[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07679620":3,"trial-entities:NCT07679620":151,"trial-summary:NCT07679620":154},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":14,"conditions":16,"keywords":18,"study_type":20,"primary_purpose":21,"phases":22,"enrollment_info":24,"interventions":27,"primary_outcomes":36,"secondary_outcomes":42,"sex":111,"minimum_age":14,"maximum_age":14,"healthy_volunteers":112,"eligibility_criteria":113,"std_ages":119,"locations":123,"central_contacts":143,"overall_officials":146,"references":149,"see_also_links":150},"NCT07679620","HSC-SPH-24-0672","Disseminating Effective Sexual Health Programs in Schools Using iCHAMPSS","RECRUITING","2028-04-01","2026-04","2026-07-01","2026-04-02","The University of Texas Health Science Center, Houston","OTHER",null,"The purpose of this study is to assess the efficacy of iCHAMPSS 2.0 in impacting Reach Effectiveness Adoption Implementation Maintenance (RE-AIM) implementation outcomes, with implementation of a sexual health evidence-based program (EBP) assess iCHAMPSS 2.0's efficacy in impacting determinants of sexual health EBP implementation and to conduct a process evaluation to monitor iCHAMPSS 2.0 implementation, reach, dosage, and barriers and facilitators to implementing iCHAMPSS 2.0 during the study.",[17],"Sexual Health Education",[19],"iCHAMPSS","INTERVENTIONAL","PREVENTION",[23],"NA",{"count":25,"type":26},75,"ESTIMATED",[28],{"type":29,"name":30,"description":31,"armGroupLabels":32},"BEHAVIORAL","iCHAMPSS 2.0","iCHAMPSS 2.0 is designed for Program Champions, critical to EBP use, such as district and school administrators, SHAC members (which include parents), and health and physical education teachers, who are highly motivated to promote sexual health education.\n\niCHAMPSS 2.0 has four features:\n\n1. the CHAMPSS Model tutorial, which familiarizes Champions with the iCHAMPSS 2.0 system\n2. a Staging Tool, which helps Champions understand their school's level of readiness to adopt, implement, and maintain a sexual health EBP, and can tailor their experience\n3. a tools library, which includes a suite of over 60 decision support tools\n4. an interactive linkage system, which is an online platform to help Champions connect with others and to receive technical assistance (TA)",[33,34,35],"Arm 1: 1 semester of implementation then 7 semesters of intervention","Arm 2: 1 semester of control, 1 semester of implementation then 7 semesters of intervention","Arm 3: 1 semesters of control, 1 semester of implementation then 6 semesters of intervention",[37,40],{"measure":38,"timeFrame":39},"Change in percentage of schools within a district implementing an EBP","From baseline to end of intervention period (about 20 to 30 months from baseline)",{"measure":41,"timeFrame":39},"Rate of implementation of the EBP",[43,45,47,49,51,53,55,58,61,64,67,70,73,76,79,82,84,87,90,93,96,98,100,102,104,106,109],{"measure":44,"timeFrame":39},"Percentage of School Health Advisory Councils (SHACs) that have recommended a sexual health EBP to their school board",{"measure":46,"timeFrame":39},"Percentage of School Health Advisory Councils (SHACs) that have adopted a sexual health EBP to their school board",{"measure":48,"timeFrame":39},"Percentage of schools with the school board's approval of an Evidence Based Program (EBP)",{"measure":50,"timeFrame":39},"Percentage of schools with the principal's approval of an EBP",{"measure":52,"timeFrame":39},"Percentage of students receiving majority (over 50%) of a sexual health EBP",{"measure":54,"timeFrame":39},"Percentage of schools that have implemented the evidence-based program for more than one academic year as assessed by the implementation survey",{"measure":56,"description":57,"timeFrame":39},"Change in perceived complexity as assessed by the staff survey","This is a 3 item questionnaire and each is scored form (1) Strongly disagree to (5) Strongly agree, maximum score of 15, higher score indicating worse outcome",{"measure":59,"description":60,"timeFrame":39},"Change in compatibility as assessed by the staff survey","This is a 5 item questionnaire and each is scored from (1) Strongly disagree to (5) Strongly agree maximum score 25, higher score indicating better outcome",{"measure":62,"description":63,"timeFrame":39},"Change in relative advantage as assessed by the staff survey","This is a 4 item questionnaire and each is scored from (1) Strongly disagree to (5) Strongly agree, maximum score of 20, higher score indicating better better outcome",{"measure":65,"description":66,"timeFrame":39},"Change in perceived social systems support in parent community as assessed by the staff survey","This is a 8 item questionnaire and each is scored from (1) not at all supportive to (4) very supportive , maximum score of 32 , higher score indicating better outcome",{"measure":68,"description":69,"timeFrame":39},"Change in presence of school policy as assessed by the staff survey","This is a 2 item questionnaire and each is scored from 1(strongly disagree) -5(strongly agree), maximum score 10, higher score indicating better outcome",{"measure":71,"description":72,"timeFrame":39},"Change in adequate resources as assessed by the staff survey","This is a 5 item questionnaire and each is scored from 1(strongly disagree) -5(strongly agree), maximum score of 25, higher score indicating better outcome",{"measure":74,"description":75,"timeFrame":39},"Change in presence of a program champion as assessed by the staff survey","This is a 4 item questionnaire and each is scored 1(strongly disagree) -5(strongly agree), maximum score 20, higher score indicating better outcome",{"measure":77,"description":78,"timeFrame":39},"Change in implementation climate as assessed by the staff survey","This is