NCT01187979.
Trial name or title | Reducing HIV in adolescents (RHIVA): a proof of concept cluster randomized controlled trial to evaluate the impact of a cash incentivised prevention intervention to reduce HIV infection in high school learners in rural KwaZulu‐Natal, South Africa |
Methods | The impact of the cash incentivised intervention will be assessed using a matched pair, cluster‐RCT design. The 14 selected high schools in the Vulindlela School Circuit will be matched in pairs. The matched pairs of schools will be the unit of randomization. Baseline measurements, using a standardized tool (structured questionnaire and biological specimens) will be undertaken simultaneously in each matched pair and will include all eligibly enrolled and consenting learners in the respective schools. On completion of baseline measurements in each matched pair of schools, the randomization code for the pair will be revealed and the intervention will be implemented in the intervention school. All schools will receive the same prevention intervention but only the intervention school will receive the cash incentives. Follow‐up measurements will be undertaken approximately 12 and 24 months after implementation of the intervention using a similar standardized assessment tool to that used at baseline. |
Participants | 4000 Grade 9 and 10 male and female students (aged 13+ years) in 14 schools |
Interventions | Behavioural: cash incentives paid to learners for reaching predetermined milestones Behavioural: standard department of education life skills curriculum |
Outcomes | Primary: HIV incidence Secondary: academic performance, substance use patterns, pregnancy, contraceptive use, participation in extra‐curricular activities, HIV risk‐reduction behaviour. Linked HIV and substance use testing will be undertaken in all learners and pregnancy testing in female learners. Other secondary endpoints will be assessed using a structured questionnaire. |
Starting date | September 2010 |
Contact information | Dr Quarraisha Abdool Karim, Centre for the AIDS Programme of Research in South Africa |
Notes | www.clinicaltrials.gov/ct2/show/NCT01187979?term=abdool+karim&rank=4 |