Trial Outcomes & Findings for Pharmacy-based Pre-exposure Prophylaxis (NCT NCT04393935)
NCT ID: NCT04393935
Last Updated: 2025-05-28
Results Overview
Participants who were prescribed PrEP through the pharmacy intervention were contacted after 3 months to see if they continued PrEP use.
COMPLETED
NA
49 participants
Month 3
2025-05-28
Participant Flow
Participants were enrolled through study pharmacies in Atlanta, Georgia, USA. Pharmacy client participant enrollment began May 19, 2022 and all follow-up assessments were completed by May 11, 2024.
Participant milestones
| Measure |
Pharmacy Delivered PrEP Intervention
Clients of the study pharmacies who participate in the intervention to receive Pre-exposure Prophylaxis (PrEP) through the pharmacy.
Pharmacy Delivered PrEP Intervention: Pharmacy client participants who are eligible and agree to the HIV test will be provided with a pre-packaged kit of a self-administered test for HIV and directed back to the private area of the pharmacy to perform their screening. Pharmacy client participants who test HIV negative will be provided with their results and be given a 30-day prescription for PrEP, culturally appropriate PrEP counseling and a follow-up appointment with a PrEP prescribing physician. Pharmacy client participants will be contacted after 3 months to determine whether they continued PrEP use.
|
|---|---|
|
Overall Study
STARTED
|
49
|
|
Overall Study
COMPLETED
|
49
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pharmacy-based Pre-exposure Prophylaxis
Baseline characteristics by cohort
| Measure |
Pharmacy Delivered PrEP Intervention
n=49 Participants
Clients of the study pharmacies who participate in the intervention to receive PrEP through the pharmacy.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
48 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
47 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
45 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
49 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Month 3Participants who were prescribed PrEP through the pharmacy intervention were contacted after 3 months to see if they continued PrEP use.
Outcome measures
| Measure |
Pharmacy Delivered PrEP Intervention
n=49 Participants
Clients of the study pharmacies who participate in the intervention to receive PrEP through the pharmacy.
|
|---|---|
|
Number of Participants Continuing PrEP
|
2 Participants
|
Adverse Events
Pharmacy Delivered PrEP Intervention
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