Trial results for a couples counseling intervention for pregnant women with HIV were posted on ClinicalTrials.gov on 2026-04-29. The study, which enrolled 478 participants, found no statistically significant differences in key health outcomes between the intervention and control groups, with p-values ranging from 0.4 to 0.9.
Background
HIV infection in pregnant women presents unique challenges, particularly in regions with high prevalence like Zambia. Effective management of HIV during pregnancy is crucial for the health of both the mother and the infant, primarily through achieving and maintaining viral suppression to prevent mother-to-child transmission. Adherence to antiretroviral therapy (ART) is a cornerstone of this management. Interventions that support adherence and broader maternal and infant health outcomes are vital in these settings.
Trial design
This completed trial (NCT04729413), with a phase of NA, enrolled 478 participants to investigate a relationship strengthening intervention for pregnant couples affected by HIV Infections and Pregnancy Related issues in Lusaka, Zambia. The objective was to test the preliminary efficacy of a novel couples' counseling intervention to promote the health of pregnant women living with HIV. The study compared a Couples Counseling Intervention group against a Control group.
Key results
The trial assessed several health outcomes for female participants. Key measurements included:
- Female Participants With Viral Suppression (<1,000 Copies/ml): In the Couples Counseling Intervention group, 82 participants achieved viral suppression, compared to 82 participants in the Control group.
- Female Participants With Self-reported 30-day Antiretroviral Therapy Adherence: 83 participants in the intervention group reported adherence, versus 86 participants in the control group.
- Female Participants With Self-reported Exclusive Breastfeeding: 15 participants in the intervention group reported exclusive breastfeeding, compared to 20 participants in the control group.
- Female Participants With Self-reported Postpartum Use of Family Planning: 61 participants in the intervention group reported postpartum family planning use, versus 64 participants in the control group.
- Female Participants With Self-reported Infant HIV Testing: 83 participants in the intervention group reported infant HIV testing, compared to 86 participants in the control group.
- Female Participants With Viral Suppression (<1,000 Copies/mL): 84 participants in the intervention group achieved viral suppression, compared to 76 participants in the control group.
Statistical analyses using Fisher Exact tests yielded p-values of 0.4, 0.6, 0.9, 0.6, 0.8, and 0.5, indicating no statistically significant differences between the intervention and control groups for the measured outcomes.
What this means
The results suggest that the couples counseling intervention, as implemented in this study, did not lead to statistically significant improvements in viral suppression, antiretroviral therapy adherence, exclusive breastfeeding, postpartum family planning use, or infant HIV testing among pregnant women with HIV when compared to the control group. While some numerical differences were observed, these were not statistically significant. This indicates that further research or alternative intervention strategies may be needed to achieve measurable improvements in these specific health indicators within this population.
Source
The information for this trial was sourced from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT04729413, titled "Happy Homes, Healthy Families: A Relationship Strengthening Intervention for Pregnant Couples Affected by HIV in Zambia," were posted on 2026-04-29 on clinicaltrials.gov.