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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04729413
Other study ID # 20-1529
Secondary ID R00MH116735-03
Status Completed
Phase N/A
First received
Last updated
Start date December 8, 2020
Est. completion date October 12, 2023

Study information

Verified date January 2024
Source University of Colorado, Denver
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 478
Est. completion date October 12, 2023
Est. primary completion date October 12, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Couples Counseling
Psychoeducational counseling on relationships and maternal and child health in the context of HIV.
Other:
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.

Locations

Country Name City State
Zambia Chipata Health Centre Lusaka

Sponsors (2)

Lead Sponsor Collaborator
University of Colorado, Denver National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

Zambia, 

Outcome

Type Measure Description Time frame Safety issue
Other Female Viral Suppression Laboratory testing of blood samples. A result of <1,000 HIV viral copies/mL indicates viral suppression. Week 6 postpartum
Other 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. Week 6 postpartum
Other 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. Week 6 postpartum
Other Self-reported postpartum use of family planning Survey question: "Are you currently using any form of family planning?" (yes) Week 6 postpartum
Other Self-reported infant HIV testing Survey question: "Has the baby been tested for HIV?" (yes) Week 6 postpartum
Primary Female Viral Suppression Laboratory testing of blood samples. A result of <1,000 HIV viral copies/mL indicates viral suppression. Month 6 postpartum
Secondary 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. Month 6 postpartum
Secondary 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. Month 6 postpartum
Secondary Self-reported postpartum use of family planning Survey question: "Are you currently using any form of family planning?" (yes) Month 6 postpartum
Secondary Self-reported infant HIV testing Survey question: "Has the baby been tested for HIV?" (yes) Month 6 postpartum
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