An interventional study of Video Format with Captions and Video Format without Captions in Human Immunodeficiency Virus (HIV) and Hepatitis C (HCV), sponsored by University of South Florida. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-13.
Sponsored by University of South Florida · Not applicable, Interventional, and Health services research
Among 725 studies in Hepatitis C with a site in United States — 29 open to participants now, 37 under way, 1 of them phase 3. Hepatitis C · United States.
Among the 725 studies in Hepatitis C with a site in United States, this one is the 10th largest by enrollment of the 594 interventional ones, is one of 10 that started in 2023, is one of 140 with no phase, and was the 705th registered.
1,743 studies on the registry are indexed under Hepatitis C; 97 are open to participants now.
This study's enrollment of 2,000 is above the median of 72 across 1,223 interventional studies indexed under Hepatitis C.
Browse Hepatitis C studies →29 of the 725 studies in Hepatitis C with a site in United States are open now, in 1 country. Each count lists the studies.
Of the 56 Hepatitis C studies recruiting now, 43 (77%) set no upper age limit and 6 (11%) stop at 75 or younger; 10 take children under 18; 26 take healthy volunteers.
This study: 18 Years and older · all sexes · healthy volunteers too.
The full table on the hub →725 studies; the count open now beside each. This study's row is marked.
First in 1981; this study’s year is marked. 10 started in 2023.
Median enrollment 60 across the 594 interventional studies, 113 across the 127 observational. Of the 633 that completed or were terminated, 286 (45%) have results posted.
286 of 725 have an industry lead sponsor. The 10 most frequent:
University of South Florida is the lead sponsor of 340 studies on the registry; 65 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 4 (24%) have results posted.
University of South Florida has 1 study filed under Hepatitis C — fewer than ten, so there is no comparison to draw.
13 of the studies in Hepatitis C with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06367465Washington University School of MedicineFeasibility and Acceptability of HCV Treatment in Pregnancy | 2026-12-28 |
| NCT06870019University of Southern CaliforniaHepatitis C Tracker Study | 2026-12-31 |
| NCT06953479LifespanImplementing Low-Barrier HCV Treatment in a Jail Setting | 2027-01 |
| NCT07631559University of California, San FranciscoPilot Study of an Adapted Partner Navigation Intervention Booster Session for Sustained Healthcare Engagement Among People Who Inject Drugs | 2027-03-01 |
| NCT06179498University of California, San FranciscoPartner Navigation Intervention for Hepatitis C Treatment Among Young People Who Inject Drugs | 2027-03-01 |
Among the 725 studies in Hepatitis C with a site in United States, from their registry updates:
A major impediment to emergency department (ED)-based HIV/HCV screening success is that often ED patients at risk for, or later diagnosed with, HIV and HCV decline testing. In this R01 project, the research team will assess how well a promising, easy-to-use, one-time, minimal-training-needed, very brief persuasive health communication intervention (PHCI) increases acceptance of testing among adult ED patients who either currently, formerly or never injected drugs and initially declined HIV/HCV screening. The research team will conduct a randomized, controlled trial (RCT) at EDs within the Mount Sinai Health System to compare the efficacy of the PHCI when delivered by a video vs. an HIV/HCV counselor. Patients who initially declined HIV/HCV screening will be stratified by injection-drug use (IDU) history cohorts: (1) current/former PWIDs, (2) never/non-PWIDs. Within each IDU history cohort, the research team will randomly assign participants (1:1:1) to a PHCI delivered by: (1) a video with captions, (2) a video without captions, (3) an HIV/HCV counselor. This R01 project will be conducted at Mount Sinai affiliate hospitals EDs. For Aim 2, the research team will determine if screening acceptance is similar across IDU history cohorts. For Aim 3, the research team will further compare the two delivery forms of the PHCI through a health economics assessment, both independent of IDU history and within each IDU history cohort.
As part of routine practice at Mount Sinai Health System EDs, the ED Nurses initiate HIV/HCV screening for all patients able to provide consent. ED patients eligible for recruitment into the RCT portion of the study are those who declined HIV/HCV screening. RCs will review the electronic health records (EHRs) of patients present in the ED during data collection periods and determine which patients are potentially eligible.
Participation in the RCT involves a one-time encounter. All research-related activities will occur in the ED. As such, drop-out during this brief RCT (\<30 minutes from recruitment through final study questionnaires) is expected to be minimal (\<5%). RCs will coordinate with participants and ED staff to facilitate participant involvement while they are receiving medical care. If necessary, participants can continue participating in designated areas of the ED (e.g., waiting room, family room) after they are discharged and there are study-related tasks remaining. There are no research related follow-ups needed.
