People Who Inject DrugsCARENCT07385183

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

An observational study of People Who Inject Drugs and PrEP Adherence, run by Heather Henderson.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: People Who Inject Drugs, PrEP Adherence
What is being tested?: PrEP adherence and PrEP perspectives
How many people: 200 participants
Where: No sites listed yet
Study dates: Feb 2026to Aug 2027
Phase: Observational
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Tampa General Hospital Emergency Department

Who may be able to join

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;

Who cannot join

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 locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Hope Brunner, BSN, RN contact

813-844-7289

hbrunner@tgh.org

About this study

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
Being tested: PrEP adherence, PrEP perspectives
Keywords: PrEP, People who Use/Inject Drugs

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PrEP adherenceOther
PrEP adherence: Determine adherence rates and persistence with PrEP regimen over time and understand the facilitators and barriers to adherence and persistence
PrEP perspectivesOther
Awareness and understanding of PrEP from non-PrEP using patients and clinicians who provide care for PWID.

Study groups in NCT07385183
Study group	Role	What they receive
PrEP arm		patients receiving PrEP and being followed for 1 year Receives: 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 Receives: Other: PrEP perspectives
Clinician Interview		Collection clinician perceptions on PrEP Receives: Other: PrEP perspectives

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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
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.
Measured: 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
Number of patients identified as eligible for F/TAF in the acute care setting and proportion successfully enrolled in the intervention pathway.
Measured: Enrollment through 12 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2026Aug 2027

First posted3 Feb 2026
Study startFeb 2026 (estimated)
Primary completionAug 2027 (estimated)
Study completionAug 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (13)Papers the sponsor has linked to this study.
Other trials for People Who Inject DrugsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 200 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07385183
Sponsor's protocol ID: CARE
Acronym: CARE
Status last verified: Jan 2026
First submitted: 6 Jan 2026
Last updated: 3 Feb 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Information collected as part of the research will not be used or distributed for future research studies.

Publications

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/
PubMed 27559558
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.
PubMed 28392673
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.
PubMed 27258374
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.
Maryshow TA, Caro J. Pilot study on offering HIV pre-exposure prophylaxis (PrEP) to people who inject drugs (PWID) in the inpatient setting.
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.
PubMed 15189396
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.
PubMed 38331310
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.
Food and Drug Administration (FDA). Descovy® (emtricitabine and tenofovir alafenamide) prescribing information. U.S. Food and Drug Administration.
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.
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.
PubMed 23769234
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.
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.
PubMed 30419926

Interested in taking part?

Hope Brunner, BSN, RN

813-844-7289

hbrunner@tgh.org

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

Active, not recruiting
Advancing Access to HIV/HCV Testing for People Who Inject Drugs (PWID)
HIV Infections
Active, not recruiting
Pre-exposure Prophylaxis (PrEP) for Health
Substance Dependence, HIV (Human Immunodeficiency Virus)
RecruitingEarly Phase 1
Simplifying Hepatitis C Pathways for People Who Inject Drugs in Armenia, Georgia, and Tanzania
Hepatitis C, RDT
RecruitingObservational study
Low Dead-space Injecting Equipment Distribution Program for People Who Inject Drugs in Low- and Middle-income Countries
Drug Use, Hepatitis
Recruiting
Reducing Stigma in People Who Inject Drugs (PWID) With HIV Using a Rapid Start Antiretroviral Therapy Intervention (ART)
Hiv, Drug Use

All People Who Inject Drugs trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: CARE: Comprehensive Assessment of Real-world Effectiveness of F/TAF in Persons Who Use Drugs (PWUD)
ClinicalTrials.gov ID: NCT07385183
Acronym / sponsor ID: CARE / CARE
Conditions: People Who Inject Drugs, PrEP Adherence
Keywords: PrEP, People who Use/Inject Drugs
Study type: Observational
Recruitment status: Not yet recruiting
Enrolment: 200 participants (estimated)
Lead sponsor: Heather HendersonUniversity, hospital or other
Collaborators: Gilead Sciences, Tampa General Hospital, University of South Florida
Study start: Feb 2026 (estimated)
Primary completion: Aug 2027 (estimated)
Study completion: Aug 2027 (estimated)
First posted: 3 Feb 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 3

Arm	Type	Receives
PrEP arm	–	Other: PrEP adherence, Other: PrEP perspectivespatients receiving PrEP and being followed for 1 year
Interview only group	–	Other: PrEP perspectivespatients who do not wish to receive PrEP and complete a single interview assessing why they do not want PrEP
Clinician Interview	–	Other: PrEP perspectivesCollection clinician perceptions on PrEP

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Tampa General Hospital Emergency Department

Key inclusion criteria (3 listed)

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;

Key exclusion criteria (3 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PrEP adherencePrEP adherence: Determine adherence rates and persistence with PrEP regimen over time and understand the facilitators and barriers to adherence and persistence	Other	PrEP arm
PrEP perspectivesAwareness and understanding of PrEP from non-PrEP using patients and clinicians who provide care for PWID.	Other	Clinician Interview, Interview only group, PrEP arm

Primary outcome

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

2 secondary outcomes

Qualitative Themes Related to PrEP Initiation and Continuation
Time frame: 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
Time frame: Enrollment through 12 months.

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2026.
Background: PubMed 27559558Consolidated 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/
Background: PubMed 28392673Taylor 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.
Background: PubMed 27258374Smith 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.
BackgroundSherbuk 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.
BackgroundMaryshow TA, Caro J. Pilot study on offering HIV pre-exposure prophylaxis (PrEP) to people who inject drugs (PWID) in the inpatient setting.
Background: PubMed 15189396Lancaster 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.
Background: PubMed 38331310Kunselman 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.
BackgroundKelley 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.
BackgroundFood and Drug Administration (FDA). Descovy® (emtricitabine and tenofovir alafenamide) prescribing information. U.S. Food and Drug Administration.
BackgroundEdelman 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: PubMed 23769234Choopanya 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.
BackgroundCenters 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.
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.Link provided by the sponsor.
Individual participant dataSharing planned: No. Information collected as part of the research will not be used or distributed for future research studies.

Related trials for People Who Inject Drugs

Active, not recruiting
Advancing Access to HIV/HCV Testing for People Who Inject Drugs (PWID)
HIV Infections
Active, not recruiting
Pre-exposure Prophylaxis (PrEP) for Health
Substance Dependence, HIV (Human Immunodeficiency Virus)
RecruitingEarly Phase 1
Simplifying Hepatitis C Pathways for People Who Inject Drugs in Armenia, Georgia, and Tanzania
Hepatitis C, RDT
RecruitingObservational study
Low Dead-space Injecting Equipment Distribution Program for People Who Inject Drugs in Low- and Middle-income Countries
Drug Use, Hepatitis
Recruiting
Reducing Stigma in People Who Inject Drugs (PWID) With HIV Using a Rapid Start Antiretroviral Therapy Intervention (ART)
Hiv, Drug Use

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Hope Brunner, BSN, RN contact

813-844-7289

hbrunner@tgh.org

Heather Henderson, PhD, MCAP principal investigator

University of South Florida

Questions about this trial

What is this clinical trial studying?

An observational study of People Who Inject Drugs and PrEP Adherence, run by Heather Henderson.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 3 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Hope Brunner, BSN, RN (813-844-7289, hbrunner@tgh.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adherence and Persistence Rates of Oral PrEP (F/TAF) Among Persons Who Use Drugs Over 12 Months (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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07385183, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2026.