Zachary Kwena1, Liza Kimbo2, Lynae A Darbes3, Abigail M Hatcher4, Anna Helova2, George Owino5, Harsha Thirumurthy6, Elizabeth A Bukusi5, Thomas Braun7, Meredith Kilgore2, Maria Pisu8, Ashutosh Tamhane9, Van T Nghiem2, Kawango Agot10, Torsten B Neilands11, Janet M Turan2. 1. Research, Care and Treatment Programme, Centre for Microbiology Research, Kenya Medical Research Institute, Nairobi, Kenya. zkwena@kemri-ucsf.org. 2. Department of Health Care Organization and Policy, School of Public Health, University of Alabama at Birmingham, Birmingham, AL, USA. 3. Center for Sexuality and Health Disparities, Department of Health Behavior and Biological Sciences, School of Nursing, University of Michigan, Ann Arbor, MI, USA. 4. School of Public Health, University of Witwatersrand, Johannesburg, South Africa. 5. Research, Care and Treatment Programme, Centre for Microbiology Research, Kenya Medical Research Institute, Nairobi, Kenya. 6. Department of Medical Ethics & Health Policy, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA. 7. Department of Biostatistics, School of Public Health, University of Michigan, Ann Arbor, MI, USA. 8. Division of Preventive Medicine, Department of Medicine, School of Medicine, University of Alabama at Birmingham, Birmingham, AL, USA. 9. Department of Medicine, School of Medicine, University of Alabama at Birmingham, Birmingham, AL, USA. 10. Impact Research and Development Organization, Kisumu, Kenya. 11. Division of Prevention Sciences, Department of Medicine, University of California San Francisco, San Francisco, USA.
Abstract
BACKGROUND: HIV-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. METHODS: This 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. DISCUSSION: The 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 REGISTRATION: ClinicalTrials.gov NCT03547739 . Registered on May 9, 2018.
RCT Entities:
BACKGROUND: HIV-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. METHODS: This 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. DISCUSSION: The 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 REGISTRATION: ClinicalTrials.gov NCT03547739 . Registered on May 9, 2018.
Entities:
Keywords:
Antiretroviral therapy (ART); Couple home testing and counseling (CHTC); Couple relationships; HIV self-testing kits (HIVST); Intimate partner violence (IPV); Prevention of mother-to-child transmission (PMTCT); Randomized controlled trial (RCT)
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