Clinical trial NCT04417127: Harambee: Integrated Community-based HIV/NCD Care & Microfinance Groups in Kenya
Official title: Harambee: Integrated Community-based HIV/NCD Care & Microfinance Groups in Kenya
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: HIV/AIDS
Noncommunicable Diseases
Hypertension
Diabetes
Keywords: HIV, Noncommunicable Diseases, microfinance, differentiated care, mobile care, telemedicine, task-shifting
Lead sponsor: Brown University
Sponsor class: OTHER
Collaborators: name: Johns Hopkins University
name: Moi University
name: Purdue University
name: University of Toronto
name: NYU Langone Health
name: Academic Model Providing Access to Healthcare (AMPATH)
name: National Institute of Mental Health (NIMH)
First posted: 2020-06-04
Enrollment: 1215
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Aim 1: Cluster randomized trial where 40 existing microfinance (MF) groups with n=900 members are randomized in a 1:1 ratio to receive either integrated community-based care (ICB) (Study Arm A) or standard care (Study Arm B). The ICB intervention will be delivered during regular MF group meetings monthly during trial months 1-6 and quarterly during months 7-18. The intervention will include (1) clinical teams visits with vital signs screening, consultations, medication distribution (ART and other chronic/acute medications), POC laboratory testing (creatinine, blood glucose, hemoglobin A1C, viral load); (2) peer support; (3) referrals to facilities as needed. Members of MF groups randomized to Study Arm B will continue to receive care at an AMPATH facility. Study Arm C will include n=300 participants who receive standard care at an AMPATH facility and are not involved in MF. Aim 2: Mediation analyses with n=50 trial participants. Aim 3: Cost-effectiveness analyses with n=5 budget staff.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The objective of this project is to demonstrate the effectiveness and longer-term sustainability of a differentiated care delivery model for improving HIV treatment outcomes. The central hypothesis is that the integration of community-based HIV and NCD care with group microfinance will improve retention in care and rates of viral suppression (VS) among people living with HIV (PLHIV) in Kenya via two mechanisms: improved household economic status and easier access to care.

The specific aims are as follows:

1. To evaluate the extent to which integrated community-based HIV care with group microfinance affects retention in care and VS among n=900 PLHIV in rural western Kenya using a cluster randomized intervention design of n=40 existing (fully HIV+) microfinance groups to receive either: (A) integrated community-based HIV and NCD care or (B) standard care. Data from the two trial arms will be augmented with a matched contemporaneous control group of n=300 patients receiving standard care and not involved in microfinance (group C), comparing outcomes in groups A, B and C. The hypothesize is that A \> B \> C in terms of viral suppression and retention in care.
2. To identify specific mechanisms through which microfinance and integrated community-based care impact VS. Using a mixed methods approach, the study will characterize the mechanisms of effect on patient outcomes. Investigators will conduct quantitative mediation analysis to examine two main mediating pathways (household economic conditions and easier access to care), as well as exploratory mechanisms (food security, social support, HIV- related stigma). Investigators will also use qualitative methods and multi-stakeholder panels to contextualize implementation of the intervention.
3. To assess the cost-effectiveness of microfinance and integrated community-based care delivery to maximize future policy and practice relevance of this promising intervention strategy. The working hypothesis is that the differentiated model will be cost-effective in terms of cost per HIV suppressed person-time, cost per patient retained in care, and cost per disability-adjusted life year saved.

The main expected outcomes will be rigorous evidence of effectiveness, mechanisms and cost-effectiveness of a differentiated model for achieving the last key step in the HIV care continuum. These results are expected to have an important positive impact in terms of improved, high-quality services that address known individual and structural barriers to care and promote long-term sustainability of care for PLHIV in rural settings with high HIV prevalence.


Eligibility criteria: Inclusion Criteria:

* 18 years of age or older at study baseline
* HIV-positive
* Have received any care through AMPATH since 2010
* Initiated ART at least 6 months prior to study baseline
* Have participated in at least one microfinance group meeting in the prior 12 months at study baseline (for Study Arms A \& B)
* Willing and able to provide informed consent.

