Clinical trial NCT01187979: Reducing HIV in Adolescents
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: HIV Infections
Keywords: Cash incentive
HIV prevention
Adolescents
South Africa
HIV
Lead sponsor: Centre for the AIDS Programme of Research in South Africa
Sponsor class: NETWORK
Collaborators: name: MIET Africa
name: KwaZulu-Natal Department of Education
name: Embassy of the Kingdom of the Netherlands (EKN)
First posted: 2010-08-25
Enrollment: 3217
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: HIV-incidence rates
timeFrame: annually, after every 12 months of follow up
Secondary outcomes:
measure: Academic performance measured as an overall passing grade (50%)
timeFrame: 6 monthly
measure: voluntary uptake of HIV testing
timeFrame: annually, after every 12 months of follow up
measure: Substance use patterns
timeFrame: annually, after every 12 months of follow up
measure: Pregnancy rates in female learners
timeFrame: annually, after every 12 months of follow up
measure: Contraceptive use patterns in female learners
timeFrame: annually, after every 12 months of follow up
measure: Participation in extra-curricular activities
timeFrame: annually, after every 12 months of follow up
measure: HIV risk reduction behaviour
timeFrame: Annually, after every 12 months of follow up
Other outcomes:
Locations:
city: Durban
country: South Africa
facility: Vulindlela Clinical Research Site
state: KwaZulu-Natal
Study officials:
affiliation: Associate Scientific Director
name: Quarraisha Abdool Karim, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pettifor AE, Rees HV, Kleinschmidt I, Steffenson AE, MacPhail C, Hlongwa-Madikizela L, Vermaak K, Padian NS. Young people's sexual health in South Africa: HIV prevalence and sexual behaviors from a nationally representative household survey. AIDS. 2005 Sep 23;19(14):1525-34. doi: 10.1097/01.aids.0000183129.16830.06.
citation: Fernald LC, Hou X, Gertler PJ. Oportunidades program participation and body mass index, blood pressure, and self-reported health in Mexican adults. Prev Chronic Dis. 2008 Jul;5(3):A81. Epub 2008 Jun 15.
citation: Hargreaves JR, Glynn JR. Educational attainment and HIV-1 infection in developing countries: a systematic review. Trop Med Int Health. 2002 Jun;7(6):489-98. doi: 10.1046/j.1365-3156.2002.00889.x.
citation: Ayton SG, Pavlicova M, Abdool Karim Q. Identification of adolescent girls and young women for targeted HIV prevention: a new risk scoring tool in KwaZulu Natal, South Africa. Sci Rep. 2020 Aug 3;10(1):13017. doi: 10.1038/s41598-020-69842-x.