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
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 3,217
- Locations
- 1
- Primary Endpoint
- HIV-incidence rates
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 13 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Control
All eligibly enrolled learners in the intervention schools will receive a prevention program delivered by MIET Africa and the KwaZulu-Natal Department of Education. No cash incentives will be paid for meeting milestones
Intervention: Life skills curriculum (Behavioral)
Cash incentive
All eligibly enrolled learners in the intervention schools will receive a cash incentivised prevention program delivered by MIET Africa and the KwaZulu-Natal Department of Education
Intervention: Cash incentives (Behavioral)
Cash incentive
All eligibly enrolled learners in the intervention schools will receive a cash incentivised prevention program delivered by MIET Africa and the KwaZulu-Natal Department of Education
Intervention: Life skills curriculum (Behavioral)
Outcomes
Primary Outcomes
HIV-incidence rates
Time Frame: annually, after every 12 months of follow up
To evaluate the efficacy of a cash-incentivised prevention intervention in reducing HIV-incidence rates in high-school learners
Secondary Outcomes
- Pregnancy rates in female learners(annually, after every 12 months of follow up)
- Academic performance measured as an overall passing grade (50%)(6 monthly)
- voluntary uptake of HIV testing(annually, after every 12 months of follow up)
- Substance use patterns(annually, after every 12 months of follow up)
- Contraceptive use patterns in female learners(annually, after every 12 months of follow up)
- Participation in extra-curricular activities(annually, after every 12 months of follow up)
- HIV risk reduction behaviour(Annually, after every 12 months of follow up)
Investigators
Dr Quarraisha Abdool Karim
Principal Investigator and Protocol Chair
Centre for the AIDS Programme of Research in South Africa