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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1
Partners in Hope
Lilongwe, Malawi