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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
- Source :
- Trials, Trials, Vol 22, Iss 1, Pp 1-16 (2021)
- Publication Year :
- 2020
-
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
- Subjects :
- Counseling
Male
Prevention of mother-to-child transmission (PMTCT)
Intimate partner violence (IPV)
medicine.medical_specialty
Medicine (miscellaneous)
HIV Infections
030312 virology
Couple home testing and counseling (CHTC)
law.invention
Antiretroviral therapy (ART)
03 medical and health sciences
Study Protocol
0302 clinical medicine
Randomized controlled trial
law
Pregnancy
Intervention (counseling)
medicine
Couple relationships
Humans
Pharmacology (medical)
030212 general & internal medicine
Child
HIV self-testing kits (HIVST)
Randomized Controlled Trials as Topic
Protocol (science)
Family health
Family Health
0303 health sciences
lcsh:R5-920
business.industry
Transmission (medicine)
Attendance
Prevention of mother to child transmission
Infant
Kenya
Infectious Disease Transmission, Vertical
Test (assessment)
Family medicine
Female
Randomized controlled trial (RCT)
business
lcsh:Medicine (General)
Subjects
Details
- ISSN :
- 17456215
- Volume :
- 22
- Issue :
- 1
- Database :
- OpenAIRE
- Journal :
- Trials
- Accession number :
- edsair.doi.dedup.....8e3444f3e40acd56487b0141f26eb863