Clinical trials: People Who Inject Drugs, open to volunteers
Hepatitis C
ETHOS ENGAGE: Enhancing Treatment of Hepatitis C in Opioid Substitution Settings
The overall goals of the ETHOS II Project are to enhance hepatitis C virus (HCV) care in drug treatment clinics and needle and syringe programs (NSPs) in New South Wales and Australia, and to develop a translational framework for…
- Trial name
- ETHOS II (NCT03685045)
- Testing
- Campaign days
- Where
- 32 sites in Australia
- Volunteers
- 6,000 people, healthy volunteers welcome
- Sponsor
- Kirby Institute
HIV Pre-exposure Prophylaxis, HEPATITIS C (HCV)
Trauma-informed, Resilience-based Telehealth Intervention for Improving HIV Prevention and HCV Care for Persons Who Inject Drugs in the Deep South (Pilot Testing: Aim3)
Evaluate the feasibility, acceptability, and usability of the intervention (primary outcomes) and coping skills and resilience (secondary outcomes) of the telehealth intervention over two months (8 weekly sessions) in a…
- Conditions
- HIV Pre-exposure Prophylaxis, HEPATITIS C (HCV), Opioid Use Disorder
- Trial name
- NCT06799702
- Testing
- Telehealth Behavioral Intervention for promoting HIV and HCV care and MOUD among Persons who inject drugs (PWID)
- Where
- United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- University of Georgia
HIV Infections, HCV
A Setting Focus Overdose Prevention Intervention
A pilot injection-setting targeted peer-driven intervention to reduce HIV and hepatitis C virus transmission and overdose risk behaviors among people who inject drugs (PWID).
- Conditions
- HIV Infections, HCV, Drug Overdose
- Trial name
- Oasis (NCT05320835)
- Testing
- HIV, HCV and overdose prevention
- Where
- United States
- Volunteers
- 285 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins Bloomberg School of Public Health
Systemic Inflammation, Immune Dysregulation
Assessment of Metformin for Restoration of Immune Homeostasis in HIV+ and HIV- Individuals With a History of Injection Drug Use
This randomized clinical trial (RCT) evaluates whether metformin can reduce systemic inflammation and improve immune function in individuals with a history of injection drug use, with or without HIV.
- Conditions
- Systemic Inflammation, Immune Dysregulation, Injection Drug Use, HIV
- Trial name
- (MET-IH) (NCT06829238)
- Testing
- Metformin, Jynneos, Capvaxvie
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- University of Alabama at Birmingham
Intimate Partner Violence (IPV), People Who Inject Drugs
Intimate Partner Violence Among People Who Inject Drugs - Prevalence, Risk Factors and Experiences
There are around 15,6 million people who inject drugs (PWID) worldwide, of which around 3,5 million are women who inject drugs (WWID) (1). In Sweden, estimates suggest 8000-21000 PWID (2).
- Trial name
- NCT06269952
- Testing
- No intervention
- Where
- Sweden
- Volunteers
- 500 people
- Sponsor
- Region Stockholm
Hiv, Substance Use Disorders
Yuva Sath: A Peer-led Behavioral Intervention to Support Substance Use Treatment and HIV Prevention Among Young People Who Inject Drugs in India
The goal of this pilot randomized controlled trial is to learn if Yuva Sath, a youth-tailored peer-led behavioral intervention, can support substance use treatment engagement and HIV prevention among young people who inject drugs…
- Trial name
- NCT06510192
- Testing
- Yuva Sath
- Volunteers
- 60 people
- Sponsor
- Massachusetts General Hospital
Hepatitis C
Partner Navigation Intervention for Hepatitis C Treatment Among Young People Who Inject Drugs
The Partner Navigation Intervention Study is a randomized controlled study (RCT) to assess the efficacy and mechanism of action of the first behavioral intervention to increase hepatitis C (HCV) treatment initiation among adult…
- Trial name
- NCT06179498
- Testing
- Partner Navigation Intervention
- Where
- United States
- Volunteers
- 500 people
- Sponsor
- University of California, San Francisco
People Who Inject Drugs, PrEP Adherence
CARE: Comprehensive Assessment of Real-world Effectiveness of F/TAF in Persons Who Use Drugs (PWUD)
This study looks at how to help people who use drugs start and keep taking medicine that can prevent HIV. The medicine is called PrEP (pre-exposure prophylaxis).
- Trial name
- CARE (NCT07385183)
- Testing
- PrEP adherence, PrEP perspectives
- Volunteers
- 200 people
- Sponsor
- Heather Henderson
HEPATITIS C (HCV), Opioid Use Disorder
Pilot Study of an Adapted Partner Navigation Intervention Booster Session for Sustained Healthcare Engagement Among People Who Inject Drugs
This study builds upon an ongoing NIH-funded randomized controlled trial (R01DA053325) evaluating a Partner Navigation Intervention to increase hepatitis C virus (HCV) treatment initiation among young adult people who inject…
- Conditions
- HEPATITIS C (HCV), Opioid Use Disorder, Substance Use Disorder (SUD), Drug Use Disorders
- Trial name
- NCT07631559
- Testing
- Partner navigation intervention booster session
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- University of California, San Francisco
HIV Prevention
Adaptive Intervention Strategies for HIV PrEP Care in Rural People Who Inject Drugs
During this 5-year study, stepped-care adaptive interventions will be deployed in three rural syringe service programs in a Sequential Multiple Assignment Randomized Trial (SMART) design to test the optimal intervention pathways…
- Trial name
- NCT06666309
- Testing
- SBCM-PrEP + Text Messaging, CDC-PrEP + Text Messaging, T-SBCM
- Where
- 4 sites in United States
- Volunteers
- 424 people, healthy volunteers welcome
- Sponsor
- Hilary L Surratt, PhD
COVID-19
A Spatial Analysis of Hotspots and Targeted Injection Settings Pilot Intervention for HIV Prevention Among People Who Inject Drugs
Conduct a study of people who use drugs (PWUD) perceptions of and access to COVID-19 vaccines as well as reasons for vaccine hesitancy/barriers
- Trial name
- NCT05769023
- Testing
- Intervention test
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Johns Hopkins Bloomberg School of Public Health
HIV, Substance Use Disorder (SUD)
Long-acting Cabotegravir Injectable Pre-exposure Prophylaxis for People Who Inject Drugs
The goal of this study is to determine the feasibility and impact of delivering long-acting injectable cabotegravir HIV pre-exposure prophylaxis and suite of support services to adults who inject non-prescription drugs who are…
- Conditions
- HIV, Substance Use Disorder (SUD), Injection Drug Use
- Trial name
- ASCEND (NCT07199335)
- Testing
- APRETUDE (cabotegravir)
- Where
- 2 sites in United States
- Volunteers
- 100 people
- Sponsor
- Massachusetts General Hospital
Stigma, Social, Drug Abuse Illicit
Lower Intersecting HIV-related Stigmas to Facilitate Treatment as Prevention (LIFT)
The purpose of this study is to reduce HIV transmission risk among people who inject drugs (PWID) through a multilevel intervention known as LIFT.
- Conditions
- Stigma, Social, Drug Abuse Illicit, HIV (Human Immunodeficiency Virus)
- Trial name
- LIFT (NCT07541131)
- Testing
- LIFT for People Who Use Drugs, LIFT for MMT Providers
- Where
- Kyrgyzstan
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- University of California, San Diego
Hiv, Opioid Use Disorder
Optimizing Evidence-based HIV Prevention Targeting People Who Inject Drugs on PrEP
The investigators will conduct an optimization trial among N=256 PWID newly started on medication for opioid use disorder and Pre-Exposure Prophylaxis (PrEP) to assess the performance of four intervention components (Attention…
- Trial name
- MOST (NCT05669534)
- Testing
- community-friendly health recovery program, Pre-Exposure Prophylaxis and Post-Exposure Prophylaxis
- Where
- United States
- Volunteers
- 256 people
- Sponsor
- University of Connecticut
Drug Abuse, Intravenous, Substance Dependence
A Cross-Sectional Observational Study on Retained Drug Needle Fragments in People Who Use Intravenous Drugs
In addition to the well-known toxicological harms of intravenous drug (IVD) use, there can also be local tissue complications, including infections, venous sclerosis, tissue necrosis, and drug needle fragment retentions.
- Conditions
- Drug Abuse, Intravenous, Substance Dependence, Needle Injury, Soft Tissue Injuries
- Trial name
- NCT05679284
- Testing
- Low-dose X-ray of subcutaneous tissues
- Where
- Finland
- Volunteers
- 100 people
- Sponsor
- Tampere University Hospital
HIV Prevention
The PROTECT (PrEP Optimization Through Telehealth Care and Treatment) Trial
The expansion of HIV pre-exposure prophylaxis (PrEP) care has been endorsed as a key strategy for reducing new HIV infections, however, PrEP trials among people who inject drugs (PWID) are rare and uptake of PrEP has been…
- Trial name
- PROTECT (NCT06845774)
- Testing
- CDC PrEP with active referral, TelePrEP
- Where
- United States
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Hilary L Surratt, PhD
Hepatitis C, RDT
Simplifying Hepatitis C Pathways for People Who Inject Drugs in Armenia, Georgia, and Tanzania
The goal of this non-randomised, quasi-experimental, prospective comparative trial is to trial simplified care pathways for hepatitis C testing and treatment for people who inject drugs in Armenia, Georgia, and Tanzania.
- Trial name
- CUTTS HepC (NCT06159504)
- Testing
- sofosbuvir/velpatasvir (SOF/VEL), Shortened read time of rapid diagnostic test for hepatitis C virus.
- Where
- Armenia
- Volunteers
- 3,040 people
- Sponsor
- Médecins du Monde
Tuberculosis
DRug Use & Infections in ViEtnam: TuBerculosis Control
The overarching purpose of the proposed research is to demonstrate that a targeted, multi-component community-based intervention among PWID in Hai Phong will decrease TB prevalence among this very high-risk population.
- Trial name
- DRIVE-TB (NCT05655702)
- Testing
- Community based TB intervention
- Where
- 2 sites in Vietnam
- Volunteers
- 4,000 people, healthy volunteers welcome
- Sponsor
- ANRS, Emerging Infectious Diseases
Hiv, Drug Use
Reducing Stigma in People Who Inject Drugs (PWID) With HIV Using a Rapid Start Antiretroviral Therapy Intervention (ART)
This study seeks to develop an RS-ART implementation strategy by utilizing the Delphi method and interviewing experts and PWID regarding their experiences with ART.
- Trial name
- RS-ART (NCT06541028)
- Testing
- Rapid-Start ART (RS-ART)
- Where
- 3 sites in Malaysia
- Volunteers
- 135 people
- Sponsor
- Yale University
Opioid Use Disorder
PrEP and MOUD Rapid Access for Persons Who Inject Drugs: The CHORUS+ Study
The US opioid overdose epidemic has been accompanied by an increase in human immunodeficiency (HIV) among persons who inject drugs.
- Trial name
- CHORUS+ (NCT05769218)
- Testing
- CHORUS+, Standard of care
- Where
- 2 sites in United States
- Volunteers
- 284 people
- Sponsor
- Boston Medical Center