Trial Outcomes & Findings for The Sub-Saharan Africa Regional Partnership for Mental Health Capacity Building (NCT NCT03711786)

Last Updated: 2023-03-01

Results Overview

This primary outcome is measured at the level of the clinician-patient visit out of all clinic visits during the intervention period, including visits with both consented and non-consented patients. The outcome is based on aggregate clinic process data including number of visits for which the patient is not already engaged in depression treatment (denominator) and number of visits for which the patient is screened for depression (numerator) on each clinic day at each facility. Completion of depression screening (successful outcome) is defined as the clinician completing the Patient Health Questionnaire-2 (PHQ-2), and, if the PHQ-2 score is \>0, also completing the PHQ-9 with the patient.

Recruitment status

COMPLETED

Study phase

Target enrollment

946 participants

Primary outcome timeframe

Measured based on data from clinic visits on each clinic day throughout study period

Results posted on

2023-03-01

Participant Flow

Ten clinics began the pre-randomization run-in period. All ten continued into the randomized intervention period. Primary outcomes (clinical care indicators) are measured at the level of the visit; visits do not overlap between the run-in and intervention periods. Secondary outcomes are measured at the level of the enrolled participant over 12 months of follow-up; enrolled participants do not overlap between the run-in and intervention periods. The numbers below represent participants.

357 participants were enrolled during the run-in period before randomization. These participants are reported according to the arm to which their clinic was later assigned. 589 participants were enrolled during the intervention period post-randomization. By protocol, participants completed the study at 12 months post-consent. However, for logistical reasons the decision was made to conclude the study early and so the final 91 participants completed the study at 6 months.

Unit of analysis: Clinics

Participant milestones

Participant milestones
Measure	Basic Implementation Package The basic implementation package is a clinic-level strategy that involves identifying an internal coordinator who is one of the full-time on-site providers at the clinic. The internal coordinator provides mentoring to peers and support to leadership in implementing the treatment program and aligning it with clinic priorities.	Enhanced Implementation Package The enhanced implementation package is a clinic-level strategy that combines the internal coordinator (basic arm) with an external quality assurance committee. This committee will complete quarterly audits at the facility to evaluate compliance with the depression treatment protocol as well as providing high-level support in implementing the treatment program through clinical expertise and limited on-site presence.
Period 1: Recruited in Study Months 1-5 STARTED	168 5	189 5
Period 1: Recruited in Study Months 1-5 3-month Assessment	162 5	186 5
Period 1: Recruited in Study Months 1-5 6-month Assessment	156 5	179 5
Period 1: Recruited in Study Months 1-5 12-month Assessment	148 5	183 5
Period 1: Recruited in Study Months 1-5 COMPLETED	148 5	183 5
Period 1: Recruited in Study Months 1-5 NOT COMPLETED	20 0	6 0
Period 1: Recruited in Study Months 6-32 STARTED	301 5	288 5
Period 1: Recruited in Study Months 6-32 3-month Assessment	275 5	264 5
Period 1: Recruited in Study Months 6-32 6-month Assessment	277 5	267 5
Period 1: Recruited in Study Months 6-32 12-month Assessment	237 5	220 5
Period 1: Recruited in Study Months 6-32 COMPLETED	279 5	258 5
Period 1: Recruited in Study Months 6-32 NOT COMPLETED	22 0	30 0

Reasons for withdrawal

Reasons for withdrawal
Measure	Basic Implementation Package The basic implementation package is a clinic-level strategy that involves identifying an internal coordinator who is one of the full-time on-site providers at the clinic. The internal coordinator provides mentoring to peers and support to leadership in implementing the treatment program and aligning it with clinic priorities.	Enhanced Implementation Package The enhanced implementation package is a clinic-level strategy that combines the internal coordinator (basic arm) with an external quality assurance committee. This committee will complete quarterly audits at the facility to evaluate compliance with the depression treatment protocol as well as providing high-level support in implementing the treatment program through clinical expertise and limited on-site presence.
Period 1: Recruited in Study Months 1-5 Lost to Follow-up	13	4
Period 1: Recruited in Study Months 1-5 Withdrawal by Subject	0	1
Period 1: Recruited in Study Months 1-5 Death	7	1
Period 1: Recruited in Study Months 6-32 Lost to Follow-up	17	21
Period 1: Recruited in Study Months 6-32 Withdrawal by Subject	0	5
Period 1: Recruited in Study Months 6-32 Death	5	4

