Clinical trials: People Who Inject Drugs
Hepatitis C
Surveillance and Treatment of Prisoners With Hepatitis C
The purpose of the study is to assess how feasible it is to treat and prevent the transmission of Hepatitis C in the prison setting to achieve substantial reductions in the incidence and prevalence of Hepatitis C.
- Trial name
- SToP-C (NCT02064049)
- Testing
- Sofosbuvir/velpatasvir
- Where
- 4 sites in Australia
- Volunteers
- 3,692 people, healthy volunteers welcome
- Sponsor
- Kirby Institute
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
Chronic Hepatitis C
Pilot Treatment as Prevention for HCV Among Persons Who Actively Inject Drugs
This project is a randomized trial of two strategies to treat persons with genotype 1 HCV who currently inject drugs (PWIDs) with a once daily regime of ledipasvir-sofosbuvir (LDV-SOF) for 8 weeks.
- Trial name
- BYE-C (NCT02609893)
- Testing
- modified directly observed therapy (mDOT), unobserved dosing, Motivational Interviewing-based counseling
- Where
- United States
- Volunteers
- 31 people
- Sponsor
- Phillip Coffin, MD, MIA
People Who Inject Drugs
Evaluation of an Educational Intervention on Abscesses in People Who Self-inject Drugs
The goal of this cluster randomised controlled trial (cRCT) is to to evaluate the effectiveness of an educational intervention combining training in hand-washing with the supply of MONO-RUBs on the reduction of skin abscesses…
- Trial name
- HAWA (NCT06131788)
- Testing
- Educational hand hygiene intervention
- Where
- 22 sites in France
- Volunteers
- healthy volunteers welcome
- Sponsor
- Institut National de la Santé Et de la Recherche Médicale, France
Hepatitis C
Increasing HCV Linkage to Care Among People Who Inject Drugs
Our study will test the effectiveness of a simplified approach to delivering Hepatitis C Virus (HCV) care in a street-based mobile medical clinic among people who inject drugs in increasing treatment initiation, retention, and…
- Trial name
- NCT04741750
- Testing
- Simplified HCV care within a mobile medical unit
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- Family Health Centers of San Diego
Hiv, Substance Use Disorders
Intervention to Improve HIV Self-care Among People Who Inject Drugs
This study will implement a pilot randomized controlled trial (RCT, N=50) to refine and assess the feasibility and acceptability of an emotion regulation and communication skills intervention designed to improve engagement in…
- Trial name
- iSTRIVE (NCT05819411)
- Testing
- Project iSTRIVE, incentivized Directly Observed Therapy (iDOT)
- Where
- United States
- Volunteers
- 42 people
- Sponsor
- Massachusetts General Hospital
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
Hepatitis C, Drug Use
DRug Use & Infections in ViEtnam - Hepatitis C (DRIVE-C)
The study aims to assess the effectiveness of a model of hepatitis C screening and integrated care, targeting people who inject drugs (PWIDs) in Hai Phong, Vietnam.
- Conditions
- Hepatitis C, Drug Use, Viral Hepatitis C
- Trial name
- DRIVE-C (NCT03537196)
- Testing
- Sofosbuvir 400 mg and Daclatasvir 60 mg, Sofosbuvir 400 mg and Daclatasvir 90 mg, Ribavirin
- Where
- 2 sites in Vietnam
- Volunteers
- 979 people
- Sponsor
- ANRS, Emerging Infectious Diseases
Skin and Soft Tissue Infections, Hiv
ASAP: Access to Syringes at Pharmacies for the Prevention of Bloodborne Infections Among People Who Inject Drugs
Access to Syringes at Pharmacies (ASAP) is a refinement of an evidence-based, pharmacy intervention to increase pharmacy-based sales of syringes to PWID in order to reduce bloodborne illnesses among them.
- Conditions
- Skin and Soft Tissue Infections, Hiv, Hepatitis C, Bloodstream Infection
- Trial name
- ASAP (NCT05270135)
- Testing
- ASAP
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- University of Arizona
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
Chronic Hepatitis C, People Who Inject Drugs
Treatment of HCV-Infected Recent Injection Drug Users in U.S. Liver Clinics
Direct antiviral therapy (standard of care) administered to chronic hepatitis C-infected patients, in two hepatology clinics, who had used intravenous drugs in the past 6 months of signing informed consent (IC).
