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Completed

NCT Number: NCT04417127

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Integrated Community-Based (ICB) Care

Other

During quarterly intervention visits, a clinical officer (CO) travels to the location of the microfinance group meeting. The CO meets privately with each patient one-on-one, provides brief medical consultations, and distributes ART and other medications for diabetes and hypertension as needed. ART medicines are provided at no cost to patients from AMPATH HIV pharmacies; medications for diabetes and hypertension are dispensed to patients from AMPATH Revolving Fund Pharmacies at a standardized price. The CO conducts point-of-care laboratory testing if medically indicated. Every 6 months, the CO conducts a more intensive HIV clinical evaluation. The cost of point-of-care tests administered at study baseline and study end line are covered by the study. Additional tests during the trial are paid for by the patient. COs make referrals to facilities for emergency or acute care needs. Each visit includes a health education discussion conducted in a group.

Group-level Microfinance

Other

Group microfinance uses a client-driven model that involves community savings groups where members mobilize and manage their own savings, provide interest-bearing loans to group members, offer a limited form of financial insurance, and contribute to a social fund that is used for income-generating activities and in cases of emergency or welfare issues of group members.

For this study, group microfinance will refer to existing, active AMPATH Group Integrated Savings for Empowerment (GISE) microfinance groups with a majority of group members who are AMPATH HIV patients and have disclosed their HIV status. Groups will be considered active if the group was formed at least 6 months prior to study baseline, is consistently meeting as scheduled, and is actively engaging in saving and loaning.

Primary outcomes

  1. HIV-1 RNA Viral Load Suppression at 18-months

    Time frame: 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 outcomes

  1. Retention in Care Each Quarter During 18-months of Follow-up

    Time frame: 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.

  2. Change in Systolic Blood Pressure (SBP)

    Time frame: Between baseline and 18 months

    Change in systolic blood pressure (mm Hg) at 18 months as compared to baseline

  3. Change in Random Blood Sugar (mmol/L)

    Time frame: Between baseline and 18 months

    Change in random blood sugar (mmol/L) at 18 months as compared to baseline

Sponsors and collaborators

Lead sponsor

Brown University

Other

Collaborators

  • Academic Model Providing Access to Healthcare (AMPATH)
  • Johns Hopkins University
  • Moi University
  • NYU Langone Health
  • National Institute of Mental Health (NIMH)
  • Purdue University
  • University of Toronto

Registry information

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Jun 4, 2020
Registry last updated
Oct 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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