain or nausea were unlikely. However, unintended pyschosocial effects might occur, e.g., anxiety about discussing sexual behavior or concern about confidentiality. Such issues were not addressed in these reports. Unexpected behavioral effects were also possible, e.g., an increase in unsafe sexual behavior. For most studies, change in sexual behavior was a planned outcome measure, and might not be considered an AE. We did not include behavioral outcomes in our review. Some studies reported on negative trends in the planned outcome measures, such as more 'transactional sex' at the interim measure or more unintended pregnancies in the intervention group (Jewkes 2008).

Relevant subgroups. We did not find any analysis of relevant subgroups, such as those at high risk for pregnancy or HIV/STI. Outcomes were reported by demographic variables such as age or marital status, but not examined within group. Some differences were noted regarding changes in knowledge or behavior but not for biological outcomes. These studies were not likely powered to examine our outcomes by subgroup.

Quality of the evidence

As noted in Data synthesis, we did not conduct a formal GRADE assessment with an evidence profile and summary of findings table. Meta-analysis was not viable due to the varied interventions, which is typical with these types of programs. Without a meta-analysis, a summary of findings table is not feasible. We did use principles from GRADE to assess the evidence quality.

Our assessment was based on details from the individual studies. Most trials provided sufficient information. In many cases, design articles rather than outcome reports provided the detail. The studies also provided substantial information on the fidelity of implementation (Table 1). Four trials met four of our five fidelity criteria. The data most often lacking were provider credentials, assessing adherence to the protocol, and assessing intervention receipt. The overall quality of evidence is considered moderate to low for this review (Table 10). Of the three trials with evidence of high or moderate quality, one had evidence of an intervention effect and that was negative (Table 9). Losses to follow up were high in most trials. The only study with low losses was the clinic-based trial with a 12-month follow up, shorter than several others.

Table 10. Quality of evidence
  1. 1Quality could be high, moderate, low, or very low. RCTs were considered high quality then downgraded a level for each of the following: a) randomization sequence generation and allocation concealment: no information on either, or one was inadequate; b) intervention fidelity information for <= 3 criteria; c) follow up < 6 months; d) losses to follow up >= 20%.
    2Due to out-migration of cohort, losses were > 20%. Design was changed to cross-sectional survey for final data collection.

StudyRandomization and
allocation
concealment
Intervention
fidelity
>= 4
Follow up
>= 6 months
Losses < 20%Quality of evidence1
Petersen 2007++++High
Ross 2007+++-Moderate
Stephenson 2008+++-Moderate
Boyer 2005+-+-Low
Cowan 2010 2+-+-Low
Jewkes 2008-++-Low
Kamali 2003--+-Very low
Studies meeting criteria5471 Moderate to low overall

Most studies reported an a priori sample size calculation for the biological outcomes of STI (Boyer 2005), HIV (Kamali 2003; Ross 2007; Jewkes 2008; Cowan 2010), or pregnancy (Stephenson 2008). The individually randomized trial (Petersen 2007) was powered to detect a difference in contraceptive use rather than our outcome of pregnancy.

Potential biases in the review process

The assessment of evidence quality involves judgment. We focused on five criteria for intervention fidelity that we believed to be pertinent in reviewing behavioral interventions and have found useful in conducting similar reviews. Other researchers might emphasize different criteria. In addition, we focused on certain design features for the overall quality assessment that are relevant to these types of studies. Again, others may have chosen different factors or cutoffs. Our approach and the evidence are presented for the reader.

Most trials were cluster randomized and the investigators conducted adjusted analyses. We could not analyze the data within the review, but presented the data as reported. Since most of the studies found no significant effect of the intervention, using the reported results is unlikely to have positively biased our conclusions. Given the differences in interventions and populations, we would not have conducted meta-analysis even if we had the individual participant data.

