Adverse Events Module
For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.
Adverse Events Module path is as follows:
Study -> Results Section -> Adverse Events Module -> Event Groups
Study -> Results Section -> Adverse Events Module -> Serious Events
Study -> Results Section -> Adverse Events Module -> Other Events
Adverse Events Module
Ignite Creation Date:
2025-12-26 @ 11:07 AM
Ignite Modification Date:
2025-12-26 @ 11:07 AM
NCT ID:
NCT03681912
Description:
All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed because the study was deemed no more than minimal risk.
Frequency Threshold:
0
Time Frame:
Not applicable as we did not monitor for adverse events.
Study:
NCT03681912
Study Brief:
Tailored Motivational Interviewing Implementation-Effectiveness Trial in Multidisciplinary Adolescent HIV Care Settings
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Implementation Block 1 | Competency: 12-Item Motivational Interviewing (MI) Coach Rating Scale (CRS) performed monthly but reported quarterly, starting at 3 months. Competency: 12-Item Motivational Interviewing (MI) Coach Rating Scale (CRS): Coaching feedback will be triggered by a provider falling below the competency threshold on the standardized patient interaction. Everyone will receive coaching for two assessments in the month following training. After that, if mean scores fall below competency, then the provider will receive a 45-minute coaching session by the external Motivational Interviewing Network of Trainers (MINT) facilitator. Feedback on two highest and two lowest ratings, review of the audio recording and interactive coaching activities (e.g., fidelity assessments) targeting the lowest ratings. While many aspects of this implementation strategy are adaptable, organizational leadership will review data on completion of coaching feedback sessions and will determine corrective action for suboptimal adherence. | 0 | None | 0 | 0 | 0 | 0 | View |
| Implementation Block 2 | Competency: 12-Item Motivational Interviewing (MI) Coach Rating Scale (CRS) performed monthly but reported quarterly, starting at 6 months. Competency: 12-Item Motivational Interviewing (MI) Coach Rating Scale (CRS): Coaching feedback will be triggered by a provider falling below the competency threshold on the standardized patient interaction. Everyone will receive coaching for two assessments in the month following training. After that, if mean scores fall below competency, then the provider will receive a 45-minute coaching session by the external Motivational Interviewing Network of Trainers (MINT) facilitator. Feedback on two highest and two lowest ratings, review of the audio recording and interactive coaching activities (e.g., fidelity assessments) targeting the lowest ratings. While many aspects of this implementation strategy are adaptable, organizational leadership will review data on completion of coaching feedback sessions and will determine corrective action for suboptimal adherence. | 0 | None | 0 | 0 | 0 | 0 | View |
| Implementation Block 3 | Competency: 12-Item Motivational Interviewing (MI) Coach Rating Scale (CRS) performed monthly but reported quarterly, starting at 9 months. Competency: 12-Item Motivational Interviewing (MI) Coach Rating Scale (CRS): Coaching feedback will be triggered by a provider falling below the competency threshold on the standardized patient interaction. Everyone will receive coaching for two assessments in the month following training. After that, if mean scores fall below competency, then the provider will receive a 45-minute coaching session by the external Motivational Interviewing Network of Trainers (MINT) facilitator. Feedback on two highest and two lowest ratings, review of the audio recording and interactive coaching activities (e.g., fidelity assessments) targeting the lowest ratings. While many aspects of this implementation strategy are adaptable, organizational leadership will review data on completion of coaching feedback sessions and will determine corrective action for suboptimal adherence. | 0 | None | 0 | 0 | 0 | 0 | View |
| Implementation Block 4 | Competency: 12-Item Motivational Interviewing (MI) Coach Rating Scale (CRS) performed monthly but reported quarterly, starting at 12 months. Competency: 12-Item Motivational Interviewing (MI) Coach Rating Scale (CRS): Coaching feedback will be triggered by a provider falling below the competency threshold on the standardized patient interaction. Everyone will receive coaching for two assessments in the month following training. After that, if mean scores fall below competency, then the provider will receive a 45-minute coaching session by the external Motivational Interviewing Network of Trainers (MINT) facilitator. Feedback on two highest and two lowest ratings, review of the audio recording and interactive coaching activities (e.g., fidelity assessments) targeting the lowest ratings. While many aspects of this implementation strategy are adaptable, organizational leadership will review data on completion of coaching feedback sessions and will determine corrective action for suboptimal adherence. | 0 | None | 0 | 0 | 0 | 0 | View |
| Implementation Block 5 | Competency: 12-Item Motivational Interviewing (MI) Coach Rating Scale (CRS) performed monthly but reported quarterly, starting at 15 months. Competency: 12-Item Motivational Interviewing (MI) Coach Rating Scale (CRS): Coaching feedback will be triggered by a provider falling below the competency threshold on the standardized patient interaction. Everyone will receive coaching for two assessments in the month following training. After that, if mean scores fall below competency, then the provider will receive a 45-minute coaching session by the external Motivational Interviewing Network of Trainers (MINT) facilitator. Feedback on two highest and two lowest ratings, review of the audio recording and interactive coaching activities (e.g., fidelity assessments) targeting the lowest ratings. While many aspects of this implementation strategy are adaptable, organizational leadership will review data on completion of coaching feedback sessions and will determine corrective action for suboptimal adherence. | 0 | None | 0 | 0 | 0 | 0 | View |
