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临床试验/NCT03977181
NCT03977181已完成不适用

Leveraging Community-based Platforms to Improve Access and Adherence to PrEP for Young Women in South Africa

Foundation for Professional Development (Pty) Ltd2 个研究点 分布在 1 个国家目标入组 480 人开始时间: 2018年10月26日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
480
试验地点
2
主要终点
The incremental cost-effectiveness ratio per incidence HIV case averted

研究概览

简要总结

The investigators aim to 1) speed up access to and delivery of PrEP to young women, and 2) compare interventions to support and maximize the prevention-effective use of PrEP. Specifically, the investigators aim to answer the following two questions: 1) how can the study use existing community-based platforms to identify and deliver PrEP to those in need? and 2) which adherence support interventions are most likely to engender effective use of PrEP? The investigators propose to answer these questions by leveraging existing community-based HIV testing platforms in South Africa and use a mixed methods approach to optimize the PrEP cascade and evaluate a community-based PrEP adherence program for young women.

详细描述

Worldwide, about 1.9 million people became infected with HIV in 2015, most of whom live in Southern and East Africa. In South Africa, the HIV incidence rate among young women ages 15-24 (2.5%) is four times higher than their male counterparts (0.6%). Recent HIV prevention trials in South Africa documented incidence rates of 5-6% per year in 15-24 year old young women. Given this high incidence of HIV, implementing effective HIV prevention strategies - including PrEP - is crucial to controlling HIV globally.

The proposed study leverages existing community-based HIV counseling and testing platforms in South Africa and evaluates, using a mixed methods approach, a community-based PrEP adherence program for young women whilst optimizing the PrEP cascade. Numerous barriers have been described that delay or block young women from accessing clinic-based health services, especially reproductive health and HIV testing and prevention services. Consequently, reaching young women at large scale with HIV prevention services requires delivery platforms outside of clinic-based facilities. Community-based counseling and testing programs have shown the greatest coverage and potential to achieve high levels of knowledge of HIV serostatus and linkage to HIV care. Using community-based counseling and testing programs, this proposal will deliver PrEP as part of a population-level combination prevention program, which is necessary to substantially reduce HIV incidence.

The investigators propose to answer key research questions through the following; Specific Aims: 1) Assess young women's uptake of PrEP when delivered through large-scale community-based HIV counseling and testing platforms in urban and rural settings in South Africa, 2) Evaluate community-based scalable interventions to achieve prevention-effective adherence to PrEP among young women, and 3) Evaluate the cost per young woman initiated on PrEP and provided adherence support through community-based platforms, and the cost-effectiveness per incident HIV infection averted. In order to achieve Aim 1, the study will leverage from on-going, at-scale CBCT programs and platforms (mobile unit and systematic home-based testing) to identify and link young women to community-based PrEP initiation services. In order to achieve Aim 2, the study will perform a 3-arm randomized controlled trial, with participants randomized to one of the following arms: Arm 1) a group-based community health club akin to an ART adherence club; Arm 2) one-on-one adherence counseling and support; Arm 3) community-based medication dispensary.

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

盲法说明

The allocation of study arm is concealed to study staff during randomization

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

  • Self-identified as female (regardless of assigned sex at birth)
  • 16 - 25 years of age.
  • HIV negative (confirmed during CBCT testing)
  • At risk for HIV acquisition
  • Express interest in taking PrEP

排除标准

  • Planning to relocate in the next 12 months
  • Positive HIV test at screening or enrolment
  • Breastfeeding
  • Current participation in other HIV prevention studies (clinical or behavioural)
  • Current use of ARV drugs for post-exposure prophylaxis (PEP)
  • Presence of any disease or health condition, self-reported or identified by initiation clinician, that may prevent participation.

结局指标

主要结局

The incremental cost-effectiveness ratio per incidence HIV case averted

时间窗: 10 months

Dynamic infectious disease model of HIV

The cost per adolescent girl and young women on pre-exposure prophylaxis

时间窗: 10 months

Itemized cost menus

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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