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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01DA055533-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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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 QDSâ„¢ (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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Persuasive Health Communication Intervention delivered by Health Educator | Active Comparator | Healthcare provider educator getting patients screened for HIV/HCV. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Video Format with Captions | Other | A video with captions created by the research team will be played to persuade patients to participate in HIV and Hepatitis C (HCV) screening. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | 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. | Day 1, up to 5 minutes after intervention |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Day 1, up to 5 minutes after intervention |
| The number of patients that accept HIV/HCV testing by former injection-drug use |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Roland C Merchant, MD | Contact | (212) 524-9814 | Roland.Merchant@mountsinai.org |
| Name | Affiliation | Role |
|---|---|---|
| Roland C Merchant, MD | University of South Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Icahn School of Medicine at Mount Sinai | Recruiting | New York | New York | 10128 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39134444 | Derived | 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. |
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All of the individual participant data collected during the trial, after deidentification.
Specify Other Time FrameAfter last patient enrolled up to a year from that time point.
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.
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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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.
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Participants will be told during consent that they will be randomized and assigned to a group. Participants will be told that the two groups are to watch a video or listen to a health educator. Therefore, participants are not prevented from having knowledge of the interventions assigned to them.
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| Video Format without Captions | Other | A video without captions created by the research team will be played to persuade patients to participate in HIV and Hepatitis C (HCV) screening. |
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| Health Educator | Other | The video created by the research will be compared to a healthcare provider in terms of effectiveness in getting patients screened for HIV/HCV. |
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The number of patients that accept HIV/HCV testing by former injection-drug use |
| 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 | 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. | End of study, at 5 years |
| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D006525 | Hepatitis, Viral, Human |
| D018178 | Flaviviridae Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |