Ignite Creation Date:
2025-12-24 @ 10:32 PM
Ignite Modification Date:
2026-01-04 @ 9:36 AM
Study NCT ID:
NCT03058835
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-09-21
First Post:
2017-02-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
IN-US-276-1340: Pre-Exposure Prophylaxis to Prevent HIV Acquisition in US Women: A Demonstration Project
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-09-26', 'releaseDate': '2025-09-05'}], 'estimatedResultsFirstSubmitDate': '2025-09-05'}}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069480', 'term': 'Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination'}], 'ancestors': [{'id': 'D000068698', 'term': 'Tenofovir'}, {'id': 'D063065', 'term': 'Organophosphonates'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000068679', 'term': 'Emtricitabine'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D000225', 'term': 'Adenine'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D003853', 'term': 'Deoxyribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D004338', 'term': 'Drug Combinations'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-12-13', 'size': 375417, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2023-05-01T12:11', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 125}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-09-15', 'studyFirstSubmitDate': '2017-02-08', 'studyFirstSubmitQcDate': '2017-02-15', 'lastUpdatePostDateStruct': {'date': '2023-09-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-02-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Describe attitudes toward PrEP among a population of women at risk for HIV acquisition, living in HIV prevalent areas', 'timeFrame': '24 Weeks', 'description': 'Attitudes towards PrEP will be assessed with questionnaires at weeks 12 and 24.'}, {'measure': 'Assess feasibility of Truvada procurement through the established Gilead access program', 'timeFrame': '24 Weeks', 'description': 'Logistic regression comparing the proportion of participants with tenofovir plasma levels greater than 0.3 will be analyzed'}, {'measure': 'Evaluate adherence to Truvada PrEP at week 12 and week 24 using dried blood spots', 'timeFrame': '24 Weeks', 'description': 'Adherence to Truvada PrEP will be assessed at week 12 and week 24 using dried blood spots and questionnaire responses concerning adherence to PrEP'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True}, 'conditionsModule': {'keywords': ['HIV', 'Truvada'], 'conditions': ['PrEP Adherence Monitoring']}, 'descriptionModule': {'briefSummary': 'The overall aim of this study is to assess attitudes toward PrEP, feasibility of Truvada PrEP procurement through the established access procedures, and adherence to Truvada PrEP among US women at risk for HIV acquisition.', 'detailedDescription': 'Study Design:\n\nThis is a 24 week prospective pilot study assessing attitudes toward and feasibility of using Truvada PrEP in a population of women at risk for HIV acquisition.At this site 31 HIV- uninfected women desiring PrEP will be enrolled at each site (confirm number). We will have to consent about 50 women which includes screen failures.The study will assess attitudes towards and adherence to PrEP with questionnaires at weeks 12 and 24. Tenofovir levels procured at week 12 and 24 week of PrEP will be used to assess adherence to PrEP.\n\nPrimary objectives:\n\n1. Describe attitudes toward PrEP among a population of women at risk for HIV acquisition, living in HIV prevalent areas.\n2. Assess feasibility of Truvada procurement through the established Gilead access program\n3. Evaluate adherence at week 12 and week 24 using dried blood spots\n\nSecondary objective:\n\n1. Describe HIV incidence\n2. Describe associations of positive and negative attitudes toward PrEP with acceptance of PrEP and subsequent adherence\n3. Assess adherence at weeks 12 and 24\n4. Evaluate the relationship between PrEP adherence and sexual activity\n5. Compare geographic areas with respect to PrEP attitudes\n6. Mentor junior investigators at each site.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 - 64 years old\n* Able to give consent\n* "At risk" for HIV as defined by any of the following:\n\n 1. unprotected sex (in past 6 months) with 1 or more men of unknown HIV status\n 2. evaluated for an STI within 6 months prior to screening\n 3. sex in last 6 months with an HIV-infected partner\n 4. IDU with report of using previously used or shared needles in past 6 months or has been in a methadone, buprenorphine, or suboxone treatment program in past 6 months or engaging in high-risk sexual behaviors\n 5. individuals engaging in transactional sex (i.e sex for money, drugs, or housing)\n 6. Infrequently uses condoms during sex with 1 or more partners of unknown HIV status who are known to be at substantial risk of HIV infection (IDU or bisexual male partner)\n* CrCl ≥ 60 ml/min\n* HIV- uninfected women desiring PrEP\n\nExclusion Criteria:\n\n* Active alcohol or drug use or dependence which may interfere with adherence to study requirements\n* HIV-infected at screening or enrollment\n* Estimated CrCl \\< 60 mL/min\n* Past participation in an HIV vaccine study\n* Positive Hepatitis B surface antigen test\n* Underlying medical condition with survival unlikely during follow-up period\n* Any condition that in the opinion of study staff would make participation in the study unsafe or interfere with achieving study objectives\n* Pregnant or breast feeding\n* Actively trying to achieve pregnancy'}, 'identificationModule': {'nctId': 'NCT03058835', 'briefTitle': 'IN-US-276-1340: Pre-Exposure Prophylaxis to Prevent HIV Acquisition in US Women: A Demonstration Project', 'organization': {'class': 'OTHER', 'fullName': 'Rutgers, The State University of New Jersey'}, 'officialTitle': 'IN-US-276-1340: Pre-Exposure Prophylaxis to Prevent HIV Acquisition in US Women: A Demonstration Project', 'orgStudyIdInfo': {'id': 'Pro20150001562'}, 'secondaryIdInfos': [{'id': 'IN-US-276-1340', 'type': 'OTHER', 'domain': 'Gilead Sciences Inc.'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PrEP with Truvada', 'description': 'All study participants will be assigned to this arm and will receive Truvada tablets (tenofovir disoproxil and emtricitabine) for PrEP', 'interventionNames': ['Drug: tenofovir disoproxil and emtricitabine']}], 'interventions': [{'name': 'tenofovir disoproxil and emtricitabine', 'type': 'DRUG', 'otherNames': ['Truvada tablets'], 'description': 'Pre-exposure Prophylaxis with Truvada will be distributed to all participants eligible to receive PrEP.', 'armGroupLabels': ['PrEP with Truvada']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory University', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Rush University Medical Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '07103', 'city': 'Newark', 'state': 'New Jersey', 'country': 'United States', 'facility': 'New Jersey Medical School Clinical Research Center', 'geoPoint': {'lat': 40.73566, 'lon': -74.17237}}, {'zip': '26505', 'city': 'Morgantown', 'state': 'West Virginia', 'country': 'United States', 'facility': 'West Virginia University', 'geoPoint': {'lat': 39.62953, 'lon': -79.9559}}], 'overallOfficials': [{'name': 'Shobha Swaminathan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'New Jersey Medical School'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rutgers, The State University of New Jersey', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Shobha Swaminathan', 'investigatorAffiliation': 'Rutgers, The State University of New Jersey'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2025-09-05', 'type': 'RELEASE'}, {'date': '2025-09-26', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Shobha Swaminathan, Professor, Rutgers, The State University of New Jersey'}}}}