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Background: HIV prevention among young people in southern Africa is a public health priority. There is little rigorous evidence of the effectiveness of different intervention approaches. We describe findings of a cluster randomized trial of a community-based, multicomponent HIV, and reproductive health intervention aimed at changing social norms for adolescents in rural Zimbabwe., Methods: Thirty rural communities were randomized to early or deferred implementation of the intervention in 2003. Impact was assessed in a representative survey of 18-22-year-olds after 4 years. Participants self-completed a questionnaire and gave a dried blood spot sample for HIV and herpes simplex virus-2 (HSV-2) antibody testing. Young women had a urinary pregnancy test. Analyses were by intention-to-treat and were adjusted for clustering., Findings: Four thousand six hundred and eighty-four, 18-22-year-olds participated in the survey (97.1% of eligible candidates, 55.5% women). Just over 40% had been exposed to at least 10 intervention sessions. There were modest improvements in knowledge and attitudes among young men and women in intervention communities, but no impact on self-reported sexual behavior. There was no impact of the intervention on prevalence of HIV or HSV-2 or current pregnancy. Women in intervention communities were less likely to report ever having been pregnant., Interpretation: Despite an impact on knowledge, some attitudes, and reported pregnancy, there was no impact of this intervention on HIV or HSV-2 prevalence, further evidence that behavioral interventions alone are unlikely to be sufficient to reverse the HIV epidemic. The challenge remains to find effective HIV prevention approaches for young people in the face of continued and unacceptably high HIV incidence, particularly among young women.

Objective: To assess the effectiveness of a community-based HIV prevention intervention for adolescents in terms of its impact on (1) HIV and Herpes simplex virus type 2 (HSV-2) incidence and on rates of unintended pregnancy and (2) reported sexual behaviour, knowledge and attitudes., Methods: Cluster randomised trial of a multi-component HIV prevention intervention for adolescents based in rural Zimbabwe. Thirty communities were selected and randomised in 2003 to early or deferred intervention implementation. A baseline bio-behavioural survey was conducted among 6791 secondary school pupils (86% of eligibles) prior to intervention implementation., Results: Baseline prevalences were 0.8% (95% CI: 0.6-1.0) for HIV and 0.2% (95% CI: 0.1-0.3%) for HSV-2. Four girls (0.12%) were pregnant. There was excellent balance between study arms. Orphans who made up 35% of the cohort were at increased risk of HIV [age-sex adjusted odds ratio 3.4 (95% CI: 1.7-6.5)]. 11.9% of young men and 2.9% of young women reported that they were sexually active (P < 0.001); however, there were inconsistencies in the sexual behaviour data. Girls were less likely to know about reproductive health issues than boys (P < 0.001) and were less likely to have used and to be able to access condoms (P < 0.001)., Conclusion: This is one of the first rigorous evaluations of a community-based HIV prevention intervention for young people in southern Africa. The low rates of HIV suggest that the intervention was started before this population became sexually active. Inconsistency and under-reporting of sexual behaviour re-emphasise the importance of using externally validated measures of sexual risk reduction in behavioural intervention studies.

Objective: To determine the feasibility and acceptability of conducting a community randomized trial (CRT) of an adolescent reproductive health intervention (ARHI) using biological measures of effectiveness., Setting: Four secondary schools and surrounding communities in rural Zimbabwe., Methods: Discussions were held with pupils, parents, teachers and community leaders to determine acceptability. A questionnaire and urine sampling survey was undertaken among Form 1 and 2 pupils. Studies were undertaken to inform likely participation and follow up in a future CRT. A community survey of 16-19-year-olds was conducted to determine levels of secondary school attendance and likely HIV prevalence at final follow up in the event of a trial., Results: Form 1 and 2 pupils aged 12-18 years (n = 723; median age, 15 years) participated in the research. Prevalences of HIV, Chlamydia and gonorrhoea were 3.6% [95% confidence interval (CI), 2.3-5.3%], 0.4% (95% CI, 0.1-1.3%) and 1.9% (95% CI, 1.0-3.3%) respectively. There was poor correlation between biological evidence of sexual experience and questionnaire responses, due to concerns about confidentiality. Only 13% (95% CI, 4-27%) of those infected with HIV and/or a sexually transmitted disease admitted to having had sex. In the community survey of 573 adolescents aged 16-19 years, 6.6% (95% CI, 3.9-10.3%) of females and 5.1% (95% CI, 2.9-8.2%) of males were HIV positive. High participation and retention rates are achievable within a trial in this setting., Conclusions: It is acceptable and feasible to conduct randomized trials to establish the effectiveness of ARHIs. However, self-reported behavioural outcomes will probably be biased, emphasizing the importance of using externally validated biological outcome measures to determine effectiveness.