We excluded many studies because they did not have pregnancy prevention as an intervention objective, although some used pregnancy as an outcome measure. Pregnancy incidence is a useful measure of unprotected sex, regardless of whether the intervention addresses contraception. While our eligibility criterion limited the number of studies, it helped focus the review and is unlikely to have introduced bias.

The interventions could have affected outcome measures that we did not include, such as contraceptive use or sexual behavior. We had extracted other outcome data from four trials for a different project (Lopez 2013). One trial showed a positive effect for the intervention group on condom use and on knowledge of pregnancy prevention (Ross 2007), but three did not show any difference in use of condoms or other contraceptives (Boyer 2005; Petersen 2007; Cowan 2010). Still, some studies assessed behavioral outcomes that we did not examine. The interventions might have had some effect on those measures.

Agreements and disagreements with other studies or reviews

Findings from related reviews may vary by eligibility criteria for interventions and outcomes. Many studies examine behavioral measures of condom use along with biological outcomes. Further, investigators may use several condom use measures, e.g., first condom use, condom use with last sex, or condom use with new or regular sex partner. We limited the outcomes to biological assessments, which are more reliable and valid indicators of unprotected sex than self-report. The available evidence was further limited with our criterion of pregnancy prevention as part of the intervention along with prevention of HIV/STI.

Several reviews of behavioral interventions have included pregnancy prevention as an intervention or an outcome measure. Chin 2012 reviewed comprehensive risk-reduction programs and reported favorable results for all their outcomes. However, most were self-reported, including pregnancy and HIV incidence. The review of Blank 2012 focused on contraceptive service provision and use, and included pregnancy as an outcome. The interventions that promoted condom use had some favorable results for condom use but did not address pregnancy.

Four trials in the current review are also in a review of theory-based interventions to improve contraceptive use (Lopez 2013). The outcome criteria for the earlier review included use of condoms and other contraceptives. Still, no significant differences were found in the behavioral measures in three studies included here (Boyer 2005; Petersen 2007; Cowan 2010). Ross 2007 reported some positive differences for the intervention group in condom use and knowledge of pregnancy prevention.

Others reviews have focused on promotion of condom use. Carvalho 2011 identified five eligible studies focused on women with HIV; the meta-analysis did not show a difference in condom use. Free 2011 found 139 RCTs of interventions to promote condom use, but few studies had their primary outcome measures. Of 10 trials with data on 'any STI,' seven showed some reductions in STI for the intervention group (Free 2011). Four studies had self-reported pregnancy, and three of those showed reductions in pregnancy. For 'condom use at last sex', 9 of 18 trials reported an increase in use. Many other reviews, such as Wariki 2012, focus on preventing HIV/STI transmission and did not address pregnancy prevention.

Authors' conclusions

Implications for practice

We found few studies and little clinical evidence of effectiveness of interventions to promote condom use for dual protection. We required that the intervention address preventing pregnancy and disease. Nearly all the trials provided multiple sessions in a group format, and most were multifaceted. Implementation would be complex and require significant resources. Interventions that are feasible for resource-limited settings are still needed. We did not find any favorable results for pregnancy or HIV and only some for other STI. Many interventions that appear promising have not been examined using biological outcomes.

Implications for research

Only RCTs met our eligibility criteria, mainly due to requiring a biological outcome. The trials generally provided sufficient evidence for assessing quality. The low quality evidence for this review was largely due to high losses in these long-term trials as well as limited information intervention fidelity. Effective interventions to promote condom use are needed for preventing pregnancy and transmission of HIV/STI. The literature contains many reports with self-reported outcomes, including multiple measures of condom use. Behavioral interventions should be tested more rigorously, using valid and reliable outcome measures.

Acknowledgements

From FHI 360, Carol Manion provided input on the search strategy and Laurie Stockton reviewed some search results.

David Grimes, formerly of FHI 360, conducted the secondary data abstraction for three trials from an earlier review (Lopez 2013).

