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

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

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.

Study Overview

• Status: Completed
• Conditions: HIV Infections; Pregnancy Related
• Intervention / Treatment: Behavioral: Couples Counseling; Other: Enhanced Standard of Care

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.

• Study Type: Interventional
• Enrollment (Actual): 478
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Zambia
  • Lusaka Province
    • Lusaka, Lusaka Province, Zambia
      • Chipata Health Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Couples Counseling Intervention; 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.	Behavioral: Couples Counseling; Psychoeducational counseling on relationships and maternal and child health in the context of HIV.
Sham Comparator: Control; 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).	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.; Other Names: Control/comparator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Female Participants With Viral Suppression (<1,000 Copies/ml)	Laboratory testing of blood samples. A result of <1,000 HIV viral copies/mL indicates viral suppression.	Month 6 postpartum

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Female Participants With Viral Suppression (<1,000 Copies/mL)	Laboratory testing of blood samples. A result of <1,000 HIV viral copies/mL indicates viral suppression.	Week 6 postpartum
Female Participants With 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
Female Participants With 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
Female Participants With Self-reported Postpartum Use of Family Planning	Survey question: "Are you currently using any form of family planning?" (yes)	Week 6 postpartum
Female Participants With Self-reported Infant HIV Testing	Survey question: "Has the baby been tested for HIV?" (yes)	Week 6 postpartum

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Karen Hampanda, PhD, University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start (Actual): December 8, 2020
• Primary Completion (Actual): October 12, 2023
• Study Completion (Actual): October 12, 2023

Study Registration Dates

• First Submitted: January 25, 2021
• First Submitted That Met QC Criteria: January 25, 2021
• First Posted (Actual): January 28, 2021

Study Record Updates

• Last Update Posted (Actual): April 29, 2026
• Last Update Submitted That Met QC Criteria: April 24, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Blood-Borne Infections; Urogenital Diseases; Genital Diseases; Immune System Diseases; Infections; RNA Virus Infections; Virus Diseases; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; HIV Infections
• Other Study ID Numbers: 20-1529; R00MH116735-03 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No