CARE: Comprehensive Assessment of Real-world Effectiveness of F/TAF in Persons Who Use Drugs (PWUD)
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHeather Henderson
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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;
Trial population
Tampa General Hospital Emergency Department
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
PrEP adherence
Other interventionPrEP adherence: Determine adherence rates and persistence with PrEP regimen over time and understand the facilitators and barriers to adherence and persistence
PrEP perspectives
Other interventionAwareness and understanding of PrEP from non-PrEP using patients and clinicians who provide care for PWID.
Treatment groups
200 Participants
are divided into 3 treatment groupsGroup A: PrEP arm2 interventions
Group B: Interview only group1 intervention
Group C: Clinician Interview1 intervention
Trial outcomes
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.
Time frame
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
1
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.
Time frame
For PrEP using participants: enrollment through 12 months. For interview only and clinician groups: single interview session.2
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.
Time frame
Enrollment through 12 months.Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Heather Henderson
Lead sponsor
University of South Florida
Sponsor institution
Gilead Sciences
Collaborator
Tampa General Hospital
Collaborator
University of South Florida
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: