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 |
|---|---|---|---|---|---|---|---|---|
| Treatment As Usual (TAU) | We have elected to compare the CM plus stepped care condition to TAU to test its efficacy against a "real world" control and because CM plus stepped care is a comprehensive stand alone intervention that would substitute for TAU. While annual AUDIT-C screening is mandatory at the 7 sites, providing interventions for patients with unhealthy alcohol use is a matter of physician judgment and individual clinical practice with wide practice variation. HIV clinicians will not receive knowledge of the results of follow-up research assessments. We will conduct a Treatment Services Review at each follow-up to assess for receipt of addiction treatment services received since the last assessment and assess for contamination. | 0 | None | 2 | 60 | 4 | 60 | View |
| Contingency Management Plus Stepped Care (Step 2) | Step 1: Contingency management (CM); Step 2: Addiction physician management and motivational enhancement therapy We provide a priori intervals and criteria (drinking targets) that dictate increasing the intensity of treatment (stepping up) based on research and standards in the field. All CM plus stepped care subjects will undergo PEth testing at 3 months to determine the efficacy of Step 1. Patients with a PEth \> 8 ng/ml will continue on to Step 2. Contingency Management Counseling: CM is an efficacious treatment for individuals with substance use disorders. In line with operant conditioning, CM provides reinforcers (rewards) contingent upon attaining specified goals such as decreased substance use and/or abstinence. Addiction Physician Management: Patients in the CM plus stepped care arm who have PEth \> 8 ng/ml at 3 months will progress to Step 2 and receive onsite treatment from an Addiction Psychiatrist (APM) in the HIV clinic. APM will provide care that is typically provided by physicians in specialty referral programs. Motivational Enhancement Therapy: Patients in the CM plus stepped care arm who have PEth \> 8 ng/ml at 3 months will progress to Step 2 and receive onsite MotivationalEnhancement Therapy (MET) from the Social Worker (SW) in the HIV clinic. The SW's role is to assist the patient in moving through the stages of change using motivational interviewing and reflective listening to help patients identify internal motivation to reduce alcohol use. | 2 | None | 7 | 60 | 3 | 60 | View |