HIV InfectionsCHARIOTNCT05897099
Comprehensive HIV and Harm Prevention Via Telehealth
A study testing Comprehensive Tele-harm Reduction and Off-site Linkage to HIV Prevention in people with HIV Infections, run by University of Miami at 2 sites in United States.
Trial summary
The purpose of this study is to test 2 different ways to offer medications to prevent human immunodeficiency virus (HIV), cure hepatitis C virus (HCV) (if applicable) and treat substance use disorder (if desired) in people who inject drugs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- Comprehensive Tele-harm Reduction and Off-site Linkage to HIV Prevention
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 2 sitesUnited States
- Study dates
- 7 Oct 2024to 31 May 2028
- Phase
- Interventional
- 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
Who may be able to join
- age 18 or older
- able to speak English or Spanish
- willing and able to sign informed consent, provide locator information and medical records release
- non-reactive result on rapid HIV test
- use of SSP to exchange syringes 2 times in the past 3 months
- planning to stay in the area for 12 months
Who cannot join
- reactive HIV test
- currently on medications for opioid use disorder (MOUD) by urine drug screen
- currently on PrEP by self-report
- Principal or site investigator discretion
- currently in prison or jail
- current enrollment in Clinical Trials Network 121
- receipt of tele-harm reduction in previous 3 months
- signs or symptoms of acute HIV infection
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
IDEA Miami
Miami, Florida, 33136
- Not yet recruiting
IDEA Syringe Services Program
Miami, Florida, 33136
Hansel Tookes, MD, 305-243-1615, hetookes@med.miami.edu
hetookes@med.miami.edu
About this study
Official title: Comprehensive HIV and Harm Prevention Via Telehealth: CHARIOT, a Randomized Controlled Trial
The purpose of this study is to test 2 different ways to offer medications to prevent human immunodeficiency virus (HIV), cure hepatitis C virus (HCV) (if applicable) and treat substance use disorder (if desired) in people who inject drugs.
- Conditions
- HIV Infections
- Being tested
- Comprehensive Tele-harm Reduction, Off-site Linkage to HIV Prevention
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comprehensive Tele-harm ReductionBehavioural
Comprehensive Tele-Harm Reduction is on-demand services including low-barrier access to PrEP, medications for substance use disorder and hepatitis C treatment. It includes mobile phlebotomy, peer harm reduction counseling, medication management, telehealth mental health/substance use disorder services-- all delivered via an syringe services program.
Off-site Linkage to HIV PreventionBehavioural
The community engagement team is comprised of peers and social workers and provides the wraparound support needed.The team will assist participants in scheduling appointments at community health clinics. The community engagement team provides active clinic referral- that is, a member of the team will accompany patients to the first clinic visit.
| Study group | Role | What they receive |
|---|---|---|
| Comprehensive Tele-harm Reduction | Experimental | Participants will have enhanced access to a physician and clinical psychologist via remote video technology wherever the participant is located and prefers engagement (SSP, home, shelter, encampment). Participants will be in this group for 12 months. Receives: Behavioral: Comprehensive Tele-harm Reduction |
| Off-site Linkage to HIV prevention | Active comparator | Participants in this group will receive off-site linkage to HIV care by having case management/social work services through our community engagement team. Participants will be in this group for 12 months. Receives: Behavioral: Off-site Linkage to HIV Prevention |
What is being measured
The primary outcome is the main question the study is designed to answer.
HIV prevention via pre-exposure prophylaxis (PrEP)
Intracellular levels of tenofovir diphosphate (TFV-DP) by DBS or cabotegravir injection in previous 8 weeks or lenacapavir injection in previous 6 months by electronic health record abstraction
Measured: up to 12 months
HIV prevention via medications for opioid use disorder
Buprenorphine/norbuprenorphine or methadone on urine drug screen; or naltrexone or buprenorphine extended-release injection in previous 4 weeks by electronic health record abstraction
Measured: up to 12 months
Secondary outcomes (7)
syringe coverage
Number of syringes distributed/(number of injections per day x days between exchanges)
Measured: up to 12 months
PrEP Adherence
TFV-DP level of 700 fmol/punch on DBS for Truvada; TFV-DP level of 950 fmol/punch on DBS for Descovy
Measured: up to 12 months
Engagement in HCV treatment
Direct acting antiviral prescription confirmed on electronic health record abstraction
Measured: Up to 12 months
HCV cure
Negative HCV RNA viral load at least 12 weeks post treatment completion
Measured: up to 12 months
treatment of sexually transmitted infections
Medical records show prescription of appropriate antibiotics
Measured: up to 12 months
time to harm
Time to: (1) emergency department visit or hospitalization for injection-related infection or overdose; (2) incident HIV infection; (3) incident HCV infection; or (4) death from overdose
Measured: up to 12 months
number of harms
Count of (1) emergency department visit or hospitalization for injection-related infection or overdose; (2) incident HIV infection; (3) incident HCV infection; or (4) death from overdose
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2023
- Study start7 Oct 2024
- Primary completion31 Mar 2028 (estimated)
- Study completion31 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Hansel Tookes, University of Miami
- Investigators
- Hansel Tookes, MD, Principal investigator, University of MiamiTyler Bartholomew, PhD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05897099
- Sponsor's protocol ID
- 20230061
- Other IDs
- R01DA058352
- Acronym
- CHARIOT
- Status last verified
- Feb 2026
- First submitted
- 1 Jun 2023
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bartholomew TS, Plesons M, Serota DP, Alonso E, Metsch LR, Feaster DJ, Ucha J, Suarez E Jr, Forrest DW, Chueng TA, Ciraldo K, Brooks J, Smith JD, Barocas JA, Tookes HE. Project CHARIOT: study protocol for a hybrid type 1 effectiveness-implementation study of comprehensive tele-harm reduction for engagement of people who inject drugs in HIV prevention services. Addict Sci Clin Pract. 2024 Mar 25;19(1):21. doi: 10.1186/s13722-024-00447-9.
