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

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.

• Couples Counseling (Behavioral): Psychoeducational counseling on relationships and maternal and child health in the context of HIV.
• Enhanced Standard of Care (Other), also known as Control/comparator: Enhanced standard of care with education on pregnancy and postpartum health, similar to what is presented to women at routine antenatal and postpartum care.

Primary outcomes

• Female Participants With Viral Suppression (<1,000 Copies/ml) [Month 6 postpartum]: Laboratory testing of blood samples. A result of <1,000 HIV viral copies/mL indicates viral suppression.

Secondary outcomes

• Female Participants With 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.
• Female Participants With 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.
• Female Participants With Self-reported Postpartum Use of Family Planning [Month 6 postpartum]: Survey question: "Are you currently using any form of family planning?" (yes)
• Female Participants With Self-reported Infant HIV Testing [Month 6 postpartum]: Survey question: "Has the baby been tested for HIV?" (yes)

Other outcomes

• Female Participants With Viral Suppression (<1,000 Copies/mL) [Week 6 postpartum]: Laboratory testing of blood samples. A result of <1,000 HIV viral copies/mL indicates viral suppression.
• Female Participants With Self-reported 30-day Antiretroviral Therapy Adherence [Week 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.
• Female Participants With Self-reported Exclusive Breastfeeding [Week 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.
• Female Participants With Self-reported Postpartum Use of Family Planning [Week 6 postpartum]: Survey question: "Are you currently using any form of family planning?" (yes)
• Female Participants With Self-reported Infant HIV Testing [Week 6 postpartum]: Survey question: "Has the baby been tested for HIV?" (yes)

Sex: All, ages: 18 Years to any

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.

Participant flow

Outcome results

• Female Participants With Viral Suppression (<1,000 Copies/ml) (Primary), Count of participants, Participants: Couples Counseling Intervention 82; Control 82 (p 0.4)
• Female Participants With Self-reported 30-day Antiretroviral Therapy Adherence (Secondary), Count of participants, Participants: Couples Counseling Intervention 83; Control 86
• Female Participants With Self-reported Exclusive Breastfeeding (Secondary), Count of participants, Participants: Couples Counseling Intervention 15; Control 20 (p 0.6)
• Female Participants With Self-reported Postpartum Use of Family Planning (Secondary), Count of participants, Participants: Couples Counseling Intervention 61; Control 64 (p >0.9)
• Female Participants With Self-reported Infant HIV Testing (Secondary), Count of participants, Participants: Couples Counseling Intervention 83; Control 86
• Female Participants With Viral Suppression (<1,000 Copies/mL) (Other pre specified), Count of participants, Participants: Couples Counseling Intervention 84; Control 76 (p 0.6)
• Female Participants With Self-reported 30-day Antiretroviral Therapy Adherence (Other pre specified), Count of participants, Participants: Couples Counseling Intervention 85; Control 81
• Female Participants With Self-reported Exclusive Breastfeeding (Other pre specified), Count of participants, Participants: Couples Counseling Intervention 83; Control 78 (p 0.8)
• Female Participants With Self-reported Postpartum Use of Family Planning (Other pre specified), Count of participants, Participants: Couples Counseling Intervention 23; Control 18 (p 0.5)
• Female Participants With Self-reported Infant HIV Testing (Other pre specified), Count of participants, Participants: Couples Counseling Intervention 80; Control 79 (p 0.3)

Adverse events

Time frame: From enrollment during pregnancy up 6 months postpartum, approximately 15 months

Serious adverse events by term

• Study Protocol and Statistical Analysis Plan (PDF, 2020-09-18)
• Informed Consent Form (PDF, 2020-06-01)

• Karen Hampanda, PhD, Principal investigator, University of Colorado, Denver

NIH grants: R00MH116735