People Who Inject Drugs, PrEP Adherence
Conditions
Keywords
PrEP, People who Use/Inject Drugs
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.
Interventions
OTHERPrEP adherence
PrEP adherence: Determine adherence rates and persistence with PrEP regimen over time and understand the facilitators and barriers to adherence and persistence
OTHERPrEP perspectives
Awareness and understanding of PrEP from non-PrEP using patients and clinicians who provide care for PWID.
Sponsors
Heather Henderson
Gilead Sciences
Tampa General Hospital
University of South Florida
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Prep Initiation Inclusion: 18 years of age or older; Communicate in English; Confirmatory test of HIV-negative; Documented or identified history of injection drug use within the last six-months or have documented or identified general drug use within the last twelve months; Be able to provide at least one contact person including name and phone number where participant can be reached for follow-up * Clinician Interview Inclusion: At least 18 years of age; Healthcare provider or peer navigator, a person with lived experience in substance use disorder who will help navigate the patient through care, currently employed in TGH ED * Interview Inclusion: At least 18 years of age; Communicate in English; Confirmatory test of HIV-negative; Documented or identified history of injection drug use within the last six-months or have documented or identified general drug use within the last twelve months;
Exclusion criteria
* PrEP Initiation Exclusion: Under 18 years of age; Determined to be HIV-positive following confirmatory testing; Have a CrCl of less than 30ml/min, making them only eligible for long-acting injectable PrEP if CrCl is a limiting factor for oral PrEP; Have significant cognitive or developmental impairment to the extent that they are unable to provide informed consent; Are currently incarcerated or have pending legal action that may prevent an individual from completing the study; Pregnant. * Clinician Interview Exclusion: Under 18 years of age; Not currently employed as a healthcare provider or peer navigator in the TGH ED. * Interview Exclusion: Under 18 years of age; Have significant cognitive or developmental impairment to the extent that they are unable to provide informed consent; Are currently incarcerated or have pending legal action that may prevent an individual from completing the study;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adherence and Persistence Rates of Oral PrEP (F/TAF) Among Persons Who Use Drugs Over 12 Months | 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. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Identification and Enrollment of F/TAF Eligible Patients | Enrollment through 12 months. | Number of patients identified as eligible for F/TAF in the acute care setting and proportion successfully enrolled in the intervention pathway. |
| 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. | 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. |
Contacts
CONTACTHope Brunner, BSN, RN
PRINCIPAL_INVESTIGATORHeather Henderson, PhD, MCAP
University of South Florida
Outcome results
None listed