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

Study Overview
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Brief Summary
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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: 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. 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. 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.

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

Conditions
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HIV/AIDS, Noncommunicable Diseases, Hypertension, Diabetes

Intervention / Treatment
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* Other: Integrated Community-Based (ICB) Care
* Other: Microfinance


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Aim 1: Cluster randomized trial where 40 existing microfinance (MF) groups with n=900 members are randomized in a 1:1 ratio to receive either integrated community-based care (ICB) (Study Arm A) or standard care (Study Arm B). The ICB intervention will be delivered during regular MF group meetings monthly during trial months 1-6 and quarterly during months 7-18. The intervention will include (1) clinical teams visits with vital signs screening, consultations, medication distribution (ART and other chronic/acute medications), POC laboratory testing (creatinine, blood glucose, hemoglobin A1C, viral load); (2) peer support; (3) referrals to facilities as needed. Members of MF groups randomized to Study Arm B will continue to receive care at an AMPATH facility. Study Arm C will include n=300 participants who receive standard care at an AMPATH facility and are not involved in MF. Aim 2: Mediation analyses with n=50 trial participants. Aim 3: Cost-effectiveness analyses with n=5 budget staff.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Microfinance with Integrated Community-based Care<br>20 microfinance groups with n=450 participants will be randomized to receive the ICB intervention. | Other: Integrated Community-Based (ICB) Care<br>* The intervention will include the following components: (1) integrated care visits by clinical team occurring monthly during months 1-6 of the trial, and then quarterly for the remaining months (7-18), which include vital signs screening, consultation with a clinical officer, medication distribution (ART and other chronic and acute medications), and point- of-care (POC) laboratory testing (creatinine, blood glucose and hemoglobin A1C, and viral load as it becomes available); (2) peer support for promoting ART adherence during every monthly MF meeting; (3) referrals to facilities for emergency or acute care needs that are not feasible to address in the community. Integrated care refers to delivery of primary, HIV and NCD-related care, incorporating a focus on both chronic and acute needs.<br>Other: Microfinance<br>* 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.<br>|
| Active Comparator: Microfinance with Standard of Care<br>20 microfinance groups with n=450 participants will be randomized to continue to receive standard of care from an AMPATH-supported rural health facility. | Other: Microfinance<br>* 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.<br>|
| No Intervention: Standard of Care without Microfinance<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Viral Suppression | HIV viral load less than 400 copies/mL at 18 months as compared to baseline | Between baseline and 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retention in Care | Proportion of scheduled visits that were attended during the study period | Between baseline and 18 months | 
| Change in Systolic Blood Pressure (SBP) | Change in systolic blood pressure at 18 months as compared to baseline | Between baseline and 18 months | 
| Change in glycated hemoglobin (HbA1c) | Change in HbA1c level at 18 months as compared to baseline | Between baseline and 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, Noncommunicable Diseases, microfinance, differentiated care, mobile care, telemedicine, task-shifting