Trial Outcomes & Findings for Pre-Exposure Prophylaxis in the Emergency Department (NCT NCT04429971)
NCT ID: NCT04429971
Last Updated: 2025-12-09
Results Overview
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.
COMPLETED
NA
26 participants
30 days post-ED visit
2025-12-09
Participant Flow
Of 1455 patients screened, 169 were eligible, 26 were randomized and received their assigned intervention.
Participant milestones
| Measure |
Out-patient Care for PrEP Initiation
PrEP screening program with referral to out-patient care for PrEP initiation
PrEP screening program: ICAP Pre-Exposure Prophylaxis (PrEP) Screening for Substantial Risk and Eligibility tool
|
Immediate PreP Initiation
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
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
13
|
|
Overall Study
30-Day Completed
|
9
|
10
|
|
Overall Study
60-Day Completed
|
6
|
7
|
|
Overall Study
90-Day Completed
|
6
|
5
|
|
Overall Study
COMPLETED
|
6
|
5
|
|
Overall Study
NOT COMPLETED
|
7
|
8
|
Reasons for withdrawal
| Measure |
Out-patient Care for PrEP Initiation
PrEP screening program with referral to out-patient care for PrEP initiation
PrEP screening program: ICAP Pre-Exposure Prophylaxis (PrEP) Screening for Substantial Risk and Eligibility tool
|
Immediate PreP Initiation
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
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
7
|
8
|
Baseline Characteristics
Pre-Exposure Prophylaxis in the Emergency Department
Baseline characteristics by cohort
| Measure |
Out-patient Care for PrEP Initiation
n=13 Participants
PrEP screening program with referral to out-patient care for PrEP initiation
PrEP screening program: ICAP Pre-Exposure Prophylaxis (PrEP) Screening for Substantial Risk and Eligibility tool
|
Immediate PreP Initiation
n=13 Participants
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
|
Total
n=26 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Race/Ethnicity, Customized
Missing
|
1 Participants
n=4 Participants
|
0 Participants
n=50 Participants
|
1 Participants
n=518 Participants
|
|
Highest level of education
Some high school, no diploma
|
1 Participants
n=4 Participants
|
2 Participants
n=50 Participants
|
3 Participants
n=518 Participants
|
|
Age, Continuous
|
29.0 years
n=4 Participants
|
34 years
n=50 Participants
|
32.5 years
n=518 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=4 Participants
|
2 Participants
n=50 Participants
|
4 Participants
n=518 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=4 Participants
|
11 Participants
n=50 Participants
|
22 Participants
n=518 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=4 Participants
|
4 Participants
n=50 Participants
|
6 Participants
n=518 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=4 Participants
|
7 Participants
n=50 Participants
|
17 Participants
n=518 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=4 Participants
|
2 Participants
n=50 Participants
|
3 Participants
n=518 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=4 Participants
|
1 Participants
n=50 Participants
|
1 Participants
n=518 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
4 Participants
n=4 Participants
|
8 Participants
n=50 Participants
|
12 Participants
n=518 Participants
|
|
Race/Ethnicity, Customized
More than one race
|
3 Participants
n=4 Participants
|
2 Participants
n=50 Participants
|
5 Participants
n=518 Participants
|
|
Race/Ethnicity, Customized
White
|
5 Participants
n=4 Participants
|
2 Participants
n=50 Participants
|
7 Participants
n=518 Participants
|
|
Highest level of education
High school graduate/GED or equivalent
|
5 Participants
n=4 Participants
|
5 Participants
n=50 Participants
|
10 Participants
n=518 Participants
|
|
Highest level of education
Some college (4-year college or university)
|
3 Participants
n=4 Participants
|
2 Participants
n=50 Participants
|
5 Participants
n=518 Participants
|
|
Highest level of education
College graduate (4-year college or university)
|
3 Participants
n=4 Participants
|
3 Participants
n=50 Participants
|
6 Participants
n=518 Participants
|
|
Highest level of education
Post-college/graduate degree
|
1 Participants
n=4 Participants
|
