Reducing HIV in Adolescents

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT01187979
• Date of registration: 12/08/2010
• Prospective Registration: Yes
• Primary sponsor: Centre for the AIDS Programme of Research in South Africa
• Public title: Reducing HIV in Adolescents RHIVA
• Scientific 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
• Date of first enrolment: September 2010
• Target sample size: 3217
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01187979
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

South Africa

Contacts

• Name: Quarraisha Abdool Karim, PhD
• Affiliation: Associate Scientific Director

Key inclusion & exclusion 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



Age minimum: 13 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

HIV Infections

Intervention(s)

Behavioral: Life skills curriculum

Behavioral: Cash incentives

Primary Outcome(s)

HIV-incidence rates [Time Frame: annually, after every 12 months of follow up]

Secondary Outcome(s)

Contraceptive use patterns in female learners [Time Frame: annually, after every 12 months of follow up]

voluntary uptake of HIV testing [Time Frame: annually, after every 12 months of follow up]

Pregnancy rates in female learners [Time Frame: annually, after every 12 months of follow up]

Substance use patterns [Time Frame: annually, after every 12 months of follow up]

Academic performance measured as an overall passing grade (50%) [Time Frame: 6 monthly]

HIV risk reduction behaviour [Time Frame: Annually, after every 12 months of follow up]

Participation in extra-curricular activities [Time Frame: annually, after every 12 months of follow up]

Secondary ID(s)

CAPRISA 007

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

KwaZulu-Natal Department of Education

Embassy of the Kingdom of the Netherlands (EKN)

MIET Africa