Hepatitis C, HIV Infections, IV Drug Usage
Conditions
Keywords
heroin, needle exchange, syringe services program
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.
Interventions
BEHAVIORALTele-Harm Reduction
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.
OTHERoff-site linkage
standard of care linkage to a Ryan White clinic
Sponsors
University of Miami
National Institute on Drug Abuse (NIDA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Viral suppression | up to 12 months | HIV viral load \<200 copies/ml time-averaged |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Initiation of medications for opioid use disorder | up to 12 months | Positive urine drug screen for buprenorphine, naltrexone or methadone at study follow-up visit after MOUD is prescribed. |
| HCV cure | up to 12 months | HCV treatment initiated resulting in negative HCV RNA at 12 weeks post treatment completion |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORHansel Tookes, MD, MPH
University of Miami
Outcome results
None listed