Ignite Creation Date:
2025-12-24 @ 10:22 PM
Ignite Modification Date:
2026-03-15 @ 9:17 PM
Study NCT ID:
NCT03138135
Status:
COMPLETED
Last Update Posted:
2021-04-09
First Post:
2017-04-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
HOME Study: a Combination Support Package to Increase Uptake of PrEP and HIV/STI Testing
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D040242', 'term': 'Risk Reduction Behavior'}], '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': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 104}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2018-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-06', 'studyFirstSubmitDate': '2017-04-14', 'studyFirstSubmitQcDate': '2017-05-01', 'lastUpdatePostDateStruct': {'date': '2021-04-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Who uses home HIV self-testing and home STI self-collection.', 'timeFrame': '9 months', 'description': 'Testing and self-collection rates by occasion, age, county, race/ethnicity, and prior testing history. Aggregate descriptive analysis.'}, {'measure': 'Who uses a buddy.', 'timeFrame': '9 months', 'description': 'Differences in testing with a buddy by occasion, age, county, race/ethnicity, and prior testing history. Aggregate descriptive analysis.'}, {'measure': 'Use of HIV prevention services.', 'timeFrame': '9 months', 'description': 'Proportion of HIV uninfected participants who attend group or individual counseling services.'}], 'primaryOutcomes': [{'measure': 'Efficacy of the HOME package to support linkage to PrEP or HIV care', 'timeFrame': '9 months', 'description': 'Between-arm differences in initiation of PrEP; qualitative evaluation of linkage to HIV care.'}, {'measure': 'Efficacy of the HOME package to increase HIV and STI testing frequency.', 'timeFrame': '9 months', 'description': 'The proportion of participants reporting HIV and STI testing rates between visits.'}], 'secondaryOutcomes': [{'measure': 'Feasibility of the individual components of the study intervention.', 'timeFrame': '9 months', 'description': 'Combined analysis of overall use of study intervention: Usage of home HIV self-testing, with and without buddies, as well as STI-self collection; Proportion of participants who log-in to the HOME Study site at least once, distribution of numbers of log-ins, and use of HOME Study pages, as measured by numbers of clicks and views for each page.'}, {'measure': 'Acceptability of the HOME package to support linkage to HIV care or PrEP.', 'timeFrame': '9 months', 'description': 'Acceptability scores from online questionnaires and the distribution of repeated scores at follow-up timepoints.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['PrEP', 'HIV prevention', 'Risk reduction', 'STI prevention', 'Home HIV testing', 'HIV testing', 'STI testing'], 'conditions': ['HIV Prevention', 'Sexually Transmitted Diseases', 'Pre-Exposure Prophylaxis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://helpfighthiv.org', 'label': 'Bridge HIV Health Equity Studies homepage'}]}, 'descriptionModule': {'briefSummary': 'Home HIV self-testing has been FDA approved and allows users to read their own HIV test results at home, while home sexually transmitted infection (STI) test self-collection allows men to use a swab at home and mail it in for testing. The purpose of this study is to learn how Men who have Sex with Men (MSM) use these new testing options, a set of online support tools, and the option to test with someone to support them (a testing "buddy").\n\nWe will also evaluate whether the online tools help these men to connect with HIV prevention services such as Pre-Exposure Prophylaxis (PrEP) if they test HIV negative, and to HIV care services if they test HIV positive.', 'detailedDescription': 'Participants will be randomized 2:1 after enrollment to the intervention and control condition. Data obtained from this study will be used to inform the further tailoring and distribution of an intervention for young Black and Latino MSM to increase utilization of home HIV self-testing and linkage to HIV treatment and Pre-Exposure Prophylaxis (PrEP).'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Cisgender male', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Self-identify as Black or Latino.\n* Report anal sex with at least one male sex partner in the prior 12 months.\n* HIV negative by self-report.\n* Currently own a cell phone.\n* Willing and able to provide written informed consent.\n\nExclusion Criteria:\n\n* Inadequate contact information for follow-up.\n* In a mutually monogamous sexual relationship for the past 12 months.\n* Currently taking PrEP.\n* Does not have reliable access to the Internet.\n* Does not live, work, or play in the San Francisco Bay Area.\n* Planning to move out of the Bay Area during the 9 month study period.\n* Previously participated in the HOME Pilot study.\n* Any medical, psychiatric, or social condition, or occupational, or other responsibility that, in the judgment of the investigator, would make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.'}, 'identificationModule': {'nctId': 'NCT03138135', 'briefTitle': 'HOME Study: a Combination Support Package to Increase Uptake of PrEP and HIV/STI Testing', 'organization': {'class': 'OTHER', 'fullName': 'Public Health Foundation Enterprises, Inc.'}, 'officialTitle': 'HOME Study: Evaluation of a Combination Support Package to Increase Uptake of Pre-exposure Prophylaxis and HIV/STI Testing Among Young Black and Latino MSM in the San Francisco Bay Area.', 'orgStudyIdInfo': {'id': '16-20492'}, 'secondaryIdInfos': [{'id': 'R01AI104309', 'link': 'https://reporter.nih.gov/quickSearch/R01AI104309', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'The Intervention group will receive the HOME Study intervention.', 'interventionNames': ['Behavioral: HOME Study intervention']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'The Control group will receive standard of care.', 'interventionNames': ['Behavioral: Control']}], 'interventions': [{'name': 'HOME Study intervention', 'type': 'BEHAVIORAL', 'description': 'Access to home HIV test kits, home STI self-collection kits, the HOME Study website, and the SexPro HIV risk assessment tool.', 'armGroupLabels': ['Intervention']}, {'name': 'Control', 'type': 'BEHAVIORAL', 'description': 'Counseling about the importance of quarterly HIV/STI testing and a PrEP information pamphlet.', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94102', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Bridge HIV, San Francisco Department of Public Health', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'overallOfficials': [{'name': 'Hyman Scott, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Public Health Foundation Enterprises; San Francisco Department of Public Health'}, {'name': 'Susan Buchbinder, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Public Health Foundation Enterprises; San Francisco Department of Public Health'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Public Health Foundation Enterprises, Inc.', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Allergy and Infectious Diseases (NIAID)', 'class': 'NIH'}, {'name': 'San Francisco Department of Public Health', 'class': 'OTHER_GOV'}, {'name': 'University of California, San Francisco', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, Bridge HIV', 'investigatorFullName': 'Susan Buchbinder', 'investigatorAffiliation': 'Public Health Foundation Enterprises, Inc.'}}}}