Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2026-01-01 @ 2:00 AM
Study NCT ID:
NCT05412433
Status:
RECRUITING
Last Update Posted:
2025-03-12
First Post:
2022-06-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinic-based HIV Identification and Prevention Project Using Electronic Resources
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D055361', 'term': 'Multilevel Analysis'}], 'ancestors': [{'id': 'D013223', 'term': 'Statistics as Topic'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1170}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-10-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-10', 'studyFirstSubmitDate': '2022-06-02', 'studyFirstSubmitQcDate': '2022-06-07', 'lastUpdatePostDateStruct': {'date': '2025-03-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of PrEP prescriptions written for each patient', 'timeFrame': '4 weeks', 'description': 'Number of PrEP prescriptions written for each patient up to 4 weeks after office visit.'}, {'measure': 'Adoption of Electronic History Form', 'timeFrame': '6 months', 'description': 'Proportion of consecutive eligible patients in each clinic who completed the eHxForm.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['HIV prevention', 'PrEP', 'Cis-gender women'], 'conditions': ['HIV Prevention', 'Primary Care', 'PrEP']}, 'referencesModule': {'references': [{'pmid': '37361343', 'type': 'DERIVED', 'citation': 'Izadi LH, Mmeje O, Drabo EF, Perin J, Martin S, Coleman JS. An effectiveness-implementation trial protocol to evaluate PrEP initiation among U.S. cisgender women using eHealth tools vs. standard care. Front Reprod Health. 2023 Jun 8;5:1196392. doi: 10.3389/frph.2023.1196392. eCollection 2023.'}]}, 'descriptionModule': {'briefSummary': 'Hybrid Type II effectiveness-implementation trial to investigate whether electronic medical and sexual history data collection with HIV risk categorization/scoring will increase pre-exposure prophylaxis (PrEP) uptake among cis-gender women attending routine well-woman gynecologic preventative visits.', 'detailedDescription': "Forty-two Obgyn providers will be randomized into 1 of three arms. Patients of enrolled providers who attend an ObGyn clinic for any preventative visit will complete an electronic history form (eHxForm) before clinic through a message sent through the patient portal (MyChart), email, or secure text messaging. The sexual history questions will be scored and categorized into 3 categories. Patients with a low score (0-3) will receive an electronic message offering a laboratory HIV test per USPSTF guidelines. If she accepts, then an automated Epic order will be placed for the provider to sign during the office visit.\n\nPatients with a medium/high score (4-10) will be assigned a study arm based on their provider's group (arm 1: control, arm 2: patient will view score and a PrEP video, arm 3: procedures in arm 2 PLUS providers will receive an electronic health record alert that the patient may have HIV risk factors. This will occur automatically via programming integrated into the electronic health record. The primary outcome is PrEP uptake. The implementation strategy will be evaluated using the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '15 Years', 'genderBased': True, 'genderDescription': 'Cisgender', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients of enrolled providers aged 15-65 years\n* Presenting for preventive care (i.e., well-woman exam, sexually transmitted infection testing, pre-conception counseling, or birth control).\n\nExclusion Criteria:\n\n* Pregnant and has established prenatal care, i.e., visit is for prenatal care\n* Non-English or non-Spanish speaking\n* Living with HIV\n* Unable to complete the eHxForm'}, 'identificationModule': {'nctId': 'NCT05412433', 'acronym': 'CHIPPER', 'briefTitle': 'Clinic-based HIV Identification and Prevention Project Using Electronic Resources', 'organization': {'class': 'OTHER', 'fullName': 'Johns Hopkins University'}, 'officialTitle': 'Clinic-based HIV Identification and Prevention Project Using Electronic Resources', 'orgStudyIdInfo': {'id': 'IRB00331706'}, 'secondaryIdInfos': [{'id': '1R01MH132146', 'link': 'https://reporter.nih.gov/quickSearch/1R01MH132146', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard of Care', 'description': 'Participants in this arm will receive standard of care', 'interventionNames': ['Behavioral: Control']}, {'type': 'EXPERIMENTAL', 'label': 'Patient Level + Multilevel', 'description': 'Participants in the arm will receive the patient level and multi-level intervention', 'interventionNames': ['Behavioral: Patient Level', 'Behavioral: Multilevel']}, {'type': 'EXPERIMENTAL', 'label': 'Multilevel', 'description': 'Participants in this arm will receive the multi-level intervention', 'interventionNames': ['Behavioral: Multilevel']}], 'interventions': [{'name': 'Patient Level', 'type': 'BEHAVIORAL', 'description': 'Electronic data collection with scoring, patient awareness of HIV risk score, patient viewing of PrEP animations', 'armGroupLabels': ['Patient Level + Multilevel']}, {'name': 'Multilevel', 'type': 'BEHAVIORAL', 'description': 'Electronic data collection with scoring, patient awareness of HIV risk score, patient viewing of PrEP animations, provider electronic health records (EHR) alerts', 'armGroupLabels': ['Multilevel', 'Patient Level + Multilevel']}, {'name': 'Control', 'type': 'BEHAVIORAL', 'description': 'Standard of care', 'armGroupLabels': ['Standard of Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jenell Coleman, MD', 'role': 'CONTACT'}], 'facility': 'Johns Hopkins Health System', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'centralContacts': [{'name': 'Jenell Coleman, MD MPH', 'role': 'CONTACT', 'email': 'colemanj@jhmi.edu', 'phone': '410-614-4496'}], 'overallOfficials': [{'name': 'Jenell Coleman, MD MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johns Hopkins University', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Michigan', 'class': 'OTHER'}, {'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}