PubMed 38528570
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive HIV and Harm Prevention Via Telehealth: CHARIOT, a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05897099
- Acronym / sponsor ID
- CHARIOT / 20230061
- Conditions
- HIV Infections
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 7 Oct 2024 (actual)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 31 May 2028 (estimated)
- First posted
- 9 Jun 2023 (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.
The purpose of this study is to test 2 different ways to offer medications to prevent human immunodeficiency virus (HIV), cure hepatitis C virus (HCV) (if applicable) and treat substance use disorder (if desired) in people who inject drugs.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Comprehensive Tele-harm Reduction | Experimental | Behavioral: Comprehensive Tele-harm ReductionParticipants will have enhanced access to a physician and clinical psychologist via remote video technology wherever the participant is located and prefers engagement (SSP, home, shelter, encampment). Participants will be in this group for 12 months. |
| Off-site Linkage to HIV prevention | Active comparator | Behavioral: Off-site Linkage to HIV PreventionParticipants in this group will receive off-site linkage to HIV care by having case management/social work services through our community engagement team. Participants will be in this group for 12 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- age 18 or older
- able to speak English or Spanish
- willing and able to sign informed consent, provide locator information and medical records release
- non-reactive result on rapid HIV test
- use of SSP to exchange syringes 2 times in the past 3 months
Key exclusion criteria (8 listed)
- reactive HIV test
- currently on medications for opioid use disorder (MOUD) by urine drug screen
- currently on PrEP by self-report
- Principal or site investigator discretion
- currently in prison or jail
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 |
|---|---|---|
| Comprehensive Tele-harm ReductionComprehensive Tele-Harm Reduction is on-demand services including low-barrier access to PrEP, medications for substance use disorder and hepatitis C treatment. It includes mobile phlebotomy, peer harm reduction counseling, medication management, telehealth mental health/substance use disorder services-- all delivered via an syringe services program. | Behavioural | Comprehensive Tele-harm Reduction |
| Off-site Linkage to HIV PreventionThe community engagement team is comprised of peers and social workers and provides the wraparound support needed.The team will assist participants in scheduling appointments at community health clinics. The community engagement team provides active clinic referral- that is, a member of the team will accompany patients to the first clinic visit. | Behavioural | Off-site Linkage to HIV prevention |
Primary outcome
HIV prevention via pre-exposure prophylaxis (PrEP)
Time frame: up to 12 months
Intracellular levels of tenofovir diphosphate (TFV-DP) by DBS or cabotegravir injection in previous 8 weeks or lenacapavir injection in previous 6 months by electronic health record abstraction
HIV prevention via medications for opioid use disorder
Time frame: up to 12 months
Buprenorphine/norbuprenorphine or methadone on urine drug screen; or naltrexone or buprenorphine extended-release injection in previous 4 weeks by electronic health record abstraction
7 secondary outcomes
syringe coverage
Time frame: up to 12 months
PrEP Adherence
Time frame: up to 12 months
Engagement in HCV treatment
Time frame: Up to 12 months
HCV cure
Time frame: up to 12 months
treatment of sexually transmitted infections
Time frame: up to 12 months
time to harm
Time frame: up to 12 months
number of harms
Time frame: up to 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 17 Feb 2026.
- Derived from this study: PubMed 38528570Bartholomew TS, Plesons M, Serota DP, Alonso E, Metsch LR, Feaster DJ, Ucha J, Suarez E Jr, Forrest DW, Chueng TA, Ciraldo K, Brooks J, Smith JD, Barocas JA, Tookes HE. Project CHARIOT: study protocol for a hybrid type 1 effectiveness-implementation study of comprehensive tele-harm reduction for engagement of people who inject drugs in HIV prevention services. Addict Sci Clin Pract. 2024 Mar 25;19(1):21. doi: 10.1186/s13722-024-00447-9.
- Individual participant dataSharing planned: No
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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.
Hansel Tookes, MD principal investigator
University of Miami
Tyler Bartholomew, PhD principal investigator
University of Miami
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Comprehensive Tele-harm Reduction and Off-site Linkage to HIV Prevention in people with HIV Infections, run by University of Miami at 2 sites in United States.
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 6 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Hansel Tookes, MD (3052431615, hetookes@med.miami.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HIV prevention via pre-exposure prophylaxis (PrEP) (time frame: up to 12 months). The study lists 2 primary outcomes in all. 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 NCT05897099, which also lists 1 linked publication.
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 17 Feb 2026.