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.

Four secondary schools and surrounding communities in rural Zimbabwe.

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.

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.

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.