Trials / Completed
CompletedNCT04729413
Happy Homes, Healthy Families: A Relationship Strengthening Intervention for Pregnant Couples Affected by HIV in Zambia
Promoting HIV Health Behaviors Among Pregnant Couples in Zambia Using an Adaptive Relationship Strengthening Intervention
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 478 (actual)
- Sponsor
- University of Colorado, Denver · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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 health during and after pregnancy. The study further hypothesizes that the couples-based intervention will improve interpersonal dynamics, such as communication, and in intrapersonal factors, such as women's mental health, which will mediate intervention effects on HIV care and treatment outcomes. The study will test the hypotheses through two specific aims: (1) compare service utilization and prevention of mother-to-child transmission (PMTCT) outcome indicators in two study conditions; and (2) establish the effect of the intervention on intra- and inter-personal mechanisms influencing outcomes.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Couples Counseling | Psychoeducational counseling on relationships and maternal and child health in the context of HIV. |
| OTHER | Enhanced Standard of Care | Enhanced standard of care with education on pregnancy and postpartum health, similar to what is presented to women at routine antenatal and postpartum care. |
Timeline
- Start date
- 2020-12-08
- Primary completion
- 2023-10-12
- Completion
- 2023-10-12
- First posted
- 2021-01-28
- Last updated
- 2024-01-26
Locations
1 site across 1 country: Zambia
Source: ClinicalTrials.gov record NCT04729413. Inclusion in this directory is not an endorsement.