Happy Homes, Healthy Families: A Relationship Strengthening Intervention for Pregnant Couples Affected by HIV in Zambia
NCT ID: NCT04729413
Last Updated: 2024-01-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
478 participants
INTERVENTIONAL
2020-12-08
2023-10-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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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.
Couples Counseling
Psychoeducational counseling on relationships and maternal and child health in the context of HIV.
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).
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.
Interventions
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Couples Counseling
Psychoeducational counseling on relationships and maternal and child health in the context of HIV.
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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National Institute of Mental Health (NIMH)
NIH
University of Colorado, Denver
OTHER
Responsible Party
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Principal Investigators
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Karen Hampanda, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Colorado, Denver
Locations
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Chipata Health Centre
Lusaka, , Zambia
Countries
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Other Identifiers
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20-1529
Identifier Type: -
Identifier Source: org_study_id
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