Ethics approval and consent to participate
TB
ADVERSE EVENTS, EMERGENCY

The study protocol was submitted and approved by the WHO Ethics Research Committee, the University of Witwatersrand Human Research Ethics Committee, the Oromia Regional Health Bureau: Public Health Emergency Management and Health Research Directorate, and the Johns Hopkins University School of Medicine Institutional Review Board. Any changes to the protocol or informed consent forms will be reviewed and approved by all IRBs and ethics committees as an amendment after review by the study team and Sponsor.
Written informed consent will be sought by GCP-trained study and clinic staff from TB index patients for permission to collect their data and, in the intervention clinics, permission to visit their home. Written consent from the child’s caregivers will be sought to collect their child’s data and for TPT services in the home. Separate consent will be sought from the caregiver for participation in two costing interviews. Healthcare workers and caregivers will also be asked to provide consent for time and motion observations. Assent will be obtained in Ethiopia for all child contacts 12 years and older. As all child contacts are less than 5 years old, assent will not be obtained in South Africa. Consent for HIV testing and TPT are not explicitly included in the consent, families will be able to refuse aspects of medical care as they would in a clinical setting. Consent will be obtained from GCP-trained study team members, including some clinic staff in Ethiopia. Remuneration in the amount of 50 Ethiopian Birr or 250 South Africa Rand will be provided to each caregiver for participation in the costing survey. There is no remuneration for participation in the trial.Biological specimens will not be collected or stored by the study. Consent will not be obtained for ancillary studies.
Participants may withdraw from the study at any time and without any consequence to their care. Data already collected will be maintained with the participant’s approval. Notably, discontinuation of TPT differs from study withdrawal. Children in the intervention arm must transfer care back to the clinic.
Each participant will receive a unique participant identification number (PIN). All data collected and entered onto clinical report forms and the REDCap database will not be identifiable, except for treatment start and end dates. A logbook linking the PIN with the participant’s name will be maintained by the research assistant and accessible only to the study team in locked, fireproof cabinets at each clinic.
Protocol-defined adverse events did not include adverse events related to TPT since all TPT was given according to National Guideline. Protocol-defined risks included loss of confidentiality and incorrect initiation of TPT. Therefore, no ancillary or post-trial care or compensation will be provided to participants.
Community advisory boards at each site will relay study results to the participants and their communities. A final report will be sent to the National TB Program, the WHO, and UNITAID. Study results will be presented at scientific meetings and published in peer-reviewed, open-access journals.