Secondary Distribution of HIV Self-tests Through Antenatal and HIV Testing Services: a Pragmatic Cluster-randomized Trial (STAR-ANC)
试验速览
- 阶段
- 不适用
- 入组人数
- 10,000
- 试验地点
- 1
- 主要终点
- Proportion of partners tested for HIV
研究概览
简要总结
A three arm cluster randomized trial randomizing government primary health clinics to a) standard of care (SOC) with clinic invitation only; b) standard of care (SOC) and one self-test kit to give to sexual partner (s); c) standard of care (SOC) and self-test kit and monetary incentive given to partner conditional on clinic attendance and completion of pre-set procedures to determine secondary accuracy.
Trial to be conducted in four districts (Blantyre, Zomba, Machinga and Chikwawa) in Malawi in collaboration with the Ministry of Health.
Two primary outcomes:
- proportion of male partners of antenatal care clinic attendees reported by the woman to have tested for human immunodeficiency virus (HIV) within 28 days of enrolling the woman
- Number of new HIV positives identified by providing trial services to newly tested HIV positive clients in routine HIV testing service within 28 days of enrolling the index client.
Data analysed as intention to treat with all eligible antenatal care (ANC) attendees and index clients at each health facility as the denominator, with unpaired t-test used to compare each intervention arm to the standard of care (SOC).
详细描述
Type of study: This proposal is for a 3-arm pragmatic cluster randomised trial (CRT) using primary care clinics as the unit of randomisation. The three arms are: 1) Standard of care (SOC) with written invitation to the partner, and two intervention arms of 2) standard of care (SOC) + HIV self-test kits delivered by the partner; and 3) arm 2 plus a monetary incentive for partners who participate in a linked-accuracy study.
Problem: Malawi's Ministry of Health (MoH) uses a highly decentralized approach for delivery of HIV services that delivers over 3 million HIV tests each year, and has taken the country close to The Joint United Nations Programme on HIV and AIDS (UNAIDS) 90-90-90 targets. However, a testing gap remains among populations with barriers to accessing facility-based HIV testing services (HTS), including men. The investigators recently showed partner-delivered (secondary distribution) of HIV self-testing (HIVST) kits, via women attending antenatal care (ANC) in urban Blantyre, to be effective at increasing the uptake of HIV testing and subsequent HIV care and prevention services among male partners. However, unanswered questions that remain to be addressed include:
- the accuracy of HIV self-testing (HIVST) when kits are provided by secondary distribution
- how effective secondary distribution is when fully devolved to Ministry of Health (MoH) providers ("pragmatic")
- whether the high safety profile and acceptability of secondary distribution of HIV self-test kits from antenatal care (ANC) clinics can be generalised to other clinic services.
Role of Ministry of Health (MoH), implementers and researchers: HIV self-test kits will be delivered by the HIV Department of Ministry of Health (MoH), Malawi, in partnership with Population Services International (PSI)-Malawi. Ministry of Health (MoH) aims to routinely scale-up secondary distribution from antenatal care (ANC) clinics in high HIV prevalence districts, and HIV testing services (HTS) nationally if results are satisfactory.
Research Question: Can secondary distribution of HIV self-tests through antenatal care and HIV testing services improve coverage of HIV testing in sexual partners of pregnant women and newly-diagnosed people living with HIV (PLHIV), while maintaining low costs and acceptable linkage, safety and accuracy?
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Standard of care
Provide personalised clinic invitation slips (letters) to partners to come for HIV testing, and to access post-test services
HIV self-testing only
HIV self-testing only
干预措施: HIV self-testing only (Diagnostic Test)
HIV self-testing secondary accuracy
HIV self-testing secondary accuracy
干预措施: HIV self-testing only (Diagnostic Test)
HIV self-testing secondary accuracy
HIV self-testing secondary accuracy
干预措施: HIV self-testing secondary accuracy (Behavioral)
结局指标
主要结局
Proportion of partners tested for HIV
时间窗: 28 days
For antenatal care clinic attendees, this is as reported by the women during their next antenatal care visit
Number of newly diagnosed HIV positive people
时间窗: 28 days
A count of number of sexual contacts of index HIV positive clients attending the clinic for post-test services
次要结局
- Proportion of partners of antenatal care clinic attendees who start HIV treatment, undergo circumcision, or attend discordant couples clinic(28 days)
- Risk of adverse events (e.g. partnership breakdown, intimate partner violence, etc.) related to self-testing reported by antenatal care clinic attendees or HIV-positive index clients(28 days)