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

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04417127
• Other study ID #: R01MH118075
• Secondary ID: R01MH118075
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 26, 2020
• Est. completion date: April 24, 2024

Study information

• Verified date: July 2023
• Source: Brown University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1215
• Est. completion date: April 24, 2024
• Est. primary completion date: April 24, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• HIV/AIDS
• Hypertension
• Noncommunicable Diseases

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.
• 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.

Locations

Country	Name	City	State
Kenya	Moi University/ Moi Teaching and Referral Hospital	Eldoret

Sponsors (8)

Lead Sponsor	Collaborator
Brown University	Academic Model Providing Access to Healthcare (AMPATH), Johns Hopkins University, Moi University, National Institute of Mental Health (NIMH), NYU Langone Health, Purdue University, University of Toronto

Country where clinical trial is conducted

Kenya, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Viral Suppression	HIV viral load less than 400 copies/mL at 18 months as compared to baseline	Between baseline and 18 months
Secondary	Retention in Care	Proportion of scheduled visits that were attended during the study period	Between baseline and 18 months
Secondary	Change in Systolic Blood Pressure (SBP)	Change in systolic blood pressure at 18 months as compared to baseline	Between baseline and 18 months
Secondary	Change in glycated hemoglobin (HbA1c)	Change in HbA1c level at 18 months as compared to baseline	Between baseline and 18 months