Exclusion Criteria:

* Currently participating in the BIGPIC study
* Unable to provide informed consent for participation

Primary outcomes:
measure: Viral Suppression
timeFrame: Between baseline and 18 months
Secondary outcomes:
measure: Retention in Care
timeFrame: Between baseline and 18 months
measure: Change in Systolic Blood Pressure (SBP)
timeFrame: Between baseline and 18 months
measure: Change in glycated hemoglobin (HbA1c)
timeFrame: Between baseline and 18 months
Other outcomes:
Locations:
city: Eldoret
country: Kenya
facility: Moi University/ Moi Teaching and Referral Hospital
Study officials:
References:
citation: Kafu C, Wachira J, Omodi V, Said J, Pastakia SD, Tran DN, Onyango JA, Aburi D, Wilson-Barthes M, Galarraga O, Genberg BL. Integrating community-based HIV and non-communicable disease care with microfinance groups: a feasibility study in Western Kenya. Pilot Feasibility Stud. 2022 Dec 28;8(1):266. doi: 10.1186/s40814-022-01218-6.
citation: Genberg BL, Wilson-Barthes MG, Omodi V, Hogan JW, Steingrimsson J, Wachira J, Pastakia S, Tran DN, Kiragu ZW, Ruhl LJ, Rosenberg M, Kimaiyo S, Galarraga O. Microfinance, retention in care, and mortality among patients enrolled in HIV care in East Africa. AIDS. 2021 Oct 1;35(12):1997-2005. doi: 10.1097/QAD.0000000000002987.
citation: Genberg BL, Wachira J, Steingrimsson JA, Pastakia S, Tran DNT, Said JA, Braitstein P, Hogan JW, Vedanthan R, Goodrich S, Kafu C, Wilson-Barthes M, Galarraga O. Integrated community-based HIV and non-communicable disease care within microfinance groups in Kenya: study protocol for the Harambee cluster randomised trial. BMJ Open. 2021 May 18;11(5):e042662. doi: 10.1136/bmjopen-2020-042662.
citation: Tran DN, Ching J, Kafu C, Wachira J, Koros H, Venkataramani M, Said J, Pastakia SD, Galarraga O, Genberg BL. Interruptions to HIV Care Delivery During Pandemics and Natural Disasters: A Qualitative Study of Challenges and Opportunities From Frontline Healthcare Providers in Western Kenya. J Int Assoc Provid AIDS Care. 2023 Jan-Dec;22:23259582231152041. doi: 10.1177/23259582231152041.
citation: Wilson-Barthes M, Steingrimsson J, Lee Y, Tran DN, Wachira J, Kafu C, Pastakia SD, Vedanthan R, Said JA, Genberg BL, Galarraga O. Economic outcomes among microfinance group members receiving community-based chronic disease care: Cluster randomized trial evidence from Kenya. Soc Sci Med. 2024 Jun;351:116993. doi: 10.1016/j.socscimed.2024.116993. Epub 2024 May 17.
citation: Liang A, Wilson-Barthes M, Galarraga O. Cost-effectiveness of differentiated care models that incorporate economic strengthening for HIV antiretroviral therapy adherence: a systematic review. Cost Eff Resour Alloc. 2024 May 24;22(1):46. doi: 10.1186/s12962-024-00557-w.
citation: Vidal M. The Methodus medendi innovation in Giorgio Baglivi's work. Med Secoli. 2000;12(1):171-90.
citation: Lyons C, Ching J, Tran DN, Kafu C, Wachira J, Koros H, Venkataramani M, Said J, Pastakia SD, Galarraga O, Genberg B. Social, economic and food insecurity among people living with HIV in Kenya during coinciding public health and environmental emergencies: a mixed-methods study. BMJ Public Health. 2024 Sep 23;2(2):e000836. doi: 10.1136/bmjph-2023-000836. eCollection 2024 Dec.