Protection of participants
ADVERSE EVENTS, EVENT
The risks associated with participating in this study can be categorized as minimal (i.e., risks are regarded as being similar to everyday risks, and there is adequate surveillance and protections integrated into the ongoing evaluation plan to discover adverse events promptly and keep their effects minimal). We will use procedures to promptly detect and respond to adverse events so as to minimize their effects. Nonetheless, we will convene a Data and Safety Monitoring Board (DSMB), a three-person team with expertise in statistical analysis and public health research among marginalized populations. DSMB will convene to (1) periodically review and evaluate the accumulated study data for participant safety, study conduct and progress, and, when appropriate, effectiveness, and (2) make recommendations to National Institute of Health concerning the continuation, modification, or termination of the trial. The DSMB considers study-specific data as well as relevant background knowledge about the intervention and population under study. Prior to initiating any data review, the DSMB will be responsible for defining its deliberative processes, including: event triggers that would call for an unscheduled review, stopping procedures that are consistent with the protocol, and voting procedures. The DSMB is also responsible for maintaining the confidentiality of its internal discussions and activities as well as the contents of reports provided to it.The DSMB will review the protocol for any major concern prior to implementation. During the study period, the DSMB will review cumulative study data to evaluate safety, study conduct, and scientific validity and integrity of the trial at 6-month intervals. As part of this responsibility, DSMB members must be satisfied that the timeliness, completeness, and accuracy of the data submitted to them for review are sufficient for evaluation of the safety and welfare of all study participants. The DSMB will also assess the performance of overall study operations and any other relevant issues, as necessary.