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

Zachary Kwena,Liza Kimbo,Ashutosh Tamhane,Anna Helova,Meredith Kilgore,Harsha Thirumurthy,Janet M Turan,Van T Nghiem,Elizabeth A Bukusi,Maria Pisu,Abigail M Hatcher,Thomas Braun,Kawango Agot,Torsten B Neilands,George Owino,Lynae A Darbes

doi:10.1186/s13063-020-04956-1

Abstract

BackgroundHIV-related maternal deaths and HIV infection among infants remain unacceptably high across sub-Saharan Africa despite increased antenatal care attendance and provision of antiretroviral therapy to pregnant women. In the Jamii Bora (“Better Family” in Swahili) Study, we seek to test the efficacy of an interdependence theory-based couple intervention. The intervention reaches pregnant women and male partners through home visits by male-female pairs of lay health workers. The aim is to increase access to home-based couples’ HIV testing and counseling services to improve family health.MethodsThis is a three-arm randomized control trial among 1080 pregnant women 15 years of age or older, living with their male partners, and who have not undergone couples’ HIV testing and counseling in Kisumu and Migori Counties in Kenya. Couples will be randomized into three groups: home-based couple visits, HIV self-testing kits for couple use, or standard care (male partner clinic invitation letters). Participants will be followed up to 18 months postpartum. The study has three aims: in aim 1, we will determine the effects of the intervention on our primary outcome of couple HIV testing, compared to HIV self-testing kits and standard care; in aim 2, we will examine the intervention impact on HIV prevention behaviors, facility delivery, and postnatal healthcare utilization, as well as secondary health outcomes of maternal viral suppression and HIV-free child survival up to 18 months for couples living with HIV; and in aim 3, we will compare the cost-effectiveness of the home-based couple intervention to the less resource-intensive strategies used in the other two study arms. Assessments with couples are conducted at baseline, late pregnancy, and at months 3, 6, 12, and 18 after birth.DiscussionThe results from this study will inform decision-makers about the cost-effective strategies to engage pregnant couples in the prevention of mother-to-child transmission and family health, with important downstream benefits for maternal, paternal, and infant health.Trial registrationClinicalTrials.gov NCT03547739. Registered on May 9, 2018

Highlights

The provision of antiretroviral therapy (ART) improves maternal health and is a key pillar for the elimination of mother-to-child transmission of HIV [1]
This is true in Kenya, where antenatal care attendance is high [3], but crucial dropoffs occur in the uptake of and adherence to key maternal and child health and prevention of mother-to-child transmission (PMTCT) services [4]
The final results from this study will enhance our ability to improve HIV prevention behaviors, identification of pregnant women and male partners infected with HIV, and HIV treatment engagement and reduce the viral load for pregnant women and their male partners

Summary

Introduction

Background and rationale The provision of antiretroviral therapy (ART) improves maternal health and is a key pillar for the elimination of mother-to-child transmission of HIV [1]. HIV-related maternal deaths and HIV infection among infants remain unacceptably high across sub-Saharan Africa [2] This is true in Kenya, where antenatal care attendance is high [3], but crucial dropoffs occur in the uptake of and adherence to key maternal and child health and prevention of mother-to-child transmission (PMTCT) services [4]. Even though HIV testing rates have been increasing over time, 12% of pregnant women in Kenya transmitted HIV to their infants in 2017 [4] Among those who initially access PMTCT, rates of subsequent dropout are high, reaching rates of 42% after 12 months in some parts of sub-Saharan Africa [5]. HIV-related maternal deaths and HIV infection among infants remain unacceptably high across subSaharan Africa despite increased antenatal care attendance and provision of antiretroviral therapy to pregnant women. The aim is to increase access to home-based couples’ HIV testing and counseling services to improve family health

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