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:
2025-12-25 @ 4:15 AM
Ignite Modification Date:
2025-12-26 @ 3:15 AM
NCT ID:
NCT05417620
Description:
None
Frequency Threshold:
0
Time Frame:
up to 1 year
Study:
NCT05417620
Study Brief:
Le Kip Kip: A Campaign to Change Social Norms and Build Sustainable Demand for PrEP Among Women in South Africa
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Standard of Care | Full-time peer educators employed by the TB HIV Care programme to engage women, layer PrEP promotion across prevention programs, and implement "refer a friend" strategies, information, education and communication (IEC) materials, service user testimonials, risk reduction posters to increase young women's perception of risk, working after hours/weekends to reach young women, working with school governing bodies, and door-to-door outreach. Standard of Care: Full-time peer educators employed by the TB HIV Care programme to engage women, layer PrEP promotion across prevention programs, and implement "refer a friend" strategies, information, education and communication (IEC) materials, service user testimonials, risk reduction posters to increase young women's perception of risk, working after hours/weekends to reach young women, working with school governing bodies, and door-to-door outreach. | 0 | None | 0 | 301 | 0 | 301 | View |
| Enhanced Social Media Campaign + PrEP Champions | Social Media Campaign: PrEP social influence campaign, which will use online approaches to promote PrEP within communities in addition to the standard of care activities. A combination of static imagery and brief videos will be used to engage these groups via social media platforms. A Facebook page will be created and maintained that can be accessed by anyone anywhere, but will only be advertised/promoted in the intervention districts. PrEP Champions: Venue-based PrEP champions will receive supplies (e.g. a hat, pin and posters, flyers, IEC material) to wear to promote PrEP, facilitate linkage between women interested in PrEP and the TB HIV Care PrEP programme. PrEP champions will be either peers with experience taking PrEP, venue managers or local influencers that have repeated contact with the women the programme is intended to serve. | 0 | None | 0 | 55 | 0 | 55 | View |
| Enhanced Social Media Campaign + PrEP Champions + Community Mobilization | Social Media Campaign: PrEP social influence campaign, which will use online approaches to promote PrEP within communities in addition to the standard of care activities. A combination of static imagery and brief videos will be used to engage these groups via social media platforms. A Facebook page will be created and maintained that can be accessed by anyone anywhere, but will only be advertised/promoted in the intervention districts. PrEP Champions: Venue-based PrEP champions will receive supplies (e.g. a hat, pin and posters, flyers, IEC material) to wear to promote PrEP, facilitate linkage between women interested in PrEP and the TB HIV Care PrEP programme. PrEP champions will be either peers with experience taking PrEP, venue managers or local influencers that have repeated contact with the women the programme is intended to serve. Community Mobilization: PrEP community mobilization teams will be recruited to promote PrEP. The team will present information about PrEP and the PrEP programme at the ward councilors meeting, Learning Support Agent meetings with parents/guardians, local events/fairs, community meetings and through engaging men, women and parents across the community through informal conversations. Teams will be wearing branded material and will focus on presenting factual information and decreasing PrEP stigma. | 0 | None | 0 | 105 | 0 | 105 | View |
| Enhanced Social Media Campaign + Community Mobilization | Social Media Campaign: PrEP social influence campaign, which will use online approaches to promote PrEP within communities in addition to the standard of care activities. A combination of static imagery and brief videos will be used to engage these groups via social media platforms. A Facebook page will be created and maintained that can be accessed by anyone anywhere, but will only be advertised/promoted in the intervention districts. Community Mobilization: PrEP community mobilization teams will be recruited to promote PrEP. The team will present information about PrEP and the PrEP programme at the ward councilors meeting, Learning Support Agent meetings with parents/guardians, local events/fairs, community meetings and through engaging men, women and parents across the community through informal conversations. Teams will be wearing branded material and will focus on presenting factual information and decreasing PrEP stigma. | 0 | None | 0 | 48 | 0 | 48 | View |
| Enhanced Social Media Campaign | Social Media Campaign: PrEP social influence campaign, which will use online approaches to promote PrEP within communities in addition to the standard of care activities. A combination of static imagery and brief videos will be used to engage these groups via social media platforms. A Facebook page will be created and maintained that can be accessed by anyone anywhere, but will only be advertised/promoted in the intervention districts. | 0 | None | 0 | 92 | 0 | 92 | View |
Serious Events(If Any):
Other Events(If Any):