Implementing Assisted Partner Services for HIV Testing and Treatment in Western Kenya
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 4,941
- 试验地点
- 1
- 主要终点
- Linking a new positive or known positive not in care to a treatment center
研究概览
简要总结
This study includes different designs with Aim 1 being a cluster randomized controlled trial to investigate the use of HIV self-testing (HIVST) as a mode of HIV testing in Western Kenya in addition to the standard of care, assisted partner services (aPS). Aim 2 includes focus group discussions, in-depth interviews, semi-structured interviews, direct observation of facility infrastructure and clinic procedures, and data extraction from facility and county/national databases and expenditure reports to study acceptability, costs, and implementation aspects of HIVST within the aPS framework.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 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
- 否
入选标准
- •Men and women
- •Tests HIV positive and is not in care or on treatment
- •≥18 years old
- •Willing and able to provide informed consent
- •Able to provide locator information for sexual partners
- •≥18 years old
- •Willing and able to provide informed consent
排除标准
- •Pregnancy
- •Reports intimate partner violence during last month
- •<18 years old
- •<18 years old
研究组 & 干预措施
Standard aPS
Subjects receive standard assisted partner services from their local HIV testing services (HTS) counselor.
干预措施: Standard aPS (Diagnostic Test)
aPS + HIVST
Subjects receive standard assisted partner services from their local HIV testing services (HTS) counselor as well as the option to do HIV self-testing (HIVST) instead of testing at the local HTS location.
干预措施: HIVST (Diagnostic Test)
结局指标
主要结局
Linking a new positive or known positive not in care to a treatment center
时间窗: 1 year
Identify if there's a difference between standard aPS and aPS+HIVST in the number of participants that are linked to care at a treatment center.
Initiating ART, or re-initiating ART if previously lost to follow-up
时间窗: 1 year
Identify if there's a difference between standard aPS and aPS+HIVST in the number of participants that initiate (or re-initiate) ART.
Number of newly diagnosed HIV-infected or known positive and not in care
时间窗: 1 year
Identify if there's a difference between standard aPS and aPS+HIVST in the number of participants newly being diagnosed with HIV after participation, or those known to be positive but not currently under care.
Number of participants testing for the first time
时间窗: 1 year
Identify if there's a difference between standard aPS and aPS+HIVST in the number of participants choosing to get HIV tested for the first time.
次要结局
- Difficulty of interpreting the HIVST results(1 year)
- Difficulty of using the HIVST kit(1 year)
研究者
Carey Farquhar
Professor, School of Medicine: Global Health
University of Washington