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

NCT04729413 | Completed Results

• 2 other identifiers: 20-1529R00MH116735-03
• Study Type: interventional
• Target: 478
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Infections; Pregnancy Related

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Female Participants With Self-reported 30-day Antiretroviral Therapy Adherence

  Month 6 postpartum

• Female Participants With Self-reported Exclusive Breastfeeding

  Month 6 postpartum

• Female Participants With Self-reported Postpartum Use of Family Planning

  Month 6 postpartum

• Female Participants With Self-reported Infant HIV Testing

  Month 6 postpartum

Other Outcomes (5)

• Female Participants With Viral Suppression (<1,000 Copies/mL)

  Week 6 postpartum

• Female Participants With Self-reported 30-day Antiretroviral Therapy Adherence

  Week 6 postpartum

• Female Participants With Self-reported Exclusive Breastfeeding

  Week 6 postpartum

Study Arms (2)

Couples Counseling Intervention

EXPERIMENTAL

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

Control

SHAM COMPARATOR

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

Interventions

Couples Counseling BEHAVIORAL

Psychoeducational counseling on relationships and maternal and child health in the context of HIV.

Couples Counseling Intervention

Enhanced Standard of Care OTHER

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

Also known as: Control/comparator

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Colorado, Denver: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Chipata Health Centre

Lusaka, Lusaka Province, Zambia

Location

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Results Point of Contact

• Title: Dr. Karen Hampanda
• Organization: University of Colorado

KAREN.HAMPANDA@CUANSCHUTZ.EDU

303-724-2041

Study Officials

• Karen Hampanda, PhD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: January 25, 2021
• First Posted: January 28, 2021
• Study Start: December 8, 2020
• Primary Completion: October 12, 2023
• Study Completion: October 12, 2023
• Last Updated: April 29, 2026
• Results First Posted: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

ZA (1)