Baseline Characteristics

The Sub-Saharan Africa Regional Partnership for Mental Health Capacity Building

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Basic Implementation Package n=27187 Medical Visits The basic implementation package is a clinic-level strategy that involves identifying an internal coordinator who is one of the full-time on-site providers at the clinic. The internal coordinator provides mentoring to peers and support to leadership in implementing the treatment program and aligning it with clinic priorities.	Enhanced Implementation Package n=33587 Medical Visits The enhanced implementation package is a clinic-level strategy that combines the internal coordinator (basic arm) with an external quality assurance committee. This committee will complete quarterly audits at the facility to evaluate compliance with the depression treatment protocol as well as providing high-level support in implementing the treatment program through clinical expertise and limited on-site presence.	Total n=60774 Medical Visits Total of all reporting groups
Age, Categorical <=18 years	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	456 Participants n=5 Participants	462 Participants n=7 Participants	918 Participants n=5 Participants
Age, Categorical >=65 years	10 Participants n=5 Participants	15 Participants n=7 Participants	25 Participants n=5 Participants
Age, Continuous	51.1 years STANDARD_DEVIATION 9.9 • n=5 Participants	50.5 years STANDARD_DEVIATION 9.8 • n=7 Participants	50.8 years STANDARD_DEVIATION 9.8 • n=5 Participants
Sex: Female, Male Female	366 Participants n=5 Participants	392 Participants n=7 Participants	758 Participants n=5 Participants
Sex: Female, Male Male	103 Participants n=5 Participants	85 Participants n=7 Participants	188 Participants n=5 Participants
Race/Ethnicity, Customized Black African non-Hispanic	469 Participants n=5 Participants	477 Participants n=7 Participants	946 Participants n=5 Participants
Region of Enrollment Malawi	469 Participants n=5 Participants	477 Participants n=7 Participants	946 Participants n=5 Participants

PRIMARY outcome

Timeframe: Measured based on data from clinic visits on each clinic day throughout study period

Population: The population for this outcome is all screening-eligible clinician-patient visits during the study period, not patient participants. Aggregate data are captured for visits with both consented and non-consented patients. The enrolled participants (n=301 and 288) constitute a small portion of all captured visits (n=27,187 and 33,587), but non-consented patients (who are not uniquely identified) represent a large portion.

Outcome measures

Outcome measures
Measure	Basic Implementation Package n=27187 Visits The basic implementation package is a clinic-level strategy that involves identifying an internal coordinator who is one of the full-time on-site providers at the clinic. The internal coordinator provides mentoring to peers and support to leadership in implementing the treatment program and aligning it with clinic priorities.	Enhanced Implementation Package n=33587 Visits The enhanced implementation package is a clinic-level strategy that combines the internal coordinator (basic arm) with an external quality assurance committee. This committee will complete quarterly audits at the facility to evaluate compliance with the depression treatment protocol as well as providing high-level support in implementing the treatment program through clinical expertise and limited on-site presence.
Fidelity in Depression Screening: Number of Screening-eligible Visits at Which Depression Screening is Completed	14712 Visits	15888 Visits

PRIMARY outcome

Timeframe: Measured based on data from clinic visits on each clinic day throughout study period

Population: The population for this outcome is all depression treatment-eligible clinician-patient visits during the study period, not patient participants. Aggregate data are captured for visits with both consented and non-consented patients. The enrolled participants (n=301 and 288) constitute a portion of all captured visits for this outcome (n=610 and 545), but non-consented patients (who are not uniquely identified) represent an additional portion.