The research team will enroll a total of 2,000 adult ED patients who meet all study criteria and agree to participate in the RCT, stratified by IDU history. Assuming 0.6 participants completing the study/hour (1 study completion/75 minutes of recruitment, enrollment, and data collection), the research team could recruit up to ≈5,184 participants (720 collection days x 12 hours/data collection/day x 0.6 participants/hour) over 3 years.
The research team will be collecting data using the QDS™ (NOVA Research Company) program installed on a tablet computer. The program has the ability to encrypt collected data, to which only the researcher has ability to de-crypt data sets (NOVA Research cannot recover lost passwords for the researcher). The program also has a data management system, allowing data export for use in analytical packages like SPSS, Stata. Internet access is not necessary for this program to function. The data can be stored on the tablet computer for the meantime, then synced once internet is available.
1,743 studies on the registry are indexed under Hepatitis C; 97 are open to participants now.
This study's enrollment of 2,000 is above the median of 72 across 1,223 interventional studies indexed under Hepatitis C.
Browse Hepatitis C studies →University of South Florida is the lead sponsor of 340 studies on the registry; 65 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 4 (24%) have results posted.
Compared within Hepatitis C, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Acquired Immunodeficiency Syndrome. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A video with captions created by the research team will be played to persuade patients to participate in HIV and Hepatitis C (HCV) screening.
Other: Video Format with Captions
A video with captions created by the research team will be played to persuade patients to participate in HIV and Hepatitis C (HCV) screening.
Other: Video Format without Captions
Healthcare provider educator getting patients screened for HIV/HCV.
Other: Health Educator
A video with captions created by the research team will be played to persuade patients to participate in HIV and Hepatitis C (HCV) screening.
A video without captions created by the research team will be played to persuade patients to participate in HIV and Hepatitis C (HCV) screening.
The video created by the research will be compared to a healthcare provider in terms of effectiveness in getting patients screened for HIV/HCV.
Number of patients who accept HIV/HCV testing after watching the video with captions
The number of patients who accept HIV/HCV testing after watching the video with captions
Time frame: Day 1, up to 5 minutes after intervention
Number of patients who accept HIV/HCV testing after watching the video without captions
The number of patients who accept HIV/HCV testing after watching the video captions
Time frame: Day 1, up to 5 minutes after intervention
Number of patients who accept HIV/HCV testing after speaking with a health educator
The number of patients who accept HIV/HCV testing after speaking with a health educator.
Time frame: Day 1, up to 5 minutes after intervention
The number of patients that accept HIV/HCV testing by no prior injection-drug use
The number of patients that accept HIV/HCV testing by no prior injection-drug use
Time frame: Day 1, up to 5 minutes after intervention
The number of patients that accept HIV/HCV testing by former injection-drug use
The number of patients that accept HIV/HCV testing by former injection-drug use
Time frame: Day 1, up to 5 minutes after intervention
The number of patients that accept HIV/HCV testing by current injection-drug use
The number of patients that accept HIV/HCV testing by current injection-drug use
Time frame: Day 1, up to 5 minutes after intervention
Health economics assessment of PHCI
The research team will further compare the two delivery forms of the PHCI through a health economics assessment, both independent of IDU history and within each IDU history cohort. This will measure cost-benefit analysis in terms of cost of each intervention in relation to how effective it is on persuading real world populations to test for HIV and HCV.
Time frame: End of study, at 5 years
Plan to share: Yes — All of the individual participant data collected during the trial, after deidentification.
Supporting information: Study protocol
Time frame: Specify Other Time FrameAfter last patient enrolled up to a year from that time point.
Access criteria: Investigators whose proposed use of the data has been approved by an independent review committee ('learned intermediary') identified for this purpose. To achieve aims in the approved proposal. Specify Other Mechanism Secured excel file sent through email.
Ran from Dec 2023 to primary completion in Jul 2026, 31 months.
Of 150 non-industry interventional studies with no phase under Hepatitis C, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 42. This study's 31 months is above that.
Counting every sponsor, half of 153 studies reached it within 25 months; a quarter within 14 and three quarters within 42.
Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 13, 2026: primary completion Aug 2026 → Jul 2026 and completion Aug 2026 → Jul 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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