[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100582544":3},{"organization":4,"outcomesModule":7,"designInfo":29,"detailedDescription":35,"studyPopulation":28,"armGroups":36,"interventions":47,"overallOfficials":53,"centralContacts":58,"locations":64,"responsibleParty":81,"collaborators":83,"id":87,"slug":28,"hasResults":88,"nctId":89,"briefTitle":90,"officialTitle":90,"acronym":91,"eligibilityCriteria":92,"healthyVolunteers":93,"sex":94,"minAge":95,"maxAge":96,"enrollmentInfo":97,"targetDuration":28,"studyType":100,"phases":101,"briefSummary":103,"conditions":104,"keywords":106,"overallStatus":111,"whyStopped":28,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":121},{"fullName":5,"class":6},"The University of Texas Medical Branch, Galveston","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":28},[9,13],{"measure":10,"description":11,"timeFrame":12},"Number of participants with increased willingness to access or use PrEP","To assess whether participation in Project ROLE versus usual care will increase the willingness of Black women to access and\u002For use PrEP","baseline and day of enrollment and baseline, 1-month, 3-month, and 6-month",{"measure":14,"description":15,"timeFrame":12},"Number of healthcare providers increased willingness to prescribe and\u002For refer PrEP","To assess whether participation in Project ROLE versus usual care will increase the willingness of healthcare providers to prescribe and\u002For refer PrEP to Black women",[17,21,24],{"measure":18,"description":19,"timeFrame":20},"Number of Black Women started to use of PrEP","To assess whether Black women started to use PrEP.","1- month, 3-months, and 6-months follow-up visits",{"measure":22,"description":23,"timeFrame":20},"Number of PrEP prescriptions or referrals by healthcare providers","Using the clinical notes of electronic clinical records at participating CHCs.",{"measure":25,"description":26,"timeFrame":27},"PrEP adherence among those who initiated PrEP","Assess, using a urine drug screen, whether Black women who initiated PrEP adhered to the PrEP regimen.","3-months and 6-months follow-up visits",null,{"allocation":30,"interventionModel":31,"interventionModelDescription":28,"primaryPurpose":32,"observationalModel":28,"timePerspective":28,"maskingInfo":33},"RANDOMIZED","PARALLEL","PREVENTION",{"masking":34,"maskingDescription":28,"whoMasked":28},"NONE","The primary objective of this R34 proposal is to increase willingness for pre-exposure prophylaxis (PrEP) initiation and actual PrEP initiation among BW, increase willingness to prescribe\u002Frefer PrEP to BW among HCPs in Houston\u002FHarris County, a high-priority End the HIV Epidemic (EHE) jurisdiction. The investigator hypothesizes that a video-log (vlog) series-based health communication intervention disseminated through community health centers (CHCs) and social media will increase willingness for and use of PrEP among BW. Specifically, the intervention will: 1) encourage BW to access and use PrEP; and 2) increase HCP willingness to prescribe and refer PrEP to BW. Our team will explore two aims: 1) inform and develop health messages for Project ROLE with 2023 findings from focus groups with PrEP-eligible BW and key informant interviews with HCPs providing care to BW, and 2) assess the feasibility, acceptability, and preliminary impact of Project ROLE in two real-world settings with a pilot randomized controlled trial (RCT) and a social media campaign.\n\nAim 1: A qualitative study using focus groups with Black women and key informant interviews with healthcare providers. (Will not be included in the clinical trial.)\n\nAim 2a: Pilot randomized controlled trial of a behavioral intervention with both Black women and healthcare providers.\n\nAim 2b: Social media marketing campaign to reach and engage Black women and healthcare providers in health communication about PrEP. (Will not be included in the clinical trial.)