Clinical trial NCT03547739: Testing Strategies for Couple Engagement in PMTCT and Family Health in Kenya
Official title: Testing Strategies for Couple Engagement in PMTCT and Family Health in Kenya
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Human Immunodeficiency Virus
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: Kenya Medical Research Institute
name: University of Michigan
name: University of Witwatersrand, South Africa
name: University of Pennsylvania
name: National Institute of Mental Health (NIMH)
First posted: 2018-06-06
Enrollment: 1600
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study will test the efficacy and cost-effectiveness of an interdependence theory-based couples intervention in Kenya that reaches pregnant women and male partners through home visits by male-female pairs of lay health workers, and includes offer of home-based CHTC services.

Detailed description: Despite the potential for antiretroviral therapy to improve maternal health and reduce mother-to-child transmission of HIV to as low as 1%, HIV-related maternal deaths and HIV infection among infants remain unacceptably high across sub-Saharan Africa. This is particularly true in Kenya, where crucial drop-offs occur in the cascade of prevention of mother-to-child transmission (PMTCT) services. Weak health systems contribute to insufficient service coverage, but many barriers lie beyond the clinic-in the partner, family, and community factors that shape women's health decisions. The investigators' research in a high HIV prevalence area of southwestern Kenya has shown that many women avoid couples HIV testing and do not adhere to PMTCT regimens because they fear negative consequences from a male partner. Men can play a crucial supportive role for family health, but male partners in Kenya are poorly engaged in antenatal care and uptake of couples HIV testing during pregnancy is low. Pregnant women desire to be tested for HIV together with their partner and need the support for mutual disclosure involved in couples HIV testing and counseling (CHTC), regardless of whether they know their own HIV status. In this context, the investigators will test the efficacy of an interdependence theory-based couples intervention that reaches pregnant women and male partners through home visits by male-female pairs of lay health workers, and includes offer of home-based CHTC services. The randomized pilot study of this intervention with 96 pregnant couples (R34MH102103) demonstrated significant increases in uptake of couples testing (64% in intervention vs. 23% in control, p\<0.001) and significant improvements in health behaviors such as exclusive breastfeeding and postpartum care. The investigators will now conduct a more robust investigation to determine whether this intervention improves uptake of couples HIV testing and health outcomes over and above less intensive male engagement strategies being used in the region. This theory-based couples intervention has strong potential to increase couple HIV testing and collaboration for family health. The study will inform decision-makers about cost-effective strategies to engage pregnant couples in PMTCT and family health, with important downstream benefits for maternal, paternal, and infant health.

Eligibility criteria: Inclusion Criteria:

* Women at 36 weeks of pregnancy or less
* 15 years of age or older
* Has been offered HIV testing at ANC
* Is currently in a stable relationship with a male partner and living with that male partner - Has not yet participated in couple HIV testing during this pregnancy.
* Male partner is the person identified by the pregnant woman as her primary male partner and should also be 15 years of age or older.
* Not in an HIV-positive concordant relationship.

Exclusion Criteria:

* Greater than 36 weeks of pregnancy
* Less than 15 years of age
* Not currently in a stable relationship with a male partner
* Does not currently live with male partner
* Has not been offered HIV testing at ANC

Primary outcomes:
measure: Change in couple HIV testing uptake from baseline to 12 months postpartum (all couples)
timeFrame: Baseline, 3 months postpartum, 12 months postpartum
Secondary outcomes:
measure: HIV re-testing
timeFrame: Baseline, 3 months postpartum, 12 months postpartum
measure: Number of new male HIV-positive diagnoses
timeFrame: Baseline, 3 months postpartum, 12 months postpartum
measure: Number of new discordant couples
timeFrame: Baseline, 3 months postpartum, 12 months postpartum
measure: Use of PMTCT interventions (for HIV-positive women only)
timeFrame: 3 months postpartum, 12 months postpartum, 18 months postpartum
measure: Utilization of maternal and child health (MCH) services (all couples in the study)
timeFrame: 3 months postpartum, 12 months postpartum, 18 months postpartum
measure: Pre-Exposure Prophylaxis (PrEP) uptake (discordant partners at follow-ups)
timeFrame: 3 months postpartum, 12 months postpartum, 18 months postpartum
measure: Woman's linkage to HIV care (HIV-positive women)
timeFrame: Baseline, 3 months postpartum, 12 months postpartum, 18 months postpartum
measure: Woman's enrollment in HIV care (HIV-positive women)
timeFrame: Baseline, 3 months postpartum, 12 months postpartum, 18 months postpartum
measure: Woman's adherence to HIV care (HIV-positive women)
timeFrame: Baseline, 3 months postpartum, 12 months postpartum, 18 months postpartum
measure: Number of HIV care visits (HIV-positive women)
timeFrame: Baseline, 3 months postpartum, 12 months postpartum, 18 months postpartum
measure: Man's linkage to HIV care (HIV-positive men)
timeFrame: Baseline, 3 months after baby's birth, 12 months after baby's birth, 18 months after baby's birth
measure: Man's enrollment in HIV care (HIV-positive men)
timeFrame: Baseline, 3 months after baby's birth, 12 months after baby's birth, 18 months after baby's birth
measure: Man's adherence to HIV care (HIV-positive men)
timeFrame: Baseline, 3 months after baby's birth, 12 months after baby's birth, 18 months after baby's birth
measure: Number of HIV care visits (HIV-positive men)
timeFrame: Baseline, 3 months after baby's birth, 12 months after baby's birth, 18 months after baby's birth
measure: Maternal HIV viral suppression (HIV-positive women)
timeFrame: Baseline, 3 months postpartum, 12 months postpartum, 18 months postpartum
measure: HIV-free child survival
timeFrame: 18 months after the birth
measure: Result of infant HIV test
timeFrame: 3 months after birth, 12 months after birth, 18 months after birth
measure: Date of infant HIV test
timeFrame: 3 months after birth, 12 months after birth, 18 months after birth
Other outcomes:
Locations:
city: Nairobi
country: Kenya
facility: Kenya Medical Research Institute
Study officials:
affiliation: University of Alabama at Birmingham
name: Janet M Turan, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Michigan
name: Lynae Darbes, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kwena Z, Kimbo L, Darbes LA, Hatcher AM, Helova A, Owino G, Thirumurthy H, Bukusi EA, Braun T, Kilgore M, Pisu M, Tamhane A, Nghiem VT, Agot K, Neilands TB, Turan JM. Testing strategies for couple engagement in prevention of mother-to-child transmission of HIV and family health in Kenya: study protocol for a randomized controlled trial. Trials. 2021 Jan 6;22(1):19. doi: 10.1186/s13063-020-04956-1.
citation: Borgstede SJ, Elly A, Helova A, Kwena Z, Darbes LA, Hatcher A, Thirumurthy H, Owino G, Pisu M, Owuor K, Braun T, Turan JM, Bukusi EA, Nghiem VT. Cost of Home-Based Couples Human Immunodeficiency Virus Counseling and Testing and Human Immunodeficiency Virus Self-Testing During Pregnancy and Postpartum in Southwestern Kenya. Value Health Reg Issues. 2023 Mar;34:125-132. doi: 10.1016/j.vhri.2022.11.003. Epub 2023 Jan 27.