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

Not Applicable

Completed

Conditions: HIV/AIDS
Hypertension
Noncommunicable Diseases
Diabetes

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 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 1200

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

Primary Outcome Measures

Name	Time	Method
HIV-1 RNA Viral Load Suppression at 18-months	18 months	Participants whose 18-month viral load assessment occurred before January 1, 2023 were considered suppressed if their viral load was \<400 copies/mL. Following changes to Kenya's national HIV monitoring cutoffs that occurred during the trial, patients whose 18- month viral load assessment was on or after January 1, 2023 were considered suppressed if their viral load was \<200 copies/mL.

Secondary Outcome Measures

Name	Time	Method
Retention in Care Each Quarter During 18-months of Follow-up	Between baseline and 18 months	A participant was considered retained in HIV care if they attended at least one HIV care visit in each quarter a visit was scheduled (always retained in care), where attending a visit was defined as attending a visit within +/- 28 days of their scheduled visit date (following AMPATH care protocols). Patients who had no visit(s) scheduled in a given quarter were considered retained for that quarter.
Change in Systolic Blood Pressure (SBP)	Between baseline and 18 months	Change in systolic blood pressure (mm Hg) at 18 months as compared to baseline
Change in Random Blood Sugar (mmol/L)	Between baseline and 18 months	Change in random blood sugar (mmol/L) at 18 months as compared to baseline

Trial Locations

Locations (1): Moi University/ Moi Teaching and Referral Hospital
🇰🇪
Eldoret, Kenya
Moi University/ Moi Teaching and Referral Hospital
🇰🇪Eldoret, Kenya