A Pilot Prospective Cohort Evaluation of Uptake and Adherence to PrEP in Young South African Women
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Drug adherence
研究概览
简要总结
This study has two phases. It will be conducted in one site in CT only. Phase I is to enumerate interest in PrEP uptake among young South African women exposed to a culturally-appropriate social marketing campaign. This enumeration will also serve as a recruitment strategy for a cohort with open-label PrEP access in Phase II. The cohort will assess PrEP acceptability and adherence among 200 HIV-uninfected young women who are offered open-label daily oral PrEP and randomized to receive or not receive a short term cash incentive conditional on study drug adherence.
详细描述
3P for Prevention Study (Perception, Partners, Pills) Synopsis A Pilot Prospective Cohort Evaluation of Uptake and Adherence to PrEP in Young South African Women Background: Despite the wide scale implementation of antiretroviral treatment as prevention and HIV testing, the HIV incidence among young South African women remains unacceptably high, with recent HIV Prevention trials in the Western Cape documenting an incidence as high as 5-6% per year.
In collaboration with others, we conducted formative research in Masiphumelele about the content and format of a communication campaign with clear and compelling messages about PrEP that could increase PrEP demand among young at-risk women in the community context. McCann is currently developing a social marketing campaign about oral PrEP, based on these results. This campaign will be used during the recruitment of this cohort. In addition to understanding what will initially attract women to PrEP, for those women who choose to take PrEP, there is a need to understand adherence support interventions that are scalable and sustainable. Drawing on behavioural economics theories, recent trials of young African women have shown that financial incentives can improve health behaviour.
This study has two phases. It will be conducted in one site in CT only. Phase I is to enumerate interest in PrEP uptake among young South African women exposed to a culturally-appropriate social marketing campaign. This enumeration will also serve as a recruitment strategy for a cohort with open-label PrEP access in Phase II. The cohort will assess PrEP acceptability and adherence among 200 HIV-uninfected young women who are offered open-label daily oral PrEP and randomized to receive or not receive a short term cash incentive conditional on study drug adherence.
Design:
Using the results of the 2016 census, recruitment staff will identify the homes of up to 1000 young women currently between the ages of 16-25. Up to 800 women will be shown a video explaining oral PrEP and take a short survey before and after the video. The survey questions will include demographics, sexual relationships, risk taking, and knowledge and opinions about PrEP. The remaining 200 women will not be shown the video but will be asked the survey questions to serve as a comparison group to evaluate the effect of the PrEP video on initial interest in PrEP. Young women who are interested in learning more about oral PrEP will be referred to community education sessions. We will document the number of women who are interested in learning more about PrEP and the number of attendees at the educational sessions.
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
- 16 Years 至 25 Years(Child, Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female at birth
- •HIV uninfected at screening and enrollment
- •Age 16-25 years old at screening, inclusive
- •Per participant report, sexually active, defined as having vaginal or anal intercourse with a male partner at least once in the month prior to screening
- •Willing and able to provide informed consent
- •Able and willing to provide adequate locator information
排除标准
- •Not planning to be in the area for periods longer than a month in the first three months and longer than 3 months from Month 3 - 12
- •A positive HIV test at Enrollment, even if subsequent testing indicates that the person is HIV-1 uninfected
- •Renal dysfunction (Creatinine Clearance <60 mL/min, Cockroft Gault equation)
- •Previous participation in an oral PrEP study
研究组 & 干预措施
Incentivised - Conditional Cash Transfer
Cash incentive for good drug levels assed by Dried Blood Spot
干预措施: Incentivised - Conditional Cash Transfer (Behavioral)
Incentivised - Conditional Cash Transfer
Cash incentive for good drug levels assed by Dried Blood Spot
干预措施: Truvada 200Mg-300Mg Tablet (Drug)
结局指标
主要结局
Drug adherence
时间窗: 3 months
200 women measuring cash incentive for drug adherence with half the Cohort
次要结局
未报告次要终点
