Reducing HIV in Adolescents

A Proof of Concept Cluster Randomised 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

The purpose of this study is to assess the impact of a cash-incentivised prevention intervention on reducing HIV incidence rates in high-school learners in rural KwaZulu-Natal.

The impact of the cash incentivised intervention will be assessed using a matched pair, cluster randomised controlled trial 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 randomisation. Baseline measurements, using a standardised 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 randomisation 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 standardised assessment tool to that used at baseline. At baseline and during follow-up assessments in intervention and control schools, 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.

Inclusion Criteria:

Learners must meet all of the following criteria at enrolment in order to be eligible for inclusion in the study:

• Male or female learner in Grade 9 or 10 in one of the 14 selected schools
• Willing and able to provide informed consent and/or assent to participate in the study
• Willing to provide locator data for home visits if necessary
• Not planning to move to another school or relocate in the next 36 months
• Willing to be finger-printed to verify identity for study procedure purposes
• Willing to participate in this study
• Willing to complete all study procedures

Exclusion Criteria:

• Refusal by the learner and/or parent or legal guardian to participate in the study.
• Unable to provide necessary informed consents
• Cognitively challenged learners