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
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Infeccion de Amor (Infectious Love) | Participants will view four IA intervention episodes, one per week starting immediately after the baseline survey and orientation. Participants will receive an email to their preferred email address with a password to access the episode on the IA's website: https://www.infecciondeamor.com. Each 10-minute episode can be watched more than once during the week and presents a situation with notable HIV risk and ways the characters avoided risk (e.g., condom use) or confronted consequences of poor practices (e.g., HIV infection). | 0 | None | 0 | 31 | 0 | 31 | View |
| Wait-listed | Participants will receive IA in the same manner as the intervention group. Participants will start watching the telenovela episodes 4 months after their baseline survey (after T3 survey). Participants will be informed at recruitment of this group condition and the study randomization. During the waiting time, participants will be called on a monthly basis to encourage participation and refer to services if needed. Infeccion de Amor (Infectious Love): Infectious Love is a filmed dramatized story (telenovela/soap opera) Infección de Amor (IA), or "Infectious Love" - culturally tailored for US Latinas and delivered online. IA is a four-episode HIV prevention telenovela co-created with Latinas and a community-based participatory and interdisciplinary. Participants have one week window to watch the 10-minute episodes from their preferred device and location. | 0 | None | 0 | 27 | 0 | 27 | View |