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Clinical Trials/NCT03304912
NCT03304912
Completed
Not Applicable

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

Drexel University1 site in 1 country105 target enrollmentApril 3, 2018
ConditionsHIV/AIDS

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
HIV/AIDS
Sponsor
Drexel University
Enrollment
105
Locations
1
Primary Endpoint
PrEP Uptake at Week 1
Status
Completed
Last Updated
2 years ago

Overview

Brief 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.

Detailed Description

This prospective mixed methods study will be initiated within the largest SEP in the mid-Atlantic region. Over six months, we will use semi-structured and in-depth interviews based on the Behavioral Model for Vulnerable Populations, and drug-level monitoring for emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) adherence, to address the following specific aims: (1) Describe WWID's engagement in the PrEP care continuum (focusing on critical moments when women could disengage or need additional support to remain in care). (2) Identify factors from the Behavioral Model for Vulnerable Populations that are associated with WWID's engagement in the PrEP care continuum. (3) Explore how and why model factors are associated with WWID's decisions and ability to engage in PrEP care. A paired model of PrEP and SEP services has yet to be tested.

Registry
clinicaltrials.gov
Start Date
April 3, 2018
End Date
October 8, 2019
Last Updated
2 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Alexis Roth

Assistant Professor

Drexel University

Eligibility Criteria

Inclusion Criteria

  • HIV sero-negative
  • Age ≥18 years
  • Reporting non-prescription injection drug use and any of the following:
  • Syringe sharing
  • Injecting drugs with a HIV-positive partner
  • Recent opioid agonist treatment but still injecting drugs
  • Sex exchange
  • Inconsistent condom use
  • Recent bacterial sexually transmitted infection (STI)
  • and/or sex with a HIV-positive partner

Exclusion Criteria

  • HIV seropositivity
  • Currently taking PrEP
  • Pregnant, breastfeeding or trying to become pregnant
  • Previous enrollment in the study

Outcomes

Primary Outcomes

PrEP Uptake at Week 1

Time Frame: 1 week

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.

Secondary Outcomes

  • PrEP Uptake at Week 12(12 weeks)
  • PrEP Uptake at Week 24(24 weeks)
  • PrEP Adherence Based on Urinalysis at 12 Weeks(12 weeks)
  • PrEP Adherence Based on Self-report at 12 Weeks(12 weeks)

Study Sites (1)

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