Engaging Men Through HIV Self-Testing With Differentiated Care to Improve ART Initiation and Viral Suppression Among Men in Malawi
2 other identifiers
interventional
930
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable hiv
Started Aug 2021
Longer than P75 for not_applicable hiv
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 21, 2021
CompletedFirst Posted
Study publicly available on registry
April 26, 2021
CompletedStudy Start
First participant enrolled
August 2, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2025
CompletedMay 15, 2023
May 1, 2023
3.7 years
April 21, 2021
May 12, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
ART Initiation
6 months
ART Retention
18 months
Proportion of female clients and men who self-report at least one adverse event
18 months
Study Arms (2)
Facility-Based ART
ACTIVE COMPARATORMen escorted to nearest health facility for ART initiation and continuation.
Home-Based ART
EXPERIMENTALHome-based ART initiation and continuation provided for 3-months.
Interventions
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.
Community-based male-specific counseling followed by linkage to a local health facility for ART initiation and continuation.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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)
- ≥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
- +10 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of California, Los Angeleslead
- Partners in Hope, Inc.collaborator
- Medical University of South Carolinacollaborator
- Charles University, Czech Republiccollaborator
- University of Cape Towncollaborator
- National Institute of Mental Health (NIMH)collaborator
Study Sites (1)
Partners in Hope
Lilongwe, Malawi
Related Publications (3)
Hubbard J, Mphande M, Robson I, Balakasi K, Phiri K, Chikuse E, Thorp M, Phiri S, Choko AT, Cornell M, Coates T, Dovel K. Core components of male-specific person-centred HIV care: a qualitative analysis from client and healthcare worker perspectives in Malawi. BMJ Public Health. 2024 Dec 22;2(2):e001100. doi: 10.1136/bmjph-2024-001100. eCollection 2024 Dec.
PMID: 40018627DERIVEDHolland KN, Hubbard J, Mphande M, Robson I, Phiri K, Onoya D, Chikuse E, Dovel K, Choko A. Implementation of Male-Specific Motivational Interviewing in Malawi: An Assessment of Intervention Fidelity and Barriers to Scale-Up. medRxiv [Preprint]. 2024 Sep 26:2024.09.24.24314326. doi: 10.1101/2024.09.24.24314326.
PMID: 39399024DERIVEDChoko AT, Coates TJ, Mphande M, Balakasi K, Robson I, Phiri K, Phiri S, Kulich M, Sweat M, Cornell M, Hoffman RM, Dovel K. Engaging men through HIV self-testing with differentiated care to improve ART initiation and viral suppression among men in Malawi (ENGAGE): A study protocol for a randomized control trial. PLoS One. 2023 Feb 24;18(2):e0281472. doi: 10.1371/journal.pone.0281472. eCollection 2023.
PMID: 36827327DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of University of California Global Health Institute
Study Record Dates
First Submitted
April 21, 2021
First Posted
April 26, 2021
Study Start
August 2, 2021
Primary Completion
March 31, 2025
Study Completion
June 30, 2025
Last Updated
May 15, 2023
Record last verified: 2023-05