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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 17 October 2012
Main ID:  NCT01187979
Date of registration: 12/08/2010
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: 4000
Recruitment status: Active, not recruiting
URL:  http://clinicaltrials.gov/show/NCT01187979
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention  
Countries of recruitment
Contacts
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: Both
Health Condition(s) or Problem(s) studied
HIV Infections
Intervention(s)
Behavioral: Cash incentives
Behavioral: Life skills curriculum
Primary Outcome(s)
HIV-incidence rates [Time Frame: annually, after every 12 months of follow up]
Secondary Outcome(s)
Academic performance measured as an overall passing grade (50%) [Time Frame: 6 monthly]
Contraceptive use patterns in female learners [Time Frame: annually, after every 12 months of follow up]
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]
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]
voluntary uptake of HIV testing [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)
Embassy of the Kingdom of the Netherlands (EKN)
KwaZulu-Natal Department of Education
MIET Africa
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