Clinical trials: Directly Observed Therapy
Hepatitis C
A Direct obserVed therApy vs fortNightly CollEction Study for HCV Treatment - ADVANCE HCV Study
Hepatitis C is a blood borne virus that can seriously damage the liver. An estimated 50,000 Scots have been infected with Hepatitis C virus (HCV). The main driver for spread of HCV infection is intravenous drug use.
- Trial name
- ADVANCE (NCT03236506)
- Testing
- Elbasvir/Grazoprevir 50 MG-100 MG Oral Tablet, Psychological intervention, Sofosbuvir 400 MG
- Where
- 2 sites in United Kingdom
- Volunteers
- 129 people
- Sponsor
- University of Dundee
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
Opioid-Related Disorders
Trial of Adherence App for Buprenorphine Treatment (TAAB) Study
The purpose of this study is to pilot test a smartphone application that allows video-based directly observed therapy for participants receiving buprenorphine treatment for opioid use disorder in office-based settings.
- Trial name
- NCT03779997
- Testing
- Video-based DOT Application
- Where
- 2 sites in United States
- Volunteers
- 78 people
- Sponsor
- University of Washington
HIV Prevention, Transgender Health
Study of Truvada for HIV Pre Exposure Prophylaxis Using Daily Directly Observed Therapy to Look at Potential Interactions Between Truvada and Hormone Therapy
Truvada (Emtricitabine or FTC and tenofovir disoproxil fumarate or TDF) has been approved for HIV prevention since 2012. Drug concentrations after receipt of oral Truvada for HIV Pre Exposure Prophylaxis (or PrEP) appeared to be…
- Trial name
- I-BrEATHe (NCT04050371)
- Testing
- 200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate
- Where
- United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- University of California, San Francisco
HIV
Emtricitabine/Tenofovir Alafenamide as Salvage ART
Background: HIV attacks the immune system. Antiretroviral therapy (ART) is a combination of drugs used for treating HIV infection. For some people, ART drugs stop working against their HIV.
- Trial name
- NCT02556333
- Testing
- FTC/TAF
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Tuberculosis
Innovative Approach in Tuberculosis Care in Armenia
Randomized trial tests effectiveness of self-administered drug intake by empowered TB patients - supervised by a trained family member and supported by medical counseling and reminders - to improve treatment adherence and…
- Trial name
- NCT02082340
- Testing
- TB knowledge and socio-psychological counseling session, SMS text messages, phone calls
- Where
- Armenia
- Volunteers
- 392 people
- Sponsor
- Varduhi Petrosyan
HIV Infections
Helping HIV Infected Patients in South Africa Adhere to Drug Regimens
Three or more anti-HIV drugs are taken in combination as part of a treatment regimen. These drug regimens must be closely followed in order to be successful.
- Trial name
- NCT00076804
- Testing
- Directly Observed Therapy
- Where
- South Africa
- Volunteers
- 274 people
- Sponsor
- Johns Hopkins University
Pulmonary Tuberculosis
Directly Observed Therapy Short Course-Plus Versus DOTS for Retreatment of Relapsed Pulmonary Tuberculosis in Guangzhou
This is a prospective, randomized, parallel, controlled study comparing the efficacy and outcomes in the retreatment of pulmonary Tuberculosis (TB) in Guangzhou in a group using pretreatment susceptibility tests in selection of…
- Trial name
- NCT01618422
- Testing
- Directly Observed Therapy (DOTS) plus, Directly Observed Therapy (DOTS)
- Where
- China
- Volunteers
- 225 people
- Sponsor
- Chinese University of Hong Kong
Hepatitis C, Chronic
Role of Pegylated Interferon in Combination With DAAs to Cure Hepatitis C As Soon As Possible - Hepatitis C [ASAP-C]
The primary objective of this pilot trial is to compare the efficacy, measured as sustained virologic response (SVR) at least 12 weeks after completion of therapy, across three study regimens/delivery modalities: Arm 1 - 4 weeks…
- Trial name
- NCT03480932
- Testing
- Sofosbuvir, Daclatasvir, Pegylated Interferon alfa-2a
- Where
- India
- Volunteers
- 150 people
- Sponsor
- Johns Hopkins Bloomberg School of Public Health
Tuberculosis, Drug-resistant Tuberculosis
An Evaluation of Traditional Directly Observed Therapy (DOT) and Electronic DOT for TB Treatment
This study is a U.S.-based, 1 site (with 4 clinical settings), randomized controlled trial (with funding from the Centers for Disease Control and Prevention's (CDC) Antibiotic Resistance Solutions Initiative) that will be…
- Conditions
- Tuberculosis, Drug-resistant Tuberculosis, Adherence, Medication, Adherence, Patient
- Trial name
- NCT03266003
- Testing
- Electronic DOT, In-person DOT
- Where
- 4 sites in United States
- Volunteers
- 216 people
- Sponsor
- Centers for Disease Control and Prevention
Hepatitis C, Medication Adherence
Smartphone Based aDOT Treatment With Fixed-Dose Elbasvir and Grazoprevir in PWIDs
People who Inject Drugs (PWIDs) constitute 60% of the approximately 5 million people in the United States infected with hepatitis C virus (HCV).