Data and analyses

Download statistical data

Comparison 1. Pregnancy and STI prevention: motivational interviewing versus general health counseling
Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size
1 Pregnancy (by 12 months)1737Odds Ratio (M-H, Fixed, 95% CI)0.88 [0.55, 1.42]
Analysis 1.1.

Comparison 1 Pregnancy and STI prevention: motivational interviewing versus general health counseling, Outcome 1 Pregnancy (by 12 months).

Appendices

Appendix 1. Search strategies

MEDLINE via PubMed (01 Oct 2013)

((condom*[Title/Abstract] OR protected[Title/Abstract] OR unprotected[Title/Abstract]) AND (pregnan* OR antigen OR semen OR HIV OR STI OR "sexually transmitted")) NOT (emergency[Title] OR "men who have sex with men"[Title] OR MSM[Title] OR microbicide*[Title]) AND ((Clinical Trial[ptyp] OR Comparative Study[ptyp] OR Evaluation Studies[ptyp]) AND Humans[Mesh])

CENTRAL (25 Jun 2013)

Title, Abstract, Keywords: condom*
AND Title, Abstract, Keywords: pregnan* OR antigen OR semen OR HIV OR STI OR sexually transmitted

POPLINE (12 Feb 2013)

Keyword: Condoms OR female condoms
Filter by Research Report

EMBASE (14 Feb 2013)

condom*:ab AND (pregnan*:ab OR antigen:ab OR semen:ab OR hiv:ab OR 'sexually transmitted disease':ab) AND (educat*:ab OR counsel*:ab OR communicat*:ab OR behavioral:ab OR use:ab OR continuation:ab) NOT (emergency:ti OR 'men who have sex with men':ti OR msm:ti OR microbicide*:ti) AND [obstetrics and gynecology]/lim AND [humans]/lim

LILACS (04 Apr 2013)

condom OR condoms OR Condones OR preservativos [Words]
AND pregnancy OR Embarazo OR gravidez OR pregnancies OR pregnant OR embarazadas OR gestantes OR antigen OR antigeno OR semen OR HIV OR SIDA OR VIH OR STI OR sexually transmitted diseases OR Enfermedades de Transmisión Sexual OR Doenças Sexualmente Transmissíveis OR sexually transmitted OR Transmisión Sexual OR Sexualmente Transmissíveis [Words]
NOT emergency OR Urgencia OR Emergência OR MSM OR microbicide OR microbicides OR Antiinfecciosos OR Anti-Infecciosos [Title words]

OpenGrey (02 Jul 2013)

condom*

COPAC (03 Jul 2013)

Subject: (condom* OR protected OR unprotected) AND (pregnan* OR antigen OR semen OR HIV OR STI OR "sexually transmitted"))
Material type: Electronic resources, computer programs, etc.; Journals and other periodicals; Theses

ClinicalTrials.gov (01 Apr 2013)

Intervention: Contracept* OR condom* OR protected OR unprotected
Outcomes: pregnan* OR birth OR antigen OR PSA OR semen OR HIV OR STI OR sexually transmitted
Gender: Studies with female participants

ICTRP (01 Apr 2013)

Condition: pregnan% OR birth OR antigen OR PSA OR semen OR HIV OR STI OR sexually transmitted
intervention:  Contracept% OR condom% OR protected OR unprotected
Recruitment status: All

Contributions of authors

LM Lopez initiated and drafted the review. LM Lopez and C Otterness reviewed the search results, extracted and entered data from four trials and additional outcomes from three trials in an earlier review (Lopez 2013). MF Gallo and M Steiner provided input on the concept and inclusion criteria as well as content expertise. M Chen contributed to the Methods, reviewed the evidence quality assessment, and provided assistance with data presentation. All authors reviewed and commented on the manuscript.

Declarations of interest

None known

Sources of support

Internal sources

  • No sources of support supplied

External sources

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

    For conducting the review (FHI 360 staff)

  • US Agency for International Development, USA.

