Our Research

Harambee Study Design

This study employed a two-arm cluster-randomized trial, with randomization occurring at the level of Microfinance (MF) group clusters, stratified by county, using a computer-generated sequence to allocate groups into either MF+ICB or MF+SOC arms. Participants were chosen from eligible MF groups based on specific criteria, including age ≥18, HIV-positive status, prior receipt of HIV-related care through AMPATH, initiation of ART at least 6 months prior to baseline, consistent attendance at GISE group meetings, possession of an AMPATH Medical Record System (AMRS) ID, and willingness and ability to provide informed consent. The intervention, delivered during monthly MF meetings, involved integrated care visits, peer support, and referrals, with the clinical team conducting clinical evaluations, medication distribution, and point-of-care laboratory testing. Care teams coordinated with participants’ needs, focusing on non-HIV-related needs during the initial intervention period. The control arm, MF with Standard of Care (SOC), maintained regular MF meetings and received standard care from an AMPATH-supported rural health facility, following current AMPATH HIV and Chronic Disease Management (CDM) program procedures. SOC participants were not involved in MF activities and continued to receive routine care from AMPATH-supported health facilities.

The data collection for this study involves assessments for primary and secondary outcomes at 9 and 18 months, including viral load testing and surveys, with additional data collected at 9 months for two trial arms. Clinical data is collected by field clinical officers using secure tablets during intervention visits. The primary outcome is viral suppression at 18 months, with secondary outcomes including retention in care, changes in blood pressure, and HbA1c levels. The analytical approach includes matching individuals from the Standard of Care (SOC) arm to intervention arms based on gender and age, using coarsened exact matching. A mixed effects model will assess primary and secondary outcomes. Quantitative and qualitative mediation analyses will explore mechanisms, and a cost-effectiveness analysis will compare intervention arms.

Study Population 

Up to 1,200 adults, aged ≥18 years, who are living with HIV and receiving care from an Academic Model Providing Access to Healthcare (AMPATH) facility. The study population will consist of at least 40 and up to 58 active microfinance group clusters, each with a majority of members who are living with HIV.

Study Sites 

The study sites include 2 counties in western Kenya, Busia and Trans Nzoia, and associated health clinics.

Study Aims

Study Intervention

The intervention involves the integration of care within microfinance (MF) groups for people living with HIV (PLHIV) in Kenya. A clinical team, including a clinical officer, pharmacy technician, peer navigator, and social worker, delivers Integrated Community-Based (ICB) care during monthly MF meetings. This intervention spans 18 months and comprises monthly care visits for the first 6 months and then quarterly visits, covering clinical evaluation, consultation, medication distribution (including antiretroviral therapy), and point-of-care laboratory testing. Additionally, peer support for ART adherence is provided during MF meetings, and participants receive referrals to facilities for emergency or acute care needs. The care teams coordinate with the participants’ needs, focusing on non-HIV-related needs and screening for non-communicable diseases during the initial visits. Standardized care protocols from the AMPATH Clinical Protocols and Standard Operating Procedures directory guide the handling of various health issues. At each MF group meeting, routine triage and screening occur, and participants receive health education in a group setting, followed by individual consultations with a clinical officer. Prescriptions are provided, dispensed by a pharmaceutical technician, and additional support is offered through peer navigators and social workers for counseling or facilitating referrals.

Study Status 

As of August 31, 2023, all human subjects involvement and data collection for the 18-month trial has successfully concluded. The primary effectiveness analyses, causal mediation analyses, and cost-effectiveness analyses are underway.

Project Protocol

Integrated community-based HIV and non-communicable disease care within microfinance groups in Kenya: study protocol for the Harambee cluster randomised trial

Becky L. Genberg, Juddy Wachira, Jon A Steingrimsson, Sonak Pastakia, Dan N Tina Tran, Jamil AbdulKadir Said, Paula Braitstein, Joseph W. Hogan, Rajesh Vedanthan, Suzanne Goodrich, Catherine Kafu, Marta Wilson-Barthes, Omar Galárraga