Nctid:
NCT06230367
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000015658", "term"=>"HIV Infections"}], "ancestors"=>[{"id"=>"D000086982", "term"=>"Blood-Borne Infections"}, {"id"=>"D000003141", "term"=>"Communicable Diseases"}, {"id"=>"D000007239", "term"=>"Infections"}, {"id"=>"D000015229", "term"=>"Sexually Transmitted Diseases, Viral"}, {"id"=>"D000012749", "term"=>"Sexually Transmitted Diseases"}, {"id"=>"D000016180", "term"=>"Lentivirus Infections"}, {"id"=>"D000012192", "term"=>"Retroviridae Infections"}, {"id"=>"D000012327", "term"=>"RNA Virus Infections"}, {"id"=>"D000014777", "term"=>"Virus Diseases"}, {"id"=>"D000091662", "term"=>"Genital Diseases"}, {"id"=>"D000091642", "term"=>"Urogenital Diseases"}, {"id"=>"D000007153", "term"=>"Immunologic Deficiency Syndromes"}, {"id"=>"D000007154", "term"=>"Immune System Diseases"}], "browseLeaves"=>[{"id"=>"M10283", "name"=>"Infections", "relevance"=>"LOW"}, {"id"=>"M6368", "name"=>"Communicable Diseases", "relevance"=>"LOW"}, {"id"=>"M18250", "name"=>"HIV Infections", "asFound"=>"HIV Infections", "relevance"=>"HIGH"}, {"id"=>"M3522", "name"=>"Acquired Immunodeficiency Syndrome", "relevance"=>"LOW"}, {"id"=>"M2593", "name"=>"Blood-Borne Infections", "relevance"=>"LOW"}, {"id"=>"M15558", "name"=>"Sexually Transmitted Diseases", "relevance"=>"LOW"}, {"id"=>"M17933", "name"=>"Sexually Transmitted Diseases, Viral", "relevance"=>"LOW"}, {"id"=>"M18640", "name"=>"Lentivirus Infections", "relevance"=>"LOW"}, {"id"=>"M15026", "name"=>"Retroviridae Infections", "relevance"=>"LOW"}, {"id"=>"M17522", "name"=>"Virus Diseases", "relevance"=>"LOW"}, {"id"=>"M15149", "name"=>"RNA Virus Infections", "relevance"=>"LOW"}, {"id"=>"M2876", "name"=>"Genital Diseases", "relevance"=>"LOW"}, {"id"=>"M2875", "name"=>"Urogenital Diseases", "relevance"=>"LOW"}, {"id"=>"M16355", "name"=>"Syndrome", "relevance"=>"LOW"}, {"id"=>"M10199", "name"=>"Immunologic Deficiency Syndromes", "relevance"=>"LOW"}, {"id"=>"M10200", "name"=>"Immune System Diseases", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Infections", "abbrev"=>"BC01"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"Urinary Tract, Sexual Organs, and Pregnancy Conditions", "abbrev"=>"BXS"}, {"name"=>"Immune System Diseases", "abbrev"=>"BC20"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"SINGLE", "whoMasked"=>["PARTICIPANT"], "maskingDescription"=>"Control group content is written to affect an experience as if one were in the intervention group."}, "primaryPurpose"=>"PREVENTION", "interventionModel"=>"PARALLEL", "interventionModelDescription"=>"Participants will be randomized to either the intervention or control group"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>5000}}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"2024-01-15", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-01", "completionDateStruct"=>{"date"=>"2026-07-31", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-01-19", "studyFirstSubmitDate"=>"2024-01-10", "studyFirstSubmitQcDate"=>"2024-01-19", "lastUpdatePostDateStruct"=>{"date"=>"2024-01-30", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-30", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2026-07-31", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"HIV Incidence", "timeFrame"=>"12-months post-intervention and immediately post-intervention", "description"=>"HIV Incidence determined by home testing kit"}], "secondaryOutcomes"=>[{"measure"=>"Self-reported HIV incidence", "timeFrame"=>"Post-Intervention, 3-months post, 6-months post, 9-months post, 12-month post", "description"=>"Self-reported HIV Status"}, {"measure"=>"Proportion of Participants Testing for an STI", "timeFrame"=>"12-month post intervention and immediately post-intervention", "description"=>"This outcome will be measured as a cumulative indicator of whether the individual has tested for an STI"}, {"measure"=>"Proportion of Participants having used PrEP/PEP", "timeFrame"=>"12-month post-Intervention and immediately post-intervention", "description"=>"This outcome will be measured as a cumulative indicator of whether the individual has used pre-exposure or post-exposure prophylaxis for HIV"}]}, "oversightModule"=>{"oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["HIV Infections"]}, "descriptionModule"=>{"briefSummary"=>"SHAG is a text messaging-based HIV prevention program designed for cisgender sexual minority boys and men 13-20 years of age across the United States. Investigators will test it against a control group that receives messages about healthy lifestyle.", "detailedDescription"=>"SHAG is a text messaging-based HIV prevention program designed for cisgender sexual minority boys and men 13-20 years of age across the United States. Investigators will test it against a control group that receives messages about healthy lifestyle. Harnessing the power of technology, young people will be recruited online and largely enrolled digitally. The main outcome of interest is HIV incidence. The impact of the intervention on STI testing and pre-exposure prophylaxis (PrEP) will also be examined."