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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: Completed study, sponsored by Drexel University.

NCT03304912 is a clinical trial that has completed, run by Drexel University. The registered enrollment target is 105 participants. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

Number of WWID accepting a paper Truvada prescription to fill at their preferred pharmacy or obtaining Truvada from the SSP among those who returned to care as verified in electronic medical records.

Interventions

  • BEHAVIORAL PrEP Education and option to accept a PrEP prescription

Trial Details

FieldValue
Enrollment Target 105 participants
Start Date 2018-04-03
Est. Completion 2019-10-08
Drexel University

92 total trials

What the finished NCT03304912 record still lists

NCT03304912 is an observational study that tracks outcomes without assigning an intervention. The registered 105 participants enrollment target is mid-sized for trials with a published cap.

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 does not publish any study locations in the registry export this page uses.

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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Source: ClinicalTrials.gov NCT03304912, the US trial registry maintained by the National Library of Medicine. NCT03304912 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.