Ignite Creation Date:
2025-12-25 @ 4:15 AM
Ignite Modification Date:
2026-02-25 @ 5:51 PM
Study NCT ID:
NCT04155320
Status:
COMPLETED
Last Update Posted:
2022-05-18
First Post:
2019-11-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impart: Provider-Assisted HIV Partner Notification
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}], 'ancestors': [{'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': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Outcomes assessor is blinded as to treatment allocation during analyses.'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 55}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2021-11-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-17', 'studyFirstSubmitDate': '2019-11-05', 'studyFirstSubmitQcDate': '2019-11-05', 'lastUpdatePostDateStruct': {'date': '2022-05-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Notified', 'timeFrame': '6 weeks from index patient enrollment', 'description': 'Number of partners who are notified of shared HIV exposure'}, {'measure': 'Tested', 'timeFrame': '6 weeks from index patient enrollment', 'description': 'Number of partners who receive HIV testing subsequent to notification'}, {'measure': 'Diagnosed', 'timeFrame': '6 weeks from index patient enrollment', 'description': 'Number of partners who are HIV diagnosed subsequent to testing'}], 'secondaryOutcomes': [{'measure': 'Linked to Care', 'timeFrame': '6 weeks from index patient enrollment', 'description': 'Number of partners who have been evaluated for treatment by a physician subsequent to diagnosis'}, {'measure': 'Initiated ART', 'timeFrame': '6 weeks from index patient enrollment', 'description': 'Number of partners who have initiated antiretroviral therapy (ART) subsequent to linkage to care'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['contact tracing', 'HIV prevention', 'partner notification'], 'conditions': ['HIV Infections', 'Partner Communication']}, 'referencesModule': {'references': [{'pmid': '37339342', 'type': 'DERIVED', 'citation': 'Culbert GJ, Levy JA, Steffen AD, Waluyo A, Earnshaw VA, Rahadi A. Impart: findings from a prison-based model of HIV assisted partner notification in Indonesia. J Int AIDS Soc. 2023 Jun;26(6):e26132. doi: 10.1002/jia2.26132.'}]}, 'descriptionModule': {'briefSummary': 'Researchers will conduct a 2-arm pilot randomized controlled trial with HIV-infected index patients recruited from two all-male prisons in Indonesia to assess the acceptability and feasibility of provider-assisted HIV partner notification (provider referral) and examine its potential to increase the number of partners who are tested for HIV and subsequently linked to prevention and treatment services.', 'detailedDescription': 'This study compares three options for partner notification:\n\n* Option 1 (Self-tell): Participant is encouraged to disclose his HIV+ status to his partner(s) and given information about sites where his partner(s) can receive free HIV testing.\n* Option 2 (Tell together): Participant discloses his HIV+ status to his partners with a counselor (project staff) present. Counselor refers the partner to HIV testing, including a study-affiliated HIV testing site.\n* Option 3 (Provider referral): Project staff (nurse or peer educator) will notify the partner anonymously - without identifying the participant (index patient). Partners are offered immediate HIV testing in their home or at a study-affiliated HIV testing site.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria for HIV-positive Prisoners (N=65): Index patients must beat least 18 years of age, HIV-seropositive and aware of their HIV+ status; (HIV-infection documented by a rapid HIV test); sexually active and/or sharing needles in the 12 months before incarceration; incarcerated within the past 3 years and ≥6 months of their prison sentence remaining. We will limit enrollment to index patients who are willing to notify partners and have 1 or more partner(s) who have not yet been notified.\n\nInclusion Criteria for Partners: Eligible partners will be persons who participants (index patients) are able to identify by first and/or last name, residential address and/or mobile phone number, and physical descriptors (e.g., approximate height) and have given nurses permission to contact. No named partner will be excluded on the basis of religion, ethnicity, age, sex, or gender identity.'}, 'identificationModule': {'nctId': 'NCT04155320', 'briefTitle': 'Impart: Provider-Assisted HIV Partner Notification', 'organization': {'class': 'OTHER', 'fullName': 'University of Illinois at Chicago'}, 'officialTitle': 'Provider-Assisted HIV Partner Notification & Testing With Prisoners in Indonesia: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '2018-0754'}, 'secondaryIdInfos': [{'id': 'R34MH115779', 'link': 'https://reporter.nih.gov/quickSearch/R34MH115779', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group A', 'description': 'Subjects are encouraged to disclose their HIV status to their partner(s) with or without a counselor present (Options 1 \\& 2).', 'interventionNames': ['Behavioral: Standard Care']}, {'type': 'EXPERIMENTAL', 'label': 'Group B', 'description': 'Subjects may choose to notify their partners themselves, with or without a counselor present (Options 1 \\& 2), or choose to have one or more partners notified anonymously by project staff (Option 3).', 'interventionNames': ['Behavioral: IMPART']}], 'interventions': [{'name': 'IMPART', 'type': 'BEHAVIORAL', 'description': 'Subjects receive counseling about partner notification and are assisted in identifying all their partners and choosing a notification method for each partner. Subjects have the option to: 1) disclose their HIV status to their partner(s) by themselves (self-tell), 2) disclose their HIV status to their partner(s) with a healthcare provider present (tell together), or 3) have their partner(s) notified confidentially by a disease notifier (anonymous provider referral), who will locate partners, notify them of potential HIV exposure, and offer them HIV testing. Partners with an initial reactive HIV screening test will be referred to care and treatment services.', 'armGroupLabels': ['Group B']}, {'name': 'Standard Care', 'type': 'BEHAVIORAL', 'description': 'Subjects receive counseling about partner notification and are assisted in identifying all their partners and choosing a notification method for each partner. Subjects are responsible for contacting and notifying their partner(s) on their own. Subjects have the option to: 1) disclose their HIV status to their partner(s) by themselves (self-tell) or 2) disclose their HIV status to their partner(s) with a healthcare provider present (tell together). Subjects may decide which partners to notify and may choose the same or a different method for each partner.', 'armGroupLabels': ['Group A']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Jakarta Pusat', 'state': 'West Java', 'country': 'Indonesia', 'facility': 'Rutan Cipinang'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Illinois at Chicago', 'class': 'OTHER'}, 'collaborators': [{'name': 'Indonesia University', 'class': 'OTHER'}, {'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Gabriel John Culbert', 'investigatorAffiliation': 'University of Illinois at Chicago'}}}}