IV Drug UsageT-SHARPNCT05208697
Tele-Harm Reduction
A study testing Tele-Harm Reduction and off-site linkage in people with IV Drug Usage and HIV Infections, run by University of Miami at 3 sites in United States.
Trial summary
The purpose of this study is to test 2 different methods for offering medications that treat HIV, cure Hepatitis C Virus (HCV) (if applicable) and treat substance use disorder (if desired) to people who inject drugs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- IV Drug Usage, HIV Infections, Hepatitis C
- What is being tested?
- Tele-Harm Reduction and off-site linkage
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 3 sitesUnited States
- Study dates
- 10 Oct 2022to 30 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- enrolled in IDEA Miami or IDEA Tampa SSPs
- injection drug use in past 12 months by self-report
- willing and able to sign informed consent, provide locator information and medical records release
- testing reactive for HIV by rapid test
- HIV RNA>200 copies/ml as determined by on-site labs or abstracted medical records (result within 3 months of randomization date)
Who cannot join
- testing HIV negative via rapid test
- receipt of THR intervention in the past 6 months
- inability to provide informed consent
- planning to leave the area within 12 months
- Principal or site investigator discretion
- currently in prison or jail
- Enrollment in Clinical Trials Network 121
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Care Resource The SPOT
Fort Lauderdale, Florida, 33311
University of Miami
Miami, Florida, 33136
University of South Florida
Tampa, Florida, 33612
About this study
Official title: Tele-Harm Reduction for Rapid Initiation of Antiretrovirals in People Who Inject Drugs: a Randomized Controlled Trial
The purpose of this study is to test 2 different methods for offering medications that treat HIV, cure Hepatitis C Virus (HCV) (if applicable) and treat substance use disorder (if desired) to people who inject drugs.
- Conditions
- IV Drug Usage, HIV Infections, Hepatitis C
- Being tested
- Tele-Harm Reduction, off-site linkage
- Keywords
- heroin, needle exchange, syringe services program
- Medical subject headings
- HIV Infections, Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tele-Harm ReductionBehavioural
THR is telehealth-enhanced, on-demand services including low-barrier access to antiretrovirals, medications for substance use disorder and hepatitis C treatment. It includes mobile phlebotomy, harm reduction counseling, medication management, telehealth mental health/substance use disorder services-- all delivered via an SSP, integrated with the provision of evidence-based naloxone and injection equipment.
off-site linkageOther
standard of care linkage to a Ryan White clinic
| Study group | Role | What they receive |
|---|---|---|
| Tele-Harm Reduction (THR) | Experimental | THR utilizes 2 components. Component 1: telehealth technology facilitated by a peer harm reduction counselor to connect the participant with medical case managers and enroll patients in Ryan White/AIDS Drug Assistance Program (ADAP). Component 2: utilizes the syringe services program (SSP)-based peer harm reduction counselor to work with participants in identifying individual-specific barriers and facilitators to medication adherence. Receives: Behavioral: Tele-Harm Reduction |
| off-site linkage to HIV care | Active comparator | introduces the participant to an SSP HIV/HCV linkage specialist and discusses linkage to a traditional Ryan White clinic Receives: Other: off-site linkage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Viral suppression
HIV viral load <200 copies/ml time-averaged
Measured: up to 12 months
Secondary outcomes (2)
Initiation of medications for opioid use disorder
Positive urine drug screen for buprenorphine, naltrexone or methadone at study follow-up visit after MOUD is prescribed.
Measured: up to 12 months
HCV cure
HCV treatment initiated resulting in negative HCV RNA at 12 weeks post treatment completion
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 posted26 Jan 2022
- Study start10 Oct 2022
- Primary completion16 Jan 2026
- Study completion30 Apr 2026
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 IV Drug UsageStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
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, MPH, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05208697
- Sponsor's protocol ID
- 20201516
- Other IDs
- DP2DA053720
- Acronym
- T-SHARP
- Status last verified
- Sep 2026
- First submitted
- 12 Jan 2022
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tookes HE, Oxner A, Serota DP, Alonso E, Metsch LR, Feaster DJ, Ucha J, Suarez E Jr, Forrest DW, McCollister K, Rodriguez A, Kolber MA, Chueng TA, Zayas S, McCoy B, Sutherland K, Archer C, Bartholomew TS. Project T-SHARP: study protocol for a multi-site randomized controlled trial of tele-harm reduction for people with HIV who inject drugs. Trials. 2023 Feb 7;24(1):96. doi: 10.1186/s13063-023-07074-w.
