1. Integrated community-based HIV and non-communicable disease care within microfinance groups in Kenya: study protocol for the Harambee cluster randomised trial
- Author
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Becky L. Genberg, Sonak D. Pastakia, Dan N Tina Tran, Catherine Kafu, Rajesh Vedanthan, Jon A. Steingrimsson, Marta Wilson-Barthes, Joseph W. Hogan, Suzanne Goodrich, Omar Galárraga, Juddy Wachira, Jamil Said, and Paula Braitstein
- Subjects
medicine.medical_specialty ,hypertension ,Cost-Benefit Analysis ,HIV & AIDS ,diabetes & endocrinology ,HIV Infections ,030312 virology ,Peer support ,law.invention ,03 medical and health sciences ,0302 clinical medicine ,Acquired immunodeficiency syndrome (AIDS) ,Health facility ,law ,Intervention (counseling) ,Medicine ,health economics ,Humans ,030212 general & internal medicine ,Noncommunicable Diseases ,Randomized Controlled Trials as Topic ,0303 health sciences ,Microfinance ,Health economics ,business.industry ,General Medicine ,Non-communicable disease ,medicine.disease ,Kenya ,Institutional research ,Family medicine ,HIV/AIDS ,business ,Delivery of Health Care - Abstract
IntroductionIn Kenya, distance to health facilities, inefficient vertical care delivery and limited financial means are barriers to retention in HIV care. Furthermore, the increasing burden of non-communicable diseases (NCDs) among people living with HIV complicates chronic disease treatment and strains traditional care delivery models. Potential strategies for improving HIV/NCD treatment outcomes are differentiated care, community-based care and microfinance (MF).Methods and analysisWe will use a cluster randomised trial to evaluate integrated community-based (ICB) care incorporated into MF groups in medium and high HIV prevalence areas in western Kenya. We will conduct baseline assessments with n=900 HIV positive members of 40 existing MF groups. Group clusters will be randomised to receive either (1) ICB or (2) standard of care (SOC). The ICB intervention will include: (1) clinical care visits during MF group meetings inclusive of medical consultations, NCD management, distribution of antiretroviral therapy (ART) and NCD medications, and point-of-care laboratory testing; (2) peer support for ART adherence and (3) facility referrals as needed. MF groups randomised to SOC will receive regularly scheduled care at a health facility. Findings from the two trial arms will be compared with follow-up data from n=300 matched controls. The primary outcome will be VS at 18 months. Secondary outcomes will be retention in care, absolute mean change in systolic blood pressure and absolute mean change in HbA1c level at 18 months. We will use mediation analysis to evaluate mechanisms through which MF and ICB care impact outcomes and analyse incremental cost-effectiveness of the intervention in terms of cost per HIV suppressed person-time, cost per patient retained in care and cost per disability-adjusted life-year saved.Ethics and disseminationThe Moi University Institutional Research and Ethics Committee approved this study (IREC#0003054). We will share data via the Brown University Digital Repository and disseminate findings via publication.Trial registration numberNCT04417127.
- Published
- 2021