Reducing HIV in Adolescents

Centre for the AIDS Programme of Research in South Africa3,217 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

3,217

Conditions

HIV Infections

Interventions

Cash incentivesBEHAVIORAL

Cash incentives paid to learners for reaching pre-determined milestones

Life skills curriculumBEHAVIORAL

Standard department of education lifeskills curriculum

Eligibility

Sex: ALLMin age: 13 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Vulindlela Clinical Research Site

Durban, KwaZulu-Natal, South Africa

Outcomes

Primary Outcomes

HIV-incidence rates

To evaluate the efficacy of a cash-incentivised prevention intervention in reducing HIV-incidence rates in high-school learners

Time frame: annually, after every 12 months of follow up

Secondary Outcomes

Academic performance measured as an overall passing grade (50%)

To support learners improving academic performance, attend school, complete schooling and improve their self-esteem, learners will be incentivised to pass their June and November examinations, with a minimum of a 50% average. Educators from the selected schools will design, administer and mark the June and November examination papers.

Time frame: 6 monthly

voluntary uptake of HIV testing

Learners must provide the receipt from the clinic that specifies that the learner was tested for HIV.

Time frame: annually, after every 12 months of follow up

Substance use patterns

Urine specimens will be utilised for testing for the presence of recreational drugs.

Time frame: annually, after every 12 months of follow up

Pregnancy rates in female learners

A dipstick pregnancy test will be performed on the urine sample of all female learners at baseline and at the two annual follow-up visits.

Time frame: annually, after every 12 months of follow up

Contraceptive use patterns in female learners

Annual behavioural questionnaires will monitor self-reported contraceptive use.

Time frame: annually, after every 12 months of follow up

Participation in extra-curricular activities

Data from ClinicalTrials.gov

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