HIV/AIDSNCT04417127
Harambee: Integrated Community-based HIV/NCD Care & Microfinance Groups in Kenya
A study testing Integrated Community-Based (ICB) Care and Group-level Microfinance in people with HIV/AIDS and Noncommunicable Diseases, run by Brown University at 1 site in Kenya.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV/AIDS, Noncommunicable Diseases, Hypertension
- What is being tested?
- Integrated Community-Based (ICB) Care and Group-level Microfinance
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- 1 siteKenya
- Study dates
- 26 Nov 2020to 6 Dec 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Currently participating in the BIGPIC study
- Unable to provide informed consent for participation
Trial locations and contacts
1 site in 1 country.
About this study
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:
Read more
- 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.
- 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.
- 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.
- Conditions
- HIV/AIDS, Noncommunicable Diseases, Hypertension, Diabetes
- Being tested
- Integrated Community-Based (ICB) Care, Group-level Microfinance
- Keywords
- HIV, Noncommunicable Diseases, microfinance, differentiated care, mobile care, telemedicine, task-shifting
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Noncommunicable Diseases, Hypertension, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrated Community-Based (ICB) CareOther
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 MicrofinanceOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Integrated Community-Based (ICB) Care; Other: Group-level Microfinance |
| 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. Receives: Other: Group-level Microfinance |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 18 months
Secondary outcomes (3)
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.
Measured: 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
Measured: 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
Measured: Between baseline and 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2020
- Study start26 Nov 2020
- Primary completion21 Sep 2023
- Study completion6 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for HIV/AIDSStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 1,200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brown University
- Sponsor type
- University, hospital or other
- Collaborators
- 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)
- Responsible party
- Principal investigator, Omar Galarraga, PhD, Brown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04417127
- Sponsor's protocol ID
- R01MH118075
- Other IDs
- R01MH118075
- Status last verified
- Oct 2025
- First submitted
- 2 Jun 2020
- Last updated
- 31 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 36578093Genberg 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.
PubMed 34115646Genberg 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.
PubMed 34006540Tran 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.
PubMed 36718505Wilson-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.
PubMed 38781744Liang 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.
PubMed 38790050Ardehali 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.
PubMed 39622542Lyons 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.
PubMed 40018611Wachira J, Mosong B, Kafu C, Wilson-Barthes M, Tran DNT, Vedanthan R, Pastakia DS, Lee Y, Hogan J, Galarraga O, Genberg BL. Correlates of Severe Psychological Distress Among Adults Living with HIV in Western Kenya. AIDS Behav. 2026 Jul 16. doi: 10.1007/s10461-026-05245-9. Online ahead of print.
PubMed 42461484
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Harambee: Integrated Community-based HIV/NCD Care & Microfinance Groups in Kenya
- ClinicalTrials.gov ID
- NCT04417127
- Acronym / sponsor ID
- R01MH118075
- Conditions
- HIV/AIDS, Noncommunicable Diseases, Hypertension, Diabetes
- Keywords
- HIV, Noncommunicable Diseases, microfinance, differentiated care, mobile care, telemedicine, task-shifting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,200 participants (actual)
- Lead sponsor
- Brown UniversityUniversity, hospital or other
- Collaborators
- 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)
- Study start
- 26 Nov 2020 (actual)
- Primary completion
- 21 Sep 2023 (actual)
- Study completion
- 6 Dec 2023 (actual)
- First posted
- 4 Jun 2020 (actual)
- Results
- Posted 31 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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.
- 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.
- 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Microfinance with Integrated Community-based Care | Experimental | Other: Integrated Community-Based (ICB) Care, Other: Group-level MicrofinanceA 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 | Other: Group-level MicrofinanceA 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (2 listed)
- Currently participating in the BIGPIC study
- Unable to provide informed consent for participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Integrated Community-Based (ICB) CareDuring 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. | Other | Microfinance with Integrated Community-based Care |
| Group-level MicrofinanceGroup 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. | Other | Microfinance with Integrated Community-based Care, Microfinance with Usual (Facility-Based) Care |
Primary outcome
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.
3 secondary outcomes
Retention in Care Each Quarter During 18-months of Follow-up
Time frame: Between baseline and 18 months
Change in Systolic Blood Pressure (SBP)
Time frame: Between baseline and 18 months
Change in Random Blood Sugar (mmol/L)
Time frame: Between baseline and 18 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 36578093Kafu 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.
- Background: PubMed 34115646Genberg 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.
- Background: PubMed 34006540Genberg 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.
- Background: PubMed 36718505Tran 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.
- Background: PubMed 38781744Wilson-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.
- Background: PubMed 38790050Liang 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.
- Background: PubMed 39622542Ardehali 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.
- Background: PubMed 40018611Lyons 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.
- Derived from this study: PubMed 42461484Wachira J, Mosong B, Kafu C, Wilson-Barthes M, Tran DNT, Vedanthan R, Pastakia DS, Lee Y, Hogan J, Galarraga O, Genberg BL. Correlates of Severe Psychological Distress Among Adults Living with HIV in Western Kenya. AIDS Behav. 2026 Jul 16. doi: 10.1007/s10461-026-05245-9. Online ahead of print.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Integrated Community-Based (ICB) Care and Group-level Microfinance in people with HIV/AIDS and Noncommunicable Diseases, run by Brown University at 1 site in Kenya.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HIV-1 RNA Viral Load Suppression at 18-months (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04417127, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2025.