- Trial name
- NCT03127358
- Testing
- AiCure, AiCure with gamification
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- Albert Einstein College of Medicine
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
Depression, Hemodialysis-Induced Symptom
Identifying and Treating Depression in Hemodialysis Patients
Depression is present in about 20-30% of hemodialysis patients and is associated with morbidity and mortality. However, depression is inadequately diagnosed and treated among dialysis patients.
- Trial name
- NCT03390933
- Testing
- Fluoxetine
- Where
- United States
- Volunteers
- 16 people
- Sponsor
- MetroHealth Medical Center
Hepatitis C, Chronic
Directly Observed Therapy for HCV in Chennai, India
The primary objective of this pilot trial is to evaluate the feasibility of 12 weeks vs. 24 weeks of field-based directly observed therapy (DOT) for HCV therapy in a resource-limited setting.
- Trial name
- C-DOT (NCT02541409)
- Testing
- Sofosbuvir, Pegylated Interferon alfa-2a, Ribavirin
- Where
- India
- Volunteers
- 50 people
- Sponsor
- Johns Hopkins Bloomberg School of Public Health
Hepatitis C, Medication Adherence
Intensive Models of HCV Care for Injection Drug Users
Injection drug users (IDUs) constitute 60% of the approximately 5 million people in the U.S. infected with hepatitis C virus (HCV). HCV treatment leading to sustained viral response (SVR) is associated with increased survival.
- Trial name
- NCT01857245
- Testing
- Intensive Models (mDOT and CGT) of HCV Care
- Where
- United States
- Volunteers
- 150 people
- Sponsor
- Prisma Health-Upstate
Tuberculosis
Wirelessly Observed Therapy in Comparison to Directly Observed Therapy for the Treatment of Tuberculosis
This study uses an ingestion sensor and a wearable sensor (worn as a patch on the skin), which are new Proteus Digital Health (PDH) technologies approved by the FDA, to collect information about patients taking their TB…
- Trial name
- NCT01960257
- Testing
- Digital Health Feedback System, SOC DOT
- Where
- 2 sites in United States
- Volunteers
- 92 people
- Sponsor
- University of California, San Diego
Latent Tuberculosis Infection
Study 33: Adherence to Latent Tuberculosis Infection Treatment 3HP SAT Versus 3HP DOT
The study is an open label, multicenter, randomized (three arms: DOT (standard control), SAT, SAT with SMS reminders) controlled clinical trial.
- Trial name
- iAdhere (NCT01582711)
- Testing
- Self Administered Therapy (SAT), SMS reminders, isoniazid and rifapentine
- Where
- 12 sites in United States, China and 2 more
- Volunteers
- 1,002 people
- Sponsor
- Centers for Disease Control and Prevention
HIV Infections
Determining the Effects of Observed and Self-Administered Drug Regimens in HIV Infected Adults
Highly active antiretroviral therapy (HAART) has led to better health and survival rates among people with HIV/AIDS. The purpose of this study was to measure the effect of trained partner supervision when taking medication versus…
- Trial name
- NCT00608569
- Testing
- Lopinavir/ritonavir, Emtricitabine/Tenofovir disoproxil fumarate, Tenofovir disoproxil fumarate
- Where
- 9 sites in Botswana, Brazil and 6 more
- Volunteers
- 529 people
- Sponsor
- Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
HIV/AIDS, Mobile Health
Youth Ending the HIV Epidemic
Young adults have a disproportionately high rate of HIV infection, high rates of attrition at all stages of the HIV care continuum, an increased risk of antiretroviral therapy (ART) nonadherence and virologic failure, and a high…
- Conditions
- HIV/AIDS, Mobile Health, Young Adults
- Trial name
- YEHE (NCT05789875)
- Testing
- aDOT-CEI
- Where
- United States
- Volunteers
- 28 people
- Sponsor
- University of California, San Francisco
Hepatitis C, Chronic
A Collaborative Trial in Injectors of Individualized Treatment for Genotype 2/3
This sudy will determine whether shortening treatment for hepatitis C is feasible, safe and effective for patients who are current injection drug users or receiving opiate substitution therapy and who are responding well to…
- Trial name
- ACTIVATE (NCT01364090)
- Testing
- Pegylated interferon alfa 2b, Ribavirin
- Where
- 17 sites in Australia, Belgium and 5 more
- Volunteers
- 93 people
- Sponsor
- Kirby Institute