HIV Infections, Pregnancy Related
Conditions
Brief 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.
Detailed 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.
Interventions
BEHAVIORALCouples Counseling
Psychoeducational counseling on relationships and maternal and child health in the context of HIV.
OTHEREnhanced 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.
Sponsors
University of Colorado, Denver
National Institute of Mental Health (NIMH)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Couples are randomized 1:1 to receive the intervention (couples counseling and health education) or control (enhanced standard of care) in parallel for the duration of the study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Female Participants With Viral Suppression (<1,000 Copies/ml) | Month 6 postpartum | Laboratory testing of blood samples. A result of \<1,000 HIV viral copies/mL indicates viral suppression. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Female Participants With Self-reported 30-day Antiretroviral Therapy Adherence | 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. |
| Female Participants With Self-reported Exclusive Breastfeeding | 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. |
| Female Participants With Self-reported Postpartum Use of Family Planning | Month 6 postpartum | Survey question: "Are you currently using any form of family planning?" (yes) |
| Female Participants With Self-reported Infant HIV Testing | Month 6 postpartum | Survey question: "Has the baby been tested for HIV?" (yes) |
Countries
Zambia
Contacts
PRINCIPAL_INVESTIGATORKaren Hampanda, PhD
University of Colorado, Denver
Participant flow
Recruitment details
Recruitment occurred from December 2020 - January 2023 at a public district hospital in Lusaka, Zambia.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous Female participants | 30.7 years STANDARD_DEVIATION 5.8 |
| Age, Continuous Male participants | 37.1 years STANDARD_DEVIATION 7.9 |
| Number of Female Participants with Viral Suppression (<1,000 copies/ml) | 111 Participants |
| Race/Ethnicity, Customized African (Zambian) Female participants | 118 Participants |
| Race/Ethnicity, Customized African (Zambian) Male participants | 118 Participants |
| Region of Enrollment Zambia | 478 participants |
| Sex: Female, Male Female | 118 Participants |
| Sex: Female, Male Male | 118 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 242 | 1 / 236 |
| other Total, other adverse events | 0 / 242 | 0 / 236 |
| serious Total, serious adverse events | 5 / 242 | 2 / 236 |
Outcome results
None listed