Comprehensive HIV and Harm Prevention Via Telehealth
- Conditions
- HIV Infections
- Interventions
- Behavioral: Comprehensive Tele-harm ReductionBehavioral: Off-site Linkage to HIV Prevention
- Registration Number
- NCT05897099
- Lead Sponsor
- University of Miami
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 350
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Comprehensive Tele-harm Reduction Comprehensive Tele-harm Reduction Participants will have enhanced access to a physician and clinical psychologist via remote video technology wherever the participant is located and prefers engagement (SSP, home, shelter, encampment). Participants will be in this group for 12 months. Off-site Linkage to HIV prevention Off-site Linkage to HIV Prevention Participants in this group will receive off-site linkage to HIV care by having case management/social work services through our community engagement team. Participants will be in this group for 12 months.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (2)
IDEA Miami
🇺🇸Miami, Florida, United States
IDEA Syringe Services Program
🇺🇸Miami, Florida, United States