| Sustainment Block 1 Facilitated CoP | Randomized Guided Development of COPs with an internal facilitator after one year of implementation. Randomized Guided Development of COPs with an internal facilitator after one year of implementation.: Development of the CoP will be guided by scheduling and assisting in setting the agenda for the first three meetings to encourage MI practice, peer coaching and potentially fidelity monitoring, and prevent drift. In addition to CoP, half the sites will be randomized to receive an internal facilitator who will be trained to continue quarterly fidelity monitoring and coaching feedback when scores fall below competency. | 0 | None | 0 | 0 | 0 | 0 | View |
| Sustainment Block 2 Facilitated CoP | Randomized Guided Development of COPs with an internal facilitator after one year of implementation. Randomized Guided Development of COPs with an internal facilitator after one year of implementation.: Development of the CoP will be guided by scheduling and assisting in setting the agenda for the first three meetings to encourage MI practice, peer coaching and potentially fidelity monitoring, and prevent drift. In addition to CoP, half the sites will be randomized to receive an internal facilitator who will be trained to continue quarterly fidelity monitoring and coaching feedback when scores fall below competency. | 0 | None | 0 | 0 | 0 | 0 | View |
| Sustainment Block 3 Facilitated CoP | Randomized Guided Development of COPs with an internal facilitator after one year of implementation. Randomized Guided Development of COPs with an internal facilitator after one year of implementation.: Development of the CoP will be guided by scheduling and assisting in setting the agenda for the first three meetings to encourage MI practice, peer coaching and potentially fidelity monitoring, and prevent drift. In addition to CoP, half the sites will be randomized to receive an internal facilitator who will be trained to continue quarterly fidelity monitoring and coaching feedback when scores fall below competency. | 0 | None | 0 | 0 | 0 | 0 | View |
| Sustainment Block 4 Facilitated CoP | Randomized Guided Development of COPs with an internal facilitator after one year of implementation. Randomized Guided Development of COPs with an internal facilitator after one year of implementation.: Development of the CoP will be guided by scheduling and assisting in setting the agenda for the first three meetings to encourage MI practice, peer coaching and potentially fidelity monitoring, and prevent drift. In addition to CoP, half the sites will be randomized to receive an internal facilitator who will be trained to continue quarterly fidelity monitoring and coaching feedback when scores fall below competency. | 0 | None | 0 | 0 | 0 | 0 | View |
| Sustainment Block 5 Facilitated CoP | Randomized Guided Development of CoPs with an internal facilitator after one year of implementation. Randomized Guided Development of COPs with an internal facilitator after one year of implementation.: Development of the CoP will be guided by scheduling and assisting in setting the agenda for the first three meetings to encourage MI practice, peer coaching and potentially fidelity monitoring, and prevent drift. In addition to CoP, half the sites will be randomized to receive an internal facilitator who will be trained to continue quarterly fidelity monitoring and coaching feedback when scores fall below competency. | 0 | None | 0 | 0 | 0 | 0 | View |
| Sustainment Block 1 CoP Alone | After one year of implementation, site is randomized to receive CoP development without internal facilitation. CoP development without internal facilitation.: Development of the CoP will be guided by scheduling and assisting in setting the agenda for the first three meetings to encourage MI practice, peer coaching and potentially fidelity | 0 | None | 0 | 0 | 0 | 0 | View |
| Sustainment Block 2 CoP Alone | After one year of implementation, site is randomized to receive CoP development without internal facilitation. CoP development without internal facilitation.: Development of the CoP will be guided by scheduling and assisting in setting the agenda for the first three meetings to encourage MI practice, peer coaching and potentially fidelity | 0 | None | 0 | 0 | 0 | 0 | View |
| Sustainment Block 3 CoP Alone | After one year of implementation, site is randomized to receive CoP development without internal facilitation. CoP development without internal facilitation.: Development of the CoP will be guided by scheduling and assisting in setting the agenda for the first three meetings to encourage MI practice, peer coaching and potentially fidelity | 0 | None | 0 | 0 | 0 | 0 | View |
| Sustainment Block 4 CoP Alone | After one year of implementation, site is randomized to receive CoP development without internal facilitation. CoP development without internal facilitation.: Development of the CoP will be guided by scheduling and assisting in setting the agenda for the first three meetings to encourage MI practice, peer coaching and potentially fidelity | 0 | None | 0 | 0 | 0 | 0 | View |
| Sustainment Block 5 CoP Along | After one year of implementation, site is randomized to receive CoP development without internal facilitation. CoP development without internal facilitation.: Development of the CoP will be guided by scheduling and assisting in setting the agenda for the first three meetings to encourage MI practice, peer coaching and potentially fidelity | 0 | None | 0 | 0 | 0 | 0 | View |
Serious Events(If Any):
Other Events(If Any):