Ignite Creation Date:
2025-12-24 @ 3:40 PM
Ignite Modification Date:
2025-12-25 @ 1:50 PM
Study NCT ID:
NCT07292792
Status:
RECRUITING
Last Update Posted:
2025-12-18
First Post:
2025-11-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Unlocking PrEP Study: Integration of Peer Health Navigation Into Comprehensive Re-entry Services
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}], 'ancestors': [{'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012897', 'term': 'Slow Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-05-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-11-21', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-05', 'studyFirstSubmitDate': '2025-11-21', 'studyFirstSubmitQcDate': '2025-12-05', 'lastUpdatePostDateStruct': {'date': '2025-12-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-11-21', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility of Integrating a PrEP-Focused Health Coach', 'timeFrame': '18 Months', 'description': 'Feasibility will be assessed by (1) the proportion of Unlocking Doors clients who engage with the health coach. This indicator reflects whether the health coach can be effectively integrated into existing re-entry workflows.'}, {'measure': 'Acceptability of the Health Coach Model', 'timeFrame': '18 Months', 'description': 'Acceptability will be measured through mean Likert-scale ratings from clients and staff regarding satisfaction, comfort, and perceived usefulness of health coach interactions. Qualitative feedback will supplement these ratings to capture overall acceptability.'}, {'measure': 'Appropriateness of the Health Coach Model', 'timeFrame': '18 Months', 'description': "Appropriateness will be assessed through Likert-scale ratings evaluating the perceived relevance, fit, and value of integrating a health coach into Unlocking Doors' services, as well as how well the model aligns with client needs."}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['PrEP'], 'conditions': ['HIV Disease', 'HIV Prevention']}, 'descriptionModule': {'briefSummary': 'This 18-month study, "Integration of peer health navigation into comprehensive re-entry services: improving PrEP implementation for justice-involved individuals," aims to increase PrEP awareness and uptake among people with a history of justice involvement in Dallas, primarily clients of Unlocking Doors.', 'detailedDescription': 'This 18-month study, "Integration of peer health navigation into comprehensive re-entry services: improving PrEP implementation for justice-involved individuals," aims to increase PrEP awareness and uptake among people with a history of justice involvement in Dallas, primarily clients of Unlocking Doors. Guided by the EPIS (Exploration, Preparation, Implementation, Sustainment) framework, the study will:\n\nConduct qualitative interviews with Unlocking Doors staff, clients, health coaches, and PrEP providers to identify barriers and facilitators to integrating a health coach focused on sexual health, HIV testing, and PrEP.\n\nUse rapid qualitative analysis to adapt the health coach intervention and workflows.\n\nImplement a health coach model embedded in Unlocking Doors to offer general and sexual health discussions, PrEP education, HIV/syphilis testing, and linkage to PrEP care and other services.\n\nEnroll up to 600 consented/screened individuals to achieve a target of 100 participants in the intervention.\n\nAssess feasibility, acceptability, and appropriateness of the model, as well as changes in PrEP knowledge, interest, referrals, and uptake over time.\n\nThe study is led by PI: Ank Nijhawan in UTSW Infectious Diseases.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adults (18+) receiving re-entry services at Unlocking Doors, including justice-involved individuals and staff participating in qualitative interviews. Participants are engaged in general health, sexual health, and PrEP-related discussions with a health coach as part of the intervention.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age 18 years or older\n2. Client of Unlocking Doors\n3. Able to provide informed consent\n4. Willing to participate in discussions about general health, sexual health, HIV prevention, and PrEP\n5. Willing to complete health screening and eligibility assessment\n6. For qualitative interview participants:\n\n * Unlocking Doors staff, clients, or PrEP providers who agree to participate in a one-time interview.\n\nExclusion Criteria:\n\n1. Under 18 years of age\n2. Unable to provide informed consent\n3. Not receiving services at Unlocking Doors\n4. Non-English speakers\n5. Diagnosed with HIV\n6. Incarcerated individuals at the time of recruitment'}, 'identificationModule': {'nctId': 'NCT07292792', 'briefTitle': 'The Unlocking PrEP Study: Integration of Peer Health Navigation Into Comprehensive Re-entry Services', 'organization': {'class': 'OTHER', 'fullName': 'University of Texas Southwestern Medical Center'}, 'officialTitle': 'Integration of Peer Health Navigation Into Comprehensive Re-entry Services: Improving PrEP Implementation for Justice-involved Individuals', 'orgStudyIdInfo': {'id': 'STU-2024-0736'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Health Coach Intervention Group', 'description': 'Participants in this group are clients of Unlocking Doors who meet eligibility criteria and choose to enroll in the study. They receive the health coach intervention, which includes general health and sexual health discussions, HIV and syphilis testing, PrEP education, PrEP eligibility screening, linkage to PrEP care, and referrals to other health or re-entry services. Their PrEP knowledge, interest, and engagement, as well as feasibility and acceptability of the model, are assessed throughout the study.', 'interventionNames': ['Behavioral: Health Coach Intervention']}], 'interventions': [{'name': 'Health Coach Intervention', 'type': 'BEHAVIORAL', 'description': "The intervention integrates a PrEP-focused health coach into Unlocking Doors' re-entry services. The health coach provides clients with general health guidance, sexual health education, HIV and syphilis testing, PrEP education, PrEP eligibility screening, and linkage to PrEP care. The coach also offers ongoing navigation and referrals to medical, behavioral health, and re-entry services as needed. The aim of the intervention is to increase PrEP awareness, interest, and uptake among justice-involved individuals while assessing feasibility, acceptability, and appropriateness of embedding a health coach within legal re-entry services.", 'armGroupLabels': ['Health Coach Intervention Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75390', 'city': 'Dallas', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ank E Nijhawan, MD', 'role': 'CONTACT'}], 'facility': 'UT Southwestern Medical Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], 'centralContacts': [{'name': 'Laura A Hansen, MA', 'role': 'CONTACT', 'email': 'Laura.Hansen@UTSouthwestern.edu', 'phone': '7133057882'}], 'overallOfficials': [{'name': 'Ank E Nijhawan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Texas Southwestern Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Texas Southwestern Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Unlocking Doors', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor- Internal Medicine', 'investigatorFullName': 'Ank Nijhawan', 'investigatorAffiliation': 'University of Texas Southwestern Medical Center'}}}}