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Completed

NCT Number: NCT04729413

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chipata Health Centre

Lusaka, Lusaka Province, Zambia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Couples counseling

Behavioral

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

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.

Other names: Control/comparator

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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)

  4. Female Participants With Self-reported Infant HIV Testing

    Time frame: Month 6 postpartum

    Survey question: "Has the baby been tested for HIV?" (yes)

Other outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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)

  5. Female Participants With Self-reported Infant HIV Testing

    Time frame: Week 6 postpartum

    Survey question: "Has the baby been tested for HIV?" (yes)

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Promoting HIV Health Behaviors Among Pregnant Couples in Zambia Using an Adaptive Relationship Strengthening Intervention

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Jan 28, 2021
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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