CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 105 enrolled
Drug / intervention
PrEP Education and option to accept a PrEP prescriptionbehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03304912
NCT03304912N/ACompleted

Packaging Pre-Exposure Prophylaxis (PrEP) to Prevent HIV Transmission Among Women Who Inject Drugs

Drexel University·observational·Posted Oct 9, 2017·Updated Jul 12, 2023

In Brief

An observational study evaluating PrEP Education and option to accept a PrEP prescription for HIV/AIDS. Completed, enrolled 105 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsHIV/AIDS
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedOct 9, 2017
Enrollment StartApr 3, 2018
Primary CompletionOct 8, 2019
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 8.7 years ago

Interventions

PrEP Education and option to accept a PrEP prescriptionbehavioral

Participants will receive educational information about PrEP, be offered a PrEP prescription, and those who choose to initiated PrEP will be monitored for side-effects and adherence at their follow-up visit. There is no group assignment within this study and WWID do not have to choose to initiate PrEP. Rather, the goal of this study is to understand factors that impact PrEP initiation (and engagement in the PrEP care continuum).