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NCT04097834 · ClinicalTrials.gov registry record
Integrating PrEP Into Family Planning Services at Title X Clinics in the Southeastern US
A clinical trial, sponsored by University of North Carolina, Chapel Hill.
- Completed
- Registry status
- 103
- Enrollment target
NCT04097834: Completed study, sponsored by University of North Carolina, Chapel Hill.
NCT04097834 is a clinical trial that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 103 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04097834 has completed, sponsored by University of North Carolina, Chapel Hill.
- COMPLETED
- Registry status
- 103 participants
- Enrollment target
Study 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 which examine prescribing PrEP have not included young women. PrEP provides a way for women to take control of their HIV prevention and may be a good option for some women. Family planning clinics are a trusted source of preventative, routine, and symptom-driven gynecological care for adolescent and young adult women (AYAW). Thus, these clinics are a natural setting to provide PrEP services for AYAW. This study will examine how effectively three clinics in Atlanta are able to implement a PrEP program for their eligible female patients as well as follow a cohort of 300 women for six months (150 starting PrEP immediately and 150 electing to not take PrEP, at least initially) to characterize individual, provider, and clinic-level variables and constructs that are associated with PrEP uptake, continuation, and adherence. Both participant and biological data will be collected to answer the primary research question. Women will provide blood, urine, oral, vaginal, anal, and hair samples at three different time points. These samples will be tested to measure incident sexually transmitted infections and unplanned pregnancies as well as PrEP adherence (for women who initiated PrEP). Ultimately, this data will describe each clinic's effectiveness at providing PrEP services to AYAW.
Primary Outcome
Among participants with a PrEP prescription at baseline, the proportion who initiate PrEP measured via pharmacy prescription fill data, medical chart abstraction, and participant self-report
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 103 participants |
| Start Date | 2019-10-07 |
| Est. Completion | 2022-03-31 |
What the finished NCT04097834 record still lists
NCT04097834 is an observational study that tracks outcomes without assigning an intervention. The registered 103 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT04097834 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04097834 about?
NCT04097834 is a clinical study titled "Integrating PrEP Into Family Planning Services at Title X Clinics in the Southeastern US". 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 which examine prescribing PrEP have not included young women. PrEP provides a way for women to take c...
What is the current status of trial NCT04097834?
This trial is currently completed. The enrollment target is 103 participants. The study started on 2019-10-07. Estimated completion is 2022-03-31.
Who is sponsoring clinical trial NCT04097834?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
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