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NCT03304912 · ClinicalTrials.gov registry record
Packaging PrEP to Prevent HIV Among WWID
A clinical trial, sponsored by Drexel University.
- Completed
- Registry status
- 105
- Enrollment target
NCT03304912 is a clinical trial that has completed, run by Drexel University. The registered enrollment target is 105 participants.
The verdict
NCT03304912 has completed, sponsored by Drexel University.
- COMPLETED
- Registry status
- 105 participants
- Enrollment target
Study Summary
Evidence suggests women who inject drugs (WWID) are disproportionately vulnerable to HIV. If HIV incidence continues unchecked, 1 in 23 WWID in the United States will acquire HIV. This observational study will evaluate a novel approach for the delivery of pre-exposure prophylaxis (PrEP) care: pairing PrEP with community-based syringe exchange program (SEP) services. The rationale is that (1) SEPs may currently provide prescription medications and long-term monitoring for other conditions such as buprenorphine for opioid dependence, so providing PrEP care is a natural extension of what is already being done successfully; (2) SEPs are a viable access point for many HIV-uninfected WWID who would be considered eligible for PrEP under current clinical guidelines; and (3) PrEP interventions, delivered in settings already utilized and trusted by WWID, will increase uptake, adherence and retention in PrEP. We will enroll a cohort of 125 women and follow-them over six months. At their first study visit, they will educated about and offered a prescription for PrEP. Those who indicate an interest in PrEP will be able to return to the SEP one week later to obtain a paper PrEP prescription or medication. All participants will be followed for six months using qualitative interviews and surveys to understand facilitators and barriers to PrEP uptake and engagement over time. In addition, we will collect urine and test it to detect the level of drug concentration among women who initiate PrEP. This will allow us to know whether their level of adherence translated to prevention effective drug levels.
Interventions
- BEHAVIORAL PrEP Education and option to accept a PrEP prescription
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 105 participants |
| Start Date | 2018-04-03 |
| Est. Completion | 2019-10-08 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03304912
The ClinicalTrials.gov registry entry for NCT03304912 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 105 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Drexel University, which has 92 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which PrEP Education and option to accept a PrEP prescription is the first listed.
NCT03304912 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03304912 about?
NCT03304912 is a clinical study titled "Packaging PrEP to Prevent HIV Among WWID". Evidence suggests women who inject drugs (WWID) are disproportionately vulnerable to HIV. If HIV incidence continues unchecked, 1 in 23 WWID in the United States will acquire HIV. This observational study will evaluate a novel approach for the delivery of pre-exposure prophylaxis (PrEP) care: pairin...
What is the current status of trial NCT03304912?
This trial is currently completed. The enrollment target is 105 participants. The study started on 2018-04-03. Estimated completion is 2019-10-08.
What interventions are being tested in trial NCT03304912?
The interventions under investigation include: PrEP Education and option to accept a PrEP prescription (BEHAVIORAL).
Who is sponsoring clinical trial NCT03304912?
This trial is sponsored by Drexel University, which has 92 total clinical trials registered on ClinicalTrials.gov.
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