Table 5.
Defining, monitoring and reporting of harm
| 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 |
DSMB Data and Safety Monitoring Board, IRB Institutional Review Board, NIMH National Institute of Mental Health, PI principal investigator