Trial Outcomes & Findings for Pre-Exposure Prophylaxis in the Emergency Department (NCT NCT04429971)

Of 1455 patients screened, 169 were eligible, 26 were randomized and received their assigned intervention.

Pre-Exposure Prophylaxis in the Emergency Department

Engagement is care is defined by attending at least 1 out-patient clinic appointment with a PrEP provider within 30-days of the ED visit.

PrEPPED Satisfaction and Acceptability Survey is a patient satisfaction questionnaire was developed by the study team. It's a series of independent Likert questions from 1-6 addressing different aspects of the program. Full scale from 0 to 18, with higher score indicating more satisfaction. Satisfaction data were not collected at 30, 60, or 90 days. After study initiation, it was determined by the researchers that the satisfaction items were specific to the emergency department visit experience and not relevant to the follow-up period. Consequently, decision was made to not administer the follow-up satisfaction assessments, therefore, no data was collected so there is no data to report.

The VSQ-9 is a visit-specific satisfaction instrument adapted by the American Medical Guidelines Regimen Information Program (GRIP) survey. GRIP guide is a self-report to assess PrEP adherence at 30-days post ED visit, with 6 categorical items: excellent, very good, good, fair, poor, and very poor. Because participants were not required to follow up at a single clinic, post-discharge care settings varied widely. The VSQ-9 assesses satisfaction with a specific clinical encounter, and applying it across multiple, non-standardized settings was deemed inappropriate and unlikely to yield interpretable data. Therefore, decision was made by the researcher to not administer the VSQ-9 at 30, 60, or 90 days. Consequently, no follow-up VSQ-9 data were collected so there is no data to report.

CDC Sexual Behavior Questions (CSBQ) to measure HIV risk behavior. CSBQ is a multi-tiered, gender-specific questionnaire developed by the Centers for Disease Control and Prevention HIV-STID Behavioral Surveillance Working Group. Three separate domains - Sexual Behavior, Drug-related HIV risk, and HIV testing. Responses are yes/no with no summation. Number of participants who engaged in unsafe sexual behavior, was under substance influence and who had a HIV test.

Number of new STI diagnosis between day 1 (day after enrollment) and day 90 (final day of follow-up) broken down into days 1-30, 31-60, 61-90.

Number of new HIV diagnosis at 90-days after enrollment. This question was only asked for those individuals who had not been lost to follow-up.