Engaging Men Through HIV Self-Testing With Differentiated Care to Improve ART Initiation and Viral Suppression Among Men in Malawi

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Hiv
• Intervention / Treatment: Other: Facility-Based ART; Other: Home-Based ART

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.

Aim 2. Identify predictors of ART initiation and 6-month viral suppression in the hbART arm

Aim 3. Determine the cost-effectiveness and scalability of hbART at a national level.

Methods: We will perform an individually randomized control trial with 820 HIV-positive men who have not yet initiated ART and a subset of 110 of their female partners. Men will be individually randomized 1:1 to one of the two intervention arms described above and will be enrolled in the study for 18-months or until 12-month retention (secondary outcome) can be measured, whichever comes first. The study will be performed at 10 health facilities supported by Partners in Hope (PIH). Data collection will include baseline and follow-up surveys at 2-, 4-, and 7-months, as well as medical charter reviews for men at 2-, 4-, 7-, and 13-months after study enrollment. Qualitative interviews will be conducted with a subset of men and women to understand perceptions of the intervention and experiences with ART engagement, and cost data from a provider perspective will be collected for a cost analysis of each arm.

Anticipated results: Findings will establish the effectiveness of home-based ART among men living with HIV who have not yet engaged in treatment, and can directly inform HIV programs throughout the region. Findings will also help us assess if short-term home-based ART is sufficient to engage men in long-term facility-based care, or if additional, more resource-intensive services are needed, such as major changes to the structure of facility-based ART.

• Study Type: Interventional
• Enrollment (Actual): 930
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Malawi
  • Lilongwe, Malawi
    • Partners in Hope

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Female Partner 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Facility-Based ART; Men escorted to nearest health facility for ART initiation and continuation.	Other: Facility-Based ART; Community-based male-specific counseling followed by linkage to a local health facility for ART initiation and continuation.
Experimental: Home-Based ART; Home-based ART initiation and continuation provided for 3-months.	Other: Home-Based ART; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
6-month viral suppression among men living with HIV	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.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ART Initiation	Proportion of HIV-positive male partners tested HIV-positive who initiate ART within 6-months of enrolling in the study. Sourced by medical chart reviews.	6 months
ART Retention	Proportion of male partners who initiate and have never been >60 days late for ART within the first 12-months after treatment initiation (max 18 months after enrolment). Sourced by medical chart reviews.	18 months
Proportion of female clients and men who self-report at least one adverse event	Self-report of adverse events (IPV, unwanted disclosure, end of relationship) from female ART client and men (unwanted disclosure) enrolled in the study. Source is follow-up surveys.	18 months

Collaborators and Investigators

• Sponsor: University of California, Los Angeles
• Collaborators: Medical University of South Carolina; Charles University, Czech Republic; National Institute of Mental Health (NIMH); University of Cape Town; Partners in Hope, Malawi

Study record dates

Study Major Dates

• Study Start (Actual): August 2, 2021
• Primary Completion (Anticipated): March 31, 2025
• Study Completion (Anticipated): June 30, 2025

Study Registration Dates

• First Submitted: April 21, 2021
• First Submitted That Met QC Criteria: April 21, 2021
• First Posted (Actual): April 26, 2021

Study Record Updates

• Last Update Posted (Actual): May 15, 2023
• Last Update Submitted That Met QC Criteria: May 12, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: HIV; Sub-Saharan Africa; Antiretroviral Therapy; Men; Malawi; Viral Suppression; HIV Self-Testing; ART Initiation; ART Retention; Home-Based care
• Other Study ID Numbers: R01MH122308 (U.S. NIH Grant/Contract); R01MH122308-01A1 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No