a 6 item questionnaire and each is scored from 1(strongly disagree) -5(strongly agree), maximum score of 30, higher score indicating better outcome",{"measure":80,"description":81,"timeFrame":39},"Change in inter organizational relationships as assessed by the staff survey","This is a 4 item questionnaire and each is scored from 1(strongly disagree) -5(strongly agree), maximum score 20, higher score indicating better outcome",{"measure":83,"description":81,"timeFrame":39},"Change in intra organizational relationships as assessed by the staff survey",{"measure":85,"description":86,"timeFrame":39},"Change in perceived need as assessed by the staff survey","This is a 4 item questionnaire and each is scored from (1) Strongly disagree to (5) Strongly agree, maximum score range of 20, higher score indicating worse outcome",{"measure":88,"description":89,"timeFrame":39},"Change in self-efficacy as assessed by the staff survey","This is a 19 item questionnaire and each is scored from 1(not at all confident)-4(very confident) , maximum score range of 76, higher score indicating better outcome",{"measure":91,"timeFrame":92},"Frequency of use of iCHAMPSS 2.0 as assessed by the website analytics","From baseline to end of school year (about 7 to 12 months from baseline)",{"measure":94,"description":95,"timeFrame":92},"Time spent using iCHAMPSS 2.0 as assessed by the district coordinator survey","This will be reported categorically as less than one hour, 1-2 hours, 3-4 hours, 5-6 hours and 7 hours or more",{"measure":97,"timeFrame":92},"Number of recurring users of iCHAMPSS 2.0 as assessed by the website analytics",{"measure":99,"timeFrame":92},"Number of unique users of iCHAMPSS 2.0 as assessed by the website analytics",{"measure":101,"timeFrame":92},"Mean number of users per school district of iCHAMPSS 2.0 as assessed by the website analytics",{"measure":103,"timeFrame":92},"Percentage of school districts\u002Fschools using iCHAMPSS 2.0 as assessed by the website analytics",{"measure":105,"timeFrame":92},"Percentage of iCHAMPSS 2.0 tools used in each step as assessed by the website analytics",{"measure":107,"description":108,"timeFrame":92},"Perceived barriers to implementing iCHAMPSS 2.0 as assessed by the coordinator interviews and district coordinator surveys","This will be reported as a percentage",{"measure":110,"description":108,"timeFrame":92},"Perceived facilitators to implementing iCHAMPSS 2.0 as assessed by the coordinator interviews and district coordinator surveys","ALL",true,{"inclusion":114,"exclusion":116,"raw_text":118},[115],"Licensed educator or administrator who holds one of the following positions: 1) district or school administrator (e.g., health coordinators, instructional specialists, and curriculum coordinators), 2) health and physical education teachers, and 3) social and health service staff (e.g., nurses and counselors) in a Texas school district participating in the iCHAMPSS 2.0 study",[117],"not holding a job in a Texas school district as a school stakeholder, OR holding a job in a Texas school district as a school stakeholder but not in a school district participating in the iCHAMPSS 2.0 study","Inclusion Criteria:\n\n* Licensed educator or administrator who holds one of the following positions: 1) district or school administrator (e.g., health coordinators, instructional specialists, and curriculum coordinators), 2) health and physical education teachers, and 3) social and health service staff (e.g., nurses and counselors) in a Texas school district participating in the iCHAMPSS 2.0 study\n\nExclusion Criteria:\n\n* not holding a job in a Texas school district as a school stakeholder, OR holding a job in a Texas school district as a school stakeholder but not in a school district participating in the iCHAMPSS 2.0 study",[120,121,122],"CHILD","ADULT","OLDER_ADULT",[124],{"facility":125,"status":7,"city":126,"state":127,"zip":128,"country":129,"contacts":130,"geoPoint":140},"The University of Texas Health Science Center at Houston","Houston","Texas","77030","United States",[131,136],{"name":132,"role":133,"phone":134,"email":135},"Belinda Hernandez, PhD, MPH","CONTACT","(210) 276-9009","Belinda.Hernandez@uth.tmc.edu",{"name":137,"role":133,"phone":138,"email":139},"Laura Thormaehlen","(713) 500-9000","Laura.C.Thormaehlen@uth.tmc.edu",{"lat":141,"lon":142},29.76328,-95.36327,[144,145],{"name":132,"role":133,"phone":134,"email":135},{"name":137,"role":133,"phone":138,"email":139},[147],{"name":132,"affiliation":12,"role":148},"PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":152,"biomarkers":153},[17],[],{"nct_id":4,"found":112,"summary":155,"prompt_version":165},{"design":156,"status":157,"heading":158,"summary":159,"follow_up":160,"word_count":161,"commitments":162,"compensation":163,"drugs_mentioned":164},"This is an interventional study, meaning participants will receive a specific program. It plans to enroll 75 participants.","completed","Study of iCHAMPSS 2.0 for Sexual Health Education in Schools","This study is looking at a program called iCHAMPSS 2.0, which is designed to help schools effectively teach sexual health. The program is for school staff like administrators, teachers, and health service staff in Texas. We want to see if iCHAMPSS 2.0 helps more schools use proven sexual health education programs. Success will be measured by how many schools in a district start using these programs and how well they implement them over about 20 to 30 months. The study aims to enroll 75 participants, but its current status is unclear.","The study will measure outcomes from the start of the study until the end of the intervention period, which is about 20 to 30 months.",91,"Not specified in the trial record.","Not stated in the trial record.",[30],"v2"]