    For conducting the review (FHI 360 staff)

Characteristics of studies

Characteristics of included studies [ordered by study ID]

Boyer 2005

MethodsLocation: most likely California and South Carolina (USA); enrollment Jun 1999 to Jun 2000.
Sample size calculation (and outcome of focus): originally N=477 per group to assess decreasing STIs by 6%. Increased to 568 per group to address cluster effect; increased to 1000 per group since half of participants would be stationed where STI and pregnancy screening would not be possible at follow up.
Cluster randomized trial: platoons were assigned to study groups.
ParticipantsGeneral with N: 2157 female Marine recruits in training
Source: marine recruit training
Inclusion criteria: female Marine recruits in training
Exclusion criteria: not specified
InterventionsStudy focus: preventing STIs and unplanned pregnancies
Theory or model: Information-motivation-behavioral skills model
Treatment: four 2-hour group sessions at weeks 1, 2, 4, and 12 of 13-week recruit training. Content included condom use skills, proper condom use, barriers to condom use; contraceptive types, pros and cons, decision-making; communicating with sexual partners.
Comparison or control: same format; content included nutrition and physical performance, sports or training injuries, cervical and breast cancer.
Duration: 12 weeks for intervention; follow up at 14 months after baseline assessment
OutcomesLaboratory tested: pregnancy (tested and also reported to be unintended), Chlamydia, gonorrhea, trichomonas.
Additional data provided by investigator in 2008 (for another review): pregnancy, number of events and sample size.
NotesCluster randomized trial accounted for the cluster effects. Researchers calculated robust standard errors using the Huber-White sandwich estimator in regression models. Independent variables were intervention group, sexual history, and time between assessments.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskComputer-generated random numbers table established before the study start.
Allocation concealment (selection bias)Unclear riskPlatoons were identified prior to randomization. All female marine recruits in the platoons were eligible.
Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskNone for platoons; informed of group assignment after enrollment and baseline assessment.
Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskno information
Incomplete outcome data (attrition bias)
All outcomes
High riskLosses to follow up: 38% loss for questionnaire data and 59% loss for pregnancy data (due to deployments); study groups were similar.
Exclusions after randomization: none apparent

Cowan 2010

Methods

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

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

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

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

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

Participants

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

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

Inclusion criteria: communities with at least 250 students in ninth year of school and no HIV prevention targeting young people. Original cohort included all students in ninth year. Final survey (cross-sectional): 18 to 22 years old and living in 180 enumeration areas purposively selected.

Exclusion criteria: not specified

Interventions

Study focus: reducing rates of HIV, HSV-2, and unintended pregnancy
Theory or model: social learning theory; stages of change reportedly used for out-of-school youth program.
Treatment

  • Youth program

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

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

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

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

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

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

Outcomes

Prevalence of HIV, HSV-2, and pregnancy; cross-sectional.

Additional data provided by investigator: not applicable

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

Randomization restricted for equal number of schools per arm, balance across districts, and average N of 255 to 261 per community per arm.

One allocation out of all possible allocations that met the criteria was randomly chosen at randomization meeting.

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

Allocation concealment (selection bias)Unclear riskCommunities identified prior to randomization.
Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskno information
Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskno information
Incomplete outcome data (attrition bias)
All outcomes
Unclear risk

Losses to follow up: see design change described above.

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

Jewkes 2008

Methods

Location: rural Eastern Cape, South Africa; enrollment from Mar 2003 to Mar 2004

Sample size calculation (and outcome of focus): 35 clusters per arm for 80% power to detect 50% reduction in HIV incidence (assuming 12% 2-year cumulative incidence in control group)

Cluster randomized trial: communities assigned to study groups (64 villages and 6 townships); 7 strata; 1 with townships and 6 for villages grouped by proximity to specific parts of main roads.

Participants

General with N: 70 clusters in subsistence farming area; 2776 individuals.

Source: Eastern Cape Province; most individuals recruited from schools

Inclusion criteria, clusters: about 10 km from nearest cluster, senior or junior school, community willing to participate.

