Human Immunodeficiency Virus (HIV)NCT05968573
Persuasive Health Communication Intervention for HIV/HCV
A study testing Video Format with Captions, Video Format without Captions and Health Educator in people with Human Immunodeficiency Virus (HIV) and Hepatitis C (HCV), run by University of South Florida at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Human Immunodeficiency Virus (HIV), Hepatitis C (HCV)
- What is being tested?
- Video Format with Captions, Video Format without Captions and Health Educator
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,000 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Dec 2023to 31 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ≥18 years-old
- Speak English or Spanish, and able to provide informed consent for study participation
- Not HIV AND HCV infected/Antibody+ (per EHR review and patient report)
- Not already participating in a HIV or HCV study (e.g., HIV PrEP, HIV vaccine)
- Not tested for HIV OR HCV within the past 12 months (per EHR review and patient report)
Who cannot join
- <18 years old
- Unable to speak Spanish or English
- HIV or HCV positive
- Currently enrolled in another HIV or HCV research study
- Has tested for HIV or HCV in the past 12 months
Trial locations and contacts
1 site in 1 country.
United States1 site
Icahn School of Medicine at Mount Sinai
New York, New York, 10128
About this study
Official title: Evaluation of a Persuasive Health Communication Intervention Designed to Increase HIV/HCV Screening Among Emergency Departments Patients Who Currently, Formerly or Never Injected Drugs.
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.
Read the detailed description
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.
- Being tested
- Video Format with Captions, Video Format without Captions, Health Educator
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video Format with CaptionsOther
A video with captions created by the research team will be played to persuade patients to participate in HIV and Hepatitis C (HCV) screening.
Video Format without CaptionsOther
A video without captions created by the research team will be played to persuade patients to participate in HIV and Hepatitis C (HCV) screening.
Health EducatorOther
The video created by the research will be compared to a healthcare provider in terms of effectiveness in getting patients screened for HIV/HCV.
| Study group | Role | What they receive |
|---|---|---|
| Persuasive Health Communication Intervention delivered in video format with captions | Active comparator | A video with captions created by the research team will be played to persuade patients to participate in HIV and Hepatitis C (HCV) screening. Receives: Other: Video Format with Captions |
| Persuasive Health Communication Intervention delivered in video format without captions | Active comparator | A video with captions created by the research team will be played to persuade patients to participate in HIV and Hepatitis C (HCV) screening. Receives: Other: Video Format without Captions |
| Persuasive Health Communication Intervention delivered by Health Educator | Active comparator | Healthcare provider educator getting patients screened for HIV/HCV. Receives: Other: Health Educator |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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.
Measured: Day 1, up to 5 minutes after intervention
Secondary outcomes (4)
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
Measured: 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
Measured: 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
Measured: 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.
Measured: End of study, at 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start4 Dec 2023
- Primary completion31 Jul 2026
- Study completion31 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Human Immunodeficiency Virus (HIV)Studies of the same condition, open and under way.
- More trials run by University of South FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study has two parts: Part A: Modification of the PHCI with the assistance of current and former people who inject drugs (PWID) ED patients. Part B: Randomized Controlled Trial - this will only be conducted after completion of Part A.
- Masking
- None (open label)
- Enrolment
- 2,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Florida
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Roland Merchant, University of South Florida
- Investigators
- Roland C Merchant, MD, Principal investigator, University of South Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05968573
- Sponsor's protocol ID
- STUDY-22-01162
- Other IDs
- 1R01DA055533-01
- Status last verified
- Jul 2025
- First submitted
- 21 Jul 2023
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All of the individual participant data collected during the trial, after deidentification.
Publications
Merchant RC, Harrington N, Clark MA, Liu T, Morgan J, Cowan E, Solnick R, Wyler B. Testing a persuasive health communication intervention (PHCI) for emergency department patients who declined rapid HIV/HCV screening: a randomised controlled trial study protocol. BMJ Open. 2024 Aug 12;14(8):e089265. doi: 10.1136/bmjopen-2024-089265.
