Reducing HIV in Adolescents

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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HIV Infections

Intervention / Treatment
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* Behavioral: Cash incentives
* Behavioral: Life skills curriculum


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 13 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HIV-incidence rates | 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%) | 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 | 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 | 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 | 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 | Annual behavioural questionnaires will monitor self-reported contraceptive use. | annually, after every 12 months of follow up | 
| Participation in extra-curricular activities | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cash incentive, HIV prevention, Adolescents, South Africa, HIV