Inclusion criteria, individuals: aged 16 to 23 years (actual age range was 15 to 26 years), normally resident in village where at school, mature enough to understand study and consent.

Exclusion criteria: small size (not specified)

InterventionsStudy focus: HIV prevention
Theory or model: adult education theory; Freirian models of critical reflection; methods from assertiveness training.
Treatment: 13 core sessions and 3 meetings with activities; sessions included conception, contraception, unintended pregnancy, STI and HIV, safer sex and condoms, motivation for sexual behavior.
Comparison or control: one session with exercises about HIV and safer sex drawn from treatment curriculum.
Duration: treatment lasted about 50 hours (about 3 hours per session) over 6 to 8 weeks; control was 2 to 3 hours; follow up after 1 and 2 years.
Outcomes

HIV incidence, HSV-2 incidence

Additional data provided by investigator: not applicable

Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskStudy statistician, based in Pretoria and no knowledge of study area, generated allocation sequence; computer-generated randomization with equal numbers of villages assigned to each arm.
Allocation concealment (selection bias)High riskProject manager and field coordinators identified and randomized the clusters. Randomization done before village recruitment for logistical reasons.
Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskNone used
Blinding of outcome assessment (detection bias)
All outcomes
Low riskBlood tests conducted blind to study arm.
Incomplete outcome data (attrition bias)
All outcomes
High risk

Losses to follow up: flow chart indicates 22% not available at 12 months (624/2776) and 25% not available at 24 months (683/2776).

For primary outcome analysis (HIV incidence), reportedly 2221/2776 (80%) were available but flow chart suggests about 85%. Study groups did not differ substantially.
Exclusions after randomization: none apparent

Kamali 2003

Methods

Location: Masaka district, Uganda; baseline surveys Apr 1994 to Nov 1996

Sample size calculation (and outcome of focus): 4500 in each of 3 groups for 90% power to detect 50% reduction in HIV incidence, assuming background yearly incidence 1.5%

Cluster randomized trial: communities were assigned to study groups

Participants

General with N: 18 communities with 20,516 individuals eligible; 14,554 participated in round 1 and 15,614 in round 2.

Source: Masaka district

Inclusion criteria: communities (administrative units) with government health facility

Exclusion criteria: too far from capital for logistical reasons, proximity to another study area, or major center difficult to follow and work with.

Of 22 communities, 18 grouped into 3 'triplets' (distance within and between triplets of 15 km or 3-hour walk); 4 communities excluded, reason not specified

Interventions

Study focus: HIV prevention, community-level intervention
Theory or model: 'Behavioral change for Interventions' model
Treatment:

  • Behavioral intervention targeting all adults in community included large monthly meetings with a play and discussion (16-topic guide), frequent small meetings and individual discussions, monthly videos, leaflet distribution (HIV, STI, condoms); 16-topic guide included condom use, HIV transmission, family planning.

  • Behavioral intervention above plus syndromic management of STIs (Intervention-plus).

Comparison or control: routine government health facilities with general community development activities.

All communities: social marketing of male condoms and voluntary HIV counseling and testing.
Duration: 3 to 4 years

Outcomes

Incidence: HIV and active syphilis (all adults); HSV-2 (age 13 to 29 years); gonorrhea and chlamydia (age 13 to 39 years)

Data collected in 3 rounds (baseline = round 1); new enrollees at round 2; 18- to 24-month intervals for rounds 2 and 3 assessments. Outcomes based on those who provided data at least twice.

Additional data provided by investigator: not applicable

Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)High riskNames of communities within each triplet were written on separate cards and shuffled.
Allocation concealment (selection bias)Unclear riskCards picked at 'random.' From each triplet, first one allocated to arm A, second to arm B, and third to arm C.
Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskno information
Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskStudy team blind to data until end of study.
Incomplete outcome data (attrition bias)
All outcomes
High risk

Losses to follow up: due to refusal and unavailability:

Of those eligible, 71% to 75% provided blood samples in round 1 (baseline) or round 2 (included new residents). Round 3 included those who provided blood samples in rounds 1 and 2.