}, "eligibilityModule"=>{"sex"=>"MALE", "stdAges"=>["CHILD", "ADULT"], "maximumAge"=>"20 years", "minimumAge"=>"13 years", "healthyVolunteers"=>true, "eligibilityCriteria"=>"Inclusion Criteria:\n\n1. have been assigned male sex at birth and currently have a cisgender identity;\n2. be aged 13-20 years old;\n3. have had anal sex in the past 12 months;\n4. be English-speaking;\n5. exclusively own a cell phone with an unlimited text messaging plan and intend to have the same cell phone number for the next 6 months;\n6. have Internet access to complete online surveys;\n7. provide informed assent for those under 18, and consent for those 18 years of age and older, including a capacity to consent and a positive self-safety assessment;\n8. Willing to take an OraQuick home test to confirm HIV negativity for youth who are 19-20 years of age or 18 years old and graduated high school. If they agree to do the test but do not upload a photo of their result, they will be eligible if they self-report a negative sero-status. Youth 18 years old who have not graduated high school, and 13-17 years of age will be asked to take a home test. If they determine that they cannot do so safely, they will be allowed to self-report their sero-status; and\n9. not currently enrolled in another HIV prevention program; or\n10. know anyone already enrolled in the RCT.\n\nExclusion Criteria:\n\n* Being HIV positive"}, "identificationModule"=>{"nctId"=>"NCT06230367", "acronym"=>"SHAG", "briefTitle"=>"Sexual Health Advocacy for Guys - a Text Messaging-based HIV Prevention Program for Guys Who Are Into Guys", "organization"=>{"class"=>"OTHER", "fullName"=>"Center for Innovative Public Health Research"}, "officialTitle"=>"Harnessing the Power of Text Messaging to Reduce HIV Incidence in Adolescent Males Across the United States", "orgStudyIdInfo"=>{"id"=>"U01HD108738", "link"=>"https://reporter.nih.gov/quickSearch/U01HD108738", "type"=>"NIH"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"SHAG (Sexual Health Advocacy for Guys)", "description"=>"Young people assigned to the intervention arm will receive \\~9 weeks of daily text messages that talk about healthy sexuality and ways to reduce HIV risk. After a 3 month 'quiet' period, they will receive a week of review messages. Messages are based upon the information-motivation-behavioral model of preventive behavior.", "interventionNames"=>["Behavioral: Sexual health advocacy for guys"]}, {"type"=>"PLACEBO_COMPARATOR", "label"=>"Attention-matched control", "description"=>"Young people assigned to the control arm will receive \\~9 weeks of daily text messages that talk about healthy lifestyle, such as self-esteem and physical exercise. After a 3 month 'quiet' period, they will receive a week of review messages.", "interventionNames"=>["Behavioral: Healthy lifestyle control"]}], "interventions"=>[{"name"=>"Sexual health advocacy for guys", "type"=>"BEHAVIORAL", "description"=>"5 month HIV prevention program delivered via text messaging", "armGroupLabels"=>["SHAG (Sexual Health Advocacy for Guys)"]}, {"name"=>"Healthy lifestyle control", "type"=>"BEHAVIORAL", "description"=>"5 month control group program delivered via text messaging", "armGroupLabels"=>["Attention-matched control"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"92672-6745", "city"=>"San Clemente", "state"=>"California", "status"=>"RECRUITING", "country"=>"United States", "contacts"=>[{"name"=>"Michele L Ybarra, MPH PhD", "role"=>"CONTACT", "email"=>"Michele@InnovativePublicHealth.org", "phone"=>"877-302-6858", "phoneExt"=>"801"}, {"name"=>"Michele L Ybarra, MPH PhD", "role"=>"PRINCIPAL_INVESTIGATOR"}], "facility"=>"Center for Innovative Public Health Research", "geoPoint"=>{"lat"=>33.42697, "lon"=>-117.61199}}, {"zip"=>"92672", "city"=>"San Clemente", "state"=>"California", "status"=>"RECRUITING", "country"=>"United States", "contacts"=>[{"name"=>"Michele Ybarra, MPH PhD", "role"=>"CONTACT", "email"=>"help@projectshag.com", "phone"=>"877-302-6858", "phoneExt"=>"801"}], "facility"=>"Center for Innovative Public Health Research", "geoPoint"=>{"lat"=>33.42697, "lon"=>-117.61199}}]}, "ipdSharingStatementModule"=>{"infoTypes"=>["STUDY_PROTOCOL", "SAP", "ICF"], "timeFrame"=>"Data will be available starting 12 months after the grant ends.", "ipdSharing"=>"YES", "description"=>"Individual-level de-identified data will be made available through controlled access.", "accessCriteria"=>"* Data access requires sponsorship by an Institution on behalf of the prospective recipient.\n* Requester must provide documentation of local IRB approval\n* Requester agrees to make results of studies using the data available to the larger scientific community\n* Requester must provide a letter of collaboration with the primary study investigator\n* Use of the data is limited to not-for-profit organizations\n* Use of the data is limited to health purposes"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Center for Innovative Public Health Research", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}
