title: School based HIV prevention in Zimbabwe: feasibility and acceptability of evaluation trials using biological outcomes.
abstract: 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.
  
  
  METHODS
  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.
authors.affiliation: Department of Sexually Transmitted Diseases, Royal Free and University College Medical School, London, UK.
authors.forename: Frances M
authors.initials: FM
authors.lastname: Cowan
authors.forename: Lisa F
authors.initials: LF
authors.lastname: Langhaug
authors.forename: George P
authors.initials: GP
authors.lastname: Mashungupa
authors.forename: Tellington
authors.initials: T
authors.lastname: Nyamurera
authors.forename: John
authors.initials: J
authors.lastname: Hargrove
authors.forename: Shabbar
authors.initials: S
authors.lastname: Jaffar
authors.forename: Rosanna W
authors.initials: RW
authors.lastname: Peeling
authors.forename: David W G
authors.initials: DW
authors.lastname: Brown
authors.forename: Robert
authors.initials: R
authors.lastname: Power
authors.forename: Anne M
authors.initials: AM
authors.lastname: Johnson
authors.forename: Judith M
authors.initials: JM
authors.lastname: Stephenson
authors.forename: Mary T
authors.initials: MT
authors.lastname: Bassett
authors.forename: Richard J
authors.initials: RJ
authors.lastname: Hayes
mesh_terms: D000293:Adolescent; D002648:Child; D005240:Feasibility Studies; D005260:Female; D005500:Follow-Up Studies; D015658:HIV Infections / Q000453:epidemiology / Q000517:prevention & control*; D006801:Humans; D008297:Male; D017063:Outcome Assessment, Health Care; D015995:Prevalence; D012725:Sexual Behavior; D011795:Surveys and Questionnaires; D015030:Zimbabwe / Q000453:epidemiology