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N/A N=95

Packaging PrEP to Prevent HIV Among WWID

HIV/AIDS

Enrolled (actual)
95
Serious AEs
3.2%
Results posted
Jul 2023
Primary outcome: Primary: PrEP Uptake at Week 1 — 63 Participants

Study Design & Population

Study type
Observational
Phase
N/A
Interventions
PrEP Education and option to accept a PrEP prescription (Behavioral)
Age
Adult, Older Adult · 18+ yrs
Sex
Female
Sponsor
Drexel University
Primary completion
Oct 2019

Outcome Measures

OutcomeResultp-value
PRIMARY
PrEP Uptake at Week 1
63
SECONDARY
PrEP Uptake at Week 12
48
SECONDARY
PrEP Adherence Based on Urinalysis at 12 Weeks
1
SECONDARY
PrEP Adherence Based on Self-report at 12 Weeks
18; 9; 24
SECONDARY
PrEP Uptake at Week 24
25

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.

Eligibility Criteria

Inclusion Criteria

  • HIV sero-negative
  • Females
  • 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03304912). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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