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

University of Colorado Denver (CU Denver)

Status: Completed

Conditions: Pregnancy Related; HIV Infections

Treatments: Behavioral: Couples Counseling; Other: Enhanced Standard of Care

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04729413

R00MH116735-03 (U.S. NIH Grant/Contract)

20-1529

Details and patient eligibility

About

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.

Full 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.

Enrollment: 478 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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478 participants in 2 patient groups

Couples Counseling Intervention

Experimental group

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.

Treatment:

Behavioral: Couples Counseling

Control

Sham Comparator group

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).

Treatment:

Other: Enhanced Standard of Care