emtricitabine/tenofovir alafenamide or emtricitabine/tenofovir disoproxil

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.

Total of all reporting groups

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.

No protocol amendment was generated for this Outcome Measure. Although the outcome was prespecified in the initial protocol, the study team ultimately determined during implementation that the required data elements could not be collected reliably across sites. Because this decision did not alter the study intervention, eligibility criteria, procedures, or primary outcome, and because no participant-facing activities were affected, the team did not submit a formal protocol amendment at the time.

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.

No protocol amendment was generated for this Outcome Measure. Although the outcome was prespecified in the initial protocol, the study team ultimately determined during implementation that the required data elements could not be collected reliably across sites. Because this decision did not alter the study intervention, eligibility criteria, procedures, or primary outcome, and because no participant-facing activities were affected, the team did not submit a formal protocol amendment at the time.

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 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 analyzed at each time differ due to participants being lost to follow-up.

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.

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.

PreP screening program with immediate PrEP (iPrEP) initiation in the ED using a PrEP "starter pack" with facilitated linkage to care.

PrEP screening program: ICAP Pre-Exposure Prophylaxis (PrEP) Screening for Substantial Risk and Eligibility tool

PrEP starter pack: emtricitabine/tenofovir alafenamide or emtricitabine/tenofovir disoproxil