This primary outcome is measured at the level of the clinician-patient visit out of all treatment-eligible visits during the intervention period, including visits with both consented and non-consented patients. The outcome is based on aggregate clinic process data including number of visits for which the patient is eligible for depression treatment (denominator) and number of visits for which the patient initiates depression treatment (numerator) on each clinic day at each facility. Eligible for depression treatment is defined as PHQ-9 total score of 5 or above. Initiating depression treatment is defined as prescription of antidepressant medication or referral to Friendship Bench psychosocial counselors within 30 days of positive screen.

Outcome measures

Outcome measures
Measure	Basic Implementation Package n=610 Visits The basic implementation package is a clinic-level strategy that involves identifying an internal coordinator who is one of the full-time on-site providers at the clinic. The internal coordinator provides mentoring to peers and support to leadership in implementing the treatment program and aligning it with clinic priorities.	Enhanced Implementation Package n=545 Visits The enhanced implementation package is a clinic-level strategy that combines the internal coordinator (basic arm) with an external quality assurance committee. This committee will complete quarterly audits at the facility to evaluate compliance with the depression treatment protocol as well as providing high-level support in implementing the treatment program through clinical expertise and limited on-site presence.
Fidelity in Depression Treatment Initiation: Number of Treatment-eligible Visits for Which Depression Treatment Actually Starts Within 30 Days of Identification	601 Visits	538 Visits

PRIMARY outcome

Timeframe: Within the first three months of follow-up after initiating depression treatment

Population: Population: all clinic visits for consented participants in the first 3 months after starting depression treatment. Analysis is restricted to consented participants because the clinic visit must be linked to information from the initial visit to define whether the treatment decision follows the algorithm. Participants may have multiple clinic visits during the three months. These are routine clinic visits and are not the 3-month research assessment referenced in the participant flow.

This primary outcome is measured at the level of the clinician-patient visit out of all eligible visits during the intervention period. Eligible visits are clinical visits by consented participants within the first 90 days after initiating depression treatment. The outcome is based on clinic process data including number of clinic visits for which the participant is already engaged in depression treatment (denominator) and number of visits where the treatment decision follows the treatment algorithm (numerator) on each clinic day at each facility. Following the algorithm (positive outcome) is defined as: (1) if the participant has completed 6 counseling sessions, any action is acceptable; (2) otherwise, if the participant started counseling, either continuing counseling or starting medication; (3) if the participant started medication and PHQ-9 score \<10, continuing medication; (4) if the participant started medication and PHQ-9 score \>=10, continuing medication and increasing dose.

Outcome measures

Outcome measures
Measure	Basic Implementation Package n=85 Visits The basic implementation package is a clinic-level strategy that involves identifying an internal coordinator who is one of the full-time on-site providers at the clinic. The internal coordinator provides mentoring to peers and support to leadership in implementing the treatment program and aligning it with clinic priorities.	Enhanced Implementation Package n=81 Visits The enhanced implementation package is a clinic-level strategy that combines the internal coordinator (basic arm) with an external quality assurance committee. This committee will complete quarterly audits at the facility to evaluate compliance with the depression treatment protocol as well as providing high-level support in implementing the treatment program through clinical expertise and limited on-site presence.
Fidelity in Following the Depression Treatment Algorithm: Number of Treatment Follow-up Appointments in the First Three Months of Depression Treatment for Which the Clinical Treatment Decision Follows the Depression Treatment Guidelines	14 Visits	69 Visits

SECONDARY outcome

Timeframe: Three months post enrollment

Population: All participants who completed the 3-month assessment.

