Status:

UNKNOWN

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

Lead Sponsor:

University of California, Los Angeles

Collaborating Sponsors:

Partners in Hope, Inc.

Fogarty International Center of the National Institute of Health

Conditions:

Hiv

Eligibility:

All Genders

15+ years

Phase:

NA

Brief Summary

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 s...

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 ...

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 :

July 1 2021

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

March 31 2024

Estimated Enrollment :

470 Patients enrolled

Trial Details

Trial ID

NCT04878601

Start Date

July 1 2021

End Date

March 31 2024

Last Update

June 26 2023

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Partners in Hope

Lilongwe, Malawi