Identifying Efficient Linkage Strategies for Men
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 569
- 试验地点
- 1
- 主要终点
- Proportion of men who are retained on ART early
研究概览
简要总结
HIV self-testing (HIVST) has been found to be a highly acceptable approach for men to learn of their HIV status and has resulted in increased testing uptake. However, rates of antiretroviral therapy (ART) initiation among those tested with HIVST are difficult to capture. This clinical trial will test varying approaches to ART initiation and retention among men who test positive using HIVST to learn about the most effective strategy to engage men in ART services.
详细描述
HIV self-testing (HIVST) has been found to be a highly acceptable approach for men to learn of their HIV status and has resulted in increased testing uptake. However, rates of antiretroviral therapy (ART) initiation among those tested with HIVST are difficult to capture and some studies have suggested that linkage rates are low , particularly amongst men. The investigators propose a clinical trial to test varying approaches to ART initiation and retention among men who test HIV-positive through HIVST. Three interventions will be tested:
Standard of Care (Arm 1): phone and in-person follow-up, accompanied with male-specific counseling (given every two weeks for up to 90-days or until ART initiation is achieved, whichever comes first); Home-Based ART initiation (Arm 2): nurse-led ART initiation at home or in the community Staged Intervention (Arm 3): a staged intervention that consecutively increases in intensity every month that a participant does not initiate ART (intervals include: Days 1-14: Standard of Care; Days 14-30: Peer support with a psychosocial consellor; Days 30-90: Nurse-led Home-Based ART initiation);
The primary objective is to identify a cost-effective package comprised of male-specific counseling, peer support, community ART distribution and/or home-based ART services for ART initiation and retention among men identified as HIV-positive through HIVST in Malawi. The specific objectives are:
Aim 1. Evaluate the effectiveness of the Stepped ART Intervention (Arm 3) vs male counseling and facility navigation (Arm 1) (primary analysis) and the effectiveness of the Stepped ART Intervention (Arm 3) vs home-based ART initiation with a nurse (Arm 2) (secondary analysis) on ART initiation within 4-months after enrollment in the trial.
Aim 2. Identify individual-, community-, and facility-level factors associated with ART initiation within each intervention arm (male counseling, home-based ART and Stepped intervention) using baseline and semi-structured in-depth interviews.
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
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Inclusion Criteria:
- •≥15 years of age
- •Tested HIV positive using Ministry of Health standard algorithm (Determine + Unigold)
- •Not currently engaged in ART services, defined as:
- •Tested HIV-positive ≥14 days and not on ART ≥14 days after testing HIV-positive;
- •≥14 days late for the first four-week follow up appointment; or
- •Initiated ART but ≥60 days late for last ART appointment;
- •Has not taken ART in the past 7-days, as indicated by a point of care (POC) urine assay
- •Living inside the facility catchment area (defined as any area that HCWs from the study facility routinely visit for tracing purposes)
排除标准
- •<15 years of age
- •Never tested HIV positive using Ministry of Health standard algorithm (Determine + Unigold)
- •Tested HIV-positive <14 days ago
- •Currently engaged in ART services, defined as:
- •Initiated ART
- •<14 days late for the first four-week follow up appointment
- •Initiated ART and <60 days late for last ART appointment
- •Has taken ART in the past 7-days, as indicated by a point of care (POC) urine assay
- •Living outside the facility catchment area (defined as any area that HCWs from the study facility routinely visit for tracing purposes)
- •Female partner
- •Inclusion Criteria:
- •≥15 years of age
- •Male partner enrolled in the study
- •Male partner agrees that the female can be recruited for an in-depth interview
- •Exclusion Criteria:
- •<15 years of age
- •Male partner is not enrolled in the study
- •Male partner does not agree that the female can be recruited for an in-depth interview
研究组 & 干预措施
Male-specific counseling and facility navigation
干预措施: Male Counseling and Facility Navigation (Other)
Home-Based ART Initiation
干预措施: Home-Based ART Initiation and Facility Navigation (Other)
Stepped Intervention
干预措施: Stepped Intervention (Other)
结局指标
主要结局
Proportion of men who are retained on ART early
时间窗: 4-months.
Proportion of men who initiate ART at 3-months and attended their 4-week ART refill appointment at 4-month after enrollment. Sourced from medical chart reviews.
次要结局
- Proportion of men who initiate ART(3-months)
- Any adverse events self-reported by female ART client or male partner(4-months)
研究者
Kathryn L. Dovel, PhD
Assistant Professor
University of California, Los Angeles