search
Back to results

ASAP: Access to Syringes at Pharmacies for the Prevention of Bloodborne Infections Among People Who Inject Drugs (ASAP)

Primary Purpose

Skin and Soft Tissue Infections, Hiv, Hepatitis C

Status
Not yet recruiting
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
ASAP
Sponsored by
University of Arizona
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Skin and Soft Tissue Infections

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • full time pharmacy staff member as a pharmacist or a pharmacy technician in an Arizona pharmacy within the three study counties (Pima, Maricopa, Mohave)

Exclusion Criteria:

  • not a full time pharmacy staff member

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    Control

    ASAP Intervention

    Arm Description

    Control pharmacies will not receive the intervention training, coaching or materials. They will track the sale of syringes upon request and they will participate in the surveys.

    ASAP intervention pharmacies will receive the CEU training, coaching from research staff, ASAP materials and tracking for the sale of syringes. They will also participate in surveys.

    Outcomes

    Primary Outcome Measures

    Syringe sales increase as measured by the sales tracking instrument
    ASAP pharmacies will increase the sale of nonprescription syringes upon request
    Reduced stigma as measured by the feasibility assessment tool
    ASAP pharmacy staff will report a reduction in expressed stigma at the time of syringe sales.

    Secondary Outcome Measures

    Full Information

    First Posted
    February 15, 2022
    Last Updated
    February 25, 2022
    Sponsor
    University of Arizona
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05270135
    Brief Title
    ASAP: Access to Syringes at Pharmacies for the Prevention of Bloodborne Infections Among People Who Inject Drugs
    Acronym
    ASAP
    Official Title
    ASAP: Access to Syringes at Pharmacies for the Prevention of Bloodborne Infections Among People Who Inject Drugs
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 2022 (Anticipated)
    Primary Completion Date
    December 2022 (Anticipated)
    Study Completion Date
    March 31, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Arizona

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Access to Syringes at Pharmacies (ASAP) is a refinement of an evidence-based, pharmacy intervention to increase pharmacy-based sales of syringes to PWID in order to reduce bloodborne illnesses among them.
    Detailed Description
    The refinement integrates a motivational enhancement to reduce staff ambivalence about syringe sales to PWID (People who inject drugs), sampling improvements to assure that project pharmacies are likely serving PWID, and refinements to the intervention training content and delivery in three selected Arizona project counties of Mohave, Maricopa and Pima. Our development and refinement of ASAP relies on: 1) interviews with pharmacy staff of 6 pharmacies (2 for each county) that will assess feasibility, acceptance and likely adoption of the initial draft of the ASAP intervention, and 2) interviews and surveys among pharmacy staff of 3 pharmacies (1 from each county). ASAP's adaptations and refinements will be guided by a highly iterative process between investigators and a community advisory board (CAB). Further, the Consolidated Framework for Implementation Research (CFIR) will guide feasibility assessment with a focus on selected CFIR elements across the domains of intervention characteristics, outer and inner setting, characteristics of individuals and process. The project will occur in two phases. The Year 1 formative phase and is NOT a clinical trial will involve: 1) in-depth interviews with staff of 6 pharmacies to clarify intervention components, training and feasibility. Findings will inform the Year 2 iterative ASAP development and refinement phase and beta testing (clinical trial) between investigators and the CAB; including extensive feedback from pharmacy staff of 3 pharmacies following an ASAP beta test. Specific Aims are: Aim 1: To conduct the formative research among pharmacy staff required to develop and beta test the ASAP intervention materials (e.g., training manual, manual of operations, evaluation protocols). Aim 2: To determine the feasibility of the ASAP intervention relative to impact on pharmacy syringe related sales and pharmacy interactions with PWID at time of syringe buy request.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Skin and Soft Tissue Infections, Hiv, Hepatitis C, Bloodstream Infection

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Early Phase 1
    Interventional Study Model
    Parallel Assignment
    Model Description
    randomized control study with one intervention group and one control group.
    Masking
    Participant
    Masking Description
    Participating pharmacies will not know whether they are an intervention ASAP pharmacy or the control pharmacy
    Allocation
    Randomized
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    Control pharmacies will not receive the intervention training, coaching or materials. They will track the sale of syringes upon request and they will participate in the surveys.
    Arm Title
    ASAP Intervention
    Arm Type
    Experimental
    Arm Description
    ASAP intervention pharmacies will receive the CEU training, coaching from research staff, ASAP materials and tracking for the sale of syringes. They will also participate in surveys.
    Intervention Type
    Behavioral
    Intervention Name(s)
    ASAP
    Intervention Description
    ASAP is an intervention geared toward increasing non-stigmatized syringe sales to people who inject drugs to prevent bloodborne illnesses.
    Primary Outcome Measure Information:
    Title
    Syringe sales increase as measured by the sales tracking instrument
    Description
    ASAP pharmacies will increase the sale of nonprescription syringes upon request
    Time Frame
    by end of year 2
    Title
    Reduced stigma as measured by the feasibility assessment tool
    Description
    ASAP pharmacy staff will report a reduction in expressed stigma at the time of syringe sales.
    Time Frame
    by end of year 2

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: full time pharmacy staff member as a pharmacist or a pharmacy technician in an Arizona pharmacy within the three study counties (Pima, Maricopa, Mohave) Exclusion Criteria: not a full time pharmacy staff member
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Beth E Meyerson, PhD
    Phone
    520-626-5908
    Email
    bmeyerson@arizona.edu
    First Name & Middle Initial & Last Name or Official Title & Degree
    Terry Mullin
    Phone
    520-621-7339
    Email
    mullin@email.arizona.edu

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    ASAP: Access to Syringes at Pharmacies for the Prevention of Bloodborne Infections Among People Who Inject Drugs

    We'll reach out to this number within 24 hrs