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

Hiv Clinical Trial

— ASAP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05270135
• Other study ID #: 2011214920
• Status: Completed
• Phase: N/A
• Start date: December 1, 2022
• Est. completion date: September 30, 2023

Study information

• Verified date: December 2023
• Source: University of Arizona
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: September 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bloodstream Infection
• Communicable Diseases
• Hepatitis C
• Hiv
• Infections
• Sepsis
• Skin and Soft Tissue Infections
• Soft Tissue Infections

Intervention

Behavioral:
• ASAP
ASAP is an intervention geared toward increasing non-stigmatized syringe sales to people who inject drugs to prevent bloodborne illnesses.

Locations

Country	Name	City	State
United States	University of Arizona College of Medicine	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
University of Arizona

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Syringe sales increase as measured by the sales tracking instrument	ASAP pharmacies will increase the sale of nonprescription syringes upon request	by end of year 2
Primary	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.	by end of year 2