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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 3,217
- 试验地点
- 1
- 主要终点
- HIV-incidence rates
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 13 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •Refusal by the learner and/or parent or legal guardian to participate in the study.
- •Unable to provide necessary informed consents
- •Cognitively challenged learners
结局指标
主要结局
HIV-incidence rates
时间窗: 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
次要结局
- Academic performance measured as an overall passing grade (50%)(6 monthly)
- voluntary uptake of HIV testing(annually, after every 12 months of follow up)
- Substance use patterns(annually, after every 12 months of follow up)
- Pregnancy rates in female learners(annually, after every 12 months of follow up)
- Contraceptive use patterns in female learners(annually, after every 12 months of follow up)
- Participation in extra-curricular activities(annually, after every 12 months of follow up)
- HIV risk reduction behaviour(Annually, after every 12 months of follow up)
研究者
Dr Quarraisha Abdool Karim
Principal Investigator and Protocol Chair
Centre for the AIDS Programme of Research in South Africa