Happy Homes, Healthy Families: A Relationship Strengthening Intervention for Pregnant Couples Affected by HIV in Zambia

Not Applicable

Completed

Interventions: Other: Enhanced Standard of Care
Behavioral: Couples Counseling

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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Control	Enhanced Standard of Care	Couples assigned to the control group will receive two group health education sessions (one during pregnancy and one postpartum) covering information on pregnancy and postpartum health. Couples will also have the opportunity after the trial is complete to opt-in to receive a condensed one-session couples counseling visit (data not to be used for study purposes but offered for ethical reasons).
Couples Counseling Intervention	Couples Counseling	Couples in the intervention group will receive two group health education sessions (one during pregnancy and one postpartum) covering information on pregnancy and postpartum health, as well as three couple counseling visits (one during pregnancy and two postpartum). The couples counseling sessions will provide (1) information on key relationship topics (communication, trust and respect, love and support); (2) relationship skills exercises (role playing); and (3) the opportunity to discuss health and relationship priorities/goals of the couple.

Primary Outcome Measures

Name	Time	Method
Female Viral Suppression	Month 6 postpartum	Laboratory testing of blood samples. A result of \<1,000 HIV viral copies/mL indicates viral suppression.

Secondary Outcome Measures

Name	Time	Method
Self-reported postpartum use of family planning	Month 6 postpartum	Survey question: "Are you currently using any form of family planning?" (yes)
Self-reported 30-day antiretroviral therapy adherence	Month 6 postpartum	Survey question: "In the last 30 days, on how many days did you miss at least one dose of any of your HIV medicines?" Continuous measurement from 0 days to 30 days.
Self-reported exclusive breastfeeding	Month 6 postpartum	Survey question: "How is the baby currently being fed?" Exclusive breastfeeding is defined as providing only breastmilk to the infant for the first 6 months of life.
Self-reported infant HIV testing	Month 6 postpartum	Survey question: "Has the baby been tested for HIV?" (yes)