Clinical trial NCT04729413: Happy Homes, Healthy Families: A Relationship Strengthening Intervention for Pregnant Couples Affected by HIV in Zambia
Official title: Promoting HIV Health Behaviors Among Pregnant Couples in Zambia Using an Adaptive Relationship Strengthening Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Pregnancy Related
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2021-01-28
Enrollment: 478
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Couples are randomized 1:1 to receive the intervention (couples counseling and health education) or control (enhanced standard of care) in parallel for the duration of the study
Primary purpose: SUPPORTIVE_CARE

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 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.

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.

Primary outcomes:
measure: Female Viral Suppression
timeFrame: Month 6 postpartum
Secondary outcomes:
measure: Self-reported 30-day antiretroviral therapy adherence
timeFrame: Month 6 postpartum
measure: Self-reported exclusive breastfeeding
timeFrame: Month 6 postpartum
measure: Self-reported postpartum use of family planning
timeFrame: Month 6 postpartum
measure: Self-reported infant HIV testing
timeFrame: Month 6 postpartum
Other outcomes:
measure: Female Viral Suppression
timeFrame: Week 6 postpartum
measure: Self-reported 30-day antiretroviral therapy adherence
timeFrame: Week 6 postpartum
measure: Self-reported exclusive breastfeeding
timeFrame: Week 6 postpartum
measure: Self-reported postpartum use of family planning
timeFrame: Week 6 postpartum
measure: Self-reported infant HIV testing
timeFrame: Week 6 postpartum
Locations:
city: Lusaka
country: Zambia
facility: Chipata Health Centre
Study officials:
affiliation: University of Colorado, Denver
name: Karen Hampanda, PhD
role: PRINCIPAL_INVESTIGATOR
References: