Status:
COMPLETED
Happy Homes, Healthy Families: A Relationship Strengthening Intervention for Pregnant Couples Affected by HIV in Zambia
Lead Sponsor:
University of Colorado, Denver
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
HIV Infections
Pregnancy Related
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The objective of this study is to test the preliminary efficacy of a novel couples' counseling intervention to promote the health of pregnant women living with HIV in Lusaka, Zambia.
Detailed Description
The central hypothesis of this study is that women living with HIV in heterosexual couples that have better relationship functioning and more social support will have greater odds of achieving optimal...
Eligibility Criteria
Inclusion
- Heterosexual couple in a stable relationship (defined as sleeping under the same roof at least once a week)
- Relationship has lasted ≥ 6 months
- Both partners live in the clinic catchment area and plan to continue residing there for at least six months
- Both partners are at least 18 years of age
- Both partners willing to participate in the intervention
- Female partner is no more than 36 weeks pregnant
- Female partner is diagnosed as HIV-positive
- Severe intimate partner violence (World Health Organization definition) has not occurred within the couple in the past 6 months.
Exclusion
- Same-sex couple
- couple who does not sleep under the same roof at least once a week
- Relationship has lasted \<6 months
- One or both partners live outside the clinic catchment area
- One or both partners plan to move outside the clinic catchment area
- One or both partners are \<18 years of age
- One or both partners unwilling to participate in the intervention
- Female partner is greater than 36 weeks pregnant
- Female partner is HIV-negative
- Severe intimate partner violence (World Health Organization definition) has occurred within the couple in the past 6 months.
Key Trial Info
Start Date :
December 8 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 12 2023
Estimated Enrollment :
478 Patients enrolled
Trial Details
Trial ID
NCT04729413
Start Date
December 8 2020
End Date
October 12 2023
Last Update
January 26 2024
Active Locations (1)
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1
Chipata Health Centre
Lusaka, Zambia