Clinical Trials Directory

Trials / Completed

CompletedNCT01187979

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

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
3,217 (actual)
Sponsor
Centre for the AIDS Programme of Research in South Africa · Network
Sex
All
Age
13 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALCash incentivesCash incentives paid to learners for reaching pre-determined milestones
BEHAVIORALLife skills curriculumStandard department of education lifeskills curriculum

Timeline

Start date
2010-09-01
Primary completion
2014-08-01
Completion
2014-08-01
First posted
2010-08-25
Last updated
2017-01-19

Locations

1 site across 1 country: South Africa

Source: ClinicalTrials.gov record NCT01187979. Inclusion in this directory is not an endorsement.