Clinical trials: People Who Inject Drugs
Hepatitis C, Chronic
The No One Waits Study: Acceptability and Feasibility of Community-based Point-of-diagnosis HCV Treatment Study
Direct-acting antiviral (DAA) therapy for hepatitis C virus (HCV) offers a cure to those with chronic HCV infection. For marginalized communities, linkage to care services often aren't enough to overcome barriers to accessing the…
- Trial name
- NOW (NCT03987503)
- Testing
- Epclusa (SOF/VEL), Standard of care, Fibroscan® 430 Mini Plus
- Where
- United States
- Volunteers
- 87 people, healthy volunteers welcome
- Sponsor
- University of California, San Francisco
Hepatitis C, HIV Coinfection
Supporting Treatment Outcomes Among PWID
The goal of this study is to improve HCV care continuum outcomes for people who inject drugs (PWID), reduce potential onward transmission to others and improve HIV outcomes among those who are HIV/HCV coinfected.
- Trial name
- STOP-C (NCT04652804)
- Testing
- Low intensity HCV treatment adherence support, Medium intensity HCV treatment adherence support, High intensity HCV treatment adherence support
- Where
- India
- Volunteers
- 3,000 people
- Sponsor
- Johns Hopkins University
HIV Infections, Substance Use Disorders
Couples ART Adherence Intervention for PWID in Kazakhstan
The fastest growing HIV epidemics globally are driven by injection drug use, but only a small percentage of HIV-positive people who inject drugs (PWID) have achieved viral suppression.
- Trial name
- NCT03555396
- Testing
- SMART Couples 2, Standard of Care
- Where
- Kazakhstan
- Volunteers
- 132 people, healthy volunteers welcome
- Sponsor
- Columbia University
HIV Prevention
Integrated PrEP Interventions for People Who Inject Drugs in Rural Kentucky
The overarching goal of this study is to adapt and feasibility test an evidence-based strengths-based case management (SBCM) intervention for pre-exposure prophylaxis (PrEP) initiation, and examine preliminary efficacy of the…
- Trial name
- NCT05037513
- Testing
- SBCM-PrEP, CDC-PrEP
- Where
- United States
- Volunteers
- 80 people
- Sponsor
- Hilary L Surratt, PhD
Hepatitis C, People Who Inject Drugs
Accessible HCV Care Intervention for People Who Inject Illicit Drugs (PWID)
The proposed study will examine the feasibility, acceptability, safety, effectiveness, and cost of an Accessible Care intervention for engaging people who inject illicit drugs (PWID) in hepatitis C care.
- Conditions
- Hepatitis C, People Who Inject Drugs, PWID, HCV Coinfection
- Trial name
- NCT03214679
- Testing
- Accessible Care, Usual Care
- Where
- United States
- Volunteers
- 167 people
- Sponsor
- City University of New York, School of Public Health
HIV Infections, Drug Use
INTEGRA: A Vanguard Study of Health Service Delivery in a Mobile Health Delivery Unit
The purpose of this study is to determine the efficacy of using a mobile health delivery unit ("mobile unit") to deliver "one stop" integrated health services - particularly medication for opioid use disorder (MOUD) and…
- Conditions
- HIV Infections, Drug Use, Opioid Use, Opioid-use Disorder
- Trial name
- INTEGRA (NCT04804072)
- Testing
- Medication for opioid-use disorder (MOUD) for opioid-use disorder (OUD), HIV testing, HIV treatment for participants living with HIV not already in care
- Where
- 5 sites in United States
- Volunteers
- 447 people
- Sponsor
- HIV Prevention Trials Network
HIV Infections, Opioid-Related Disorders
SIRI Checklist: An Integrated Hospital Model to Optimize HIV Prevention in Persons Who Inject Drugs
The purpose of this study is to develop and test a serious injection-related injections (SIRI) checklist aimed at increasing evidence-based treatment for rural people who use drugs (PWUD) including innovative, long-acting…
- Conditions
- HIV Infections, Opioid-Related Disorders, Pre-Exposure Prophylaxis (PrEP)
- Trial name
- SHAPE (NCT05480956)
- Testing
- SIRI Checklist, Enhanced Peer Recovery Coach, SIRI Checklist + Enhanced Peer Recovery Coach
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- University of Alabama at Birmingham
HIV Infections, Drug Use
Scaling up an Evidence-based Intervention for Antiretroviral Therapy for PWID in Vietnam: an Implementation Trial
The purpose of this study is to compare two implementation approaches [Standard Approach (SA) vs. Tailored Approach (TA)] for scaling-up the evidence-based systems navigation and psychosocial counseling integrated intervention…
- Trial name
- SNaPR01 (NCT03952520)
- Testing
- Standard Approach (SA), Tailored Approach (TA)
- Where
- Vietnam
- Volunteers
- 1,000 people
- Sponsor
- University of North Carolina, Chapel Hill
Harm Reduction, HIV Infections
Implementation of Onsite, Rapid ART Initiation Among People Who Inject Drugs Living With HIV at Syringe Services Program
The purpose of this study is to see if providing HIV medicine right away at the IDEA Syringe Services Program will help the participant start and remain in HIV care, including having no detectable HIV in the participant's blood.
- Conditions
- Harm Reduction, HIV Infections, Drug Use
- Trial name
- NCT04650269
- Testing
- Biktarvy 50Mg-200Mg-25Mg Tablet, HIV care
- Where
- United States
- Volunteers
- 27 people
- Sponsor
- University of Miami
Hepatitis C, Medication Adherence
Patient-Centered Models of HCV Care for People Who Inject Drugs
People who inject drugs (PWID) have higher rates of hepatitis C virus (HCV) than do other groups. Effective, safe new treatments called direct-acting antiviral agents (DAAs) have been developed recently.
