Innovative Strategies to Increase ART Initiation and Viral Suppression Among HIV-positive Men in Malawi

June 23, 2023 updated by: Kathryn L. Dovel, PhD, University of California, Los Angeles
Men in Sub-Saharan Africa are less likely to test for HIV, initiate ART, and more likely to initiate ART at later stages of disease. Two overarching barriers keep HIV-positive men from accessing ART services: 1) Lack of male-friendly services, and 2) harmful gender norms. Home-based ART may improve ART initiation and retention among male partners who test HIV-positive through Index HIV self-testing (HIVST). We will pilot an intervention that provides home-based ART initiation and home-based continuation for 3-months, followed by assisted linkage to facility-based care at 4-months. 470 participants will be enrolled [209 females, 261 males]

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Men in Sub-Saharan Africa are less likely to test for HIV, initiate ART, and more likely to initiate ART at later stages of disease. Achieving epidemic control requires immediate, concentrated effort to engage this largely unreached population. Index partner testing, whereby partners of HIV-positive clients are refereed for HIV testing, is critical to identifying undiagnosed men and has been adopted as a national policy by the Malawi Ministry of Health because of its high acceptability and its dramatic increase on HIV testing uptake. Two overarching barriers keep HIV-positive men from accessing ART services: 1) Lack of male-friendly services, and 2) harmful gender norms. Home-based ART may improve ART initiation and retention among male partners who test HIV-positive through Index HIVST. We will pilot an intervention that provides home-based ART initiation and home-based continuation for male partners identified as HIV-positive through Index HIVST for 3-months, followed by assisted linkage to facility-based care at 4-months. This intervention offers opt-out ART and in-depth, male-specific counseling for 3-months before linking men to facility based care. We will directly compare home-based ART to facility-based ART, whereby a health care worker will conduct a home-visit with HIV+ male partners to provide confirmatory HIV testing and immediate assisted linkage to a nearby facility for facility-based ART initiation and continuation.

Study Type

Interventional

Enrollment (Actual)

470

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Malawi
      • Lilongwe, Malawi
        • Partners in Hope

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: hbART
Home-Based ART initiation and continuation for 3-months with male-specific counseling and assisted facility navigation at 4-months.
Other: Home-Based ART
Healthcare provider will ask ART client for permission to conduct a home visit with their HIV+ partner. Providers will conduct a home visit with HIV+ partners to provide confirmatory HIV testing and ART initiation with a 30-day supply. Monthly home-based ART follow-up visits with male-specific messaging and 30-day supply distribution will take place for 3-months. At 4-months providers will provide assisted linkage to a nearby facility to join the facility-based ART program. Additional counseling will be provided.
Active Comparator: fbART
Facility-Based ART initiation and continuation with male-specific counseling.
Other: Facility-Based ART
Healthcare provider will ask ART client for permission to conduct a home visit with their HIV+ partner. Providers will conduct a home visit with HIV+ partners to provide confirmatory HIV testing and assisted linkage to a nearby facility for facility-based ART initiation and continuation. Male clients will receive a 30-day supply each visit and return monthly.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Men's ART Initiation
Time Frame: 6 months
ART initiation within 6-months of enrollment. Sourced from medical chart reviews.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Men's 6-month Retention
Time Frame: 6 months
6-month retention (<60 days ever late for ART). Sourced from medical chart reviews.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Los Angeles

Collaborators

Fogarty International Center of the National Institute of Health
Partners in Hope, Malawi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2021

Primary Completion (Estimated)

December 31, 2023

Study Completion (Estimated)

March 31, 2024

Study Registration Dates

First Submitted

May 4, 2021

First Submitted That Met QC Criteria

May 4, 2021

First Posted (Actual)

May 7, 2021

Study Record Updates

Last Update Posted (Actual)

June 26, 2023

Last Update Submitted That Met QC Criteria

June 23, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • K01TW011484 (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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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