Engaging Men Through HIV Self-Testing With Differentiated Care to Improve ART Initiation and Viral Suppression Among Men in Malawi
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 930
- Locations
- 1
- Primary Endpoint
- 6-month viral suppression among men living with HIV
Study Overview
Brief Summary
Men in sub-Saharan Africa who test HIV-positive continue to have poor ART initiation and retention outcomes. The proposed project will test a home-based ART intervention for men who are living with HIV compared to facility-based ART. Findings will provide essential information on how to best reach men across the testing and treatment continuum, a critical step to curbing the HIV epidemic.
Detailed Description
Background: Men in sub-Saharan Africa are less likely than women to use HIV services. HIV testing strategies have dramatically improved for men through HIV self-testing (HIVST) and other male-focused strategies, but men who are identified as living with HIV are still less likely than women to initiate ART or remain in care, particularly within the first several months after initiation. In Malawi, men represent only 31% of new ART initiates2 - and men on ART are more likely than women to be lost to follow up (LTFU) at all time intervals of care than women. Men's absence from care is concerning not only for their own health, but also for the health of girls and young women who continue to be infected at unacceptably high rates. Offering ART at home or other locations convenient for men (i.e., home-based ART) for a brief period of time may help men overcome barriers related to facility-based treatment, develop coping strategies for ART engagement, and better engage in facility-based services over the long-term. In this study we will assess the impact of hbART by comparing two arms:
Facility-Based ART (fbART arm): community-based male-specific counseling followed by linkage to a local health facility for ART initiation and continuation.
Home-Based ART (hbART arm): community-based male-specific counseling followed by home-based ART initiation (or at any location that is convenient for participants) and home-based ART continuation for a 3-month period, followed by linkage to a local health facility for further ART continuation.
Objective: Our primary objective is to compare the impact of home-based ART against standard of care for ART initiation and retention among men identified as HIV-positive through HIVST in Malawi. Our specific Aims are:
Aim 1. Test the effectiveness of hbART versus fbART on ART initiation and 6-month viral suppression among men living with HIV.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 15 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Male partner ≥15 years of age
- •No reported interpersonal violence (IPV) as defined by World Health Organization (WHO) with the above male partner in the past 12-months
- •Male partner ever tested HIV-positive
- •Male partner 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;
- •Male partner living inside the facility catchment area (defined as any area that Healthcare Workers (HCWs) from the study facility routinely visit for tracing purposes)
- •Female Partner
Exclusion Criteria
- •Male partner <15 years of age
- •Reported interpersonal violence (IPV) as defined by WHO with the above male partner in the past 12-months
- •Male partner never tested HIV positive
- •Male partner tested HIV-positive <14 days ago
- •Male partner 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
- •Male partner living outside the facility catchment area (defined as any area that HCWs from the study facility routinely visit for tracing purposes)
- •Men Living with HIV 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)
- •Men Living with HIV Exclusion Criteria:
- •<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)
Outcomes
Primary Outcomes
6-month viral suppression among men living with HIV
Time Frame: 12 months
Proportion of HIV-positive men tested HIV-positive who have an undetectable viral load 6-months after initiating ART (a maximum of 12-months after enrolling in the study). Sourced by medical chart reviews.
Secondary Outcomes
- ART Retention(18 months)
- ART Initiation(6 months)
- Proportion of female clients and men who self-report at least one adverse event(18 months)
Investigators
Thomas J. Coates
Director of University of California Global Health Institute
University of California, Los Angeles