This secondary outcome is measured at the level of the consented participant. Depressive severity is determined using the Patient Health Questionnaire-9 (PHQ-9; range 0-27). The PHQ-9 is a self-reported questionnaire measuring depressive symptoms.This is a nine item measure with a response score for each item on a 4-point scale ranging from 0 (not at all) to 3 (nearly every day). Thus, the total score ranges from 0 to 27, with 0-4 indicating no depressive symptoms, 5-9 mild depression, 10-14 moderate depression, 15-19 moderately severe depression, and 20-27 severe depression. Depression remission is defined as a score \<5.

Outcome measures

Outcome measures
Measure	Basic Implementation Package n=275 Participants The basic implementation package is a clinic-level strategy that involves identifying an internal coordinator who is one of the full-time on-site providers at the clinic. The internal coordinator provides mentoring to peers and support to leadership in implementing the treatment program and aligning it with clinic priorities.	Enhanced Implementation Package n=264 Participants The enhanced implementation package is a clinic-level strategy that combines the internal coordinator (basic arm) with an external quality assurance committee. This committee will complete quarterly audits at the facility to evaluate compliance with the depression treatment protocol as well as providing high-level support in implementing the treatment program through clinical expertise and limited on-site presence.
Number of Participants Achieving Depression Remission at 3 Months	98 Participants	138 Participants

SECONDARY outcome

Timeframe: Three months post enrollment

Population: Analysis population restricted to those (1) completing 3-month assessment (n=275;264); (2) hypertension diagnosis at baseline (n=221;234); (3) completing 3-month in person (n=59;90). Item 2 above is to exclude participants who only had a diabetes diagnosis at baseline because blood glucose measures were not consistently available from clinical records. Item 3 above is because with COVID, most follow-ups moved to phone in which case BP was no longer collected.

This secondary outcome is measured at the level of the consented participant. Hypertension is measured by research assistants at each study visit while fasting blood glucose is measured as part of routine clinical care and will be abstracted. Well-controlled non-communicable disease (NCD) will be defined for hypertension patients as systolic blood pressure (BP) \<140 mmHg AND diastolic blood pressure \<90 mmHg, and for diabetes patients as fasting blood glucose \<130 mg/dl, following the Malawi Clinical Guidelines for the Management of NCDs.

Outcome measures

Outcome measures
Measure	Basic Implementation Package n=59 Participants The basic implementation package is a clinic-level strategy that involves identifying an internal coordinator who is one of the full-time on-site providers at the clinic. The internal coordinator provides mentoring to peers and support to leadership in implementing the treatment program and aligning it with clinic priorities.	Enhanced Implementation Package n=90 Participants The enhanced implementation package is a clinic-level strategy that combines the internal coordinator (basic arm) with an external quality assurance committee. This committee will complete quarterly audits at the facility to evaluate compliance with the depression treatment protocol as well as providing high-level support in implementing the treatment program through clinical expertise and limited on-site presence.
Number of Participants With Well Controlled NCD at 3 Months	35 Participants	51 Participants

Adverse Events

Basic Implementation Package

Serious events: 31 serious events

Other events: 54 other events

Deaths: 12 deaths

Enhanced Implementation Package

Serious events: 11 serious events

Other events: 90 other events

Deaths: 5 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Basic Implementation Package n=469 participants at risk The basic implementation package is a clinic-level strategy that involves identifying an internal coordinator who is one of the full-time on-site providers at the clinic. The internal coordinator provides mentoring to peers and support to leadership in implementing the treatment program and aligning it with clinic priorities.	Enhanced Implementation Package n=477 participants at risk The enhanced implementation package is a clinic-level strategy that combines the internal coordinator (basic arm) with an external quality assurance committee. This committee will complete quarterly audits at the facility to evaluate compliance with the depression treatment protocol as well as providing high-level support in implementing the treatment program through clinical expertise and limited on-site presence.
Psychiatric disorders Suicidal ideation	11.5% 54/469 • Number of events 57 • Adverse events were collected from consent through each participant's study completion, up to approximately 12 months post-consent. Deaths were assessed systematically for any participant lost to contact through consultation of clinical records and community tracing. Hospitalizations and suicidal ideation were queried systematically at each research assessment.	18.9% 90/477 • Number of events 106 • Adverse events were collected from consent through each participant's study completion, up to approximately 12 months post-consent. Deaths were assessed systematically for any participant lost to contact through consultation of clinical records and community tracing. Hospitalizations and suicidal ideation were queried systematically at each research assessment.

