Ignite Creation Date:
2025-12-25 @ 5:04 AM
Ignite Modification Date:
2025-12-26 @ 4:06 AM
Study NCT ID:
NCT01198418
Status:
COMPLETED
Last Update Posted:
2020-05-12
First Post:
2010-09-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Web-based Intervention Study to Reduce High-risk Sexual Behavior by Persons Living With HIV AIDS (PLWH)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D015658', 'term': 'HIV Infections'}], 'ancestors': [{'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus 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': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 181}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-07-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2017-11-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-05-08', 'studyFirstSubmitDate': '2010-09-08', 'studyFirstSubmitQcDate': '2010-09-09', 'lastUpdatePostDateStruct': {'date': '2020-05-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-09-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-10-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'STI incidence', 'timeFrame': 'Baseline and follow-up visits every 3 months', 'description': '* To compare the composite STI incidence of syphilis or Chlamydia trachomatis (CT) or Neisseria gonorrhea (GC) at any mucosal site among sexually active HIV-infected men during 12 months participation in an Internet risk reduction intervention compared to those that receive a survey instrument alone.\n* To compare the incidence of nonspecific urethritis by urinalysis and testing for Mycoplasma genitalum and trichomonas sp. among sexually active HIV-infected men during 12 months participation in an Internet risk reduction intervention compared to those that receive a survey instrument alone.'}], 'secondaryOutcomes': [{'measure': 'Evaluate risk factors of STIs', 'timeFrame': 'Baseline, follow-up visits every 3 months', 'description': '* Compare:a)self reported levels of unsafe sex among HIV-infected men b)intention to start ARV among HIV-infected men not currently on ARV will increase during 12 mos. participation in an internet risk reduction intervention compared to survey instrument alone\n* Compare self-reported among HIV-infected men during 12 mos. participation as measured by those reporting 100% disclosure in an internet risk reduction intervention compared to survey instrument alone\n* Collect genital tract secretions of semen for future study'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['STI', 'MSM', 'HIV', 'Prevention', 'Men having sex with men'], 'conditions': ['Sexually Transmitted Infections', 'HIV Infections']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.cctg.ucsd.edu', 'label': "(organization's website)"}]}, 'descriptionModule': {'briefSummary': 'This is a CCTG sponsored trial in collaboration with UCSD-AVRC investigators to get more information about the methods that are used on the internet to provide information on how to reduce the risk of giving or getting infections that are often or usually passed from one person to another during sexual or intimate contact (sexually transmitted infection (STI)). STIs include chlamydia, gonorrhea and syphilis. The purpose of this study is to develop methods that will allow someone who is living with HIV an easy way that they can get information and learn of ways on their own that can decrease their chances of getting sexually transmitted infections and ways that they can reduce the chance that they may transmit HIV to others.', 'detailedDescription': 'Design: CCTG 592 is a randomized, controlled study that will compare the efficacy of web-based intervention to reduce high-risk sexual behavior by persons living with HIV AIDS (PLWH).\n\nDuration: 48 weeks\n\nSample Size: 200 subjects (100 per arm) that will be randomized\n\nStudy Population: HIV-1-infected men who have sex with men (MSM) at least 18 years of age who have a recent history of transmission risk behavior.\n\nStratification: Subjects will be stratified based upon their baseline antiretroviral use, whether they have a home computer and by site.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* HIV-1 infection, as documented by any licensed screening antibody test, such as ELISA, and confirmed by a second antibody test, such as Western blot, or detectable plasma HIV-1 RNA at any time prior to study entry. If an ELISA or Western Blot are not available, HIV infection may be documented by two HIV RNA values \\> 2000 copies/mL, drawn at least 24 hours apart. The HIV RNA assays should have been run at a CLIA approved laboratory or equivalent.\n* 18 years of age or older.\n* Male.\n* At least one of the following:\n* An HIV negative or unknown status sexual partner in the past three months.\n* A sexually transmitted disease in the past 1 year (other than HIV).\n* More than 2 male partners in past year.\n* Unprotected anal sex in past 3 month.\n* Capable of signing written informed consent.\n* Read and comprehend English\n* Adequate computer skills for study.\n\nExclusion Criteria:\n\n* Uncontrolled psychiatric condition.\n* Drug or alcohol users with use that in the opinion of the investigator, would limit follow-up and adequate consent'}, 'identificationModule': {'nctId': 'NCT01198418', 'briefTitle': 'A Web-based Intervention Study to Reduce High-risk Sexual Behavior by Persons Living With HIV AIDS (PLWH)', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Diego'}, 'officialTitle': 'A Randomized Controlled Clinical Trial of an Internet-based Prevention Intervention to Reduce STI in High-risk HIV Infected MSM', 'orgStudyIdInfo': {'id': 'CCTG 592'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Internet-based counseling', 'description': 'Completes surveys monthly about their sexual and drug use behaviors as well as receives information designed to help reduce the chances of getting an STI.', 'interventionNames': ['Behavioral: Experimental']}, {'type': 'NO_INTERVENTION', 'label': 'Survey Alone', 'description': 'Completes surveys monthly about their sexual and drug use behaviors'}], 'interventions': [{'name': 'Experimental', 'type': 'BEHAVIORAL', 'description': 'Internet-based intervention that assesses transmission risk and provides prevention messages', 'armGroupLabels': ['Internet-based counseling']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of Southern California', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92103', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'University of California, San Diego', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '90502', 'city': 'Torrance', 'state': 'California', 'country': 'United States', 'facility': 'University of California, Los Angeles (Harbor)', 'geoPoint': {'lat': 33.83585, 'lon': -118.34063}}], 'overallOfficials': [{'name': 'Sheldon Morris, MD, MPh', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UC San Diego AntiViral Research Center (AVRC)'}, {'name': 'Joel Milam, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of California, San Diego'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Diego', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of California, Los Angeles', 'class': 'OTHER'}, {'name': 'University of Southern California', 'class': 'OTHER'}, {'name': 'California HIV/AIDS Research Program', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Sheldon Morris', 'investigatorAffiliation': 'University of California, San Diego'}}}}