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

April 24, 2026 updated by: University of Colorado, Denver

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
478

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Female Participants With Viral Suppression (<1,000 Copies/ml)
Time Frame: Month 6 postpartum
Laboratory testing of blood samples. A result of <1,000 HIV viral copies/mL indicates viral suppression.
Month 6 postpartum

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Female Participants With Self-reported 30-day Antiretroviral Therapy Adherence
Time Frame: Month 6 postpartum
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
Time Frame: Month 6 postpartum
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
Time Frame: Month 6 postpartum
Survey question: "Are you currently using any form of family planning?" (yes)
Month 6 postpartum
Female Participants With Self-reported Infant HIV Testing
Time Frame: Month 6 postpartum
Survey question: "Has the baby been tested for HIV?" (yes)
Month 6 postpartum

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Female Participants With Viral Suppression (<1,000 Copies/mL)
Time Frame: Week 6 postpartum
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
Time Frame: Week 6 postpartum
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
Time Frame: Week 6 postpartum
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
Time Frame: Week 6 postpartum
Survey question: "Are you currently using any form of family planning?" (yes)
Week 6 postpartum
Female Participants With Self-reported Infant HIV Testing
Time Frame: Week 6 postpartum
Survey question: "Has the baby been tested for HIV?" (yes)
Week 6 postpartum

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Colorado, Denver

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Mental Health (NIMH)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Karen Hampanda, PhD, University of Colorado, Denver

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 8, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 12, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 12, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 25, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 25, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 28, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 29, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 24, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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