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Tele-Harm Reduction (T-SHARP)

Primary Purpose

IV Drug Usage, HIV Infections, Hepatitis C

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Tele-Harm Reduction

off-site linkage

About this trial

This is an interventional treatment trial for IV Drug Usage focused on measuring heroin, needle exchange, syringe services program

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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)

Exclusion Criteria:

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

Sites / Locations

Care Resource The SPOT
University of MiamiRecruiting
University of South FloridaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Tele-Harm Reduction (THR)

off-site linkage to HIV care

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Viral suppression

HIV viral load <200 copies/ml time-averaged

Secondary Outcome Measures

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.

HCV cure

HCV treatment initiated resulting in negative HCV RNA at 12 weeks post treatment completion

Full Information

NCT ID

NCT05208697

First Posted

January 12, 2022

Last Updated

February 3, 2023

Sponsor

University of Miami

Collaborators

National Institute on Drug Abuse (NIDA)

1. Study Identification

Unique Protocol Identification Number

NCT05208697

Brief Title

Tele-Harm Reduction

Acronym

T-SHARP

Official Title

Tele-Harm Reduction for Rapid Initiation of Antiretrovirals in People Who Inject Drugs: a Randomized Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Recruiting

Study Start Date

October 7, 2022 (Actual)

Primary Completion Date

April 30, 2025 (Anticipated)

Study Completion Date

April 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Miami

Collaborators

National Institute on Drug Abuse (NIDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

IV Drug Usage, HIV Infections, Hepatitis C

Keywords

heroin, needle exchange, syringe services program

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Tele-Harm Reduction (THR)

Arm Type

Experimental

Arm Description

Arm Title

off-site linkage to HIV care

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

Tele-Harm Reduction

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

off-site linkage

Intervention Description

standard of care linkage to a Ryan White clinic

Primary Outcome Measure Information:

Title

Viral suppression

Description

HIV viral load <200 copies/ml time-averaged

Time Frame

up to 12 months

Secondary Outcome Measure Information:

Title

Initiation of medications for opioid use disorder

Description

Positive urine drug screen for buprenorphine, naltrexone or methadone at study follow-up visit after MOUD is prescribed.

Time Frame

up to 12 months

Title

HCV cure

Description

HCV treatment initiated resulting in negative HCV RNA at 12 weeks post treatment completion

Time Frame

up to 12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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) Exclusion Criteria: 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Hansel Tookes, MD, MPH

Phone

3056897030

hetookes@miami.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hansel Tookes, MD, MPH

Organizational Affiliation

University of Miami

Official's Role

Principal Investigator

Facility Information:

Facility Name

Care Resource The SPOT

City

Fort Lauderdale

State/Province

Florida

ZIP/Postal Code

33311

Country

United States

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sheryl Zayas, DO

First Name & Middle Initial & Last Name & Degree

Sheryl Zayas, DO

Facility Name

University of Miami

City

Miami

State/Province

Florida

ZIP/Postal Code

33136

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Hansel Tookes, MD, MPH

Phone

305-689-7030

hetookes@med.miami.edu

Ext

Tookes

hetookes@med.miami.edu

First Name & Middle Initial & Last Name & Degree

Hansel Tookes, MD, MPH

Facility Name

University of South Florida

City

Tampa

State/Province

Florida

ZIP/Postal Code

33612

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Asa Oxner, MD

Phone

813-732-7675

aoxner@usf.edu

First Name & Middle Initial & Last Name & Degree

Asa Oxner, MD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Tele-Harm Reduction

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