\n\nThe proposed research is significant because it will connect Black women to PrEP while increasing healthcare providers willingness to prescribe and refer PrEP to them using a health communication strategy that can guide the development of subsequent vlog-based interventions to address the national EHE plan.",[37,43],{"label":38,"type":39,"description":40,"interventionNames":41},"Intervention","EXPERIMENTAL","Participants will watch a health-informed video-log series and complete a second survey (post-test). The post-test will assess the same variables previously assessed in the pre-test.",[42],"Behavioral: Video-log (vlog) series with videos tailored to cisgender Black women or to healthcare providers",{"label":44,"type":45,"description":46,"interventionNames":28},"Standard of Care","NO_INTERVENTION","Participant will receive SOC and complete the post-test.",[48],{"type":49,"name":50,"description":51,"armGroupLabels":52,"otherNames":28},"BEHAVIORAL","Video-log (vlog) series with videos tailored to cisgender Black women or to healthcare providers","This intervention is a video-log (vlog) series based health communication intervention that will be disseminated through community health centers (CHCs) and social media to increase willingness for and use of PrEP among cisgender Black women and to increase willingness to prescribe and refer PrEP among healthcare providers.",[38],[54],{"name":55,"affiliation":56,"role":57},"Mandy Hill, DrPH,MPH,HIVPCP","University of Texas Medical Branch, Galveston","PRINCIPAL_INVESTIGATOR",[59],{"name":60,"role":61,"phone":62,"phoneExt":28,"email":63},"Mandy Hill, Dr.PH, MPH, HIVPCP","CONTACT","409-266-0509","majhill@utmb.edu",[65],{"facility":56,"status":28,"city":66,"state":67,"zip":68,"country":69,"countryCode":70,"cosmosGeoPoint":71,"geoPoint":76,"contacts":77},"Galveston","Texas","77555","United States","US",{"type":72,"coordinates":73},"Point",[74,75],-94.7977,29.30135,{"lat":75,"lon":74},[78],{"name":79,"role":61,"phone":80,"phoneExt":28,"email":28},"Mandy J. Hill, DrPH","409-772-1128",{"type":82,"investigatorFullName":28,"investigatorTitle":28,"investigatorAffiliation":28,"oldNameTitle":28,"oldOrganization":28},"SPONSOR",[84],{"name":85,"class":86},"National Institute of Mental Health (NIMH)","NIH","100582544",false,"NCT06864689","Leveraging Video Logs as a Bridge to Pre-exposure Prophylaxis (PrEP) With Tailored Messaging to Black Women and Their Healthcare Providers in Texas.","PrEP","Selection criteria for participation in pilot RCT.\n\nEligible participants in the category for Black Women (BW) must:\n\n1. be a woman\n2. be 18 years of age\n3. have been sexually active with a man within the past 6 months\n4. be fluent in English\n5. have a phone or internet access\n\nEligible participants (i.e. PrEP-eligible BW) must not:\n\n1. be unable to provide informed consent\u002Fassent for participation (i.e., have severe cognitive impairment hat would interfere with their ability to consent or understand study procedures)\n2. have psychological distress that would prohibit them from participating in the study\n3. be unable or unwilling to meet study requirements\n4. be ineligible for PrEP\n5. received a prescription for PrEP within 12 months6)be unable to fill out the evaluation independently\n\nEligible participants in the HCP category must:\n\n1. be a credentialed HCP in Texas with privileges to prescribe and\u002For refer PrEP\n2. BW must be a part of their patient pool at the clinical setting where they practice clinically\n3. be fluent in English\n4. have a phone or internet access\n5. Live and\u002For practice medicine within a 60-mile radius of Houston\u002FHarris County\n\nEligible HCP must not:\n\n1. be unable to provide informed consent for participation (e.g. have severe cognitive impairment that would interfere with their ability to consent, or ability to understand study procedures\n2. have psychological distress that would prohibit them from participating in the study\n3. be unable or unwilling to meet study requirements\n4. be unwilling to offer PrEP to BW patients\n5. have prescribed or referred PrEP to BW within the last 12 months",true,"FEMALE","18 Years","99 Years",{"count":98,"type":99},78,"ESTIMATED","INTERVENTIONAL",[102],"EARLY_PHASE1","The primary objective of this R34 proposal is to increase willingness for PrEP initiation and PrEP initiation among Black Women (BW) and increase willingness to prescribe\u002Frefer pre-exposure prophylaxis (PrEP) to CBW among healthcare providers (HCPs) in Houston\u002FHarris County, a high priority Ending the HIV Epidemic (EHE) jurisdiction.",[105],"HIV Prevention",[107,108,91,109,110],"Minoritized population","Video logs","Health communication","Behavioral intervention","NOT_YET_RECRUITING","2026-02-11",{"date":114,"type":115},"2026-02-17","ACTUAL",{"date":117,"type":99},"2026-09",{"date":119,"type":99},"2027-08-31",{"name":5,"class":6},1]