NCT05208697

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 12, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 26, 2022

Completed
9 months until next milestone

Study Start

First participant enrolled

October 10, 2022

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 16, 2026

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2026

Completed
Last Updated

May 20, 2026

Status Verified

May 1, 2026

Enrollment Period

3.3 years

First QC Date

January 12, 2022

Last Update Submit

May 18, 2026

Conditions

IV Drug UsageHIV InfectionsHepatitis C

Keywords

heroinneedle exchangesyringe services program

Outcome Measures

Primary Outcomes (1)

  • Viral suppression

    HIV viral load \<200 copies/ml time-averaged

    up to 12 months

Secondary Outcomes (2)

  • Initiation of medications for opioid use disorder

    up to 12 months

  • HCV cure

    up to 12 months

Study Arms (2)

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.

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

Other: off-site linkage

Interventions

Tele-Harm ReductionBEHAVIORAL

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.

Tele-Harm Reduction (THR)
off-site linkageOTHER

standard of care linkage to a Ryan White clinic

off-site linkage to HIV care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Care Resource The SPOT

Fort Lauderdale, Florida, 33311, United States

Location

University of Miami

Miami, Florida, 33136, United States

Location

University of South Florida

Tampa, Florida, 33612, United States

Location

Related Publications (1)

  • 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.

    PMID: 36750867DERIVED

MeSH Terms

Conditions

HIV InfectionsHepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesHepatitis, Viral, HumanFlaviviridae InfectionsHepatitisLiver DiseasesDigestive System Diseases

Study Officials

  • Hansel Tookes, MD, MPH

    University of Miami

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 12, 2022

First Posted

January 26, 2022

Study Start

October 10, 2022

Primary Completion

January 16, 2026

Study Completion

April 30, 2026

Last Updated

May 20, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations

US(3)