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临床试验/NCT04774835
NCT04774835已完成不适用

Implementing Assisted Partner Services for HIV Testing and Treatment in Western Kenya

University of Washington2 个研究点 分布在 1 个国家目标入组 4,941 人开始时间: 2021年3月1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
4,941
试验地点
2
主要终点
Number of newly diagnosed HIV-infected or known positive and not in care

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

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

结局指标

主要结局

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.

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.

次要结局

  • Difficulty of using the HIVST kit(1 year)
  • Difficulty of interpreting the HIVST results(1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Carey Farquhar

Professor, School of Medicine: Global Health

University of Washington

研究点 (2)

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