Trial Outcomes & Findings for PrEP4Her: Developing a Novel Strategy to Implement PrEP Into Women's Healthcare (NCT NCT07209722)
NCT ID: NCT07209722
Last Updated: 2026-01-26
Results Overview
Number of participants receiving a new PrEP prescription during the recruitment period
Recruitment status
COMPLETED
Target enrollment
1377 participants
Primary outcome timeframe
8 months
Results posted on
2026-01-26
Participant Flow
Participant milestones
| Measure |
Sexual Health-PRO
Patients seen during routine GYN clinic visit.
PrEP acronym (pre-exposure prophylaxis): Tracked PrEP prescriptions over 8 months among patients who completed the survey
|
Post Visit (Fidelity) Survey
Patients who completed the survey outside of clinic visit
PrEP acronym (pre-exposure prophylaxis): Tracked PrEP prescriptions over 8 months among patients who completed the survey
|
|---|---|---|
|
Overall Study
STARTED
|
1135
|
242
|
|
Overall Study
COMPLETED
|
1135
|
242
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
PrEP4Her: Developing a Novel Strategy to Implement PrEP Into Women's Healthcare
Baseline characteristics by cohort
| Measure |
Sexual Health-PRO
n=1135 Participants
Patients seen during routine GYN clinic visit.
PrEP acronym (pre-exposure prophylaxis): Tracked PrEP prescriptions over 8 months among patients who completed the survey
|
Post Visit (Fidelity) Survey
n=242 Participants
Patients who completed the survey outside of clinic visit
PrEP acronym (pre-exposure prophylaxis): Tracked PrEP prescriptions over 8 months among patients who completed the survey
|
Total
n=1377 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=25 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=50 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1135 Participants
n=25 Participants
|
242 Participants
n=25 Participants
|
1377 Participants
n=50 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=25 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=50 Participants
|
|
Age, Continuous
|
35 year
STANDARD_DEVIATION 11.5 • n=25 Participants
|
35 year
STANDARD_DEVIATION 11.5 • n=25 Participants
|
35 year
STANDARD_DEVIATION 11.5 • n=50 Participants
|
|
Sex: Female, Male
Female
|
1135 Participants
n=25 Participants
|
242 Participants
n=25 Participants
|
1377 Participants
n=50 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=25 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=50 Participants
|
|
Race/Ethnicity, Customized
Black
|
727 Participants
n=25 Participants
|
100 Participants
n=25 Participants
|
827 Participants
n=50 Participants
|
|
Race/Ethnicity, Customized
White
|
235 Participants
n=25 Participants
|
140 Participants
n=25 Participants
|
375 Participants
n=50 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
143 Participants
n=25 Participants
|
2 Participants
n=25 Participants
|
145 Participants
n=50 Participants
|
|
Race/Ethnicity, Customized
Asian
|
30 Participants
n=25 Participants
|
0 Participants
n=25 Participants
|
30 Participants
n=50 Participants
|
|
Region of Enrollment
United States
|
1135 Participants
n=25 Participants
|
242 Participants
n=25 Participants
|
1377 Participants
n=50 Participants
|
PRIMARY outcome
Timeframe: 8 monthsPopulation: All women who received care at the GYN clinic during the study period received the PrEP4Her intervention as a component of their routine standard of gynecologic care.
Number of participants receiving a new PrEP prescription during the recruitment period
Outcome measures
| Measure |
Sexual Health-PRO
n=1135 Participants
Patients seen during routine GYN clinic visit.
PrEP acronym (pre-exposure prophylaxis): Tracked PrEP prescriptions over 8 months among patients who completed the survey
|
Post Visit (Fidelity) Survey
n=242 Participants
Patients who completed the survey outside of clinic visit
PrEP acronym (pre-exposure prophylaxis): Tracked PrEP prescriptions over 8 months among patients who completed the survey
|
|---|---|---|
|
PrEP Prescriptions
|
11 Participants
|
0 Participants
|
Adverse Events
Sexual Health-PRO
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Post Visit (Fidelity) Survey
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place