Of the maximum eligible (round 2), 59% to 64% provided samples in round 3.
Exclusions after randomization: none reported

Petersen 2007

MethodsLocation: North Carolina (USA); enrollment from Mar 2003 to Sep 2004
Sample size calculation (and outcome of focus): N=1050 to measure improvements in level of contraceptive use (with 10% loss = 948)
ParticipantsGeneral with N: 764 women visiting clinics
Source: 3 primary care clinics serving 'numerous' counties
Inclusion criteria: 16 to 44 years old, at risk of unintended pregnancy (not pregnant and not planning to get pregnant, not using an IUD, and neither the woman or her partner was sterilized)
Exclusion criteria: not specified
Interventions

Study focus: pregnancy and STI prevention counseling
Theory or model: motivational interviewing
Treatment: counseling session on reproductive health, based on motivational interviewing; explored discrepancy between pregnancy intention and contraceptive use and between STI risk and condom use, information shared with participants, promoted behaviors to reduce risk. Booster session provided to participants 2 months later, in person or by telephone.
Comparison or control: brief general counseling on preventive health care, excluding counseling on pregnancy and STI prevention
Duration: 1 session (plus booster session for treatment group)

Follow-up assessments at 2, 8, and 12 months.

Outcomes

Pregnancy and chlamydia incidence (both tested but group data not shown in report).

Additional data provided by investigator in 2008 (for another review): number that completed each follow up by study arm (flow diagram of trial participants) and pregnancy by study arm.

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

Ross 2007

MethodsLocation: Mwanza Region, Tanzania; enrollment in late 1998
Sample size calculation (and outcome of focus): 10 to 11 communities per arm (with 500 per community) to detect 50% reduction in HIV incidence (from 1.6% to 0.8%)
Cluster randomized trial: 20 communities assigned to study groups; 3 strata based on HIV prevalence and geographical characteristics.
ParticipantsGeneral with N: 20 rural, well-separated, communities; 9645 adolescents
Source: Mwanza Region
Inclusion criteria: rural communities, located in 1 of 4 districts; evaluation cohort limited to students born in 1984 or later (at least age 14 at start and age 16.75 at final follow up), due to age-related differences in HIV prevalence.
Exclusion criteria: students received intervention but were not within age limits.
InterventionsStudy focus: reduce incidence of HIV, other STIs, and unwanted pregnancy among adolescents
Theory or model: primarily Social Cognitive Theory
Treatment: 3-year school curriculum, 10 to 15 lessons per year, included correct and consistent condom use (students received 1, 2, or 3 years depending on school level (grade) at project start); youth-friendly health services, community activities, and condom promotion and distribution.
Comparison or control: usual activities
Duration: follow up at 18 and 36 months after baseline
Outcomes

Incidence of HIV; prevalence of pregnancy, HSV-2, syphilis, C trachomatis, N. gonorrhoeae, T vaginalis (women only).

Initial outcome data collected from 2001 to 2002 (at 3 years); reported in Ross 2007.
Additional data provided by investigator: not applicable

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

Stephenson 2008

  1. a

    Outcomes relevant for this review may not have been the primary study outcomes.
    HIV = human immunodeficiency virus
    HSV-2 = herpes simplex virus 2
    N = number
    STI = sexually transmitted infection

Methods

Location: central and southern England (UK); enrollment 1998 to 1999

Sample size calculation (and outcome of interest): 14 schools per arm with 150 girls each to detect 33% reduction in abortion by age 20 (from 9% to 6%); 80% power.

Cluster randomized trial: 29 schools randomized, 3 strata based on sum of standardized criteria including socioeconomic factors and services (low, medium, high risk).

Participants

General with N: 27 schools; 8766 participants. Randomized 29 schools; 2 withdrew before knowing allocation, due to staff changes.

