Tele-Harm Reduction for Intravenous Drug Use

(T-SHARP Trial)

Not currently recruiting at 2 trial locations

Overseen By Hansel Tookes, MD, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Miami

Disqualifiers: HIV negative, THR intervention, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two methods to support people who inject drugs with medications for HIV, Hepatitis C, and addiction treatment. One group will use telehealth (video and phone calls) with a counselor for medicine and support services, a method known as Tele-Harm Reduction. The other group will connect with a traditional clinic for HIV care. The trial seeks participants who have injected drugs in the past year, tested positive for HIV, and are involved in certain syringe services programs in Miami or Tampa. As an unphased trial, this study offers participants the chance to contribute to innovative approaches in healthcare delivery.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators for more details.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators.

What prior data suggests that these methods are safe for people who inject drugs?

Research has shown that the Tele-Harm Reduction approach has been tested in earlier studies with people who use injectable drugs. In one small study, 35 participants began antiretroviral therapy using this method, and 78.1% controlled the virus within six months. This result indicates that most participants handled the treatment well.

Moreover, harm reduction efforts like this one are known to decrease the risk of HIV and Hepatitis C by reducing unsafe injection practices. These efforts aim to make drug use safer and help people follow their medication routines.

Overall, evidence suggests that Tele-Harm Reduction safely helps people manage their health while dealing with substance use. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Tele-Harm Reduction (THR) for intravenous drug use because it leverages telehealth technology and peer support to enhance care access and medication adherence. Unlike traditional approaches that often rely on in-person visits, THR connects participants with medical case managers through virtual platforms, making it easier for them to engage with healthcare services. Additionally, THR involves peer harm reduction counselors who help identify and overcome personal barriers to sticking with treatment. This innovative approach has the potential to improve health outcomes by providing more personalized and accessible support for individuals struggling with intravenous drug use.

What evidence suggests that this trial's methods could be effective for people who inject drugs?

Research shows that Tele-Harm Reduction (THR), a treatment option in this trial, can facilitate access to care for people who inject drugs. Studies have found that THR, which includes online health support and assistance from peer counselors, helps individuals begin treatment for HIV and Hepatitis C. Early results suggest that THR improves adherence to medication schedules, increasing the likelihood of taking medicine as directed. THR aims to quickly connect individuals to necessary medical care, aiding in virus control. In past studies, participants in the THR program were more likely to reduce risky behaviors, such as unsafe drug use and sexual practices. Overall, THR shows promise in improving health management. Another arm of this trial will explore off-site linkage to HIV care, introducing participants to an SSP HIV/HCV linkage specialist and discussing linkage to a traditional Ryan White clinic. ^{1 6 7 8 9}

Who Is on the Research Team?

Hansel Tookes

Principal Investigator

University of Miami

Are You a Good Fit for This Trial?

This trial is for adults over 18 who use intravenous drugs and are enrolled in specific Substance Use Support Programs in Miami or Tampa. Participants must have HIV with a certain viral load, may also have Hepatitis C, be willing to consent to the study, and not plan to move away within a year. Those already receiving similar interventions or unable to consent are excluded.

Inclusion Criteria

Injection drug use in past 12 months by self-report

Enrolled in IDEA Miami or IDEA Tampa SSPs

Willing and able to sign informed consent, provide locator information and medical records release

Exclusion Criteria

Planning to leave the area within 12 months

Currently in prison or jail

I have had a total hip replacement in the last 6 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive telehealth support and medication for HIV, HCV, and substance use disorder

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Off-site Linkage
• Tele-Harm Reduction

Trial Overview The study compares two methods of delivering treatments for HIV, potentially curing Hepatitis C, and addressing substance use disorder among drug users. One method involves 'Tele-Harm Reduction' while the other uses 'off-site linkage' to connect participants with care services.

How Is the Trial Designed?

Group I: Tele-Harm Reduction (THR) Experimental Treatment 1 Intervention

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.

Group II: off-site linkage to HIV care Active Control 1 Intervention

introduces the participant to an SSP HIV/HCV linkage specialist and discusses linkage to a traditional Ryan White clinic

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials

976

Recruited

423,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Published Research Related to This Trial

The Individually Tailored Support and Education for Safer Injection (ITSESI) intervention significantly reduced syringe sharing and cutaneous abscesses among people who inject drugs (PWID) in a study involving 307 participants across four European countries, demonstrating its effectiveness in harm reduction.

Field workers found the ITSESI intervention to be highly acceptable, indicating that involving them as proactive partners can enhance the intervention's accessibility and potential for wider implementation across Europe.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation and evaluation of an educational intervention for safer injection in people who inject drugs in Europe: a multi-country mixed-methods study. Roux, P., Donadille, C., Magen, C., et al.[2021]

A hospital intervention successfully provided harm reduction education and equipment, such as syringes and fentanyl test strips, to 195 patients over a 12-month period, enhancing addiction care for individuals not seeking abstinence.

The program improved patient engagement and education while reducing stigma around substance use disorders, demonstrating the effectiveness of integrating harm reduction strategies into hospital-based addiction treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Meeting people where they are: implementing hospital-based substance use harm reduction. Perera, R., Stephan, L., Appa, A., et al.[2022]

Buprenorphine is an effective treatment for opioid use disorder, but its use has been limited due to strict initiation barriers, which were further complicated by the COVID-19 pandemic.

