Diabetes, HIV/AIDS, Hypertension, Noncommunicable Diseases
Conditions
Keywords
HIV, Noncommunicable Diseases, microfinance, differentiated care, mobile care, telemedicine, task-shifting
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.
Interventions
OTHERIntegrated Community-Based (ICB) Care
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.
OTHERGroup-level Microfinance
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.
Sponsors
Johns Hopkins University
Moi University
Purdue University
University of Toronto
NYU Langone Health
Academic Model Providing Access to Healthcare (AMPATH)
National Institute of Mental Health (NIMH)
Brown University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
Aim 1: Cluster randomized trial where a minimum of 40 existing microfinance groups with n=900 members are randomized 1:1 to receive either integrated community-based care (ICB) or usual care. Delivered quarterly during community-based microfinance meetings, the intervention includes: clinical consultations, diabetes and/or hypertension management, distribution of antiretroviral therapy and NCD medications, health education, and facility referrals. Members of microfinance groups randomized to usual care will continue to receive care at a health facility. Aim 1 will also enroll an additional n=300 frequency-matched, prospectively-followed usual care patients without microfinance. Aim 2: Mediation analyses with n=40 trial participants and n=10 intervention staff. Aim 3: Cost-effectiveness analyses with n=5 budget staff.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Kenya
Participant flow
Recruitment details
1112 participants in 61 microfinance groups were screened for eligibility.
Pre-assignment details
900 participants in 57 microfinance groups were enrolled. An additional 300 participants not engaged in microfinance were frequency-matched and enrolled. We initially enrolled 1200 eligible participants in the study. We conducted randomization after (e.g., a few weeks following) enrollment to make community randomization more feasible. Between enrollment and randomization, n=45 participants left the study or were unable to be located, resulting in n=1155 participants ultimately randomized.
Participants by arm
| Arm | Count |
|---|---|
| Microfinance with Integrated, Community-based Care Approximately half of enrolled microfinance groups will be randomized to receive the ICB intervention.
Integrated Community-Based (ICB) Care: The intervention will be delivered quarterly during months 1-18 of the trial during regularly scheduled microfinance group meetings, and will include the following components: one-on-one consultation with a clinical officer in a private nearby location, distribution of antiretroviral therapy and other medications for diabetes and hypertension as needed, point-of-care laboratory testing if medically indicated, referrals to facilities for emergency or acute care needs, and group health education discussions.
Microfinance: 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. | 407 |
| Microfinance with Integrated, Community-based Care Approximately half of enrolled microfinance groups will be randomized to receive the ICB intervention.
Integrated Community-Based (ICB) Care: The intervention will be delivered quarterly during months 1-18 of the trial during regularly scheduled microfinance group meetings, and will include the following components: one-on-one consultation with a clinical officer in a private nearby location, distribution of antiretroviral therapy and other medications for diabetes and hypertension as needed, point-of-care laboratory testing if medically indicated, referrals to facilities for emergency or acute care needs, and group health education discussions.
Microfinance: 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. | 29 |
| Microfinance with Usual (Facility-based) Care Approximately half of enrolled microfinance groups will be randomized to continue to receive usual chronic disease care from an AMPATH-supported rural health facility.
Microfinance: 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. | 448 |
| Microfinance with Usual (Facility-based) Care Approximately half of enrolled microfinance groups will be randomized to continue to receive usual chronic disease care from an AMPATH-supported rural health facility.
Microfinance: 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. | 28 |
| Usual (Facility-based) Care A total of n=300 participants who receive usual care at an AMPATH health facility and who are not involved in microfinance will serve as frequency-matched, contemporaneous controls. These participants will be prospectively followed over the 18-months of the trial. | 300 |
| Usual (Facility-based) Care A total of n=300 participants who receive usual care at an AMPATH health facility and who are not involved in microfinance will serve as frequency-matched, contemporaneous controls. These participants will be prospectively followed over the 18-months of the trial. | 0 |
| Total | 1,212 |
Baseline characteristics
| Characteristic | Usual (Facility-based) Care | Total | Microfinance with Usual (Facility-based) Care | Microfinance with Integrated, Community-based Care |
|---|---|---|---|---|
| Age, Continuous | 52.6 years STANDARD_DEVIATION 10.9 | 51.8 years STANDARD_DEVIATION 11.3 | 51.4 years STANDARD_DEVIATION 11.7 | 51.7 years STANDARD_DEVIATION 11.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 300 Participants | 1155 Participants | 448 Participants | 407 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 300 Participants | 1155 Participants | 448 Participants | 407 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Kenya | 300 participants | 1155 participants | 448 participants | 407 participants |
| Sex: Female, Male Female | 230 Participants | 871 Participants | 336 Participants | 305 Participants |
| Sex: Female, Male Male | 70 Participants | 284 Participants | 112 Participants | 102 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 3 / 407 | 2 / 448 | 0 / 300 |
| other Total, other adverse events | 0 / 407 | 0 / 448 | 0 / 300 |
| serious Total, serious adverse events | 3 / 407 | 2 / 448 | 0 / 300 |
Outcome results
Primary
HIV-1 RNA Viral Load Suppression at 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.
Time frame: 18 months
Population: Number of participants who provided a blood draw for viral load assessment (primary outcome) during their 18-month study visit. If a participant had a viral load result available in their medical record within the 3 months prior to their 18-month assessment date, then this result was used to assess their 18-month viral load.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Microfinance with Integrated, Community-based Care | HIV-1 RNA Viral Load Suppression at 18-months | 326 Participants |
| Microfinance with Usual (Facility-based) Care | HIV-1 RNA Viral Load Suppression at 18-months | 365 Participants |
| Usual (Facility-based) Care | HIV-1 RNA Viral Load Suppression at 18-months | 275 Participants |
Comparison: For the primary outcome, the primary analysis was an intention-to-treat analysis that included all randomized participants comparing viral suppression at 18-months. Following studies of the effect of financial interventions, we powered the study to have at least 80% power to detect a 15% additive increase in viral suppression among microfinance group members receiving integrated community care compared to those receiving facility-based care, assuming 15% dropout.p-value: 0.2395% CI: [0.63, 1.12]Wald test
Comparison: A secondary analysis of the primary outcome included a comparison of viral suppression at 18- months, between each of the two randomized trial arms and the non-randomized, prospectively-followed, frequency-matched participants who were not engaged in microfinance. The secondary analysis used the same analytic model as the primary analysis, assuming no clustering in the non-randomized sample.p-value: <0.00195% CI: [1.48, 3.19]Wald test
Comparison: A secondary analysis of the primary outcome included a comparison of viral suppression at 18- months, between each of the two randomized trial arms and the non-randomized, prospectively-followed, frequency-matched participants who were not engaged in microfinance. The secondary analysis used the same analytic model as the primary analysis, assuming no clustering in the non-randomized sample.p-value: 0.02395% CI: [1.05, 1.92]Wald test
Secondary
Change in Random Blood Sugar (mmol/L)
Change in random blood sugar (mmol/L) at 18 months as compared to baseline
Time frame: Between baseline and 18 months
Population: Random blood sugar was only measured for participants of randomized microfinance groups who were clinically indicated to provide a blood glucose test at both baseline (month 0) and endline (month 18). Random blood sugar was not measured among frequency-matched usual care patients.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Microfinance with Integrated, Community-based Care | Change in Random Blood Sugar (mmol/L) | 0.276 mmol/L (millimoles per liter) | Standard Deviation 1.62 |
| Microfinance with Usual (Facility-based) Care | Change in Random Blood Sugar (mmol/L) | -0.172 mmol/L (millimoles per liter) | Standard Deviation 1.45 |
95% CI: [-0.701, -0.194]Wald test
Secondary
Change in Systolic Blood Pressure (SBP)
Change in systolic blood pressure (mm Hg) at 18 months as compared to baseline
Time frame: Between baseline and 18 months
Population: This outcome was only measured for participants of randomized microfinance groups who provided a blood pressure reading at both baseline (month 0) and endline (month 18). Systolic blood pressure was not measured among frequency-matched usual care patients.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Microfinance with Integrated, Community-based Care | Change in Systolic Blood Pressure (SBP) | 0.25 mm Hg (millimeters of mercury) | Standard Deviation 15.89 |
| Microfinance with Usual (Facility-based) Care | Change in Systolic Blood Pressure (SBP) | 0.046 mm Hg (millimeters of mercury) | Standard Deviation 14.26 |
95% CI: [-2.595, 2.183]Wald test
Secondary
Retention in Care Each Quarter During 18-months of Follow-up
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.
Time frame: Between baseline and 18 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Microfinance with Integrated, Community-based Care | Retention in Care Each Quarter During 18-months of Follow-up | 315 Participants |
| Microfinance with Usual (Facility-based) Care | Retention in Care Each Quarter During 18-months of Follow-up | 235 Participants |
| Usual (Facility-based) Care | Retention in Care Each Quarter During 18-months of Follow-up | 51 Participants |
Comparison: The retention in care analysis was an intention-to-treat analysis that included all enrolled participants and used the same analysis methods as those for the viral suppression (primary outcome) analysis. The retention in care analyses were not adjusted for multiplicity and should be considered hypothesis generating.p-value: <0.00195% CI: [2.58, 4.26]Wald test
Comparison: The retention in care analysis was an intention-to-treat analysis that included all enrolled participants and used the same analysis methods as those for the viral suppression (primary outcome) analysis. The retention in care analyses were not adjusted for multiplicity and should be considered hypothesis generating.p-value: <0.00195% CI: [6, 9.55]Wald test
Comparison: The retention in care analysis was an intention-to-treat analysis that included all enrolled participants and used the same analysis methods as those for the viral suppression (primary outcome) analysis. The retention in care analyses were not adjusted for multiplicity and should be considered hypothesis generating.p-value: <0.00195% CI: [2.14, 3.06]Wald test