Additional Information

Brian Pence, PhD

University of North Carolina at Chapel Hill

Phone: 919-966-7430

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Basic Implementation Package n=469 participants at risk The basic implementation package is a clinic-level strategy that involves identifying an internal coordinator who is one of the full-time on-site providers at the clinic. The internal coordinator provides mentoring to peers and support to leadership in implementing the treatment program and aligning it with clinic priorities.	Enhanced Implementation Package n=477 participants at risk The enhanced implementation package is a clinic-level strategy that combines the internal coordinator (basic arm) with an external quality assurance committee. This committee will complete quarterly audits at the facility to evaluate compliance with the depression treatment protocol as well as providing high-level support in implementing the treatment program through clinical expertise and limited on-site presence.
Gastrointestinal disorders Abdominal pain - Hospitalization	0.21% 1/469 • Number of events 2 • Adverse events were collected from consent through each participant's study completion, up to approximately 12 months post-consent. Deaths were assessed systematically for any participant lost to contact through consultation of clinical records and community tracing. Hospitalizations and suicidal ideation were queried systematically at each research assessment.	0.00% 0/477 • Adverse events were collected from consent through each participant's study completion, up to approximately 12 months post-consent. Deaths were assessed systematically for any participant lost to contact through consultation of clinical records and community tracing. Hospitalizations and suicidal ideation were queried systematically at each research assessment.
Metabolism and nutrition disorders Anaemia - Hospitalization	0.43% 2/469 • Number of events 2 • Adverse events were collected from consent through each participant's study completion, up to approximately 12 months post-consent. Deaths were assessed systematically for any participant lost to contact through consultation of clinical records and community tracing. Hospitalizations and suicidal ideation were queried systematically at each research assessment.	0.00% 0/477 • Adverse events were collected from consent through each participant's study completion, up to approximately 12 months post-consent. Deaths were assessed systematically for any participant lost to contact through consultation of clinical records and community tracing. Hospitalizations and suicidal ideation were queried systematically at each research assessment.
Respiratory, thoracic and mediastinal disorders Asthma - Hospitalization	0.21% 1/469 • Number of events 1 • Adverse events were collected from consent through each participant's study completion, up to approximately 12 months post-consent. Deaths were assessed systematically for any participant lost to contact through consultation of clinical records and community tracing. Hospitalizations and suicidal ideation were queried systematically at each research assessment.	0.00% 0/477 • Adverse events were collected from consent through each participant's study completion, up to approximately 12 months post-consent. Deaths were assessed systematically for any participant lost to contact through consultation of clinical records and community tracing. Hospitalizations and suicidal ideation were queried systematically at each research assessment.
Injury, poisoning and procedural complications Broken leg - Hospitalization	0.21% 1/469 • Number of events 1 • Adverse events were collected from consent through each participant's study completion, up to approximately 12 months post-consent. Deaths were assessed systematically for any participant lost to contact through consultation of clinical records and community tracing. Hospitalizations and suicidal ideation were queried systematically at each research assessment.	0.00% 0/477 • Adverse events were collected from consent through each participant's study completion, up to approximately 12 months post-consent. Deaths were assessed systematically for any participant lost to contact through consultation of clinical records and community tracing. Hospitalizations and suicidal ideation were queried systematically at each research assessment.
Gastrointestinal disorders Constipation - Hospitalization	0.21% 1/469 • Number of events 1 • Adverse events were collected from consent through each participant's study completion, up to approximately 12 months post-consent. Deaths were assessed systematically for any participant lost to contact through consultation of clinical records and community tracing. Hospitalizations and suicidal ideation were queried systematically at each research assessment.	0.00% 0/477 • Adverse events were collected from consent through each participant's study completion, up to approximately 12 months post-consent. Deaths were assessed systematically for any participant lost to contact through consultation of clinical records and community tracing. Hospitalizations and suicidal ideation were queried systematically at each research assessment.
Nervous system disorders Convulsions - Hospitalization	0.00% 0/469 • Adverse events were collected from consent through each participant's study completion, up to approximately 12 months post-consent. Deaths were assessed systematically for any participant lost to contact through consultation of clinical records and community tracing. Hospitalizations and suicidal ideation were queried systematically at each research assessment.	0.21% 1/477 • Number of events 1 • Adverse events were collected from consent through each participant's study completion, up to approximately 12 months post-consent. Deaths were assessed systematically for any participant lost to contact through consultation of clinical records and community tracing. Hospitalizations and suicidal ideation were queried systematically at each research assessment.
Gastrointestinal disorders Diarrhea - Hospitalization	0.00% 0/469 • Adverse events were collected from consent through each participant's study completion, up to approximately 12 months post-consent. Deaths were assessed systematically for any participant lost to contact through consultation of clinical records and community tracing. Hospitalizations and suicidal ideation were queried systematically at each research assessment.	0.21% 1/477 • Number of events 1 • Adverse events were collected from consent through each participant's study completion, up to approximately 12 months post-consent. Deaths were assessed systematically for any participant lost to contact through consultation of clinical records and community tracing. Hospitalizations and suicidal ideation were queried systematically at each research assessment.
Metabolism and nutrition disorders Elevated blood pressure - Hospitalization	2.1% 10/469 • Number of events 11 • Adverse events were collected from consent through each participant's study completion, up to approximately 12 months post-consent. Deaths were assessed systematically for any participant lost to contact through consultation of clinical records and community tracing. Hospitalizations and suicidal ideation were queried systematically at each research assessment.	0.84% 4/477 • Number of events 4 • Adverse events were collected from consent through each participant's study completion, up to approximately 12 months post-consent. Deaths were assessed systematically for any participant lost to contact through consultation of clinical records and community tracing. Hospitalizations and suicidal ideation were queried systematically at each research assessment.
Respiratory, thoracic and mediastinal disorders Emphysema - Hospitalization	0.21% 1/469 • Number of events 1 • Adverse events were collected from consent through each participant's study completion, up to approximately 12 months post-consent. Deaths were assessed systematically for any participant lost to contact through consultation of clinical records and community tracing. Hospitalizations and suicidal ideation were queried systematically at each research assessment.	0.00% 0/477 • Adverse events were collected from consent through each participant's study completion, up to approximately 12 months post-consent. Deaths were assessed systematically for any participant lost to contact through consultation of clinical records and community tracing. Hospitalizations and suicidal ideation were queried systematically at each research assessment.
Nervous system disorders Epilepsy - Hospitalization	0.21% 1/469 • Number of events 1 • Adverse events were collected from consent through each participant's study completion, up to approximately 12 months post-consent. Deaths were assessed systematically for any participant lost to contact through consultation of clinical records and community tracing. Hospitalizations and suicidal ideation were queried systematically at each research assessment.	0.00% 0/477 • Adverse events were collected from consent through each participant's study completion, up to approximately 12 months post-consent. Deaths were assessed systematically for any participant lost to contact through consultation of clinical records and community tracing. Hospitalizations and suicidal ideation were queried systematically at each research assessment.
Endocrine disorders Hyperglycemia - Hospitalization	2.3% 11/469 • Number of events 13 • Adverse events were collected from consent through each participant's study completion, up to approximately 12 months post-consent. Deaths were assessed systematically for any participant lost to contact through consultation of clinical records and community tracing. Hospitalizations and suicidal ideation were queried systematically at each research assessment.	0.84% 4/477 • Number of events 4 • Adverse events were collected from consent through each participant's study completion, up to approximately 12 months post-consent. Deaths were assessed systematically for any participant lost to contact through consultation of clinical records and community tracing. Hospitalizations and suicidal ideation were queried systematically at each research assessment.
