Reducing HIV in Adolescents (RHIVA)

January 18, 2017 updated by: Dr Quarraisha Abdool Karim, Centre for the AIDS Programme of Research in South Africa

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

3217

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • South Africa
    • KwaZulu-Natal
      • Durban, KwaZulu-Natal, South Africa
        • Vulindlela Clinical Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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
Behavioral: Life skills curriculum
Standard department of education lifeskills curriculum
Experimental: 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
Behavioral: Life skills curriculum
Standard department of education lifeskills curriculum
Behavioral: Cash incentives
Cash incentives paid to learners for reaching pre-determined milestones

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
annually, after every 12 months of follow up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Academic performance measured as an overall passing grade (50%)
Time Frame: 6 monthly
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.
6 monthly
voluntary uptake of HIV testing
Time Frame: annually, after every 12 months of follow up
Learners must provide the receipt from the clinic that specifies that the learner was tested for HIV.
annually, after every 12 months of follow up
Substance use patterns
Time Frame: annually, after every 12 months of follow up
Urine specimens will be utilised for testing for the presence of recreational drugs.
annually, after every 12 months of follow up
Pregnancy rates in female learners
Time Frame: annually, after every 12 months of follow up
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.
annually, after every 12 months of follow up
Contraceptive use patterns in female learners
Time Frame: annually, after every 12 months of follow up
Annual behavioural questionnaires will monitor self-reported contraceptive use.
annually, after every 12 months of follow up
Participation in extra-curricular activities
Time Frame: annually, after every 12 months of follow up
Attendance and participation in a life skills/sustainable livelihoods programme will be assessed. Self-reported participation in extra-curricular activities will be assessed in annual behavioural questionnaires.
annually, after every 12 months of follow up
HIV risk reduction behaviour
Time Frame: Annually, after every 12 months of follow up

The following will be assessed through a self-reported questionnaire:

condom use; primary and/or secondary sexual abstinence rates; sexually transmitted disease rates intergenerational sexual coupling (age of sexual partner(s)) age of sexual debut; frequency of HIV testing; number of concurrent sex partners; frequency of partner change; medical male circumcision rates; anal sex rates
Annually, after every 12 months of follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre for the AIDS Programme of Research in South Africa

Collaborators

MIET Africa
KwaZulu-Natal Department of Education
Embassy of the Kingdom of the Netherlands (EKN)

Investigators

  • Principal Investigator: Quarraisha Abdool Karim, PhD, Associate Scientific Director

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Actual)

August 1, 2014

Study Completion (Actual)

August 1, 2014

Study Registration Dates

First Submitted

August 12, 2010

First Submitted That Met QC Criteria

August 24, 2010

First Posted (Estimate)

August 25, 2010

Study Record Updates

Last Update Posted (Estimate)

January 19, 2017

Last Update Submitted That Met QC Criteria

January 18, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAPRISA 007

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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