[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07225062":3,"trial-entities:NCT07225062":124,"trial-summary:NCT07225062":129},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":22,"study_type":23,"primary_purpose":24,"phases":25,"enrollment_info":27,"interventions":30,"primary_outcomes":40,"secondary_outcomes":69,"sex":81,"minimum_age":82,"maximum_age":83,"healthy_volunteers":15,"eligibility_criteria":84,"std_ages":93,"locations":96,"central_contacts":116,"overall_officials":119,"references":122,"see_also_links":123},"NCT07225062","HSC-SN-25-0423","Improving HIV Prevention and Substance Use Post-Sexual Assault Services","Improving HIV Prevention and Substance Use Post-Sexual Assault Services for Adolescents and Young Adults","NOT_YET_RECRUITING","2027-06-30","2025-11","2025-11-05","2027-01-04","The University of Texas Health Science Center, Houston","OTHER",false,"The purpose of this study is to tailor existing sexual assault nurse examiner (SANE) services with same-day HIV prophylaxis and substance use screening, brief intervention, or referral using semi-structured adolescents and young adults (AYA) survivor and key informant interviews, and iterative co-design\u002Fpilot testing of adapted strategies with the youth working group (YWG), to optimize study mechanisms and outcome measures using cognitive interviews, analysis of community partner data, and recruitment and retention strategies with the youth working group (YWG) and community advisory board (CAB), to conduct a pilot randomized controlled trial with 40 AYA to test feasibility, acceptability, and initial efficacy compared to usual care, to evaluate recruitment, randomization, and follow-up strategies; adherence to intervention dose; retention benchmarks; and acceptability and to evaluate preliminary efficacy of outcome measures (uptake of post-assault HIV prevention and substance use treatment).",null,[19,20,21],"HIV Infections","Substance Use","Sexual Assault",[],"INTERVENTIONAL","PREVENTION",[26],"NA",{"count":28,"type":29},90,"ESTIMATED",[31,36],{"type":32,"name":33,"description":34,"armGroupLabels":35},"BEHAVIORAL","Enhanced intervention","The intervention has three components: 1). Exploring how to increase access to and promotion of SANE services among vulnerable AYA within the 72 hr window for nPEP treatment; 2). Enhanced SANE services to increase same-day access to nPEP and DoxyPEP and 3). An advocate-delivered screening, brief intervention, and referral to prevent and address substance misuse.",[33],{"type":32,"name":37,"description":38,"armGroupLabels":39},"Usual Care","The usual care condition will be used with control participants and entail receiving typical SANE services without modifications to enhance HIV prevention or substance use screening, brief intervention, or referral to treatment",[37],[41,44,46,48,50,52,54,56,58,60,62,64,67],{"measure":42,"timeFrame":43},"Recruitment feasibility as measured by percentage of eligible individuals screened","end of study (1 month after baseline)",{"measure":45,"timeFrame":43},"Recruitment feasibility as measured by percentage of eligible individuals enrolled",{"measure":47,"timeFrame":43},"Recruitment feasibility as measured by time delay from screening to enrollment",{"measure":49,"timeFrame":43},"Recruitment feasibility as measured by time to enroll sufficient sample size",{"measure":51,"timeFrame":43},"Recruitment feasibility as measured by percentage loss to exclusion criteria.",{"measure":53,"timeFrame":43},"Randomization strategies as measured by proportion randomized to intervention and control",{"measure":55,"timeFrame":43},"Retention as measured by the number of participants that completed the one month follow-up survey",{"measure":57,"timeFrame":43},"Retention of the intervention group as measured by the number of participants that completed the one month follow-up survey",{"measure":59,"timeFrame":43},"Retention of the control group as measured by the number of participants that completed the one month follow-up survey",{"measure":61,"timeFrame":43},"Adherence to intervention as measured by percentage of content completed in the fidelity checklist",{"measure":63,"timeFrame":43},"Acceptability as measured by percentage of data loss",{"measure":65,"description":66,"timeFrame":43},"Acceptability as measured by score on the credibility\u002Fexpectancy