Endocrine disorders Hypoglycemia - Hospitalization	1.1% 5/469 • Number of events 5 • Adverse events were collected from consent through each participant's study completion, up to approximately 12 months post-consent. Deaths were assessed systematically for any participant lost to contact through consultation of clinical records and community tracing. Hospitalizations and suicidal ideation were queried systematically at each research assessment.	0.00% 0/477 • Adverse events were collected from consent through each participant's study completion, up to approximately 12 months post-consent. Deaths were assessed systematically for any participant lost to contact through consultation of clinical records and community tracing. Hospitalizations and suicidal ideation were queried systematically at each research assessment.
Metabolism and nutrition disorders Jaundice - Hospitalization	0.21% 1/469 • Number of events 1 • Adverse events were collected from consent through each participant's study completion, up to approximately 12 months post-consent. Deaths were assessed systematically for any participant lost to contact through consultation of clinical records and community tracing. Hospitalizations and suicidal ideation were queried systematically at each research assessment.	0.00% 0/477 • Adverse events were collected from consent through each participant's study completion, up to approximately 12 months post-consent. Deaths were assessed systematically for any participant lost to contact through consultation of clinical records and community tracing. Hospitalizations and suicidal ideation were queried systematically at each research assessment.
Metabolism and nutrition disorders Low blood pressure - Hospitalization	0.21% 1/469 • Number of events 1 • Adverse events were collected from consent through each participant's study completion, up to approximately 12 months post-consent. Deaths were assessed systematically for any participant lost to contact through consultation of clinical records and community tracing. Hospitalizations and suicidal ideation were queried systematically at each research assessment.	0.00% 0/477 • Adverse events were collected from consent through each participant's study completion, up to approximately 12 months post-consent. Deaths were assessed systematically for any participant lost to contact through consultation of clinical records and community tracing. Hospitalizations and suicidal ideation were queried systematically at each research assessment.
Infections and infestations Malaria - Hospitalization	0.64% 3/469 • Number of events 3 • Adverse events were collected from consent through each participant's study completion, up to approximately 12 months post-consent. Deaths were assessed systematically for any participant lost to contact through consultation of clinical records and community tracing. Hospitalizations and suicidal ideation were queried systematically at each research assessment.	0.21% 1/477 • Number of events 1 • Adverse events were collected from consent through each participant's study completion, up to approximately 12 months post-consent. Deaths were assessed systematically for any participant lost to contact through consultation of clinical records and community tracing. Hospitalizations and suicidal ideation were queried systematically at each research assessment.
Musculoskeletal and connective tissue disorders Physical therapy referral - Hospitalization	0.21% 1/469 • Number of events 1 • Adverse events were collected from consent through each participant's study completion, up to approximately 12 months post-consent. Deaths were assessed systematically for any participant lost to contact through consultation of clinical records and community tracing. Hospitalizations and suicidal ideation were queried systematically at each research assessment.	0.00% 0/477 • Adverse events were collected from consent through each participant's study completion, up to approximately 12 months post-consent. Deaths were assessed systematically for any participant lost to contact through consultation of clinical records and community tracing. Hospitalizations and suicidal ideation were queried systematically at each research assessment.
Musculoskeletal and connective tissue disorders Rheumatism - Hospitalization	0.21% 1/469 • Number of events 1 • Adverse events were collected from consent through each participant's study completion, up to approximately 12 months post-consent. Deaths were assessed systematically for any participant lost to contact through consultation of clinical records and community tracing. Hospitalizations and suicidal ideation were queried systematically at each research assessment.	0.21% 1/477 • Number of events 1 • Adverse events were collected from consent through each participant's study completion, up to approximately 12 months post-consent. Deaths were assessed systematically for any participant lost to contact through consultation of clinical records and community tracing. Hospitalizations and suicidal ideation were queried systematically at each research assessment.