PubMed 36750867
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tele-Harm Reduction for Rapid Initiation of Antiretrovirals in People Who Inject Drugs: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05208697
- Acronym / sponsor ID
- T-SHARP / 20201516
- Conditions
- IV Drug Usage, HIV Infections, Hepatitis C
- Keywords
- heroin, needle exchange, syringe services program
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 10 Oct 2022 (actual)
- Primary completion
- 16 Jan 2026 (actual)
- Study completion
- 30 Apr 2026 (actual)
- First posted
- 26 Jan 2022 (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 methods for offering medications that treat HIV, cure Hepatitis C Virus (HCV) (if applicable) and treat substance use disorder (if desired) to people who inject drugs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tele-Harm Reduction (THR) | Experimental | Behavioral: Tele-Harm ReductionTHR utilizes 2 components. Component 1: telehealth technology facilitated by a peer harm reduction counselor to connect the participant with medical case managers and enroll patients in Ryan White/AIDS Drug Assistance Program (ADAP). Component 2: utilizes the syringe services program (SSP)-based peer harm reduction counselor to work with participants in identifying individual-specific barriers and facilitators to medication adherence. |
| off-site linkage to HIV care | Active comparator | Other: off-site linkageintroduces the participant to an SSP HIV/HCV linkage specialist and discusses linkage to a traditional Ryan White clinic |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- age 18 or older
- able to speak English
- enrolled in IDEA Miami or IDEA Tampa SSPs
- injection drug use in past 12 months by self-report
- willing and able to sign informed consent, provide locator information and medical records release
Key exclusion criteria (7 listed)
- testing HIV negative via rapid test
- receipt of THR intervention in the past 6 months
- inability to provide informed consent
- planning to leave the area within 12 months
- Principal or site investigator discretion
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 |
|---|---|---|
| Tele-Harm ReductionTHR is telehealth-enhanced, on-demand services including low-barrier access to antiretrovirals, medications for substance use disorder and hepatitis C treatment. It includes mobile phlebotomy, harm reduction counseling, medication management, telehealth mental health/substance use disorder services-- all delivered via an SSP, integrated with the provision of evidence-based naloxone and injection equipment. | Behavioural | Tele-Harm Reduction (THR) |
| off-site linkagestandard of care linkage to a Ryan White clinic | Other | off-site linkage to HIV care |
Primary outcome
Viral suppression
Time frame: up to 12 months
HIV viral load <200 copies/ml time-averaged
2 secondary outcomes
Initiation of medications for opioid use disorder
Time frame: up to 12 months
HCV cure
Time frame: up to 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Derived from this study: PubMed 36750867Tookes HE, Oxner A, Serota DP, Alonso E, Metsch LR, Feaster DJ, Ucha J, Suarez E Jr, Forrest DW, McCollister K, Rodriguez A, Kolber MA, Chueng TA, Zayas S, McCoy B, Sutherland K, Archer C, Bartholomew TS. Project T-SHARP: study protocol for a multi-site randomized controlled trial of tele-harm reduction for people with HIV who inject drugs. Trials. 2023 Feb 7;24(1):96. doi: 10.1186/s13063-023-07074-w.
- 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. This study is not recruiting at the moment.
Hansel Tookes, MD, MPH principal investigator
University of Miami
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tele-Harm Reduction and off-site linkage in people with IV Drug Usage and HIV Infections, run by University of Miami at 3 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 7 inclusion and 7 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: finished, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Viral suppression (time frame: up to 12 months). 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 NCT05208697, 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 9 Sep 2026.