Status:
COMPLETED
Integrating PrEP Into Family Planning Services at Title X Clinics in the Southeastern US
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute on Drug Abuse (NIDA)
Conditions:
HIV Infections
Eligibility:
FEMALE
13-45 years
Brief Summary
Pre-exposure Prophylaxis (PrEP) is a daily pill to prevent HIV that, when taken as prescribed, reduces the risk of getting HIV from sexual intercourse or drug use. In the United States, most studies w...
Detailed Description
Planning4PrEP is a mixed hybrid Type 1 effectiveness implementation study of three family planning clinics in Atlanta integrating PrEP into their services and evaluating the multi-level factors associ...
Eligibility Criteria
Inclusion
- Must be self-identified as born female
- Must be able to be provide written informed consent
- Must be able to speak and understand English as determined by staff during recruitment
- Must be 13-45 years old at time of consent
- Must have been seen for a patient visit in one of the three implementation clinics during the preceding 60 days and identified as a PrEP candidate based on point-of-care HIV testing and risk assessment
Exclusion
- HIV-infected at the time of screening by self-report or screening laboratory assessment
- Currently enrolled in an HIV vaccine trial
- Has any condition that in the opinion of study staff would make participation in the study unsafe or interfere with achieving study objectives
- Has been on PrEP for 7 or more consecutive days in the past
- Currently receiving PrEP services at any location outside the 3 implementation clinics
- Currently participating in another PrEP or candidate PrEP study
Key Trial Info
Start Date :
October 7 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 31 2022
Estimated Enrollment :
103 Patients enrolled
Trial Details
Trial ID
NCT04097834
Start Date
October 7 2019
End Date
March 31 2022
Last Update
May 10 2022
Active Locations (1)
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1
Emory University
Atlanta, Georgia, United States, 30322