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

Not Applicable

Completed

• Conditions: Hepatitis C; Hiv; Bloodstream Infection; Skin and Soft Tissue Infections
• Interventions: Behavioral: ASAP

• Registration Number: NCT05270135
• Lead Sponsor: University of Arizona

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.

Study Timeline

• Study First Submitted: 2022-02-15
• Study First Submitted QC: 2022-02-25
• Study First Posted: 2022-03-08
• Study Start: 2022-12-01
• Primary Completion: 2023-06-30
• Study Completion: 2023-09-30
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-12
• Last Update Posted: 2023-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ASAP Intervention	ASAP	This is a pilot study of the ASAP intervention pharmacies to explore the preliminary impact of intervention components: the CEU training, coaching from research staff, ASAP materials and tracking for the sale of syringes. Staff of each enrolled pharmacy will complete surveys.

Primary Outcome Measures

Name	Time	Method
Syringe sales increase as measured by the sales tracking instrument	by end of year 2	ASAP pharmacies will increase the sale of nonprescription syringes upon request
Reduced stigma as measured by the feasibility assessment tool	by end of year 2	ASAP pharmacy staff will report a reduction in expressed stigma at the time of syringe sales.

Trial Locations

Locations (1)

University of Arizona College of Medicine; 🇺🇸 Tucson, Arizona, United States