Status:
COMPLETED
Pilot Test of a Couple-Based Medication Adherence Intervention for HIV-Positive Women and Their Male Partners in South Africa
Lead Sponsor:
University of Maryland, College Park
Collaborating Sponsors:
Human Sciences Research Council
University of Washington
Conditions:
Human Immunodeficiency Virus
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to collect quantitative data related to developing and testing a couple-based intervention (CBI) for HIV-positive women's medication adherence in the region of Kwazulu-Nat...
Detailed Description
South Africa (SA) has one of the highest global HIV burdens with clear gender disparities. For men, 57% of HIV-related deaths occur among persons who have never sought HIV care. Women, in comparison, ...
Eligibility Criteria
Inclusion
- Both partners aged 18 or over
- HIV-positive woman diagnosed ≥ 3 months prior to study entry
- HIV-positive woman demonstrates difficulty with HIV treatment engagement, defined as either self-reported ART adherence difficulties, evidence of missed clinic visits over the past year (collected from medical records), or evidence of being not virally suppressed (≥ 50 copies/mL) in the past year
- In a committed, heterosexual, monogamous romantic relationship for at least 6 months
- Both partners willing to participate in treatment to support women's ART adherence
- Both partners reside in Vulindlela, or neighboring community, KwaZulu-Natal, South Africa
- Willing to have intervention sessions audio-recorded (if randomized to the intervention group)
- Able to comfortably communicate in either isiZulu or English
Exclusion
- Report of moderate or severe relationship violence past year
- Either partner previously participated in a couple-based HIV prevention or treatment program
Key Trial Info
Start Date :
November 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 15 2022
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03809364
Start Date
November 1 2021
End Date
December 15 2022
Last Update
December 27 2023
Active Locations (1)
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1
Human Sciences Research Council
Pietermaritzburg, KwaZulu-Natal, South Africa