Reducing HIV in Adolescents (RHIVA)

Centre for the AIDS Programme of Research in South Africa

Status and phase: Completed; Phase 2

Conditions: HIV Infections

Treatments: Behavioral: Cash incentives; Behavioral: Life skills curriculum

Study type: Interventional

Funder types: NETWORK; Other

Identifiers

NCT01187979

CAPRISA 007

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3,217 patients

Sex: All

Ages: 13+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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3,217 participants in 2 patient groups

Control

Active Comparator group

Description:

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

Treatment:

Behavioral: Life skills curriculum

Cash incentive

Experimental group

Description:

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

Treatment:

Behavioral: Cash incentives

Behavioral: Life skills curriculum