Ignite Creation Date:
2025-12-25 @ 1:25 AM
Ignite Modification Date:
2026-02-25 @ 4:58 PM
Study NCT ID:
NCT00538993
Status:
COMPLETED
Last Update Posted:
2018-10-18
First Post:
2007-10-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Improving Provider Counseling Interventions in HIV Practice
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 470}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2006-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-17', 'studyFirstSubmitDate': '2007-10-01', 'studyFirstSubmitQcDate': '2007-10-01', 'lastUpdatePostDateStruct': {'date': '2018-10-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2007-10-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Disclosure of HIV status to sex partners; unprotected sexual encounters.', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['HIV Infections']}, 'descriptionModule': {'briefSummary': "Hypothesis: HIV clinicians trained to deliver brief counseling messages and receiving cues from a brief computer survey on risk behaviors of their patients can counsel have an impact on patient's risk behaviors.", 'detailedDescription': 'This is a randomized controlled study. The purpose of this study is to assess the impact of the cue sheet as an aid to targeted provider behavioral counseling. All enrolled participants are HIV+ adults seen for regular medical care at a site affiliated with the Johns Hopkins AIDS Service. After consenting, participants will take an audio-assisted computer interviews to collect patient risk assessment data. For participants randomized to the intervention arm, the printed output on risk behaviors is then given to the provider along with cues for staged-based counseling for use during the same visit. Participants in the control arm take the same computerized risk assessment but there are no printed cue sheets. Risk behaviors of all participants are assessed at entry, at 6 months, and at 12 months. The main outcome measure is change in HIV transmission behaviors at 12 months for those in the intervention arm compared to the control arm.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* HIV seropositive\n* English speaking\n\nExclusion Criteria:\n\n* Cannot give informed consent'}, 'identificationModule': {'nctId': 'NCT00538993', 'briefTitle': 'Improving Provider Counseling Interventions in HIV Practice', 'organization': {'class': 'OTHER', 'fullName': 'Johns Hopkins University'}, 'orgStudyIdInfo': {'id': 'H97HA01144'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Provider receives cue sheet to assist with counseling.', 'interventionNames': ['Behavioral: Stage based counseling']}, {'type': 'NO_INTERVENTION', 'label': '2', 'description': 'Provider does not receive cue sheet.'}], 'interventions': [{'name': 'Stage based counseling', 'type': 'BEHAVIORAL', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21205', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins University School of Medicine', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Emily Erbelding, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johns Hopkins University', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of California, San Francisco', 'class': 'OTHER'}]}}}