Tele-Harm Reduction for Intravenous Drug Use

(T-SHARP Trial)

Recruiting at2 trial locations

Overseen by Hansel Tookes

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of Miami

Disqualifiers: HIV negative, THR intervention, others

No Placebo Group

Trial Summary

What is the purpose of this 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.

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.

What data supports the effectiveness of the Tele-Harm Reduction treatment for intravenous drug use?

Research shows that telehealth approaches, like Tele-Harm Reduction, can improve access to care and support for people who use drugs. For example, telephone counseling has been found to increase comfort, privacy, and access to counselors, which can help overcome barriers to treatment. ^{1 2 3 4 5}

How is the Tele-Harm Reduction treatment different from other treatments for intravenous drug use?

Tele-Harm Reduction is unique because it uses telehealth to provide harm reduction services, making it more accessible for people who inject drugs, especially those living with HIV. This approach helps initiate care quickly and aims to achieve rapid HIV viral suppression, which is not typically the focus of other harm reduction treatments. ^{1 6 7 8 9}

Research Team

Hansel Tookes

Principal Investigator

University of Miami

Eligibility Criteria

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.

Treatment Details

Interventions

• Off-site Linkage (NA)
• Tele-Harm Reduction (NA)

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.

Participant Groups

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+

Sylvia Daunert

University of Miami

Chief Executive Officer since 2011

PhD in Biochemistry and Molecular Biology, University of Kentucky

Bahar Motlagh

University of Miami

Chief Medical Officer since 2021

PhD in Biomedical Engineering, Ecole Polytechnique Montreal

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Dr. Nora Volkow

National Institute on Drug Abuse (NIDA)

Chief Executive Officer since 2003

MD from National Autonomous University of Mexico

Dr. Nora Volkow

National Institute on Drug Abuse (NIDA)

Chief Medical Officer since 2003

MD from National Autonomous University of Mexico

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. Ireland 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. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Meeting people where they are: implementing hospital-based substance use harm reduction. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Technology to support relational care for people who use drugs at home: Literature review and key informant content. [2019]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Patient Experiences with the Transition to Telephone Counseling during the COVID-19 Pandemic. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Using telehealth to improve buprenorphine access during and after COVID-19: A rapid response initiative in Rhode Island. [2023]

6. Netherlands 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. [2021]

7. England 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. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

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

9. Netherlands 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. [2022]