- Trial name
- HERO (NCT02824640)
- Testing
- Patient Navigation, modified Directly Observed Therapy
- Where
- United States
- Volunteers
- 755 people
- Sponsor
- Prisma Health-Upstate
Substance Abuse, Intravenous, HIV
Change the Cycle: An RCT to Prevent Injection Initiation
The study will test the efficacy of a hour long, one-on-one, active listening counseling session (called Change the Cycle or CTC) aimed at reducing behaviors among active people who inject drugs (PWID) that research has found to…
- Conditions
- Substance Abuse, Intravenous, HIV, Heroin Dependence, Opioid Dependence
- Trial name
- CTC (NCT02774954)
- Testing
- Change the Cycle
- Where
- 2 sites in United States
- Volunteers
- 979 people, healthy volunteers welcome
- Sponsor
- University of Southern California
HIV Infections, Behavioral Symptoms
Friendship Bench Adaptation to Improve Mental Health & HIV Care Engagement Outcomes Among PLWH and PWID in Vietnam
This project will adapt and pilot a feasible and effective problem-solving therapy designed for low-resource settings to address common mental disorders like depression and anxiety - the Friendship Bench- in a Vietnamese…
- Conditions
- HIV Infections, Behavioral Symptoms, Depression, Anxiety
- Trial name
- VITAL (NCT04790201)
- Testing
- Friendship Bench Delivered by Professional Counselor, Friendship Bench Delivered by Lay Counselor, Enhanced Usual Care
- Where
- Vietnam
- Volunteers
- 77 people
- Sponsor
- University of North Carolina, Chapel Hill
HIV, Hepatitis Virus
Feasibility of Interventions on People Who Inject Drugs in Vietnam
This study aims at assessing the feasibility of implementing an interventional cohort of people who inject drugs in Haiphong, Viet Nam.
- Conditions
- HIV, Hepatitis Virus, Substance Abuse
- Trial name
- DRIVE-IN (NCT02573948)
- Testing
- no intervention is assessed
- Where
- Vietnam
- Volunteers
- 603 people, healthy volunteers welcome
- Sponsor
- ANRS, Emerging Infectious Diseases
Hepatitis C
Randomised Study of Interferon-free Treatment for Recently Acquired Hepatitis C in PWID and People With HIV Coinfection.
The aim of the study is to determine if treatment for recently acquired hepatitis C infection (with or without HIV coinfection) can be shortened when treating with the interferon-free therapy sofosbuvir/velpatasvir (SOF/VEL).
- Trial name
- REACT (NCT02625909)
- Testing
- SOF/VEL for 6 weeks, SOF/VEL for 12 weeks
- Where
- 25 sites in United States, Australia and 6 more
- Volunteers
- 222 people
- Sponsor
- Kirby Institute
Opioid-use Disorder, Adherence, Medication
Social Networks and Methadone Maintenance Treatment Retention and Antiretroviral Therapy Retention in Tanzania
Investigators will adapt the Brief Social Behaviour and Network Therapy (B-SBNT) intervention developed to facilitate recovery among people receiving medication-assisted treatment for opioid use disorder in the United Kingdom.
- Conditions
- Opioid-use Disorder, Adherence, Medication, HIV Infections
- Trial name
- NCT04479475
- Testing
- Supportive care through community support persons
- Where
- Tanzania
- Volunteers
- 58 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins Bloomberg School of Public Health
Intravenous Drug Usage
Open Trial of a Behavioral Activation Telepsychology Intervention for People Who Inject Drugs
The study has two aims: 1) To examine the feasibility and acceptability of administering a telepsychology Behavioral Activation (BA) treatment for substance use among non-treatment-seeking people who inject drugs (PWID); 2) To…
- Trial name
- NCT04943432
- Testing
- Behavioral Activation
- Where
- United States
- Volunteers
- 23 people
- Sponsor
- University of North Carolina, Chapel Hill
HIV Infections, Stigmatization
Stigma, Risk Behaviors and Health Care Among HIV-infected Russian People Who Inject Drugs
This study is a randomized controlled trial (RCT) among 100 HIV-positive people with injection drug use, which aims to test the feasibility of the SCRIPT intervention and evaluate its effectiveness on the reduction of…
- Conditions
- HIV Infections, Stigmatization, Substance Use
- Trial name
- SCRIPT (NCT03695393)
- Testing
- ACT Therapy
- Where
- Russia
- Volunteers
- 100 people
- Sponsor
- Boston Medical Center
Hepatitis C
Scale-up of Treatment of Hepatitis C Infection Among People Who Inject Drugs
This study is a phase IV, open-label, single arm, multicentre study whose aim is to assess whether interferon-free and ribavirin-free Direct Acting Antiviral (DAA) Hepatitis C Virus (HCV) therapy with grazoprevir/elbasvir, will…
- Trial name
- DARLO-C (NCT02940691)
- Testing
- Grazoprevir/elbasvir
- Where
- 5 sites in Australia
- Volunteers
- 32 people
- Sponsor
- Kirby Institute
Health Behavior
Supported Employment COVID-19 Rapid Testing for PWID
This community-engaged project aims to improve the accessibility of rapid tests through a supported employment program for people who inject drugs (PWID).
- Trial name
- NCT05984966
- Testing
- Supported Employment
- Where
- United States
- Volunteers
- 102 people, healthy volunteers welcome
- Sponsor
- University of Oregon
Hepatitis C
Hepatitis C Pharmacy-based Strategy for Injectors
The aim of this study is evaluate the acceptability/usage of a newly implemented model of delivery of care, namely a community-pharmacy program, to provide access to medications to treat hepatitis C (HCV), and prevent overdose…
- Trial name
- HepPSI (NCT04698629)
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- University of Washington