[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05968573":3,"trial-entities:NCT05968573":113,"trial-summary:NCT05968573":118},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":45,"secondary_outcomes":56,"sex":67,"minimum_age":68,"maximum_age":69,"healthy_volunteers":15,"eligibility_criteria":70,"std_ages":84,"locations":87,"central_contacts":102,"overall_officials":104,"references":107,"see_also_links":112},"NCT05968573","STUDY-22-01162","Persuasive Health Communication Intervention for HIV\u002FHCV","Evaluation of a Persuasive Health Communication Intervention Designed to Increase HIV\u002FHCV Screening Among Emergency Departments Patients Who Currently, Formerly or Never Injected Drugs.","RECRUITING","2026-08-01","2025-07","2026-04-08","2023-12-04","University of South Florida","OTHER",true,"A major impediment to emergency department (ED)-based HIV\u002FHCV 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\u002FHCV 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\u002FHCV counselor. Patients who initially declined HIV\u002FHCV screening will be stratified by injection-drug use (IDU) history cohorts: (1) current\u002Fformer PWIDs, (2) never\u002Fnon-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\u002FHCV 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\u002FHCV 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\u002FHCV 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.\n\nParticipation 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 (\\\u003C30 minutes from recruitment through final study questionnaires) is expected to be minimal (\\\u003C5%). 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.\n\nThe 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\u002Fhour (1 study completion\u002F75 minutes of recruitment, enrollment, and data collection), the research team could recruit up to ≈5,184 participants (720 collection days x 12 hours\u002Fdata collection\u002Fday x 0.6 participants\u002Fhour) over 3 years.\n\nThe 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.",[19,20],"Human Immunodeficiency Virus (HIV)","Hepatitis C (HCV)",[],"INTERVENTIONAL","HEALTH_SERVICES_RESEARCH",[25],"NA",{"count":27,"type":28},2000,"ESTIMATED",[30,35,40],{"type":14,"name":31,"description":32,"armGroupLabels":33},"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.",[34],"Persuasive Health Communication Intervention delivered in video format with captions",{"type":14,"name":36,"description":37,"armGroupLabels":38},"Video Format without Captions","A video without captions created by the research team will be played to persuade patients to participate in HIV and Hepatitis C (HCV) screening.",[39],"Persuasive Health Communication Intervention delivered in video format without captions",{"type":14,"name":41,"description":42,"armGroupLabels":43},"Health Educator","The video created by the research will be compared to a healthcare provider in terms of effectiveness in getting patients screened for HIV\u002FHCV.",[44],"Persuasive Health Communication Intervention delivered by Health Educator",[46,50,53],{"measure":47,"description":48,"timeFrame":49},"Number of patients who accept HIV\u002FHCV testing after watching the video with captions","The number of patients who accept HIV\u002FHCV testing after watching the video with captions","Day 1, up to 5 minutes after intervention",{"measure":51,"description":52,"timeFrame":49},"Number of patients who accept HIV\u002FHCV testing after watching the video without captions","The number of patients who accept HIV\u002FHCV testing after watching the video captions",{"measure":54,"description":55,"timeFrame":49},"Number of patients who accept HIV\u002FHCV testing after speaking with a health educator","The number of patients who accept HIV\u002FHCV testing after speaking with a health educator.",[57,59,61,63],{"measure":58,"description":58,"timeFrame":49},"The number of patients that accept HIV\u002FHCV testing by no prior injection-drug use",{"measure":60,"description":60,"timeFrame":49},"The number of patients that accept HIV\u002FHCV testing by former injection-drug use",{"measure":62,"description":62,"timeFrame":49},"The number of patients that accept HIV\u002FHCV testing by current injection-drug use",{"measure":64,"description":65,"timeFrame":66},"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","ALL","18 Years",null,{"inclusion":71,"exclusion":77,"raw_text":83},[72,73,74,75,76],"≥18 years-old","Speak English or Spanish, and able to provide informed consent for study participation","Not HIV AND HCV infected\u002FAntibody+ (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)",[78,79,80,81,82],"\\\u003C18 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","Inclusion Criteria:\n\n* ≥18 years-old\n* Speak English or Spanish, and able to provide informed consent for study participation\n* Not HIV AND HCV infected\u002FAntibody+ (per EHR review and patient report)\n* Not already participating in a HIV or HCV study (e.g., HIV PrEP, HIV vaccine)\n* Not tested for HIV OR HCV within the past 12 months (per EHR review and patient report)\n\nExclusion Criteria:\n\n* \\\u003C18 years old\n* Unable to speak Spanish or English\n* HIV or HCV positive\n* Currently enrolled in another HIV or HCV research study\n* Has tested for HIV or HCV in the past 12 months",[85,86],"ADULT","OLDER_ADULT",[88],{"facility":89,"status":8,"city":90,"state":90,"zip":91,"country":92,"contacts":93,"geoPoint":99},"Icahn School of Medicine at Mount Sinai","New York","10128","United States",[94],{"name":95,"role":96,"phone":97,"email":98},"Roland C Merchant, MD","CONTACT","(212) 524-9814","Roland.Merchant@mountsinai.org",{"lat":100,"lon":101},40.71427,-74.00597,[103],{"name":95,"role":96,"phone":97,"email":98},[105],{"name":95,"affiliation":13,"role":106},"PRINCIPAL_INVESTIGATOR",[108],{"pmid":109,"type":110,"citation":111},"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\u002FHCV screening: a randomised controlled trial study protocol. BMJ Open. 2024 Aug 12;14(8):e089265. doi: 10.1136\u002Fbmjopen-2024-089265.",[],{"nct_id":4,"conditions":114,"biomarkers":117},[115,116],"Hepatitis C Infection","HIV Infection",[],{"nct_id":4,"found":15,"summary":119,"prompt_version":129},{"design":120,"status":121,"heading":122,"summary":123,"follow_up":124,"word_count":125,"commitments":126,"compensation":127,"drugs_mentioned":128},"This is a randomized, controlled study comparing three different ways to encourage HIV\u002FHCV testing. It plans to enroll 2000 adult participants.","completed","HIV\u002FHCV Screening Communication Study","This study is looking at the best way to encourage people to get screened for HIV (Human Immunodeficiency Virus) and HCV (Hepatitis C). Researchers want to see if a short video, with or without captions, is as effective as talking to a health educator in convincing adults in the emergency department to get tested. You might be able to join if you are 18 or older, speak English or Spanish, and have not been tested for HIV or HCV in the past year. The study aims to enroll 2000 participants. The goal is to find out which method leads to more people accepting HIV\u002FHCV testing.","There are no research-related follow-ups needed after your initial participation.",105,"Your participation involves a single visit to the emergency department, lasting less than 30 minutes, where you will watch a video or speak with a health educator.","Not stated in the trial record.",[41],"v2"]