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| ID | Type | Description | Link |
|---|---|---|---|
| R01MH118075 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Johns Hopkins University | OTHER |
| Moi University | OTHER |
| Purdue University | OTHER |
| University of Toronto |
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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:
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Microfinance with Integrated Community-based Care | Experimental | A minimum of 20 microfinance groups with approximately n=450 participants will be randomized to receive the ICB intervention. |
|
| Microfinance with Usual (Facility-Based) Care | Active Comparator | A minimum of 20 microfinance groups with approximately n=450 participants will be randomized to continue to receive standard of care from an AMPATH-supported rural health facility. |
|
| Usual (Facility-Based) Care without Microfinance | No Intervention | A total of n=300 participants who receive care at an AMPATH health facility and who are not involved in microfinance will serve as frequency-matched contemporaneous controls. These participants will be actively followed over the 18-months of the trial. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Moi University/ Moi Teaching and Referral Hospital | Eldoret | Kenya |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36578093 | Background | Kafu C, Wachira J, Omodi V, Said J, Pastakia SD, Tran DN, Onyango JA, Aburi D, Wilson-Barthes M, Galarraga O, Genberg BL. Integrating community-based HIV and non-communicable disease care with microfinance groups: a feasibility study in Western Kenya. Pilot Feasibility Stud. 2022 Dec 28;8(1):266. doi: 10.1186/s40814-022-01218-6. | |
| 34115646 | Background | Genberg BL, Wilson-Barthes MG, Omodi V, Hogan JW, Steingrimsson J, Wachira J, Pastakia S, Tran DN, Kiragu ZW, Ruhl LJ, Rosenberg M, Kimaiyo S, Galarraga O. Microfinance, retention in care, and mortality among patients enrolled in HIV care in East Africa. AIDS. 2021 Oct 1;35(12):1997-2005. doi: 10.1097/QAD.0000000000002987. |
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Materials generated under this project will be disseminated according to University and NIH policies regarding data sharing. Aggregate-level data collected in this collaboration will ultimately be available for public use. Opportunities for secondary analyses will be available following completion of the three-year project and publication of the main study findings. These findings will be available to the public through scientific meetings and peer-reviewed journals, as well as through a structured policy dissemination process.
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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.
1112 participants in 61 microfinance groups were screened for eligibility.
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
The n=300 participants receiving usual (facility-based) care alone were not participating in a microfinance group, and were frequency-matched to the n=900 participants who were members of the n=57 enrolled microfinance groups.
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Count of Participants | Participants | 18 months |
|
18 months
During the 18-month trial, our investigative team followed all procedures outlined in the Protection of Human Subjects Section of the Overall Project Protocol. No adverse events related to the study intervention occurred during the trial. All deaths that occurred during the trial were unrelated to the intervention or to study procedures, and were reported to the IRB of record (Moi University) within the required time frame.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Microfinance with Integrated, Community-based Care | Half of enrolled microfinance groups with approximately n=450 participants 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment | Participant was an enrolled microfinance group member receiving usual (facility-based) care. Participant died during study follow up due to cervical cancer. Their death was determined not to be associated with the research. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Omar Galarraga, PhD (Study Contact PI) | Brown University School of Public Health | +1 (401) 863-2331 | omar_galarraga@brown.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form: Updated Project Protocol | Nov 20, 2024 | Sep 11, 2025 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| D000073296 | Noncommunicable Diseases |
| D006973 | Hypertension |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| OTHER |
| NYU Langone Health | OTHER |
| Academic Model Providing Access to Healthcare (AMPATH) | OTHER |
| National Institute of Mental Health (NIMH) | NIH |
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.
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|
| 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. |
|
| Between baseline and 18 months |
| Change in Systolic Blood Pressure (SBP) | Change in systolic blood pressure (mm Hg) at 18 months as compared to baseline | Between baseline and 18 months |
| Change in Random Blood Sugar (mmol/L) | Change in random blood sugar (mmol/L) at 18 months as compared to baseline | Between baseline and 18 months |
| 34006540 | Background | Genberg BL, Wachira J, Steingrimsson JA, Pastakia S, Tran DNT, Said JA, Braitstein P, Hogan JW, Vedanthan R, Goodrich S, Kafu C, Wilson-Barthes M, Galarraga O. Integrated community-based HIV and non-communicable disease care within microfinance groups in Kenya: study protocol for the Harambee cluster randomised trial. BMJ Open. 2021 May 18;11(5):e042662. doi: 10.1136/bmjopen-2020-042662. |
| 36718505 | Background | Tran DN, Ching J, Kafu C, Wachira J, Koros H, Venkataramani M, Said J, Pastakia SD, Galarraga O, Genberg BL. Interruptions to HIV Care Delivery During Pandemics and Natural Disasters: A Qualitative Study of Challenges and Opportunities From Frontline Healthcare Providers in Western Kenya. J Int Assoc Provid AIDS Care. 2023 Jan-Dec;22:23259582231152041. doi: 10.1177/23259582231152041. |
| 38781744 | Background | Wilson-Barthes M, Steingrimsson J, Lee Y, Tran DN, Wachira J, Kafu C, Pastakia SD, Vedanthan R, Said JA, Genberg BL, Galarraga O. Economic outcomes among microfinance group members receiving community-based chronic disease care: Cluster randomized trial evidence from Kenya. Soc Sci Med. 2024 Jun;351:116993. doi: 10.1016/j.socscimed.2024.116993. Epub 2024 May 17. |
| 38790050 | Background | Liang A, Wilson-Barthes M, Galarraga O. Cost-effectiveness of differentiated care models that incorporate economic strengthening for HIV antiretroviral therapy adherence: a systematic review. Cost Eff Resour Alloc. 2024 May 24;22(1):46. doi: 10.1186/s12962-024-00557-w. |
| 39622542 | Background | Ardehali M, Kafu C, Vazquez Sanchez M, Wilson-Barthes M, Mosong B, Pastakia SD, Said J, Tran DN, Wachira J, Genberg B, Galarraga O, Vedanthan R. Food insecurity is associated with greater difficulty accessing care among people living with HIV with or without comorbid non-communicable diseases in western Kenya. BMJ Glob Health. 2024 Dec 2;9(12):e016721. doi: 10.1136/bmjgh-2024-016721. |
| 40018611 | Background | Lyons C, Ching J, Tran DN, Kafu C, Wachira J, Koros H, Venkataramani M, Said J, Pastakia SD, Galarraga O, Genberg B. Social, economic and food insecurity among people living with HIV in Kenya during coinciding public health and environmental emergencies: a mixed-methods study. BMJ Public Health. 2024 Sep 23;2(2):e000836. doi: 10.1136/bmjph-2023-000836. eCollection 2024 Dec. |
| BG001 | 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. |
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| Microfinance Groups |
|
| years |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants | No | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants | Participants |
|
| Region of Enrollment | Number | participants | Participants |
|
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.
| OG001 | 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. |
| OG002 | 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. |
|
|
|
| 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. | Posted | Count of Participants | Participants | Between baseline and 18 months |
|
|
|
|
| Secondary | Change in Systolic Blood Pressure (SBP) | Change in systolic blood pressure (mm Hg) at 18 months as compared to baseline | 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. | Posted | Mean | Standard Deviation | mm Hg (millimeters of mercury) | Between baseline and 18 months |
|
|
|
|
| Secondary | Change in Random Blood Sugar (mmol/L) | Change in random blood sugar (mmol/L) at 18 months as compared to baseline | 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. | Posted | Mean | Standard Deviation | mmol/L (millimoles per liter) | Between baseline and 18 months |
|
|
|
|
| 3 |
| 407 |
| 3 |
| 407 |
| 0 |
| 407 |
| EG001 | Microfinance with Usual (Facility-based) Care | Half of enrolled microfinance groups with approximately n=450 participants 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. | 2 | 448 | 2 | 448 | 0 | 448 |
| EG002 | Usual (Facility-based) Care | 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 | 300 | 0 | 300 | 0 | 300 |
|
| Death | General disorders | Systematic Assessment | Participant was an enrolled microfinance group member receiving usual (facility-based) care. Participant died during study follow up due to unknown causes. Their death was determined not to be associated with the research. |
|
| Death | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment | Participant was an enrolled microfinance group member receiving integrated community-based care. Participant died during study follow up due to suspected esophageal malignancy. Their death was determined not to be associated with the research. |
|
| Death | Cardiac disorders | Systematic Assessment | Participant was an enrolled microfinance group member receiving integrated community-based care. Participant died during study follow up due to stroke. Their death was determined not to be associated with the research. |
|
| Death | Infections and infestations | Systematic Assessment | Participant was an enrolled microfinance group member receiving integrated community-based care. Participant died during study follow up due to pneumonia. Their death was determined not to be associated with the research. |
|
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| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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. |
| Wald test |
| <0.001 |
| Odds Ratio, log |
| 7.51 |
| 2-Sided |
| 95 |
| 6.00 |
| 9.55 |
| Superiority |
| 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. | Wald test | <0.001 | Odds Ratio, log | 2.56 | 2-Sided | 95 | 2.14 | 3.06 | Superiority |