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| Name | Class |
|---|---|
| Gilead Sciences | INDUSTRY |
| Tampa General Hospital | OTHER |
| University of South Florida | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PrEP arm | patients receiving PrEP and being followed for 1 year |
| |
| Interview only group | patients who do not wish to receive PrEP and complete a single interview assessing why they do not want PrEP |
| |
| Clinician Interview | Collection clinician perceptions on PrEP |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Qualitative Themes Related to PrEP Initiation and Continuation | Themes identified from semi structured interviews examining stigma, access to care, social support, and structural barriers influencing PrEP initiation and continuation among persons who use drugs. Themes will be analyzed using standard qualitative thematic analysis procedures. | For PrEP using participants: enrollment through 12 months. For interview only and clinician groups: single interview session. |
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Inclusion Criteria:
Exclusion Criteria:
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Tampa General Hospital Emergency Department
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hope Brunner, BSN, RN | Contact | 813-844-7289 | hbrunner@tgh.org |
| Name | Affiliation | Role |
|---|---|---|
| Heather Henderson, PhD, MCAP | University of South Florida | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27559558 | Background | Consolidated Guidelines on HIV Prevention, Diagnosis, Treatment and Care for Key Populations - 2016 Update. Geneva: World Health Organization; 2016. Available from http://www.ncbi.nlm.nih.gov/books/NBK379694/ | |
| 28392673 | Background | Taylor SW, Psaros C, Pantalone DW, Tinsley J, Elsesser SA, Mayer KH, Safren SA. "Life-Steps" for PrEP Adherence: Demonstration of a CBT-Based Intervention to Increase Adherence to Preexposure Prophylaxis (PrEP) Medication Among Sexual-Minority Men at High Risk for HIV Acquisition. Cogn Behav Pract. 2017 Feb;24(1):38-49. doi: 10.1016/j.cbpra.2016.02.004. |
| Label | URL |
|---|---|
| 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. | View source |
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Information collected as part of the research will not be used or distributed for future research studies.
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| PrEP perspectives | Other | Awareness and understanding of PrEP from non-PrEP using patients and clinicians who provide care for PWID. |
|
| Identification and Enrollment of F/TAF Eligible Patients | Number of patients identified as eligible for F/TAF in the acute care setting and proportion successfully enrolled in the intervention pathway. | Enrollment through 12 months. |
| 27258374 | Background | Smith DK, Mendoza MC, Stryker JE, Rose CE. PrEP Awareness and Attitudes in a National Survey of Primary Care Clinicians in the United States, 2009-2015. PLoS One. 2016 Jun 3;11(6):e0156592. doi: 10.1371/journal.pone.0156592. eCollection 2016. |
| 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. |
| 15189396 | 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. |
| 38331310 | Background | Kunselman AR. A brief overview of pilot studies and their sample size justification. Fertil Steril. 2024 Jun;121(6):899-901. doi: 10.1016/j.fertnstert.2024.01.040. Epub 2024 Feb 6. |
| 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. |
| 23769234 | Background | Choopanya K, Martin M, Suntharasamai P, Sangkum U, Mock PA, Leethochawalit M, Chiamwongpaet S, Kitisin P, Natrujirote P, Kittimunkong S, Chuachoowong R, Gvetadze RJ, McNicholl JM, Paxton LA, Curlin ME, Hendrix CW, Vanichseni S; Bangkok Tenofovir Study Group. Antiretroviral prophylaxis for HIV infection in injecting drug users in Bangkok, Thailand (the Bangkok Tenofovir Study): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet. 2013 Jun 15;381(9883):2083-90. doi: 10.1016/S0140-6736(13)61127-7. Epub 2013 Jun 13. |
| 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. |
| 30419926 | Background | Biello KB, Bazzi AR, Mimiaga MJ, Biancarelli DL, Edeza A, Salhaney P, Childs E, Drainoni ML. Perspectives on HIV pre-exposure prophylaxis (PrEP) utilization and related intervention needs among people who inject drugs. Harm Reduct J. 2018 Nov 12;15(1):55. doi: 10.1186/s12954-018-0263-5. |