N/A
Completed N=478
Happy Homes, Healthy Families: A Relationship Strengthening Intervention for Pregnant Couples Affected by HIV in Zambia
HIV Infections · Pregnancy Related
Source: ClinicalTrials.gov NCT04729413 ↗
Enrolled (actual)
478
Serious AEs
1.5%
Results posted
Apr 2026
Primary outcomePrimary: Female Participants With Viral Suppression (<1,000 Copies/ml) — 82; 82 Participants — p=0.4
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Female Participants With Viral Suppression (<1,000 Copies/ml) |
84; 76 | 0.6 |
| SECONDARY Female Participants With Self-reported 30-day Antiretroviral Therapy Adherence |
85; 81 | — |
| SECONDARY Female Participants With Self-reported Exclusive Breastfeeding |
83; 78 | 0.8 |
| SECONDARY Female Participants With Self-reported Postpartum Use of Family Planning |
23; 18 | 0.5 |
| SECONDARY Female Participants With Self-reported Infant HIV Testing |
80; 79 | 0.3 |
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT04729413). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.