Community-based Distribution of Oral HIV Self-testing Kits-A Pilot Intervention and Rapid Impact Evaluation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Zambart
- 入组人数
- 8,080
- 试验地点
- 2
- 主要终点
- The proportion of the total resident adult population who know their HIV status
研究概览
简要总结
This cluster randomised trial aims to evaluate the impact of a pilot HIVST intervention of oral HIV self-testing (HIVST) as an option for HIV testing, in addition to the offer of home-based rapid HIV testing, through community health workers (CHW) on knowledge of HIV status among the general adult and adolescent population.
The primary outcome of the trial is the proportion of individuals who know their HIV status, defined as a self-report of being HIV positive or accepting testing (standard or self testing) from the CHW.
Embedded within the impact evaluation is a process evaluation that will explore the fidelity of the implementation of the intervention and outputs of the intervention. Qualitative data on actual use, management and disposal of the HIVST kits, acceptability of HIVST and any impacts on relationships (including between couples and with CHW) associated with use of HIVST kits.
详细描述
Trial Purpose This cluster randomised trial will evaluate the impact of a pilot intervention of oral HIV self-testing (HIVST) as an option for HIV testing, in addition to the offer of home-based rapid HIV testing, by community health workers (CHWs ) on knowledge of HIV status among the general adult and adolescent population.
Aim The overall aim of this trial is to investigate whether the inclusion of HIVST as an option for HIV testing, in addition to the offer of HIV testing with a finger-prick blood sample, increases the uptake of an offer of home-based HIV-testing overall relative to an offer of HIV testing with a finger-prick blood sample alone.
Secondary Objectives
- Investigate whether the inclusion of HIVST as an option for HIV testing in addition to the offer of HIV testing with a finger-prick blood sample through CHW increases the uptake of an offer of HIV-testing among specific sub-populations including men, adolescents and individuals who have not previously tested relative to an offer of HIV testing with a finger-prick blood sample alone.
- Investigate whether the inclusion of HIVST as an option for HIV testing in addition to the offer of HIV testing with a finger-prick blood sample through CHW increases the proportion of individuals' diagnosed HIV positive relative to an offer of HIV testing with a finger-prick blood sample alone.
- Measure linkage to HIV treatment and care, or prevention services when HIVST is included as an option for HIV testing in addition to the offer of HIV testing with a finger-prick blood sample through CHW and levels of couples-testing.
Trial Design This cluster randomised trial will randomise community health worker zones (66 in total) to either distribute oral HIVST kits in addition to the offer of finger-prick rapid HIV testing (33 zones) or to offer finger-prick rapid HIV testing alone (33 zones). The trial is nested within theHPTN071/PopART trial and the CHWs to be randomised all work in 4 of the intervention sites of this study.
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 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Resident in CHW zone
- •Aged 16 years and above
排除标准
- •unable to provide informed consent
研究组 & 干预措施
Oral HIV self test
In this arm, community health workers conducting door-to-door HIV testing will offer oral HIV self testing (OraQuick® HIV Self-Test (Orasure Technologies, Thailand)) as an alternative to standard of care finger-prick HIV testing for individuals who are present at the time of the visit. In addition they will provide demonstration to an adult who is present at the time of the visit and leave up to 2 oral HIV self test kits to allow testing with the partner
干预措施: OraQuick® HIV Self-Test (Orasure Technologies, Thailand) (Device)
Standard of Care
In this arm community health workers will conduct door-to-door HIV testing using the current Zambian national HIV testing algorithm of finger-prick rapid HIV tests
结局指标
主要结局
The proportion of the total resident adult population who know their HIV status
时间窗: 3 Months
Knowledge of know HIV status includes those individuals who self report to be HIV positive or who test using standard of care HIV tests or oral HIV self test kits with results reported
次要结局
- Proportion of total resident adult population who consent to participate in the intervention(3 Months)
- Proportion of male resident adult population who consent to participate in the intervention(3 Months)
- Proportion of resident adult population who have previously not been reached by the PopART intervention who consent to participate in the intervention(3 Months)
- Proportion of resident adolescent population who consent to participate in the intervention(3 Months)
- Proportion of all adults who consent to participate in the intervention who know their HIV status(3 Months)
- Proportion of adults who test for HIV amongst those eligible for testing(3 Months)
- Proportion of couples who test for HIV and receive results as a couple(3 Months)
- Factors associated with uptake of and experience with HIV self testing(3 Months)
- Linkage to HIV prevention and care(3 Months)
- Incremental cost effectiveness of the addition of oral HIV self testing into a package of door-to- door HIV testing provided by CHW(3 Months)
- Reported social harms associated with HIV testing(3 Months)