Source: schools

Inclusion criteria: Schools were comprehensive, mixed sex, nonselective, and took students until age 18. Individuals were in grade 8, aged 13 to 14 years. Peer educators were students in grade 11.

Exclusion criteria: Schools already implementing peer-led sex education.

Interventions

Study focus: prevent pregnancy and STI and improve quality of sexual relationships.

Theory or model: none

Treatment: school-based, peer-led sex education during summer session

Comparison or control: teacher-led sex education (usual method)

Duration: 3 class sessions, 1 hour each.

Follow up: phase I, 1) 6 months and 2) 18 months; phase II, 3) ages 16 to 17 and 4) ages 19 to 20.

Outcomes

Pregnancy: abortion by age 20; live births by age 20.5. Data from National Health Service, statutory abortion notification and birth registration.

Additional data provided by investigator: not applicable

NotesPhase I follow up, 6 months post-intervention, had self-reported outcomes.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskComputer-generated sequence; block size 10.
Allocation concealment (selection bias)Unclear riskNo information
Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskNo blinding
Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskImplementation and evaluation were independent.
Incomplete outcome data (attrition bias)
All outcomes
Low risk

Overall loss: missing postal codes for 25% of girls (21% intervention, 28 % control); 44 abortions for age 18 analysis due to age at abortion not available = 19% of abortions (44/232), 2% of sample (44/2380); included in age 20 analysis.

Exclusions after randomization: none apparent

Characteristics of excluded studies [ordered by study ID]

StudyReason for exclusion
Allen 1992

Not comparative for this review; outcome measures differed for HIV+ and HIV- women.

All participants received AIDS education, including information about condom use. Women who tested positive for HIV were also counseled about pregnancy prevention; outcome measure was gonorrhea. Women who tested negative for HIV were counseled about risk reduction; outcome measure was HIV seroconversion.

Allen 2003Behavioral intervention did not address contraception
Bachanas 2013Outcome report not yet available. Investigator communicated that the study did not conduct pregnancy tests. Pregnancy data came from self-report and clinic charts. Coverage may have been incomplete.
Barnet 2009Behavioral intervention did not include condoms
Black 2006Behavioral intervention did not include condoms
Boyer 1997Behavioral intervention did not address contraception
Branson 1998Behavioral intervention did not address contraception
Brou 2009Behavioral intervention did not have specific condom component
Chacko 2010Behavioral intervention did not have specific condom component
De Fine Olivarius 1992Behavioral intervention did not address contraception
Ethier 2011Behavioral intervention did not have specific condom component
Exner 2011No relevant outcome measure
Feldblum 2007Behavioral intervention did not address contraception
Fitzgerald 1999No relevant outcome measure
Grossman 2012Behavioral intervention did not have specific condom component; focused on integration of services.
Kershaw 2009Behavioral intervention did not address contraception
King 1995No relevant outcome measure
Kirby 2010Investigator provided pregnancy data for an earlier review (self-report and clinic data). Self-reported pregnancy was higher than rates from clinic charts because participants used other clinics as well, according to the report. Therefore, coverage was incomplete. STI data were also from self-reports.
Kosgei 2011Condom education was routinely offered
Morrison-Beedy 2013Behavioral intervention did not address pregnancy prevention
Ngubane 2008

Report provides contraceptive use (by type) for total cohort; in figure without absolute numbers and not by HIV status. HIV testing and counseling was provided, as was family planning counseling.

One of the researchers communicated that they did not analyze by HIV status. She also noted that the counseling was standard of care at each visit (condoms with each sex act plus an additional contraceptive to avoid pregnancy).

Ngure 2012

Behavioral intervention did not address contraception.

Ngure 2012 analyzed pregnancy by HIV status and type of contraceptive used. No mention of contraceptive counseling. Heffron 2010 analysis focused on contraceptive use by HIV status, not by any intervention.

Orr 1996Behavioral intervention did not address contraception
Temmerman 1990Behavioral intervention did not have specific condom component
Wingood 2004Behavioral intervention did not address contraception

Ancillary