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 investigative team’s 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 investigative team proposes to 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 investigative team now proposes 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.

They propose to conduct a three-arm trial among 1080 pregnant women and partners, randomizing them to home-based couple visits, HIV self-test (HIVST) kits to use with their male partner, or standard care (male partner clinic invitation letters), following couples up to 18 months postpartum. In Aim 1, they will determine the effects of the intervention on our primary outcome of couple HIV testing, compared to HIVST kits and standard care. In Aim 2, they will examine intervention impact on HIV prevention behaviors, facility delivery, and postnatal healthcare utilization. Among couples living with HIV, secondary outcomes include maternal VL suppression and HIV-free child survival up to 18 months. In Aim 3, the investigative team will compare the cost-effectiveness of the home-based couples intervention to the less resource-intensive strategies used in the other two study arms. The team's theory-based couples intervention has strong potential to increase couple HIV testing and collaboration for family health. This 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.

INVESTIGATORS AND INSTITUTIONAL AFFILIATIONS:

Name

Organization

Role on Project

Janet Turan, PhD, MPH

University of Alabama at Birmingham (UAB)

Principal Investigator

Lynae Darbes, PhD

University of Michigan (UM)

Co-Principal Investigator

Thomas Braun, PhD

University of Michigan (UM)

Co-Investigator

Elizabeth Bukusi, MBChB, M.MED, PhD, MPH, PGD, MBE

Kenya Medical Research Institute (KEMRI)

Co-Investigator

Abigail Hatcher, PhD

University of the Witwatersrand

Co-Investigator

Meredith Kilgore, PhD

University of Alabama at Birmingham (UAB)

Co-Investigator

Zachary Kwena, PhD

Kenya Medical Research Institute (KEMRI)

Site Principal Investigator

Harsha Thirumurthy, PhD

University of Pennsylvania

Co-Investigator