Project T-SHARP: study protocol for a multi-site randomized controlled trial of tele-harm reduction for people with HIV who inject drugs

Trials

Study Protocol

Daniel J. Feaster¹  Sheryl Zayas²  David W. Forrest³  Asa Oxner⁴  Bernice McCoy⁴  Edward Suarez⁵  Lisa R. Metsch⁶  Jessica Ucha⁷  Tyler S. Bartholomew⁷  Kathryn McCollister⁷  Elizabeth Alonso⁷  Teresa A. Chueng⁸  Kyle Sutherland⁸  Chetwyn Archer⁸  Allan Rodriguez⁸  Michael A. Kolber⁸  David P. Serota⁸  Hansel E. Tookes⁸ 

[1] Biostatistics Division, Department of Public Health Sciences, University of Miami Miller School of Medicine, Miami, FL, USA;Care Resource, Fort Lauderdale, Florida, USA;Department of Anthropology, University of Miami, Miami, FL, USA;Department of Internal Medicine, University of South Florida Morsani College of Medicine, Tampa, FL, USA;Department of Psychiatry, University of Miami Miller School of Medicine, Miami, Florida, USA;Department of Sociomedical Sciences, Mailman School of Public Health, Columbia University, New York, New York, USA;Division of Health Services Research and Policy, Department of Public Health Sciences, University of Miami Miller School of Medicine, Miami, FL, USA;Division of Infectious Diseases, Department of Medicine, University of Miami Miller School of Medicine, Miami, FL, USA;

关键词: HIV;    People who inject drugs;    Harm reduction;    Telehealth;    Syringe services program;   

DOI  :  10.1186/s13063-023-07074-w

 received in 2022-11-02, accepted in 2023-01-05,  发布年份 2023

来源: Springer

【 摘 要 】

BackgroundThe resurgence of HIV outbreaks and rising prevalence among people who inject drugs (PWID) remain exigent obstacles to Ending the HIV Epidemic in the USA. Adapting a low threshold, comprehensive treatment model for PWID with HIV can leverage syringe services programs (SSPs) to increase availability and accessibility of antiretrovirals (ART), medications for opioid use disorder (MOUD), and hepatitis C cure. We developed Tele-Harm Reduction, a telehealth-enhanced, harm reduction intervention delivered within an SSP venue.MethodsThe T-SHARP trial is an open-label, multi-site, randomized controlled superiority trial with two parallel treatment arms. Participants (n=240) recruited from SSPs in Miami, Ft. Lauderdale, and Tampa, Florida, who are PWID with uncontrolled HIV (i.e., HIV RNA>200) will be randomized to Tele-Harm Reduction or off-site linkage to HIV care. 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 with respect to viral suppression across follow-up (suppression at 3, 6, and 12 months post randomization). Participants with HIV RNA<200 copies/ml will be considered virally suppressed. The primary trial outcome is time-averaged HIV viral suppression (HIV RNA <200 copies/ml) over 3-, 6-, and 12-month follow-up. Secondary outcomes include initiation of MOUD measured by urine drug screen and HCV cure, defined as achieving 12-week sustained virologic response (negative HCV RNA at 12 weeks post treatment completion). A cost-effectiveness analysis will be performed.DiscussionThe T-SHARP Trial will be the first to our knowledge to test the efficacy of an innovative telehealth intervention with PWID with uncontrolled HIV delivered via an SSP to support HIV viral suppression. Tele-Harm Reduction is further facilitated by a peer to support adherence and bridge the digital divide. This innovative, flipped healthcare model sets aside the traditional healthcare system, reduces multi-level barriers to care, and meets PWID where they are. The T-SHARP trial is a pragmatic clinical trial that seeks to transform the way that PWID access HIV care and improve HIV clinical outcomes.Trial registrationClinicalTrials.gov NCT05208697. Trial registry name: Tele-Harm Reduction. Registration date: January 26, 2022.

【 授权许可】

CC BY   
© The Author(s) 2023

【 图 表 】

Fig. 8