Trial Outcomes & Findings for Harambee: Integrated Community-based HIV/NCD Care & Microfinance Groups in Kenya (NCT NCT04417127)

Last Updated: 2025-10-31

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

1200 participants

Primary outcome timeframe

18 months

Results posted on

2025-10-31

Participant Flow

1112 participants in 61 microfinance groups were screened for eligibility.

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.

Unit of analysis: Microfinance Groups

Participant milestones

Participant milestones
Measure	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.	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.	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.
Overall Study STARTED	407 29	448 28	300 0
Overall Study COMPLETED	336 29	381 28	293 0
Overall Study NOT COMPLETED	71 0	67 0	7 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Microfinance with Integrated, Community-based Care n=29 Microfinance Groups 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.	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.	Total n=57 Microfinance Groups Total of all reporting groups	Microfinance with Usual (Facility-based) Care n=28 Microfinance Groups 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.
Sex: Female, Male Male	102 Participants n=5 Participants	70 Participants n=5 Participants	284 Participants n=4 Participants	112 Participants n=7 Participants
Age, Continuous	51.7 years STANDARD_DEVIATION 11.1 • n=5 Participants	52.6 years STANDARD_DEVIATION 10.9 • n=5 Participants	51.8 years STANDARD_DEVIATION 11.3 • n=4 Participants	51.4 years STANDARD_DEVIATION 11.7 • n=7 Participants
Sex: Female, Male Female	305 Participants n=5 Participants	230 Participants n=5 Participants	871 Participants n=4 Participants	336 Participants n=7 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=7 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	407 Participants n=5 Participants	300 Participants n=5 Participants	1155 Participants n=4 Participants	448 Participants n=7 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=7 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=7 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=7 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=7 Participants
Region of Enrollment Kenya	407 participants n=5 Participants	300 participants n=5 Participants	1155 participants n=4 Participants	448 participants n=7 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=7 Participants
Race (NIH/OMB) Black or African American	407 Participants n=5 Participants	300 Participants n=5 Participants	1155 Participants n=4 Participants	448 Participants n=7 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=7 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=7 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Usual (Facility-based) Care n=291 Participants 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.	Microfinance with Integrated, Community-based Care n=335 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.	Microfinance with Usual (Facility-based) Care n=377 Participants 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.
HIV-1 RNA Viral Load Suppression at 18-months	275 Participants	326 Participants	365 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Usual (Facility-based) Care n=300 Participants 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.	Microfinance with Integrated, Community-based Care n=407 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.	Microfinance with Usual (Facility-based) Care n=448 Participants 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.
Retention in Care Each Quarter During 18-months of Follow-up	51 Participants	315 Participants	235 Participants

SECONDARY outcome

Timeframe: 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.

Change in systolic blood pressure (mm Hg) at 18 months as compared to baseline

Outcome measures

Outcome measures
Measure	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.	Microfinance with Integrated, Community-based Care n=254 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.	Microfinance with Usual (Facility-based) Care n=375 Participants 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.
Change in Systolic Blood Pressure (SBP)	—	0.25 mm Hg (millimeters of mercury) Standard Deviation 15.89	0.046 mm Hg (millimeters of mercury) Standard Deviation 14.26

SECONDARY outcome

Timeframe: 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.

Change in random blood sugar (mmol/L) at 18 months as compared to baseline

Outcome measures

Outcome measures
Measure	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.	Microfinance with Integrated, Community-based Care n=232 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.	Microfinance with Usual (Facility-based) Care n=346 Participants 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.
Change in Random Blood Sugar (mmol/L)	—	0.276 mmol/L (millimoles per liter) Standard Deviation 1.62	-0.172 mmol/L (millimoles per liter) Standard Deviation 1.45

Adverse Events

Microfinance with Integrated, Community-based Care

Serious events: 3 serious events

Other events: 0 other events

Deaths: 3 deaths

Microfinance with Usual (Facility-based) Care

Serious events: 2 serious events

Other events: 0 other events

Deaths: 2 deaths

Usual (Facility-based) Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Microfinance with Integrated, Community-based Care n=407 participants at risk 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.	Microfinance with Usual (Facility-based) Care n=448 participants at risk 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.	Usual (Facility-based) Care n=300 participants at risk 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Death	0.00% 0/407 • 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.	0.22% 1/448 • Number of events 1 • 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.	0.00% 0/300 • 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.
Cardiac disorders Death	0.25% 1/407 • Number of events 1 • 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.	0.00% 0/448 • 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.	0.00% 0/300 • 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.
General disorders Death	0.00% 0/407 • 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.	0.22% 1/448 • Number of events 1 • 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.	0.00% 0/300 • 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.
Infections and infestations Death	0.25% 1/407 • Number of events 1 • 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.	0.00% 0/448 • 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.	0.00% 0/300 • 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.

Other adverse events

Adverse event data not reported

Additional Information

Omar Galarraga, PhD (Study Contact PI)

Brown University School of Public Health

Phone: +1 (401) 863-2331

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place