questionnaire","The Credibility and Expectancy Questionnaire (CEQ) was used to assess the acceptability of the intervention. All participants completed both subscales: the credibility subscale and the expectancy subscale. Each subscale total score ranges from 0 to 10, with higher scores indicating greater perceived acceptability. The expectancy subscale is reported.",{"measure":65,"description":68,"timeFrame":43},"The Credibility and Expectancy Questionnaire (CEQ) was used to assess the acceptability of the intervention. All participants completed both subscales: the credibility subscale and the expectancy subscale. Each subscale total score ranges from 0 to 10, with higher scores indicating greater perceived acceptability. The credibility subscale is reported.",[70,73,75,77,79],{"measure":71,"timeFrame":72},"Uptake of post-assault HIV prevention as measured by self report of nPEP uptake","1-month follow-up",{"measure":74,"timeFrame":72},"Uptake of substance use treatment as self reported as reported on the self report questionnaire",{"measure":76,"timeFrame":72},"Uptake of post-assault HIV prevention as measured by self report of Doxycycline Post-Exposure Prophylaxis (DoxyPEP) uptake",{"measure":78,"timeFrame":72},"Adherence of non-occupational Post-Exposure Prophylaxis (nPEP) as reported on the self report questionnaire",{"measure":80,"timeFrame":72},"Adherence of substance use treatment as reported on the self report questionnaire","ALL","17 Years","25 Years",{"inclusion":85,"exclusion":89,"raw_text":92},[86,87,88],"experienced a sexual assault within the last 72 hours","speak English","not planning to move out of the metro area during the study.",[90,91],"noticeably intoxicated or under the influence","are overtly having severe, untreated mental illness symptoms","Inclusion Criteria:\n\n* experienced a sexual assault within the last 72 hours\n* speak English\n* not planning to move out of the metro area during the study.\n\nExclusion Criteria:\n\n* noticeably intoxicated or under the influence\n* are overtly having severe, untreated mental illness symptoms",[94,95],"CHILD","ADULT",[97],{"facility":98,"city":99,"state":100,"zip":101,"country":102,"contacts":103,"geoPoint":113},"The University of Texas Health Science Center at Houston","Houston","Texas","77030","United States",[104,109],{"name":105,"role":106,"phone":107,"email":108},"Diane M Santa Maria, DrPH,MSN,FAANRN,PHNA-BC,FSAHM","CONTACT","(713) 500-2002","Diane.M.SantaMaria@uth.tmc.edu",{"name":110,"role":106,"phone":111,"email":112},"Jennifer T Jones","713-500-9928","Jennifer.D.Torres@uth.tmc.edu",{"lat":114,"lon":115},29.76328,-95.36327,[117,118],{"name":105,"role":106,"phone":107,"email":108},{"name":110,"role":106,"phone":111,"email":112},[120],{"name":105,"affiliation":13,"role":121},"PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":125,"biomarkers":128},[126,127,20],"HIV Infection","Sexual assault",[],{"nct_id":4,"found":130,"summary":131,"prompt_version":140},true,{"design":132,"status":133,"heading":6,"summary":134,"follow_up":135,"word_count":136,"commitments":137,"compensation":138,"drugs_mentioned":139},"This is an interventional study comparing an enhanced intervention to usual care. It plans to enroll 90 participants.","completed","This study aims to improve services for young people (ages 17-25) who have experienced sexual assault, focusing on preventing HIV and addressing substance use. Researchers are testing an \"enhanced intervention\" that includes better access to sexual assault nurse examiner (SANE) services, same-day access to nPEP (non-occupational post-exposure prophylaxis, a medicine to prevent HIV after possible exposure) and DoxyPEP (doxycycline post-exposure prophylaxis, a medicine to prevent certain sexually transmitted infections), and substance use screening. This enhanced care is compared to \"usual care,\" which is the typical SANE services. The main goal of this initial study is to see how easy it is to recruit and enroll eligible participants, and how quickly they can be enrolled. The study is currently unclear about its status, but plans to enroll 90 participants.","The primary endpoints for recruitment feasibility are measured at the end of the study, one month after baseline.",128,"Not specified in the trial record.","Not stated in the trial record.",[33,37],"v2"]