Clinical trial NCT05270135: ASAP: Access to Syringes at Pharmacies for the Prevention of Bloodborne Infections Among People Who Inject Drugs
Official title: ASAP: Access to Syringes at Pharmacies for the Prevention of Bloodborne Infections Among People Who Inject Drugs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin and Soft Tissue Infections
Hiv
Hepatitis C
Bloodstream Infection
Lead sponsor: University of Arizona
Sponsor class: OTHER
First posted: 2022-03-08
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Pilot study of an intervention using one group comprised of three pharmacies and their enrolled staff.
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Syringe sales increase as measured by the sales tracking instrument
timeFrame: by end of year 2
measure: Reduced stigma as measured by the feasibility assessment tool
timeFrame: by end of year 2
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: University of Arizona College of Medicine
state: Arizona
Study officials:
References: