[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06043596":3,"trial-entities:NCT06043596":107,"trial-summary:NCT06043596":112},{"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":16,"conditions":17,"keywords":22,"study_type":23,"primary_purpose":24,"phases":25,"enrollment_info":27,"interventions":30,"primary_outcomes":40,"secondary_outcomes":45,"sex":60,"minimum_age":61,"maximum_age":62,"healthy_volunteers":63,"eligibility_criteria":64,"std_ages":71,"locations":74,"central_contacts":89,"overall_officials":96,"references":105,"see_also_links":106},"NCT06043596","1309","Evaluation of the SafeSpace App Intervention","RECRUITING","2026-09-29","2023-11","2023-11-21","2023-06-12","Child Trends","OTHER",false,"The goal of this study is to evaluate the impact of SafeSpace Sexual Health App, an innovative sexual health promotion program focused on reducing sexual risk factors and promoting sexual and reproductive health and wellbeing among young people assigned female or intersex at birth, particularly Black and\u002For Latine youth, LGBTQ+ youth, youth in states with high teen birth rates and youth who live in rural communities. This study utilizes a two-arm randomized control trial design to measure impacts of receiving the SafeSpace Sexual Health program compared to receiving a similar-length control app program, SafeSpace General Health that focuses on general health.\n\nThe investigators will ask participants to:\n\n* Keep the SafeSpace app downloaded to their device and visit the app regularly over the course of 10 weeks.\n* Provide contact information.\n* Receive and open app push notifications for 10 weeks (up to 3 per week).\n* Complete 3 online surveys over a year: baseline, short-term follow-up (10 weeks after baseline), and long-term follow up (9 months after short-term follow-up).\n* Receive occasional text messages from the study team.",null,[18,19,20,21],"Health Behavior","Health Care Utilization","Unprotected Sex","Sexually Transmitted Infections",[],"INTERVENTIONAL","PREVENTION",[26],"NA",{"count":28,"type":29},1000,"ESTIMATED",[31,36],{"type":32,"name":33,"description":34,"armGroupLabels":35},"BEHAVIORAL","SafeSpace Sexual Health","The overall goal of the program is to prevent adolescent pregnancy and STIs by increasing sexual agency, increasing the use of condoms and contraception, and promoting healthy relationships and healthy life skills among adolescents.",[33],{"type":32,"name":37,"description":38,"armGroupLabels":39},"SafeSpace General Health","This arm represents the comparison group. SafeSpace General Health will act as the active comparator, while providing youth with lessons, facts, and resources about general health topics.",[37],[41],{"measure":42,"description":43,"timeFrame":44},"Penile-vaginal sex without a condom or a more effective method of contraception","Yes = Had penile-vaginal sex without using pill, shot, patch, ring, IUD, implant, or condom every time; No = Did not have penile-vaginal sex OR always used pill, shot, patch, ring, IUD, implant, or condom during penile-vaginal sex","Past 3 months at baseline; past 9 months at long-term follow-up",[46,49,53,57],{"measure":47,"description":48,"timeFrame":44},"Penile-vaginal sex or anal sex without a condom every time","Yes = Had penile-vaginal sex or anal sex without using a condom every time OR had anal sex without use of a condom every time.\n\nNo = No penile-vaginal sex AND no anal sex; or No = No penile-vaginal sex AND condom use during anal sex every time; or No = condom use during every penile vaginal sex AND no anal sex",{"measure":50,"description":51,"timeFrame":52},"Utilization of sexual health services","Yes = has seen a health care provider (clinic or doctor's office) for any sexual or reproductive health services in the past 12 months No = did not see a health care provider for SRH services in the past 12 months","Has received SRH services in the past 12 months or has an appointment scheduled in the next 3 months at baseline; Received SRH services in the past 9 months or has an appointment scheduled in the next 3 months at