HIV InfectionsNCT04729413

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

A study testing Couples Counseling in people with HIV Infections and Pregnancy Related, run by University of Colorado, Denver at 1 site in Zambia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: HIV Infections, Pregnancy Related
What is being tested?: Couples Counseling
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 478 participants
Where: 1 siteZambia
Study dates: 8 Dec 2020to 12 Oct 2023
Phase: Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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

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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.

Trial locations and contacts

1 site in 1 country.

Zambia1 site

Chipata Health Centre
Lusaka, Lusaka Province

Other trials in Zambia

About this study

Official title: 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.

Read the 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.

Conditions: HIV Infections, Pregnancy Related
Being tested: Couples Counseling, Enhanced Standard of Care
Medical subject headings: HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Couples CounselingBehavioural
Psychoeducational counseling on relationships and maternal and child health in the context of HIV.
Enhanced Standard of CareOther
Also called 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.

Study groups in NCT04729413
Study group	Role	What they receive
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. Receives: 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). Receives: Other: Enhanced Standard of Care

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Month 6 postpartum

Secondary outcomes (4)

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.
Measured: 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.
Measured: 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)
Measured: Month 6 postpartum
Female Participants With Self-reported Infant HIV Testing
Survey question: "Has the baby been tested for HIV?" (yes)
Measured: Month 6 postpartum

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Dec 202012 Oct 2023

First posted28 Jan 2021
Study start8 Dec 2020
Primary completion12 Oct 2023
Study completion12 Oct 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HIV InfectionsStudies of the same condition, open and under way.
More trials run by University of Colorado, DenverThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Model description: 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
Masking: None (open label)
Enrolment: 478 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04729413
Sponsor's protocol ID: 20-1529
Other IDs: R00MH116735-03
Status last verified: Apr 2026
First submitted: 25 Jan 2021
Last updated: 29 Apr 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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