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Table 5 Defining, monitoring and reporting of harm

From: Collaborative care for the detection and management of depression among adults receiving antiretroviral therapy in South Africa: study protocol for the CobALT randomised controlled trial

Type of harm

Source and method of identification

Action(s) to mitigate harm to specific participants

Reporting frequency and to whom

Adverse Events

Positive response to ninth item of the PHQ-9: “Thoughts that you would be better off dead or of hurting yourself in some way”

Participant interviews (baseline, 6-month follow-up, 12-month follow-up)Flag within electronic questionnaire prompting interviewer to act

Repeat question to reduce telescoping-type reporting errorsIf ≥ 8 days in last 2 weeks, immediate referral to clinic staffIf between 1 and 7 days, then written educational material given

6 monthly report to DSMB6 monthly to IRB (with DSMB letter of recommendation)

PHQ-9 score of ≥ 20 at 12 months suggesting persistent severe depression

Participant interviews (12-month follow-up)Data report (monthly)

Summary forwarded to clinic together with recommendations for further treatment

6 monthly report to DSMB6 monthly to IRB (with DSMB letter of recommendation)

Blood pressure severely raised (≥ 180/110) placing participant at immediate risk of cardiovascular event

Participant interviews (baseline, 6-month follow-up, 12-month follow-up)Flag within electronic questionnaire prompting interviewer to act

Immediate referral to clinic staff for review

6 monthly report to DSMB6 monthly to IRB (with DSMB letter of recommendation)

Raised blood pressure at follow-up representing undiagnosed or uncontrolled hypertension

Participant interviews (baseline, 6-month follow-up, 12-month follow-up)Longitudinal patient record

Summary forwarded to clinic together with recommendations for further treatment

6 monthly report to DSMB6 monthly to IRB (with DSMB letter of recommendation)

Detectable viral load at follow-up representing possible adherence problems or treatment failure

Participant interviews (baseline, 6-month follow-up, 12-month follow-up)Research viral loadsRoutinely collected viral loadsLongitudinal patient record

Summary forwarded to clinic together with recommendations for further treatment

6 monthly report to DSMB6 monthly to IRB (with DSMB letter of recommendation)

Serious Adverse Events

Significantly raised viral load (> 1000 copies/mL) during pregnancy placing fetus at risk of HIV transmission

Participant interviews (baseline, 6-month follow-up, 12-month follow-up)Research viral loadsRoutinely collected viral loadsData report (weekly)

Immediate notification of PI (LF) or delegate (NF) who will personally call clinic and follow-up with them until we can be sure woman is back in care and appropriately treated

Notification of IRB, DSMB and NIMH within 7 days of knowledge of confirmation

Hospitalisation

Participant interviews (baseline, 6-month follow-up, 12-month follow-up)Routinely collected hospitalisation dataData report (monthly)

No immediate action other than 6 monthly review by DSMB

6 monthly report to DSMB6 monthly to IRB (with DSMB letter of recommendation)

Death (excluding suicide)

Participant interviews (loss to follow-up form)National population registerData report (monthly)

No immediate action other than 6 monthly review by DSMB

6 monthly report to DSMB6 monthly to IRB (with DSMB letter of recommendation)

Death by suicide

Participant interviews (loss to follow-up form)National population register (provided we are able to access cause of death)Data report (weekly)

Immediate notification of PI (LF), who will follow-up with fieldwork staff to confirm suicide and establish date of suicide

Notification of IRB, DSMB and NIMH within 7 days of knowledge of confirmed suicide

  1. DSMB Data and Safety Monitoring Board, IRB Institutional Review Board, NIMH National Institute of Mental Health, PI principal investigator