Delivery of Integrated PrEP and ART for Couples in Kenya
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 4,898
- 试验地点
- 2
- 主要终点
- Number of HIV-1 infected persons whose partners are tested for HIV-1 before/after PrEP as a bridge to ART is implemented
研究概览
简要总结
An implementation project to scale-up delivery of antiretroviral-based HIV-1 prevention methods to Kenyan HIV-1 serodiscordant couples in HIV-1 care centers. Pre-exposure prophylaxis (PrEP) as a bridge to antiretroviral therapy (ART) HIV-1 prevention strategy will be introduced into 24 public HIV-1 care centers in central and western Kenya according to national guidelines using a stepped wedge design, stratified by region.
详细描述
PrEP as a bridge to ART strategy will be introduced into 24 Kenyan public HIV-1 care centers according to national guidelines, in staged fashion, stratified by region (a stepped wedge design). Monitoring and evaluation activities will identify implementation barriers and solutions, characterize costs, and provide best practices for further scale-up. A research component will establish prospective open cohorts of couples at each clinic (up to 200) to study how the program is effectively implemented. Follow-up in the cohorts will be for up to 36 months at each care center and will evaluate impact, costs, and facilitators and barriers to implementation at patient, provider and health system levels.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •For HIV-1 uninfected members of the couple
- •Able and willing to provide consent for follow-up in the cohort
- •HIV-1 uninfected based on negative HIV-1 tests, per Kenya national guidelines
- •Not currently using PrEP
- •For HIV-1 infected members of the couple
- •Able and willing to provide consent for follow-up in the cohort
- •HIV-1 infected based on positive HIV-1 tests, per Kenya national guidelines
- •Not currently using ART
- •For both members of the couple - Meet criteria for initiating PrEP as per Kenya national guidelines, including:
- •HIV-1 infected member not currently using ART, on ART <6 months, or on ART but not virally suppressed based on a viral load test done at the clinic as per Kenya national guidelines or
- •Trying to conceive
- •For key delivery informants
- •Able and willing to provide consent
排除标准
- •Otherwise not eligible based on the above inclusion criteria
研究组 & 干预措施
PrEP for HIV-1 uninfected partners and ART for HIV-1 infected
Integrated PrEP as a bridge to ART HIV-1 prevention strategy
干预措施: Integrated PrEP as a bridge to ART HIV-1 prevention strategy (Other)
PrEP for HIV-1 uninfected partners and ART for HIV-1 infected
Integrated PrEP as a bridge to ART HIV-1 prevention strategy
干预措施: PrEP (Drug)
PrEP for HIV-1 uninfected partners and ART for HIV-1 infected
Integrated PrEP as a bridge to ART HIV-1 prevention strategy
干预措施: ART (Drug)
结局指标
主要结局
Number of HIV-1 infected persons whose partners are tested for HIV-1 before/after PrEP as a bridge to ART is implemented
时间窗: up to 36 months
PrEP initiation
时间窗: up to 36 months
Measure the number of HIV-1 uninfected partners initiating PrEP.
PrEP adherence
时间窗: up to 6 months
Adherence by HIV-1 uninfected partners until their HIV-1 infected partners initiate ART and sustain use for six months. Adherence will be measured by self reported and random dry blood spot for tenofovir levels
HIV-1 uninfected partners staying HIV-1 uninfected.
时间窗: up to 36 months
ART initiation
时间窗: up to 36 months
Number of HIV-1 infected partners newly initiating ART
ART adherence
时间窗: up to 6 months
Adherence measured by plasma RNA viral load. Viral load will be abstract from the HIV-infected partners records.
Facilitators and barriers to implementation of integrated PrEP and ART
时间窗: up to 36 months
Mixed methods assessment of how integrated PrEP and ART is implemented at the level of provider, health center, and health systems
PrEP delivery operational tools
时间窗: 24 months
Training manual on deliver of integrated PrEP and ART HIV prevention strategy for couples will be developed.
Cost and cost-effectiveness of the integrated PrEP and ART when delivered in public health clinics.
时间窗: up to 36 months
Time and motions to define the cost and cost-effectiveness of intervention summarized in terms of HIV infections averted, disability-adjusted life years saved, and incremental cost-effectiveness over routine HIV-1 care
次要结局
未报告次要终点
研究者
Jared Baeten
Professor, Global Health, Medicine, & Epidemiology
University of Washington