Ignite Creation Date:
2025-12-25 @ 1:19 AM
Ignite Modification Date:
2025-12-25 @ 11:27 PM
Study NCT ID:
NCT05588193
Status:
RECRUITING
Last Update Posted:
2025-04-24
First Post:
2022-10-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
ED2PrEP - Patient Focused, Low-burden Strategies for PrEP Uptake Among Emergency Departments
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1416}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2027-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-21', 'studyFirstSubmitDate': '2022-10-07', 'studyFirstSubmitQcDate': '2022-10-18', 'lastUpdatePostDateStruct': {'date': '2025-04-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PrEP Uptake', 'timeFrame': '3 months', 'description': 'Prescription of any medication to be used as HIV PrEP, captured in the electronic health record.'}], 'secondaryOutcomes': [{'measure': 'PrEP Uptake at 6 months', 'timeFrame': '6 months', 'description': 'Prescription of any medication to be used as HIV PrEP, captured in the electronic health record.'}, {'measure': 'PrEP Uptake at 12 months', 'timeFrame': '12 months', 'description': 'Prescription of any medication to be used as HIV PrEP, captured in the electronic health record.'}, {'measure': 'Linkage to status neutral healthcare', 'timeFrame': '3 months', 'description': 'Attending a clinical appointment for sexual healthcare or related to HIV, captured in the electronic health record'}, {'measure': 'Linkage to status neutral healthcare', 'timeFrame': '12 months', 'description': 'Attending a clinical appointment for sexual healthcare or related to HIV, captured in the electronic health record'}, {'measure': 'HIV and STI testing', 'timeFrame': '6 months', 'description': 'Receipt of tests for HIV and sexually transmitted infections (gonorrhea and chlamydia from any anatomic site, or syphilis) after the emergency department visit, captured in the electronic health record.'}, {'measure': 'PrEP Persistence', 'timeFrame': '6 months', 'description': 'Composite data from the electronic health record about having a prescription for PrEP medications and survey responses about current PrEP use.'}, {'measure': 'PrEP Persistence', 'timeFrame': '12 months', 'description': 'Composite data from electronic health record about having a prescription for PrEP medications and survey responses about current PrEP use.'}, {'measure': 'HIV Viral RNA levels', 'timeFrame': '3 months', 'description': 'Laboratory quantification of circulating HIV virus among individuals diagnosed with HIV in the study.'}, {'measure': 'HIV Viral RNA levels', 'timeFrame': '12 months', 'description': 'Laboratory quantification of circulating HIV virus among individuals diagnosed with HIV in the study.'}, {'measure': 'Incident HIV Diagnosis', 'timeFrame': '18 months', 'description': 'Diagnosis of HIV based on multiple data sources (electronic health record, surveys) occurring at anytime starting from ED visit through end of study period.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['HIV']}, 'descriptionModule': {'briefSummary': 'Severe inequities in HIV pre-exposure prophylaxis (PrEP) access and use in communities hardest hit by the HIV epidemic persist, further exacerbating ongoing racial/ethnic and socioeconomic disparities in HIV incidence. In these same communities, many patients at risk for HIV seek care for sexually transmitted infections (STIs) in Emergency Departments (EDs), but the structure of traditional ED care is poorly suited to address HIV prevention or provide PrEP. To advance the Prevent objective of the Ending the HIV Epidemic (EHE) initiative, ED2PrEP will leverage an implementation science approach to rigorously test two innovative strategies for increasing PrEP uptake among patients seeking STI care in EDs in one of the 48 EHE-identified geographic hotspots.', 'detailedDescription': "Severe inequities in HIV pre-exposure prophylaxis (PrEP) access and use persist among Black and Latinx communities most impacted by the HIV epidemic. The Bronx, NY, with over 90% of the population identifying as Black or Latinx, is an Ending the HIV Epidemic (EHE) priority county with the fifth highest HIV diagnosis rate in the U.S. and the lowest PrEP use in NY. Research on barriers to PrEP engagement indicate that the current structure of PrEP access and management is not consonant with the lives, priorities, or needs of the hardest hit communities, further exacerbating ongoing racial/ethnic and socioeconomic disparities in HIV incidence. Many of the same barriers leading to poor PrEP uptake in Black/Latinx communities also drive members of these communities to seek care for sexually transmitted infections (STIs), a known risk factor for HIV, in Emergency Departments (EDs). However, there is a discordance between the type of care likely to preserve the long-term health of those seeking STI care in EDs (longitudinal, behavioral, and prevention-oriented) and the care the ED is optimized to provide (acute, high intensity, life-saving/stabilizing), meaning that both patients and health systems stand to gain from a restructuring of how STI care is delivered in EDs. Innovative, efficient, and sustainable strategies for identifying and engaging high priority populations for HIV prevention seeking sexual healthcare in EDs are thus needed. The study team therefore proposes ED2PrEP, a pragmatic Type III hybrid effectiveness-implementation trial comparing two different strategies for increasing PrEP uptake among patients at risk for HIV accessing STI care in Bronx EDs. The two strategies are (1) Post-Visit Outreach (PVO) involving proactive outreach to patients following a sexual health-related ED visit. PVO will be initiated by a Sexual Health Navigator who will provide PrEP education, counseling, and linkage to existing sexual health/PrEP clinics. (2) Tele-sexual health (TSH) will involve a real-time telehealth visit with a Sexual Health Provider during sexual health-related ED visits. TSH will also include education, counseling, and linkage, in addition to the provider's ability to prescribe PrEP at the time of the visit. The project will compare the effectiveness of two strategies implemented at two different EDs for 9 months. After the first 9-month study period (Months 1-9), there will be a 1-month wash-out period (Month 10). The study team will then switch the strategies at the two ED study sites for a second 9-month study period (Months 11-19). The trial duration is approximately 31 months total which includes the two-arm implementation-effectiveness trial (19 months) and a follow-up period (12 months). Throughout the study period, the study team will collect quantitative and qualitative data to inform implementation outcomes. Patients will receive TSH the same day of their ED visit or PVO within 7 days of their ED visit. All patients 18+ years old presenting to one of the ED study sites with sexual health-related complaints who fulfill eligibility criteria will be included in the two-arm trial. For this pragmatic trial, no individual participant recruitment is needed, as all relevant outcome data and covariates are routinely collected as part of clinical care and will be extracted from the Montefiore EHR using standard extraction procedures and NYC DOHMH HIV Registry. To ensure that both ED sites are equally prepared to implement TSH, the ED site starting with TSH will receive TSH-specific trainings one week prior to the launch of the trial. For the ED site implementing TSH in the second trial period, the study team will practice TSH workflows and procedures with a clinical champion during the one-month wash-out period. Because the PVO strategy involves outreach by an SHN (not a member of ED staff) only after an ED visit is completed with no other involvement from ED staff, no ED-specific trainings are needed for this strategy. The overall study will also include an implementation science study (quantitative and qualitative sub-studies), an economic and cost analysis and seroconversion ascertainment. The trial period will be preceded by a 3-month Optimization Phase to standardize study workflows and procedures."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria for Two-Arm Trial:\n\n* Patient is \\>=18 years at time of index ED visit\n* Patient presents to one of the Montefiore ED study sites\n* The ED provider applies at least one of the pre-selected ICD-10 CM codes to the encounter and manual review by SHN confirms the visit is related to sexual health\n\nExclusion Criteria for Two-Arm Trial:\n\n* Patient is admitted to the hospital from the ED\n* Known HIV-positive status'}, 'identificationModule': {'nctId': 'NCT05588193', 'acronym': 'ED2PrEP', 'briefTitle': 'ED2PrEP - Patient Focused, Low-burden Strategies for PrEP Uptake Among Emergency Departments', 'organization': {'class': 'OTHER', 'fullName': 'Albert Einstein College of Medicine'}, 'officialTitle': 'ED2PrEP - Patient Focused, Low-burden Strategies for PrEP Uptake Among Emergency Departments Patients: a Two-arm Hybrid Implementation-effectiveness Trial', 'orgStudyIdInfo': {'id': '2021-13724'}, 'secondaryIdInfos': [{'id': 'R01AI169636', 'link': 'https://reporter.nih.gov/quickSearch/R01AI169636', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Post Visit Outreach (PVO)', 'description': "Outreach by trained patient navigators/educators after patients' ED visit for education, counseling, linkage to preventive/sexual health care.", 'interventionNames': ['Behavioral: PVO']}, {'type': 'EXPERIMENTAL', 'label': 'Tele-Sexual Healthcare (TSH) visit during the ED visit', 'description': 'Tele-sexual health visit with a specialist offered during the ED visit to patients.', 'interventionNames': ['Behavioral: TSH']}], 'interventions': [{'name': 'PVO', 'type': 'BEHAVIORAL', 'description': 'post-visit outreach', 'armGroupLabels': ['Post Visit Outreach (PVO)']}, {'name': 'TSH', 'type': 'BEHAVIORAL', 'description': 'tele-sexual health visit during the ED visit', 'armGroupLabels': ['Tele-Sexual Healthcare (TSH) visit during the ED visit']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10031', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Sarit Golub, PhD', 'role': 'CONTACT', 'email': 'sgolub@hunter.cuny.edu'}], 'facility': 'City University of New York', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10467', 'city': 'The Bronx', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Uriel Felsen, MD', 'role': 'CONTACT', 'email': 'ufelsen@montefiore.org', 'phone': '718-920-8588'}], 'facility': 'Montefiore Medical Center', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}], 'centralContacts': [{'name': 'Uriel Felsen, MD, MS', 'role': 'CONTACT', 'email': 'ufelsen@montefiore.org', 'phone': '7189208588'}, {'name': 'Viraj V Patel, MD, MPH', 'role': 'CONTACT', 'email': 'vpatel@montefiore.org', 'phone': '7189205256'}], 'overallOfficials': [{'name': 'Uriel Felsen, MD, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Albert Einstein College of Medicine'}, {'name': 'Viraj V Patel, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Albert Einstein College of Medicine'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ANALYTIC_CODE'], 'timeFrame': '6 months after publication of primary outcomes for 5 years.', 'ipdSharing': 'YES', 'description': 'All deidentified participant level data related to study outcomes.', 'accessCriteria': 'Appropriate IRB approvals, research plans approved by study MPIs, and data sharing agreements executed.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Albert Einstein College of Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Allergy and Infectious Diseases (NIAID)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}