N/A
N=1,155
Harambee: Integrated Community-based HIV/NCD Care & Microfinance Groups in Kenya
HIV/AIDS · Noncommunicable Diseases · Hypertension · Diabetes
Bottom Line
View on ClinicalTrials.gov: NCT04417127 ↗Enrolled (actual)
1,155
Serious AEs
0.4%
Results posted
Oct 2025
Primary outcome: Primary: HIV-1 RNA Viral Load Suppression at 18-months — 326; 365; 275 Participants — p=0.23
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Integrated Community-Based (ICB) Care (Other); Group-level Microfinance (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Brown University
- Primary completion
- Sep 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY HIV-1 RNA Viral Load Suppression at 18-months |
326; 365; 275 | 0.23 |
| SECONDARY Retention in Care Each Quarter During 18-months of Follow-up |
315; 235; 51 | <0.001 sig |
| SECONDARY Change in Systolic Blood Pressure (SBP) |
0.25; 0.046 | — |
| SECONDARY Change in Random Blood Sugar (mmol/L) |
0.276; -0.172 | — |
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 viral suppression among n=900 PLHIV in rural western Kenya using a cluster randomized intervention design of at least n=40 existing (fully HIV+) microfinance groups to receive either: (A) integrated community-based HIV and NCD care or (B) usual facility-based care. Data from the two trial arms will be augmented with a matched contemporaneous control group of n=300 patients receiving usual facility-based 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 viral suppression. 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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT04417127). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.