long-term follow-up.",{"measure":54,"description":55,"timeFrame":56},"Number of Sexual and Reproductive Health topics discussed with a trusted adult in the past 3 months.","Score of talking with trusted person in the past 3 months about topic categories including either sexual orientation or gender identity; when to have sex; receiving SRH services; STIs and contraception; consent or pleasure in the past 3 months. For this scale, there is a minimum score of 0 and a maximum score of 7 with a higher score indicating a better outcome","Past 3 months at baseline; past 10 weeks at short-term follow-up; past 9 months at long-term follow-up",{"measure":58,"description":59,"timeFrame":56},"Sexual agency during every recent sexual experience or no recent sexual experiences","Dependent on the frequency of a) communicating with their partners(s) about what they like, dislike, or want to try, b) asking their partner(s) what they like, dislike, or want to try, and c) asking or giving consent to their partner(s). Those who haven't engaged in sexual activity within the relevant time frame will be considered to have sexual agency","FEMALE","14 Years","18 Years",true,{"inclusion":65,"exclusion":69,"raw_text":70},[66,67,68],"Participants must be assigned female or intersex at birth","Participants must be youth in the U.S. (14-18 years old)","Participants must have daily access to an iPhone",[],"Inclusion Criteria:\n\n* Participants must be assigned female or intersex at birth\n* Participants must be youth in the U.S. (14-18 years old)\n* Participants must have daily access to an iPhone\n\nExclusion Criteria:\n\n\\- Participants must not be currently pregnant or currently trying to become pregnant\n\nOther Criteria:\n\n\\- The study's priority\u002Fpreference population is for Black and\u002For Latine youth, LGBTQ+ youth, youth from geographic areas with high teen birth rates, and youth living in rural areas.",[72,73],"CHILD","ADULT",[75],{"facility":12,"status":7,"city":76,"state":77,"zip":78,"country":79,"contacts":80,"geoPoint":86},"Bethesda","Maryland","20814","United States",[81],{"name":82,"role":83,"phone":84,"email":85},"Elizabeth Cook","CONTACT","240-223-9323","ecook@childtrends.org",{"lat":87,"lon":88},38.98067,-77.10026,[90,92],{"name":91,"role":83,"phone":84,"email":85},"Elizabeth Cook, MSPH",{"name":93,"role":83,"phone":94,"email":95},"Jennifer Manlove, PhD","240-223-9262","jmanlove@childtrends.org",[97,99,101],{"name":93,"affiliation":12,"role":98},"STUDY_DIRECTOR",{"name":100,"affiliation":12,"role":98},"Elizabeth L Cook, MSPH",{"name":102,"affiliation":103,"role":104},"Riley Steiner, PhD","Power to Decide","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":108,"biomarkers":111},[18,19,109,110],"Sexually Transmitted Disorder","Unprotected Sexual Intercourse",[],{"nct_id":4,"found":63,"summary":113,"prompt_version":123},{"design":114,"status":115,"heading":116,"summary":117,"follow_up":118,"word_count":119,"commitments":120,"compensation":121,"drugs_mentioned":122},"This is a randomized controlled trial with two groups, aiming to enroll 1000 participants. You would be randomly assigned to use one of two apps.","completed","SafeSpace App for Sexual Health in Young Women","This study is testing an app called SafeSpace Sexual Health. It aims to help young women, especially Black and\u002For Latine youth, LGBTQ+ youth, and those in certain areas, reduce sexual risks and improve their sexual and reproductive health. You would use either the SafeSpace Sexual Health app or a general health app called SafeSpace General Health. Researchers will compare how often participants have unprotected sex to see if the sexual health app is effective. The study is looking for 1000 young women in the U.S. aged 14-18 who have daily access to an iPhone and are not pregnant or trying to become pregnant. The current status of the study is unclear.","Researchers will measure unprotected sex at the start of the study and again at 9 months for long-term follow-up.",111,"Not specified in the trial record.","Not stated in the trial record.",[33,37],"v2"]