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

• ClinicalTrials.gov Identifier: NCT04417127
• Recruitment Status: Recruiting
• First Posted: June 4, 2020
• Last Update Posted: April 28, 2022
• Sponsor: Brown University
• Collaborators: Johns Hopkins University; Moi University; Purdue University; University of Toronto; NYU Langone Health; Academic Model Providing Access to Healthcare (AMPATH); National Institute of Mental Health (NIMH)
• Information provided by (Responsible Party): Omar Galarraga, PhD, Brown University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
HIV/AIDS; Noncommunicable Diseases; Hypertension; Diabetes	Other: Integrated Community-Based (ICB) Care; Other: Microfinance	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 1215 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• 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.
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Harambee: Integrated Community-based HIV/NCD Care & Microfinance Groups in Kenya
• Actual Study Start Date: November 26, 2020
• Estimated Primary Completion Date: April 24, 2024
• Estimated Study Completion Date: April 24, 2024

Arms and Interventions

Arm	Intervention/treatment
Experimental: Microfinance with Integrated Community-based Care; 20 microfinance groups with n=450 participants will be randomized to receive the ICB intervention.	Other: Integrated Community-Based (ICB) Care; The intervention will include the following components: (1) integrated care visits by clinical team occurring monthly during months 1-6 of the trial, and then quarterly for the remaining months (7-18), which include vital signs screening, consultation with a clinical officer, medication distribution (ART and other chronic and acute medications), and point- of-care (POC) laboratory testing (creatinine, blood glucose and hemoglobin A1C, and viral load as it becomes available); (2) peer support for promoting ART adherence during every monthly MF meeting; (3) referrals to facilities for emergency or acute care needs that are not feasible to address in the community. Integrated care refers to delivery of primary, HIV and NCD-related care, incorporating a focus on both chronic and acute needs.; Other: Microfinance; 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.
Active Comparator: Microfinance with Standard of Care; 20 microfinance groups with n=450 participants will be randomized to continue to receive standard of care from an AMPATH-supported rural health facility.	Other: Microfinance; 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.
No Intervention: Standard of Care without Microfinance; n=300 participants who receive care at an AMPATH health facility and who are not involved in microfinance will serve as matched contemporaneous controls. These participants will be actively followed over the 18-months of the trial.

Outcome Measures

Primary Outcome Measures :

1. Viral Suppression [ Time Frame: Between baseline and 18 months ]
   HIV viral load less than 400 copies/mL at 18 months as compared to baseline

Secondary Outcome Measures :

1. Retention in Care [ Time Frame: Between baseline and 18 months ]
   Proportion of scheduled visits that were attended during the study period
2. Change in Systolic Blood Pressure (SBP) [ Time Frame: Between baseline and 18 months ]
   Change in systolic blood pressure at 18 months as compared to baseline
3. Change in glycated hemoglobin (HbA1c) [ Time Frame: Between baseline and 18 months ]
   Change in HbA1c level at 18 months as compared to baseline

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Contacts

Contact: Omar Galarraga, PhD; 401 863 2331; omar_galarraga@brown.edu

Contact: Juddy Wachira, PhD; (+254) 070-524-2450; wachirajuddy@gmail.com

Locations

Kenya

Moi University/ Moi Teaching and Referral Hospital; Recruiting

Eldoret, Kenya

Contact: Juddy Wachira, PhD wachirajuddy@gmail.com

Sub-Investigator: Juddy Wachira, PhD

Principal Investigator: Omar Galarraga, PhD

Principal Investigator: Becky Genberg, PhD

Sponsors and Collaborators

Brown University

Johns Hopkins University

Moi University

Purdue University

University of Toronto

NYU Langone Health

Academic Model Providing Access to Healthcare (AMPATH)

National Institute of Mental Health (NIMH)

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Omar Galarraga, PhD, ASSOCIATE PROFESSOR, Brown University
• ClinicalTrials.gov Identifier: NCT04417127
• Other Study ID Numbers: R01MH118075 ( U.S. NIH Grant/Contract ); R01MH118075 ( U.S. NIH Grant/Contract )
• First Posted: June 4, 2020
• Last Update Posted: April 28, 2022
• Last Verified: April 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: Materials generated under this project will be disseminated according to University and NIH policies regarding data sharing. Aggregate-level data collected in this collaboration will ultimately be available for public use. Opportunities for secondary analyses will be available following completion of the three-year project and publication of the main study findings. These findings will be available to the public through scientific meetings and peer-reviewed journals, as well as through a structured policy dissemination process.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Omar Galarraga, PhD, Brown University:

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

Additional relevant MeSH terms:

Noncommunicable Diseases; Disease Attributes; Pathologic Processes