Adverse Events Module

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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 @ 12:39 AM
Ignite Modification Date: 2025-12-25 @ 10:49 PM
NCT ID: NCT03135067
Description: Other (Not Including Serious) Adverse Events for this study was categorized as Intimate partner violence (IPV) and social harms. IPV was only assessed via 6-month surveys, so the denominators vary from other AE categories.
Frequency Threshold: 0
Time Frame: Adverse events were monitored and recorded for the full 24 month duration of the study (June 4, 2017 - March 25, 2020).
Study: NCT03135067
Study Brief: Secondary Distribution of HIV Self-tests: an Innovative Strategy for Promoting Partner Testing and Reducing HIV Risk
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Provision of Multiple Self-tests Participants in intervention clusters will be given multiple HIV self-test kits, testing instructions, and advice to use their discretion when offering self-tests to selected sexual partners. Participants will be encouraged to offer self-tests primarily to current and potential partners with whom unprotected sex is likely. All participants will be encouraged to use condoms with sexual partners. Participants will also be advised to assess the risk of intimate partner violence (IPV) as a result of offering self-tests to partners. Participants will have opportunities to obtain additional HIV self-test kits on a monthly basis. Provision of multiple self-tests: Participants will be given multiple Oraquick Advance HIV-1/2 test kits for testing themselves more frequently and for offering to selected sexual partners. The self-test kits will be given to participants on a monthly basis as needed. The intervention is designed to facilitate partner and couples testing, with resulting reduction in risky sexual behavior and HIV incidence among participants. 1 None 0 1019 241 1017 View
Referral Vouchers for VCT Participants will be given a multiple referral vouchers for HIV testing to distribute to their sexual partners. All participants will be encouraged to use condoms with sexual partners. These referral vouchers will encourage the partners to seek HIV counseling \& testing services in local clinics. Participants will also be advised to assess the risk of intimate partner violence (IPV) as a result of offering referral vouchers to partners. Participants will have opportunities to obtain additional referral vouchers on a monthly basis. 1 None 0 991 210 985 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Intimate partner violence and social harms NON_SYSTEMATIC_ASSESSMENT Social circumstances None View