CARE: Comprehensive Assessment of Real-world Effectiveness of F/TAF in Persons Who Use Drugs (PWUD)

NCT07385183 | Not Yet Recruiting

• 1 other identifier: CARE
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study looks at how to help people who use drugs start and keep taking medicine that can prevent HIV. The medicine is called PrEP (pre-exposure prophylaxis). The study investigators will use a pill called Descovy (F/TAF), which is already approved by the FDA for HIV prevention. People who come to the emergency department (ED) and test negative for HIV may join the study. Some participants will start taking PrEP and will be followed for one year. Other participants will only do an interview about their thoughts on PrEP. The study investigators will also talk to doctors and peer support workers in the ED to learn what makes it easier or harder to offer PrEP. The main goal is to see how well PrEP can be started and continued for people who use drugs. The study investigators will look at how many people start PrEP, how many keep taking it, and what helps or makes it hard to stay on PrEP. The study investigators will also learn about the best ways to connect people to care after they leave the ED. This study does not test if the medicine works to prevent HIV-that is already known. Instead, it looks at real-life challenges and solutions for using PrEP in this group. The study may help improve HIV prevention and health care for people who use drugs.

Conditions

People Who Inject Drugs; PrEP Adherence

Keywords

PrEP; People who Use/Inject Drugs

Outcome Measures

Primary Outcomes (1)

• Adherence and Persistence Rates of Oral PrEP (F/TAF) Among Persons Who Use Drugs Over 12 Months

  This outcome measures the proportion of participants who remain on oral PrEP (F/TAF) at 1, 2, 4, 8, and 12 months after initiation in the emergency department. Adherence will be assessed through self-report interviews. Persistence is defined as continued PrEP use without discontinuation during the 12-month follow-up period. This measure will help determine real-world feasibility of maintaining PrEP among persons who use drugs and identify barriers and facilitators to adherence.

  From enrollment through 12 months for patients who use PrEP. For the interview only group and clinician group, this information is collected at a single point in time when they are interviewed.

Secondary Outcomes (2)

• Qualitative Themes Related to PrEP Initiation and Continuation

  For PrEP using participants: enrollment through 12 months. For interview only and clinician groups: single interview session.

• Identification and Enrollment of F/TAF Eligible Patients

  Enrollment through 12 months.

Study Arms (3)

PrEP arm

patients receiving PrEP and being followed for 1 year

Other: PrEP adherence; Other: PrEP perspectives

Interview only group

patients who do not wish to receive PrEP and complete a single interview assessing why they do not want PrEP

Other: PrEP perspectives

Clinician Interview

Collection clinician perceptions on PrEP

Other: PrEP perspectives

Interventions

PrEP adherence OTHER

PrEP adherence: Determine adherence rates and persistence with PrEP regimen over time and understand the facilitators and barriers to adherence and persistence

PrEP arm

PrEP perspectives OTHER

Awareness and understanding of PrEP from non-PrEP using patients and clinicians who provide care for PWID.

Clinician Interview; Interview only group; PrEP arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Tampa General Hospital Emergency Department

Sponsors & Collaborators

• Heather Henderson: lead
• Gilead Sciences: collaborator
• Tampa General Hospital: collaborator
• University of South Florida: collaborator

Related Publications (13)

• World Health Organization (WHO). Guidelines on HIV prevention, diagnosis, treatment and care for key populations. Geneva: WHO; 2016.

  BACKGROUND

• Taylor SW, Psaros C, Pantalone DW, et al. "Life-Steps" for PrEP adherence: demonstration of a CBT-based intervention to increase adherence to pre-exposure prophylaxis medication among sexual-minority men at high risk for HIV acquisition. Cognitive and Behavioral Practice. 2017;24(1):38-49.

  BACKGROUND

• Smith DK, Van Handel M, Wolitski RJ. PrEP awareness and attitudes in a national survey of primary care clinicians in the United States, 2009-2015. PLOS ONE. 2020;15(8):e0238372.

  BACKGROUND

• Sherbuk JE, Kline D, DeHovitz J, Braunstein SL. Linkage to HIV pre-exposure prophylaxis care for people who inject drugs. Journal of the International AIDS Society. 2019;22(S4):e25314.

  BACKGROUND

• Maryshow TA, Caro J. Pilot study on offering HIV pre-exposure prophylaxis (PrEP) to people who inject drugs (PWID) in the inpatient setting.

  BACKGROUND

• Lancaster GA, Dodd S, Williamson PR. Design and analysis of pilot studies: recommendations for good practice. J Eval Clin Pract. 2004 May;10(2):307-12. doi: 10.1111/j..2002.384.doc.x.

  PMID: 15189396 BACKGROUND

• Kunselman AR. A brief overview of pilot studies and their sample size justification. Fertility and Sterility. 2024. https://doi.org/10.1016/j.fertnstert.2024.01.040.

  BACKGROUND

• Kelley CF, Kahle E, Siegler A, et al. Applying a PrEP continuum of care for people who inject drugs in the United States. Clinical Infectious Diseases. 2020;70(8):1603-1610.

  BACKGROUND

• Food and Drug Administration (FDA). Descovy® (emtricitabine and tenofovir alafenamide) prescribing information. U.S. Food and Drug Administration.

  BACKGROUND

• Edelman EJ, Moore BA, Calabrese SK, et al. Primary care physicians' readiness to prescribe HIV pre-exposure prophylaxis for people who inject drugs. Addiction Science & Clinical Practice. 2019;14:35.

  BACKGROUND

• Choopanya K, Martin M, Suntharasamai P, et al.; Bangkok Tenofovir Study Group. Antiretroviral prophylaxis for HIV infection in injecting drug users in Bangkok, Thailand (the Bangkok Tenofovir Study): a randomized, double-blind, placebo-controlled phase 3 trial. Lancet. 2013;381(9883):2083-2090.

  BACKGROUND

• Centers for Disease Control and Prevention (CDC). U.S. Public Health Service: Preexposure Prophylaxis for the Prevention of HIV Infection in the United States-2021 Update: A Clinical Practice Guideline. Atlanta, GA: CDC; 2021.

  BACKGROUND

• Biello KB, Bazzi AR, Mimiaga MJ, et al. Perspectives on HIV pre-exposure prophylaxis (PrEP) utilization and related intervention needs among people who inject drugs. Harm Reduction Journal. 2018;15:55. https://doi.org/10.1186/s12954-018-0263-5.

  BACKGROUND

Related Links

• As described in the Descovy drug pamphlet, pregnancy exposure reporting is standard of care. The study team will register any pregnancies that occur while any female subject is on PrEP to the Antiretroviral Pregnancy Registry (APR) found online.

Study Officials

• Heather Henderson, PhD, MCAP

  University of South Florida

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hope Brunner, BSN, RN

CONTACT

813-844-7289; hbrunner@tgh.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor, Emergency Medicine Director, Division of Social Emergency Medicine, Population and Global Health Program Director, Idea Exchange Tampa

Study Record Dates

• First Submitted: January 6, 2026
• First Posted: February 3, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: February 3, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share