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

Sponsor
University of Colorado, Denver
Study ID
NCT04729413
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Dec 8, 2020
Status verified
Apr 2026
Primary completion
Oct 12, 2023
Completion
Oct 12, 2023

Study Design

Enrollment
478 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • 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.
  • 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).

Primary Outcome Measure

Female Participants With Viral Suppression (<1,000 Copies/ml) [ Time Frame: Month 6 postpartum ]

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