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.
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
Show all 10Show fewer
- 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.
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 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.
- 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)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Karen Hampanda, PhD, Principal investigator, University of Colorado, Denver
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