Pilot Study of Secondary Distribution of HIV Self-screening Tests by Women With HIV: An Innovative Strategy to Improve Testing, Identification, and Linkage to Treatment of Men in South Africa
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Partner HIV Testing
研究概览
简要总结
Many South African men do not visit clinics or get tested due to multiple real and perceived barriers. Nkangala District has significant gaps to identifying PLHIV who are not on ART, reaching their ART targets, especially in adult men. Over 65% of PLHIV not on ART are men, which is a gap of over 39,000 men living with HIV needing to be tested and initiated on ART.
- To improve case finding among men in Nkangala we will evaluate how best to reach partners of PLHIV (newly diagnosed or on ART) with index testing by using HIV self-screening (HIVSS) and linkage to ART start.
- Secondary distribution of HIV self-screening kits (HIVSS), whereby clients bring HIVSS kits to their partners, addresses barriers by enabling partners to screen themselves at their convenience and in the privacy of their homes.
Study Objectives: BroadReach in collaboration with UCLA, UCT and Nkangala DOH will pilot test an innovative index partner HIVSS strategy in one urban and one rural clinic to evaluate acceptability, barriers, and efficacy of secondary HIVSS distribution in a randomized control trial enrolling women newly diagnosed with HIV or on ART.
- In the intervention arm, women will receive counselling on how to use HIVSS, how to encourage their male partner to screen, and 2 oraquick HIVSS with instructions and invitation to return for confirmatory testing.
- In the standard of care arm, index women will receive counselling on the importance of disclosure to their family and partner(s) and referral for HIV testing (per South African national guidelines).
Study design: Randomized control trial of n=180 WLHIV (90 in each arm) in four facilities (urban and rural) in the Nkangala district ensure that the results are generalizable.
详细描述
Many South African men do not visit clinics or get tested due to multiple real and perceived barriers. Nkangala District has significant gaps to identifying PLHIV who are not on ART, reaching their ART targets, especially in adult men. Over 65% of PLHIV not on ART are men, which is a gap of over 39,000 men living with HIV needing to be tested and initiated on ART.
- To improve case finding among men in Nkangala we will evaluate how best to reach partners of PLHIV (newly diagnosed or on ART) with index testing by using HIV self-screening (HIVSS) and linkage to ART start.
- Secondary distribution of HIV self-screening kits (HIVSS), whereby clients bring HIVSS kits to their partners, addresses barriers by enabling partners to screen themselves at their convenience and in the privacy of their homes.
We will partner with BroadReach Healthcare, a PEPFAR partner in South Africa, to pilot test an innovative index partner HIVSS strategy in one urban and one rural public health clinic in the Nkangala district of Mpumalanga Province to evaluate acceptability, barriers, and preliminary efficacy of secondary HIVSS distribution in a randomized control trial enrolling women newly diagnosed with HIV or on ART. In the intervention arm, women will receive counselling on how to use HIVSS, how to encourage their male partner to screen, and 2 HIVSSs with HIVSS instructions and invitation to return for confirmatory testing. In the standard of care arm, index women will receive counselling on the importance of disclosure to their family and partner(s) and referral for HIV testing (per SA national guidelines). We will evaluate the following aims:
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Conduct a mixed-methods survey with N=180 HIV+ women to assess perceived acceptability and barriers (including perceived safety, IPV) to secondary HIVSS distribution by women to male partners.
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Test the feasibility and preliminary efficacy of secondary HIVSS distribution through a 1:1 randomized control trial in n=180 HIV+ women to assess, comparing standard of care to intervention arm:
-
% of index women who self-report that they gave the HIVSS or standard of care referral for testing to their male partner
-
% of male partners who either screened or tested for HIV assessed at 3 months after randomization (primary outcome)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Adult female 18+ years old
- •confirmed HIV-positive or on ART
- •confirmed to currently have a male partner and are sexually active
- •male partner is of HIV- or unknown status
- •confirmed to have a cell phone that can read and respond to SMS/WhatsApp messages
- •confirmed to be able to consent to study participation (no language constraints or psychological issues that would make it difficult to consent to participate in the study)
排除标准
- •Failure to meet all of inclusion criteria
研究组 & 干预措施
HIV self testing
HIV+ women will receive HIV self-tests (2) to bring home to her partner to offer for testing
干预措施: HIV self test (Diagnostic Test)
HIV self testing
HIV+ women will receive HIV self-tests (2) to bring home to her partner to offer for testing
干预措施: Counseling and referral for partner testing (Behavioral)
Standard of care
In the standard of care arm, women will receive standard of care partner referrals for HIV testing, including counselling about disclosure and referral for her partner(s) to return to the facility for testing.
干预措施: Counseling and referral for partner testing (Behavioral)
结局指标
主要结局
Partner HIV Testing
时间窗: 3 months
proportion of index partners who report testing
次要结局
- Positivity(3 months)
- ART Initiation(3 months)
- Viral Suppression(3 months)
研究者
Dvora Joseph Davey, PhD, MPH
Principal Investigator
University of California, Los Angeles