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Packaging PrEP to Prevent HIV Among WWID

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03304912
Recruitment Status : Recruiting
First Posted : October 9, 2017
Last Update Posted : July 24, 2018
Information provided by (Responsible Party):
Alexis Roth, Drexel University

Brief Summary:
Pre-exposure prophylaxis (PrEP) is a promising bio-medical HIV prevention strategy that involves the use of single daily dose of emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) by HIV-negative individuals to reduce risk of acquiring HIV. 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. One concern regarding PrEP implementation for WWID is that they will face a number of challenges to engaging in PrEP care. To reduce barriers and thereby increase the individual and public health benefits of PrEP, alternative approaches based outside of traditional clinical settings are needed. The proposed research is significant, because PrEP could reduce HIV acquisition among WWID. However, at present, there is little knowledge to help address PrEP implementation challenges for this understudied group. The proposed research is highly innovative, because it will address this knowledge gap by evaluating a novel approach for the delivery of PrEP care: pairing PrEP with community-based syringe exchange program (SEP) services. This approach may represent a paradigm shift that enables and encourages women in this highly vulnerable population to engage in effective biomedical HIV prevention strategies. 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. To evaluate this approach, a prospective mixed methods study will be initiated within the largest SEP in the mid-Atlantic region. Through semi-structured and in-depth interviews based on the Behavioral Model for Vulnerable Populations, and drug-level monitoring for FTC/TDF adherence, the following specific aims will be addressed: (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 BVMP 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. This is exploratory study will provide preliminary data to generate hypotheses for future intervention studies. The long-term outcome of this research program will be a reduction in HIV among WWID through the delivery of HIV prevention interventions that include PrEP. The reproducibility of this approach, resulting from utilization of an already functional service delivery system, significantly increases the potential for translation to other settings and PWID populations, including men who inject drugs, in domestic and global contexts.

Condition or disease Intervention/treatment
HIV/AIDS Behavioral: PrEP Education and option to accept a PrEP prescription

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Study Type : Observational
Estimated Enrollment : 125 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Packaging Pre-Exposure Prophylaxis (PrEP) to Prevent HIV Transmission Among Women Who Inject Drugs
Actual Study Start Date : April 3, 2018
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Group/Cohort Intervention/treatment
The cohort will be comprised of women who inject drugs who are eligible for PrEP.
Behavioral: PrEP Education and option to accept a PrEP prescription
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).

Primary Outcome Measures :
  1. PrEP Uptake: Receiving a Prescription [ Time Frame: 3 months ]

    We will operationalize PrEP uptake in two ways:

    • First, as receiving a PrEP prescription assessed through medical chart review

  2. PrEP Uptake: Filling a Prescription [ Time Frame: 3 months ]

    We will operationalize PrEP uptake in two ways:

    • Second, receiving the prescription and filling the prescription verified through pharmacy fill data

Secondary Outcome Measures :
  1. PrEP adherence based on urinalysis [ Time Frame: 3 months ]

    We will operationalize PrEP adherence in two ways:

    • First, based on the concentration of FTC in urine

  2. PrEP adherence based on self-report [ Time Frame: 3 months ]

    We will operationalize PrEP adherence in two ways:

    • Second, using a validated self-report measure

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Community sample to be recruited from a syringe exchange program.

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 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03304912

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United States, Pennsylvania
Drexel University Dornsife School of Public Health Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Alexis M Roth, PhD, MPH    267-359-6123   
Contact: Brogan L Piecara, MPH    2673596037   
Principal Investigator: Alexis M Roth, PhD, MPH         
Sponsors and Collaborators
Drexel University

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Responsible Party: Alexis Roth, Assistant Professor, Drexel University Identifier: NCT03304912     History of Changes
Other Study ID Numbers: 1R21DA043417-01A1 ( U.S. NIH Grant/Contract )
First Posted: October 9, 2017    Key Record Dates
Last Update Posted: July 24, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: N/A, IPD will not be shared.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Alexis Roth, Drexel University:
Pre-Exposure Prophylaxis
Injection Drug Use