- Trial name
- NCT05895448
- Testing
- velpatasvir and sofosbuvir once daily for 12 weeks (brand or branded generic) .
- Where
- United States
- Volunteers
- 125 people
- Sponsor
- Center For Hepatitis C, Atlanta, GA
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
HCV Infection, HIV Infections
Addressing the Cascade of Care in Vulnerable Populations With Poor Access to Healthcare in Madrid
Data on the prevalence of hepatitis C virus (HCV) for other vulnerable groups in Madrid, such as homeless persons and migrants, are scarce, and it is now necessary to implement intervention and elimination plans.
- Conditions
- HCV Infection, HIV Infections, Drug Use, HBV (Hepatitis B Virus)
- Trial name
- (UMC) (NCT04062253)
- Testing
- HCV rapid test
- Where
- Spain
- Volunteers
- 2,001 people, healthy volunteers welcome
- Sponsor
- Hospital Universitario Infanta Leonor
Hepatitis C
Same-visit Hepatitis C Testing and Treatment (The QuickStart Study)
The QuickStart study aims to assess the impact of three models of HCV care on HCV treatment uptake and cure among people who inject drugs.
- Trial name
- NCT05016609
- Testing
- OraQuick HCV Antibody test (OraSure Technologies, Inc), Xpert HCV Viral Load Finger-stick Point-of-Care test (Cepheid), Sofosbuvir/Velpatasvir (Gilead)
- Where
- 6 sites in Australia
- Volunteers
- 1,800 people, healthy volunteers welcome
- Sponsor
- Macfarlane Burnet Institute for Medical Research and Public Health Ltd
Hepatitis C, Drug Abuse, Intravenous
The TAP Study: Treating People Who Inject Drugs in Community-Based Settings Using a Social Network Approach
This study will investigate the feasibility of treating people who inject drugs (PWID) with hepatitis C virus (HCV) in community-based settings with a 12-week course of oral therapy combination of sofosbuvir plus ledipasvir.
- Trial name
- TAP (NCT02363517)
- Testing
- Sofosbuvir/ledispasvir fixed dose combination (SOF + LDP)
- Where
- Australia
- Volunteers
- 420 people
- Sponsor
- Macfarlane Burnet Institute for Medical Research and Public Health Ltd
HIV/AIDS, Hepatitis C
Study of HIV, HCV, APS and Phylogenetics for PWID
This study will determine whether assisted partner notification services (APS) can identify and link to care, the sexual and needle-sharing partners of HIV-infected and HIV/hepatitis C (HCV) co-infected persons who inject drugs…
- Trial name
- SHARP (NCT03447210)
- Testing
- Assisted Partner Services
- Where
- 3 sites in Kenya
- Volunteers
- 4,301 people
- Sponsor
- University of Washington
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
HCV
Innovate, Involve, Inspire
The study will test a Community-based Simplified HCV Testing and Treatment Algorithm (CBSA), implemented at community harm reduction fixed or mobile sites.
- Trial name
- NCT06604182
- Testing
- Community-based Simplified HCV Testing and Treatment Algorithm
- Volunteers
- 1,454 people, healthy volunteers welcome
- Sponsor
- Frontline AIDS
Hepatitis C, Substance Use Disorders
HCV Treatment in a Low-threshold Clinic
This is a cohort of people who inject drugs with chronic HCV infection. Patients are seen at a low-threshold clinic. All patients are offered treatment for HCV and subsequently followed for to years
- Trial name
- Prindsen (NCT04063839)
- Testing
- Elbasvir / Grazoprevir Oral Tablet
- Where
- Norway
- Volunteers
- 300 people
- Sponsor
- University Hospital, Akershus
Hepatitis C
Conquering Hepatitis C Via Micro-Elimination in Southwest Virginia
The objective of this protocol is to conduct a comprehensive quantitative and qualitative assessment of the impact of our innovative collaborative telehealth HCV care model on patient treatment experiences and quality of life.
- Trial name
- CHIME (NCT03876470)
- Testing
- Hepatitis C treatment as chosen by provider
- Volunteers
- 300 people
- Sponsor
- University of Virginia