دورية أكاديمية
أعرض في EDS

Integrated community-based HIV and non-communicable disease care within microfinance groups in Kenya: study protocol for the Harambee cluster randomised trial.

التفاصيل البيبلوغرافية
العنوان: Integrated community-based HIV and non-communicable disease care within microfinance groups in Kenya: study protocol for the Harambee cluster randomised trial.
المؤلفون: Genberg BL; Epidemiology, Johns Hopkins University Bloomberg School of Public Health, Baltimore, Maryland, USA., Wachira J; Behavioral Sciences, Moi University College of Health Sciences, School of Medicine, Eldoret, Kenya., Steingrimsson JA; Biostatistics, Brown University School of Public Health, Providence, Rhode Island, USA., Pastakia S; Center for Health Equity and Innovation, Purdue University College of Pharmacy, Indianapolis, Indiana, USA.; Academic Model Providing Access to Healthcare (AMPATH), Eldoret, Kenya., Tran DNT; Center for Health Equity and Innovation, Purdue University College of Pharmacy, Indianapolis, Indiana, USA.; Academic Model Providing Access to Healthcare (AMPATH), Eldoret, Kenya., Said JA; Academic Model Providing Access to Healthcare (AMPATH), Eldoret, Kenya.; Internal Medicine, Moi University School of Medicine, Eldoret, Kenya., Braitstein P; Academic Model Providing Access to Healthcare (AMPATH), Eldoret, Kenya.; Epidemiology, University of Toronto Dalla Lana School of Public Health, Toronto, Ontario, Canada., Hogan JW; Biostatistics, Brown University School of Public Health, Providence, Rhode Island, USA.; Academic Model Providing Access to Healthcare (AMPATH), Eldoret, Kenya., Vedanthan R; Global Health, New York University Grossman School of Medicine, New York, New York, USA., Goodrich S; Division of Infectious Diseases, Department of Medicine, Indiana University School of Medicine, Indianapolis, Indiana, USA., Kafu C; Academic Model Providing Access to Healthcare (AMPATH), Eldoret, Kenya., Wilson-Barthes M; Epidemiology, Brown University School of Public Health, Providence, Rhode Island, USA., Galárraga O; Health Services, Policy and Practice, Brown University School of Public Health, 121 South Main St. Box G-S121-2 Providence, Rhode Island, USA omar_galarraga@brown.edu.
المصدر: BMJ open [BMJ Open] 2021 May 18; Vol. 11 (5), pp. e042662. Date of Electronic Publication: 2021 May 18.
نوع المنشور: Clinical Trial Protocol; Journal Article; Research Support, N.I.H., Extramural
اللغة: English
بيانات الدورية: Publisher: BMJ Publishing Group Ltd Country of Publication: England NLM ID: 101552874 Publication Model: Electronic Cited Medium: Internet ISSN: 2044-6055 (Electronic) Linking ISSN: 20446055 NLM ISO Abbreviation: BMJ Open Subsets: MEDLINE
أسماء مطبوعة: Original Publication: [London] : BMJ Publishing Group Ltd, 2011-
مواضيع طبية MeSH: HIV Infections*/drug therapy , Noncommunicable Diseases*/therapy, Cost-Benefit Analysis ; Delivery of Health Care ; Humans ; Kenya ; Randomized Controlled Trials as Topic
مستخلص: Introduction: In 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 Analysis: We 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 Dissemination: The 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 Number: NCT04417127.
Competing Interests: Competing interests: None declared.
(© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
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معلومات مُعتمدة: P30 AI042853 United States AI NIAID NIH HHS; R01 MH118075 United States MH NIMH NIH HHS
فهرسة مساهمة: Keywords: HIV & AIDS; diabetes & endocrinology; health economics; hypertension
سلسلة جزيئية: ClinicalTrials.gov NCT04417127
تواريخ الأحداث: Date Created: 20210519 Date Completed: 20210603 Latest Revision: 20220721
رمز التحديث: 20231215
مُعرف محوري في PubMed: PMC8137246
DOI: 10.1136/bmjopen-2020-042662
PMID: 34006540
قاعدة البيانات: MEDLINE
الوصف
تدمد:2044-6055
DOI:10.1136/bmjopen-2020-042662