PubMed 39134444
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Persuasive Health Communication Intervention Designed to Increase HIV/HCV Screening Among Emergency Departments Patients Who Currently, Formerly or Never Injected Drugs.
- ClinicalTrials.gov ID
- NCT05968573
- Acronym / sponsor ID
- STUDY-22-01162
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,000 participants (actual)
- Lead sponsor
- University of South FloridaUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 4 Dec 2023 (actual)
- Primary completion
- 31 Jul 2026 (actual)
- Study completion
- 31 Jul 2026 (actual)
- First posted
- 1 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This study has two parts: Part A: Modification of the PHCI with the assistance of current and former people who inject drugs (PWID) ED patients. Part B: Randomized Controlled Trial - this will only be conducted after completion of Part A.
| Arm | Type | Receives |
|---|---|---|
| Persuasive Health Communication Intervention delivered in video format with captions | Active comparator | Other: Video Format with CaptionsA video with captions created by the research team will be played to persuade patients to participate in HIV and Hepatitis C (HCV) screening. |
| Persuasive Health Communication Intervention delivered in video format without captions | Active comparator | Other: Video Format without CaptionsA video with captions created by the research team will be played to persuade patients to participate in HIV and Hepatitis C (HCV) screening. |
| Persuasive Health Communication Intervention delivered by Health Educator | Active comparator | Other: Health EducatorHealthcare provider educator getting patients screened for HIV/HCV. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ≥18 years-old
- Speak English or Spanish, and able to provide informed consent for study participation
- Not HIV AND HCV infected/Antibody+ (per EHR review and patient report)
- Not already participating in a HIV or HCV study (e.g., HIV PrEP, HIV vaccine)
- Not tested for HIV OR HCV within the past 12 months (per EHR review and patient report)
Key exclusion criteria (5 listed)
- <18 years old
- Unable to speak Spanish or English
- HIV or HCV positive
- Currently enrolled in another HIV or HCV research study
- Has tested for HIV or HCV in the past 12 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Video Format with CaptionsA video with captions created by the research team will be played to persuade patients to participate in HIV and Hepatitis C (HCV) screening. | Other | Persuasive Health Communication Intervention delivered in video format with captions |
| Video Format without CaptionsA video without captions created by the research team will be played to persuade patients to participate in HIV and Hepatitis C (HCV) screening. | Other | Persuasive Health Communication Intervention delivered in video format without captions |
| Health EducatorThe video created by the research will be compared to a healthcare provider in terms of effectiveness in getting patients screened for HIV/HCV. | Other | Persuasive Health Communication Intervention delivered by Health Educator |
Primary outcome
Number of patients who accept HIV/HCV testing after watching the video with captions
Time frame: Day 1, up to 5 minutes after intervention
The number of patients who accept HIV/HCV testing after watching the video with captions
Number of patients who accept HIV/HCV testing after watching the video without captions
Time frame: Day 1, up to 5 minutes after intervention
The number of patients who accept HIV/HCV testing after watching the video captions
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 who accept HIV/HCV testing after speaking with a health educator.
4 secondary outcomes
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
Time frame: Day 1, up to 5 minutes after intervention
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
Time frame: End of study, at 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Derived from this study: PubMed 39134444Merchant RC, Harrington N, Clark MA, Liu T, Morgan J, Cowan E, Solnick R, Wyler B. Testing a persuasive health communication intervention (PHCI) for emergency department patients who declined rapid HIV/HCV screening: a randomised controlled trial study protocol. BMJ Open. 2024 Aug 12;14(8):e089265. doi: 10.1136/bmjopen-2024-089265.
- Individual participant dataSharing planned: Yes. All of the individual participant data collected during the trial, after deidentification.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roland C Merchant, MD principal investigator
University of South Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video Format with Captions, Video Format without Captions and Health Educator in people with Human Immunodeficiency Virus (HIV) and Hepatitis C (HCV), run by University of South Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients who accept HIV/HCV testing after watching the video with captions (time frame: Day 1, up to 5 minutes after intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05968573, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.