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

Not Applicable

Active, not recruiting

• Conditions: HIV/AIDS; Hypertension; Noncommunicable Diseases; Diabetes
• Interventions: Other: Microfinance; Other: Integrated Community-Based (ICB) Care

• Registration Number: NCT04417127
• Lead Sponsor: Brown University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-06-02
• Study First Submitted QC: 2020-06-02
• Study First Posted: 2020-06-04
• Study Start: 2020-11-26
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-01
• Last Update Posted: 2025-04-03
• Primary Completion: 2025-04-30
• Study Completion: 2025-04-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 1215

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Microfinance with Standard of Care	Microfinance	20 microfinance groups with n=450 participants will be randomized to continue to receive standard of care from an AMPATH-supported rural health facility.
Microfinance with Integrated Community-based Care	Microfinance	20 microfinance groups with n=450 participants will be randomized to receive the ICB intervention.
Microfinance with Integrated Community-based Care	Integrated Community-Based (ICB) Care	20 microfinance groups with n=450 participants will be randomized to receive the ICB intervention.

Primary Outcome Measures

Name	Time	Method
Viral Suppression	Between baseline and 18 months	HIV viral load less than 400 copies/mL at 18 months as compared to baseline

Secondary Outcome Measures

Name	Time	Method
Retention in Care	Between baseline and 18 months	Proportion of scheduled visits that were attended during the study period
Change in Systolic Blood Pressure (SBP)	Between baseline and 18 months	Change in systolic blood pressure at 18 months as compared to baseline
Change in glycated hemoglobin (HbA1c)	Between baseline and 18 months	Change in HbA1c level at 18 months as compared to baseline

Trial Locations

Locations (1)

Moi University/ Moi Teaching and Referral Hospital; 🇰🇪 Eldoret, Kenya