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

HIV Infections Clinical Trial

Official title:

Promoting HIV Health Behaviors Among Pregnant Couples in Zambia Using an Adaptive Relationship Strengthening Intervention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04729413
• Other study ID #: 20-1529
• Secondary ID: R00MH116735-03
• Status: Completed
• Phase: N/A
• Start date: December 8, 2020
• Est. completion date: October 12, 2023

Study information

• Verified date: January 2024
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 478
• Est. completion date: October 12, 2023
• Est. primary completion date: October 12, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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.

Related Conditions & MeSH terms

• HIV Infections
• Pregnancy Related

Intervention

Behavioral:
• Couples Counseling
Psychoeducational counseling on relationships and maternal and child health in the context of HIV.

Other:
• Enhanced Standard of Care
Enhanced standard of care with education on pregnancy and postpartum health, similar to what is presented to women at routine antenatal and postpartum care.

Locations

Country	Name	City	State
Zambia	Chipata Health Centre	Lusaka

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

Zambia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Female Viral Suppression	Laboratory testing of blood samples. A result of <1,000 HIV viral copies/mL indicates viral suppression.	Week 6 postpartum
Other	Self-reported 30-day antiretroviral therapy adherence	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.	Week 6 postpartum
Other	Self-reported exclusive breastfeeding	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.	Week 6 postpartum
Other	Self-reported postpartum use of family planning	Survey question: "Are you currently using any form of family planning?" (yes)	Week 6 postpartum
Other	Self-reported infant HIV testing	Survey question: "Has the baby been tested for HIV?" (yes)	Week 6 postpartum
Primary	Female Viral Suppression	Laboratory testing of blood samples. A result of <1,000 HIV viral copies/mL indicates viral suppression.	Month 6 postpartum
Secondary	Self-reported 30-day antiretroviral therapy adherence	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.	Month 6 postpartum
Secondary	Self-reported exclusive breastfeeding	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.	Month 6 postpartum
Secondary	Self-reported postpartum use of family planning	Survey question: "Are you currently using any form of family planning?" (yes)	Month 6 postpartum
Secondary	Self-reported infant HIV testing	Survey question: "Has the baby been tested for HIV?" (yes)	Month 6 postpartum