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

  • STATUS
    Recruiting
  • End date
    Apr 24, 2024
  • participants needed
    1215
  • sponsor
    Brown University
Updated on 10 May 2022
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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.

Details
Condition HIV/AIDS, Noncommunicable Diseases, Hypertension, Diabetes
Treatment Microfinance, Integrated Community-Based (ICB) Care
Clinical Study IdentifierNCT04417127
SponsorBrown University
Last Modified on10 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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
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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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