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

Primary Purpose

HIV Infections, Pregnancy Related

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Zambia
Study Type
Interventional
Intervention
Couples Counseling
Enhanced Standard of Care
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for HIV Infections

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Chipata Health Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Couples Counseling Intervention

Control

Arm Description

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.

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).

Outcomes

Primary Outcome Measures

Female Viral Suppression
Laboratory testing of blood samples. A result of <1,000 HIV viral copies/mL indicates viral suppression.

Secondary Outcome Measures

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.
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.
Self-reported postpartum use of family planning
Survey question: "Are you currently using any form of family planning?" (yes)
Self-reported infant HIV testing
Survey question: "Has the baby been tested for HIV?" (yes)

Full Information

First Posted
January 25, 2021
Last Updated
December 21, 2022
Sponsor
University of Colorado, Denver
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT04729413
Brief Title
Happy Homes, Healthy Families: A Relationship Strengthening Intervention for Pregnant Couples Affected by HIV in Zambia
Official Title
Promoting HIV Health Behaviors Among Pregnant Couples in Zambia Using an Adaptive Relationship Strengthening Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
December 8, 2020 (Actual)
Primary Completion Date
January 2023 (Anticipated)
Study Completion Date
January 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, Pregnancy Related

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
476 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Couples Counseling Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
Sham Comparator
Arm Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Couples Counseling
Intervention Description
Psychoeducational counseling on relationships and maternal and child health in the context of HIV.
Intervention Type
Other
Intervention Name(s)
Enhanced Standard of Care
Other Intervention Name(s)
Control/comparator
Intervention Description
Enhanced standard of care with education on pregnancy and postpartum health, similar to what is presented to women at routine antenatal and postpartum care.
Primary Outcome Measure Information:
Title
Female Viral Suppression
Description
Laboratory testing of blood samples. A result of <1,000 HIV viral copies/mL indicates viral suppression.
Time Frame
Month 6 postpartum
Secondary Outcome Measure Information:
Title
Self-reported 30-day antiretroviral therapy adherence
Description
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.
Time Frame
Month 6 postpartum
Title
Self-reported exclusive breastfeeding
Description
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.
Time Frame
Month 6 postpartum
Title
Self-reported postpartum use of family planning
Description
Survey question: "Are you currently using any form of family planning?" (yes)
Time Frame
Month 6 postpartum
Title
Self-reported infant HIV testing
Description
Survey question: "Has the baby been tested for HIV?" (yes)
Time Frame
Month 6 postpartum
Other Pre-specified Outcome Measures:
Title
Female Viral Suppression
Description
Laboratory testing of blood samples. A result of <1,000 HIV viral copies/mL indicates viral suppression.
Time Frame
Week 6 postpartum
Title
Self-reported 30-day antiretroviral therapy adherence
Description
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.
Time Frame
Week 6 postpartum
Title
Self-reported exclusive breastfeeding
Description
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.
Time Frame
Week 6 postpartum
Title
Self-reported postpartum use of family planning
Description
Survey question: "Are you currently using any form of family planning?" (yes)
Time Frame
Week 6 postpartum
Title
Self-reported infant HIV testing
Description
Survey question: "Has the baby been tested for HIV?" (yes)
Time Frame
Week 6 postpartum

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karen Hampanda, PhD
Organizational Affiliation
University of Colorado - Anschutz Medical Campus
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chipata Health Centre
City
Lusaka
Country
Zambia

12. IPD Sharing Statement

Plan to Share IPD
No

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

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