Clinical trial NCT03304912: Packaging PrEP to Prevent HIV Among WWID
Official title: Packaging Pre-Exposure Prophylaxis (PrEP) to Prevent HIV Transmission Among Women Who Inject Drugs
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV/AIDS
Keywords: Pre-Exposure Prophylaxis
Injection Drug Use
Lead sponsor: Drexel University
Sponsor class: OTHER
First posted: 2017-10-09
Enrollment: 105
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Community sample to be recruited from a syringe exchange program.

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.

Eligibility criteria: Inclusion Criteria:

* HIV sero-negative
* Females
* Age ≥18 years
* Reporting non-prescription injection drug use and any of the following:

  1. Syringe sharing
  2. Injecting drugs with a HIV-positive partner
  3. Recent opioid agonist treatment but still injecting drugs
  4. Sex exchange
  5. Inconsistent condom use
  6. Recent bacterial sexually transmitted infection (STI)
  7. 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

Primary outcomes:
measure: PrEP Uptake at Week 1
timeFrame: 1 week
Secondary outcomes:
measure: PrEP Uptake at Week 12
timeFrame: 12 weeks
measure: PrEP Adherence Based on Urinalysis at 12 Weeks
timeFrame: 12 weeks
measure: PrEP Adherence Based on Self-report at 12 Weeks
timeFrame: 12 weeks
measure: PrEP Uptake at Week 24
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Drexel University Dornsife School of Public Health
state: Pennsylvania
Study officials:
affiliation: Drexel University
name: Alexis M Roth, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: