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Behavioral interventions for improving condom use for dual protection

  1. Laureen M Lopez1,*,
  2. Conrad Otterness2,
  3. Mario Chen3,
  4. Markus Steiner1,
  5. Maria F Gallo4

Editorial Group: Cochrane Fertility Regulation Group

Published Online: 26 OCT 2013

Assessed as up-to-date: 2 OCT 2013

DOI: 10.1002/14651858.CD010662.pub2


How to Cite

Lopez LM, Otterness C, Chen M, Steiner M, Gallo MF. Behavioral interventions for improving condom use for dual protection. Cochrane Database of Systematic Reviews 2013, Issue 10. Art. No.: CD010662. DOI: 10.1002/14651858.CD010662.pub2.

Author Information

  1. 1

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

  2. 2

    Global Health Access Program, Mae Sot, Tak, Thailand

  3. 3

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

  4. 4

    The Ohio State University, Division of Epidemiology, Columbus, Ohio, USA

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

Publication History

  1. Publication Status: New
  2. Published Online: 26 OCT 2013

SEARCH

 
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

MethodsLocation: 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.


ParticipantsGeneral 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


InterventionsStudy 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


OutcomesPrevalence 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 riskRandomization 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 riskLosses 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

MethodsLocation: 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.


ParticipantsGeneral 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.


OutcomesHIV 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 riskLosses 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

MethodsLocation: 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


ParticipantsGeneral 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


InterventionsStudy 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


OutcomesIncidence: 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 riskLosses 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


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

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


OutcomesPregnancy 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


OutcomesIncidence 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

MethodsLocation: 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).


ParticipantsGeneral 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.


InterventionsStudy 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.


OutcomesPregnancy: 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 riskOverall 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 1992Not 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 2008Report 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 2012Behavioral 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

 
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]

 
Table 1. Intervention fidelity

StudyCurriculum or manualProvider credentialsTraining for interventionAssessed 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 yearTeachers (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 feedbackNot 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 discussionsNot 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 materialsNot specific:
research assistants
Not specific:

Trained
No informationLast session involved describing, practicing, discussing2

Studies meeting criteria646343.3 overall fidelity

 1Assessed participants' understanding and skills regarding the intervention.
 
Table 2. Pregnancy and STI prevention (Boyer 2005): group risk reduction versus group health promotion

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

 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.
 
Table 3. Preventing HIV, STI, and pregnancy (Ross 2007): multi-component intervention versus usual sex education activities

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)

 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.
 
Table 4. Pregnancy and STI prevention (Stephenson 2008): peer-led versus teacher-led sex education

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)

 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.
 
Table 5. Preventing HIV, HSV-2, and pregnancy (Cowan 2010): multi-component intervention versus deferred intervention

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)

 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).
 
Table 6. Preventing HIV (Kamali 2003): multi-component or multi-component + STI management versus standard activities

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)

 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.
 
Table 7. Preventing HIV and HSV-2 (Jewkes 2008): multi-component intervention versus standard program

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---

 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.
 
Table 8. Preventing HIV, STI, and pregnancy (Ross 2007 (Doyle 2010)): multi-component intervention versus usual sex education activities

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)

 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.
 
Table 9. Outcome summary

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---------

 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
 
Table 10. Quality of evidence

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 20102+-+-Low

Jewkes 2008-++-Low

Kamali 2003--+-Very low

Studies meeting criteria5471Moderate to low overall

 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.