Status:

UNKNOWN

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

Lead Sponsor:

University of California, Los Angeles

Collaborating Sponsors:

Partners in Hope, Inc.

Medical University of South Carolina

Conditions:

Hiv

Eligibility:

All Genders

15+ years

Phase:

NA

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 HI...

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 ...

Eligibility Criteria

Inclusion

  • Female Partner
  • 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

  • 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

Key Trial Info

Start Date :

August 2 2021

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

June 30 2025

Estimated Enrollment :

930 Patients enrolled

Trial Details

Trial ID

NCT04858243

Start Date

August 2 2021

End Date

June 30 2025

Last Update

May 15 2023

Active Locations (1)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 1 (1 locations)

1

Partners in Hope

Lilongwe, Malawi