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Clinical Trials/NCT04878601
NCT04878601
Active, not recruiting
Not Applicable

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

University of California, Los Angeles1 site in 1 country470 target enrollmentJuly 1, 2021
ConditionsHiv

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hiv
Sponsor
University of California, Los Angeles
Enrollment
470
Locations
1
Primary Endpoint
Men's ART Initiation
Status
Active, not recruiting
Last Updated
2 years ago

Overview

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 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]

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.

Registry
clinicaltrials.gov
Start Date
July 1, 2021
End Date
March 31, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Kathryn L. Dovel, PhD

Assistant Professor

University of California, Los Angeles

Eligibility Criteria

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

Outcomes

Primary Outcomes

Men's ART Initiation

Time Frame: 6 months

ART initiation within 6-months of enrollment. Sourced from medical chart reviews.

Secondary Outcomes

  • Men's 6-month Retention(6 months)

Study Sites (1)

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