Harambee: Integrated Community-based HIV/NCD Care & Microfinance Groups in Kenya

NCT04417127 | Completed Results DMC

• 1 other identifier: R01MH118075
• Study Type: interventional
• Target: 1,200
• Locations: 1 country
• Sites: 1

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. 1.To evaluate the extent to which integrated community-based HIV care with group microfinance affects retention in care and viral suppression among n=900 PLHIV in rural western Kenya using a cluster randomized intervention design of at least n=40 existing (fully HIV+) microfinance groups to receive either: (A) integrated community-based HIV and NCD care or (B) usual facility-based care. Data from the two trial arms will be augmented with a matched contemporaneous control group of n=300 patients receiving usual facility-based 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. 2.To identify specific mechanisms through which microfinance and integrated community-based care impact viral suppression. 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. 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.

Conditions

HIV/AIDS; Noncommunicable Diseases; Hypertension; Diabetes

Keywords

HIV, Noncommunicable Diseases, microfinance, differentiated care, mobile care, telemedicine, task-shifting

Outcome Measures

Primary Outcomes (1)

• HIV-1 RNA Viral Load Suppression at 18-months

  Participants whose 18-month viral load assessment occurred before January 1, 2023 were considered suppressed if their viral load was \<400 copies/mL. Following changes to Kenya's national HIV monitoring cutoffs that occurred during the trial, patients whose 18- month viral load assessment was on or after January 1, 2023 were considered suppressed if their viral load was \<200 copies/mL.

  18 months

Secondary Outcomes (3)

• Retention in Care Each Quarter During 18-months of Follow-up

  Between baseline and 18 months

• Change in Systolic Blood Pressure (SBP)

  Between baseline and 18 months

• Change in Random Blood Sugar (mmol/L)

  Between baseline and 18 months

Study Arms (3)

Microfinance with Integrated Community-based Care

EXPERIMENTAL

A minimum of 20 microfinance groups with approximately n=450 participants will be randomized to receive the ICB intervention.

Other: Integrated Community-Based (ICB) Care; Other: Group-level Microfinance

Microfinance with Usual (Facility-Based) Care

ACTIVE COMPARATOR

A minimum of 20 microfinance groups with approximately n=450 participants will be randomized to continue to receive standard of care from an AMPATH-supported rural health facility.

Other: Group-level Microfinance

Usual (Facility-Based) Care without Microfinance

NO INTERVENTION

A total of n=300 participants who receive care at an AMPATH health facility and who are not involved in microfinance will serve as frequency-matched contemporaneous controls. These participants will be actively followed over the 18-months of the trial.

Interventions

Integrated Community-Based (ICB) Care OTHER

During quarterly intervention visits, a clinical officer (CO) travels to the location of the microfinance group meeting. The CO meets privately with each patient one-on-one, provides brief medical consultations, and distributes ART and other medications for diabetes and hypertension as needed. ART medicines are provided at no cost to patients from AMPATH HIV pharmacies; medications for diabetes and hypertension are dispensed to patients from AMPATH Revolving Fund Pharmacies at a standardized price. The CO conducts point-of-care laboratory testing if medically indicated. Every 6 months, the CO conducts a more intensive HIV clinical evaluation. The cost of point-of-care tests administered at study baseline and study end line are covered by the study. Additional tests during the trial are paid for by the patient. COs make referrals to facilities for emergency or acute care needs. Each visit includes a health education discussion conducted in a group.

Microfinance with Integrated Community-based Care

Group-level Microfinance OTHER

Group microfinance uses a client-driven model that involves community savings groups where members mobilize and manage their own savings, provide interest-bearing loans to group members, offer a limited form of financial insurance, and contribute to a social fund that is used for income-generating activities and in cases of emergency or welfare issues of group members. For this study, group microfinance will refer to existing, active AMPATH Group Integrated Savings for Empowerment (GISE) microfinance groups with a majority of group members who are AMPATH HIV patients and have disclosed their HIV status. Groups will be considered active if the group was formed at least 6 months prior to study baseline, is consistently meeting as scheduled, and is actively engaging in saving and loaning.

Microfinance with Integrated Community-based Care; Microfinance with Usual (Facility-Based) Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Brown University: lead
• Johns Hopkins University: collaborator
• Moi University: collaborator
• Purdue University: collaborator
• University of Toronto: collaborator
• NYU Langone Health: collaborator
• Academic Model Providing Access to Healthcare (AMPATH): collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Moi University/ Moi Teaching and Referral Hospital

Eldoret, Kenya

Location

Related Publications (8)

• 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.

  PMID: 36578093 BACKGROUND

• 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.

  PMID: 34115646 BACKGROUND

• 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.

  PMID: 34006540 BACKGROUND

• 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.

  PMID: 36718505 BACKGROUND

• 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.

  PMID: 38781744 BACKGROUND

• 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.

  PMID: 38790050 BACKGROUND

• Vidal M. The Methodus medendi innovation in Giorgio Baglivi's work. Med Secoli. 2000;12(1):171-90.

  PMID: 11624711 BACKGROUND

• 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.

  PMID: 40018611 BACKGROUND

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Noncommunicable Diseases; Hypertension; Diabetes Mellitus

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Omar Galarraga, PhD (Study Contact PI)
• Organization: Brown University School of Public Health

omar_galarraga@brown.edu

+1 (401) 863-2331

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: ASSOCIATE PROFESSOR

Model Details: Aim 1: Cluster randomized trial where a minimum of 40 existing microfinance groups with n=900 members are randomized 1:1 to receive either integrated community-based care (ICB) or usual care. Delivered quarterly during community-based microfinance meetings, the intervention includes: clinical consultations, diabetes and/or hypertension management, distribution of antiretroviral therapy and NCD medications, health education, and facility referrals. Members of microfinance groups randomized to usual care will continue to receive care at a health facility. Aim 1 will also enroll an additional n=300 frequency-matched, prospectively-followed usual care patients without microfinance. Aim 2: Mediation analyses with n=40 trial participants and n=10 intervention staff. Aim 3: Cost-effectiveness analyses with n=5 budget staff.

Study Record Dates

• First Submitted: June 2, 2020
• First Posted: June 4, 2020
• Study Start: November 26, 2020
• Primary Completion: September 21, 2023
• Study Completion: December 6, 2023
• Last Updated: October 31, 2025
• Results First Posted: October 31, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

KE (1)