跳至主要内容
临床试验/NCT03142256
NCT03142256Unknown4 期

A Pilot Prospective Cohort Evaluation of Uptake and Adherence to PrEP in Young South African Women

Desmond Tutu HIV Centre2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2017年3月24日最近更新:
适应症
干预措施
相关药物

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

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

Active Comparator

Cash incentive for good drug levels assed by Dried Blood Spot

干预措施: Incentivised - Conditional Cash Transfer (Behavioral)

Incentivised - Conditional Cash Transfer

Active Comparator

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

研究者

发起方
Desmond Tutu HIV Centre
申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验