HIV Infections
Conditions
Brief summary
The purpose of this study is to test 2 different ways to offer medications to prevent human immunodeficiency virus (HIV), cure hepatitis C virus (HCV) (if applicable) and treat substance use disorder (if desired) in people who inject drugs.
Interventions
BEHAVIORALComprehensive Tele-harm Reduction
Comprehensive Tele-Harm Reduction is on-demand services including low-barrier access to PrEP, medications for substance use disorder and hepatitis C treatment. It includes mobile phlebotomy, peer harm reduction counseling, medication management, telehealth mental health/substance use disorder services-- all delivered via an syringe services program.
BEHAVIORALOff-site Linkage to HIV Prevention
The community engagement team is comprised of peers and social workers and provides the wraparound support needed.The team will assist participants in scheduling appointments at community health clinics. The community engagement team provides active clinic referral- that is, a member of the team will accompany patients to the first clinic visit.
Sponsors
University of Miami
National Institute on Drug Abuse (NIDA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
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 or Spanish * willing and able to sign informed consent, provide locator information and medical records release * non-reactive result on rapid HIV test * use of SSP to exchange syringes 2 times in the past 3 months * planning to stay in the area for 12 months
Exclusion criteria
* reactive HIV test * currently on medications for opioid use disorder (MOUD) by urine drug screen * currently on PrEP by self-report * Principal or site investigator discretion * currently in prison or jail * current enrollment in Clinical Trials Network 121 * receipt of tele-harm reduction in previous 3 months * signs or symptoms of acute HIV infection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HIV prevention via pre-exposure prophylaxis (PrEP) | up to 12 months | Intracellular levels of tenofovir diphosphate (TFV-DP) by DBS or cabotegravir injection in previous 8 weeks or lenacapavir injection in previous 6 months by electronic health record abstraction |
| HIV prevention via medications for opioid use disorder | up to 12 months | Buprenorphine/norbuprenorphine or methadone on urine drug screen; or naltrexone or buprenorphine extended-release injection in previous 4 weeks by electronic health record abstraction |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| syringe coverage | up to 12 months | Number of syringes distributed/(number of injections per day x days between exchanges) |
| PrEP Adherence | up to 12 months | TFV-DP level of 700 fmol/punch on DBS for Truvada; TFV-DP level of 950 fmol/punch on DBS for Descovy |
| Engagement in HCV treatment | Up to 12 months | Direct acting antiviral prescription confirmed on electronic health record abstraction |
| HCV cure | up to 12 months | Negative HCV RNA viral load at least 12 weeks post treatment completion |
| treatment of sexually transmitted infections | up to 12 months | Medical records show prescription of appropriate antibiotics |
| time to harm | up to 12 months | Time to: (1) emergency department visit or hospitalization for injection-related infection or overdose; (2) incident HIV infection; (3) incident HCV infection; or (4) death from overdose |
| number of harms | up to 12 months | Count of (1) emergency department visit or hospitalization for injection-related infection or overdose; (2) incident HIV infection; (3) incident HCV infection; or (4) death from overdose |
Countries
United States
Contacts
CONTACTHansel Tookes, MD
PRINCIPAL_INVESTIGATORHansel Tookes, MD
University of Miami
PRINCIPAL_INVESTIGATORTyler Bartholomew, PhD
University of Miami
Outcome results
None listed