0 Participants
n=50 Participants
|
1 Participants
n=518 Participants
|
|
Highest level of education
Missing
|
0 Participants
n=4 Participants
|
1 Participants
n=50 Participants
|
1 Participants
n=518 Participants
|
|
Estimated annual total income
< $1000
|
1 Participants
n=4 Participants
|
2 Participants
n=50 Participants
|
3 Participants
n=518 Participants
|
|
Estimated annual total income
$1001-$2500
|
0 Participants
n=4 Participants
|
1 Participants
n=50 Participants
|
1 Participants
n=518 Participants
|
|
Estimated annual total income
$5001-$10,000
|
1 Participants
n=4 Participants
|
0 Participants
n=50 Participants
|
1 Participants
n=518 Participants
|
|
Estimated annual total income
$10,001-$20,000
|
1 Participants
n=4 Participants
|
1 Participants
n=50 Participants
|
2 Participants
n=518 Participants
|
|
Estimated annual total income
$20,001-$40,000
|
0 Participants
n=4 Participants
|
3 Participants
n=50 Participants
|
3 Participants
n=518 Participants
|
|
Estimated annual total income
$40,001 or more
|
5 Participants
n=4 Participants
|
4 Participants
n=50 Participants
|
9 Participants
n=518 Participants
|
|
Estimated annual total income
Don't know
|
3 Participants
n=4 Participants
|
2 Participants
n=50 Participants
|
5 Participants
n=518 Participants
|
|
Estimated annual total income
Missing
|
2 Participants
n=4 Participants
|
0 Participants
n=50 Participants
|
2 Participants
n=518 Participants
|
|
Past-year employment status
Disabled
|
2 Participants
n=4 Participants
|
1 Participants
n=50 Participants
|
3 Participants
n=518 Participants
|
|
Past-year employment status
Looking for work/unemployed
|
3 Participants
n=4 Participants
|
3 Participants
n=50 Participants
|
6 Participants
n=518 Participants
|
|
Past-year employment status
Student
|
0 Participants
n=4 Participants
|
1 Participants
n=50 Participants
|
1 Participants
n=518 Participants
|
|
Past-year employment status
Working full time
|
5 Participants
n=4 Participants
|
4 Participants
n=50 Participants
|
9 Participants
n=518 Participants
|
|
Past-year employment status
Working part time
|
2 Participants
n=4 Participants
|
4 Participants
n=50 Participants
|
6 Participants
n=518 Participants
|
|
Past-year employment status
Prefer not to answer
|
1 Participants
n=4 Participants
|
0 Participants
n=50 Participants
|
1 Participants
n=518 Participants
|
|
Covered by health insurance/health plan
|
12 Participants
n=4 Participants
|
12 Participants
n=50 Participants
|
24 Participants
n=518 Participants
|
|
Frequency of having run out of money for basic necessities in the past year
Daily
|
0 Participants
n=4 Participants
|
2 Participants
n=50 Participants
|
2 Participants
n=518 Participants
|
|
Frequency of having run out of money for basic necessities in the past year
Monthly
|
1 Participants
n=4 Participants
|
1 Participants
n=50 Participants
|
2 Participants
n=518 Participants
|
|
Frequency of having run out of money for basic necessities in the past year
Never
|
6 Participants
n=4 Participants
|
6 Participants
n=50 Participants
|
12 Participants
n=518 Participants
|
|
Frequency of having run out of money for basic necessities in the past year
Occasionally
|
3 Participants
n=4 Participants
|
2 Participants
n=50 Participants
|
5 Participants
n=518 Participants
|
|
Frequency of having run out of money for basic necessities in the past year
Prefer not to answer
|
1 Participants
n=4 Participants
|
0 Participants
n=50 Participants
|
1 Participants
n=518 Participants
|
|
Frequency of having run out of money for basic necessities in the past year
Weekly
|
2 Participants
n=4 Participants
|
2 Participants
n=50 Participants
|
4 Participants
n=518 Participants
|
|
Experiencing homelessness
No
|
13 Participants
n=4 Participants
|
10 Participants
n=50 Participants
|
23 Participants
n=518 Participants
|
|
Experiencing homelessness
Yes
|
0 Participants
n=4 Participants
|
3 Participants
n=50 Participants
|
3 Participants
n=518 Participants
|
|
Current living situation
In a rooming, boarding, or halfway house
|
0 Participants
n=4 Participants
|
1 Participants
n=50 Participants
|
1 Participants
n=518 Participants
|
|
Current living situation
On the street(s) (Vacant lot, abandoned building, park, etc.)
