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

Brown University

Status: Active, not recruiting

Conditions: Hypertension; Noncommunicable Diseases; Diabetes; HIV/AIDS

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04417127

R01MH118075 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 1,215 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,215 participants in 3 patient groups

Microfinance with Integrated Community-based Care

Experimental group

Description:

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

Treatment:

Other: Microfinance

Other: Integrated Community-Based (ICB) Care

Microfinance with Standard of Care

Active Comparator group

Description:

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

Treatment:

Other: Microfinance

Standard of Care without Microfinance

No Intervention group

Description:

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.