New guidelines now allow buprenorphine prescriptions via audio-only telehealth, enabling real-time access to treatment through a 24/7 hotline, which connects patients with prescribers and facilitates immediate care for those at risk of overdose.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using telehealth to improve buprenorphine access during and after COVID-19: A rapid response initiative in Rhode Island. Clark, SA., Davis, C., Wightman, RS., et al.[2023]

Harm reduction (HR) services are essential during a pandemic, and adaptations such as flexible take-home supplies and safe working conditions for staff are crucial to maintain these services.

The review highlights the need for tailored HR messaging focused on infection control and service access, emphasizing a person-centered approach to effectively support individuals who inject drugs during health crises.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rapid evidence review of harm reduction interventions and messaging for people who inject drugs during pandemic events: implications for the ongoing COVID-19 response. Wilkinson, R., Hines, L., Holland, A., et al.[2021]

Technology-enabled harm reduction strategies are essential in addressing Canada's opioid crisis, particularly for individuals using drugs alone at home, highlighting the need for innovative health system responses.

Effective support programs should be co-developed with community members, focus on relational skills, and provide consistent, stigma-free services to meet users at any stage of their drug use journey.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Technology to support relational care for people who use drugs at home: Literature review and key informant content. Szelest, I., Motluk, L., Jennens, H., et al.[2019]

The Tele-Harm Reduction (THR) intervention, which combines telehealth with harm reduction strategies, was found to be acceptable and feasible for people who inject drugs (PWID) living with HIV, with 78.1% achieving viral suppression at six months after starting antiretroviral therapy.

Barriers to implementing THR included stigma and organizational challenges, but the supportive environment of the syringe service program (SSP) was identified as a key facilitator for engaging PWID in HIV care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acceptability, feasibility, and pilot results of the tele-harm reduction intervention for rapid initiation of antiretrovirals among people who inject drugs. Tookes, HE., Bartholomew, TS., Suarez, E., et al.[2022]

The rise in overdose and blood-borne infections among people who inject drugs (PWID) is linked to the opioid crisis, particularly due to the use of synthetic opioids that lead to more frequent injections.

Infectious disease specialists can play a crucial role in addressing this crisis by implementing harm reduction strategies, such as providing safer injection supplies, access to naloxone, and medications for opioid use disorder, which can improve patient outcomes and reduce stigma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Opportunities to Offer Harm Reduction to People who Inject Drugs During Infectious Disease Encounters: Narrative Review. Peckham, AM., Young, EH.[2020]

A survey of 237 patients with opioid use disorder revealed that 74% reported positive experiences with telephone counseling, highlighting benefits such as feeling supported, increased access to counselors, and overcoming transportation barriers.

Despite the advantages, some patients noted challenges like the impersonal nature of the experience and reduced privacy, indicating that while telephone counseling can enhance access, it also requires further investigation to optimize care quality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient Experiences with the Transition to Telephone Counseling during the COVID-19 Pandemic. Kang, AW., Walton, M., Hoadley, A., et al.[2023]

Harm reduction services, which provide overdose education and naloxone distribution, face significant challenges in non-urban communities due to stigma and a focus on traditional substance use treatment, as identified through qualitative interviews with 22 professionals in Rhode Island and Massachusetts.

Strategies to improve acceptance and implementation of harm reduction include educating communities about these services, engaging local advocates, and securing support from stakeholders like law enforcement, which are crucial for addressing the health consequences of opioid use in these areas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementing harm reduction in non-urban communities affected by opioids and polysubstance use: A qualitative study exploring challenges and mitigating strategies. Childs, E., Biello, KB., Valente, PK., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9102418/

Acceptability, Feasibility, and Pilot Results of the Tele ... Tele-Harm Reduction (THR) is a telehealth-enhanced, harm reduction intervention, delivered within a trusted SSP venue. It aims to facilitate initiation of care.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9904271/

Project T-SHARP: study protocol for a multi-site ... The primary objective is to compare the efficacy of Tele-Harm Reduction for initiation of ART at SSPs vs. off-site linkage to an HIV clinic ...

3. withpower.com withpower.com/trial/phase-iv-drug-usage-6-2022-37bfc

Tele-Harm Reduction for Intravenous Drug Use (T-SHARP 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 ...

4. harmreductionjournal.biomedcentral.com harmreductionjournal.biomedcentral.com/articles/10.1186/s12954-024-00961-8

Improving access to HIV care among people who inject drugs ... The primary goal of THR is to facilitate linkage to care and rapid, enduring virologic suppression among people who inject drugs (PWID) with HIV.

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0740547203001594

Targeting HIV-related outcomes with intravenous drug ... Results showed that during treatment, patients receiving HRG were more likely to be abstinent from cocaine and to report fewer unsafe sexual practices. Post- ...

6. harmreductionjournal.biomedcentral.com harmreductionjournal.biomedcentral.com/articles/10.1186/s12954-025-01238-4

U.S. substance use harm reduction efforts: a review of the ... All MOUD are associated with a reduction in HCV and HIV infections through reductions in injection-related and sex-related risk behaviors, in ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S0740547221000702

Reduction in injection risk behaviors after implementation ... This study provides preliminary evidence of reductions in injection-related risk behaviors from the IDEA SSP and highlights potential high priority groups.

8. harmreduction.org harmreduction.org/issues/safer-drug-use/facts/

Fact Sheet Safe(r) Drug Use 101 This quick and dirty fact sheet covers safer consumption tips, safer injection tips and harm reduction 101 for people who use drugs. Read the facts here.

9. psnet.ahrq.gov psnet.ahrq.gov/perspective/harm-reduction-strategies-improve-safety-people-who-use-substances

Harm Reduction Strategies to Improve Safety for People ... People who use substances (PWUS) may be at acute risk of harm, such as death from overdose or contracting an injection-related infection.