|
0 Participants
n=4 Participants
|
1 Participants
n=50 Participants
|
1 Participants
n=518 Participants
|
|
Current living situation
Other
|
0 Participants
n=4 Participants
|
1 Participants
n=50 Participants
|
1 Participants
n=518 Participants
|
|
Current living situation
Own or rent home/apartment
|
12 Participants
n=4 Participants
|
7 Participants
n=50 Participants
|
19 Participants
n=518 Participants
|
|
Current living situation
Shelter
|
1 Participants
n=4 Participants
|
2 Participants
n=50 Participants
|
3 Participants
n=518 Participants
|
|
Current living situation
Staying at home of friend(s)/other
|
0 Participants
n=4 Participants
|
1 Participants
n=50 Participants
|
1 Participants
n=518 Participants
|
PRIMARY outcome
Timeframe: 30 days post-ED visitEngagement is care is defined by attending at least 1 out-patient clinic appointment with a PrEP provider within 30-days of the ED visit.
Outcome measures
| Measure |
Out-patient Care for PrEP Initiation
n=9 Participants
PrEP screening program with referral to out-patient care for PrEP initiation
PrEP screening program: ICAP Pre-Exposure Prophylaxis (PrEP) Screening for Substantial Risk and Eligibility tool
|
Immediate PreP Initiation
n=10 Participants
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
|
|---|---|---|
|
Engagement in Care (Implementation Component)
|
1 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: 90 daysOutcome measures
| Measure |
Out-patient Care for PrEP Initiation
n=6 Participants
PrEP screening program with referral to out-patient care for PrEP initiation
PrEP screening program: ICAP Pre-Exposure Prophylaxis (PrEP) Screening for Substantial Risk and Eligibility tool
|
Immediate PreP Initiation
n=5 Participants
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
|
|---|---|---|
|
Number of Participants on PrEP Usage
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 30 days post-ED visitPopulation: 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.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 30 days post-ED visitPopulation: 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 30 days post-ED visitCDC 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.
Outcome measures
| Measure |
Out-patient Care for PrEP Initiation
n=9 Participants
PrEP screening program with referral to out-patient care for PrEP initiation
PrEP screening program: ICAP Pre-Exposure Prophylaxis (PrEP) Screening for Substantial Risk and Eligibility tool
|
Immediate PreP Initiation
n=10 Participants
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
|
|---|---|---|
|
CDC Sexual Behavior Questions (CSBQ) (RCT Component)
Sexual Behavior
|
4 Participants
|
5 Participants
|
|
CDC Sexual Behavior Questions (CSBQ) (RCT Component)
Drug-related HIV risk
|
2 Participants
|
2 Participants
|
|
CDC Sexual Behavior Questions (CSBQ) (RCT Component)
HIV testing
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 30 days, 60 days, and 90 days post-ED visitPopulation: 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 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.
Outcome measures
| Measure |
Out-patient Care for PrEP Initiation
n=9 Participants
PrEP screening program with referral to out-patient care for PrEP initiation
PrEP screening program: ICAP Pre-Exposure Prophylaxis (PrEP) Screening for Substantial Risk and Eligibility tool
|
Immediate PreP Initiation
n=10 Participants
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
|
|---|---|---|
|
Number of Participants of New STI Diagnoses (RCT Component)
day 61 to day 90
|
0 Participants
|
0 Participants
|
|
Number of Participants of New STI Diagnoses (RCT Component)
day 1 to day 30
|
1 Participants
|
2 Participants
|
|
Number of Participants of New STI Diagnoses (RCT Component)
day 31 to day 60
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 90 days post-ED visitPopulation: 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.
Outcome measures
| Measure |
Out-patient Care for PrEP Initiation
n=6 Participants
PrEP screening program with referral to out-patient care for PrEP initiation
PrEP screening program: ICAP Pre-Exposure Prophylaxis (PrEP) Screening for Substantial Risk and Eligibility tool
|
Immediate PreP Initiation
n=5 Participants
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
|
|---|---|---|
|
Number of Participants of New HIV Infection (RCT Component)
|
0 Participants
|
0 Participants
|
Adverse Events
Out-patient Care for PrEP Initiation
Immediate PreP Initiation
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Ethan Cowan, MD, MS, FACEP
Rutgers New Jersey Medical School
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place