[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07103525":3,"trial-entities:NCT07103525":106,"trial-summary:NCT07103525":110},{"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":21,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":41,"secondary_outcomes":46,"sex":50,"minimum_age":51,"maximum_age":17,"healthy_volunteers":15,"eligibility_criteria":52,"std_ages":64,"locations":67,"central_contacts":93,"overall_officials":102,"references":104,"see_also_links":105},"NCT07103525","24-01572","Initiative for Chinese Sex Workers to Promote Wellbeing and Improve HIV Prevention by Reducing intersEctional Stigma","INSPIRE: Initiative for Chinese Sex Workers to Promote Wellbeing and Improve HIV Prevention by Reducing intersEctional Stigma","NOT_YET_RECRUITING","2028-01","2026-05","2026-05-29","2026-06","NYU Langone Health","OTHER",true,"During the development phase (Aim 1), investigators will use a community-driven process to further refine a preliminary intervention design that was developed based on previous research.\n\nFor the intervention phase (Aim 2), investigators will conduct a pilot randomized controlled trial of the multi-level intervention. For the individual-level component of the intervention, investigators will recruit 70 Chinese immigrant FSWs who work in MPs in Queens, NYC (n=35 intervention participants and n=35 control participants).\n\nTo assess the feasibility and acceptability of intervention implementation (Aim 3), investigators will conduct in-depth qualitative interviews with 12 FSW study participants and the 2 peer advocates and focus groups with 4-5 staff from each of the 3 organizations (3 focus groups total and 12-15 focus group participants in total).",null,[19,20],"HIV Prevention","Wellbeing",[],"INTERVENTIONAL","PREVENTION",[25],"NA",{"count":27,"type":28},70,"ESTIMATED",[30,36],{"type":31,"name":32,"description":33,"armGroupLabels":34},"BEHAVIORAL","INSPIRE Initiative","Culturally relevant, multi-level intervention designed to increase HIV testing through reducing intersectional stigma. Intervention includes series of four one-on-one conversations (45 minutes each over a six-week period) via mobile phone between the Hunter peer advocates and FSWs, which are reinforced through weekly text messages from the peer advocates and through role-model stories shared online.",[35],"Intervention Group",{"type":31,"name":37,"description":38,"armGroupLabels":39},"Standard of Care","Standard HIV prevention information with no tailored components via one mobile phone verbal conversation with peer advocates.",[40],"Control Group",[42],{"measure":43,"description":44,"timeFrame":45},"Percentage of Participants who Completed HIV Testing","Assessed via self-report.","Follow-Up Visit 1 (Approximately Week 6)",[47],{"measure":48,"description":49,"timeFrame":45},"Percentage of Participants with PrEP Uptake","Assessed via self-report; percentage of participants who begin PrEP treatment.","FEMALE","18 Years",{"inclusion":53,"exclusion":58,"raw_text":63},[54,55,56,57],"Female Sex Workers: A person who identifies as a woman, Chinese, a massage parlor (MP) worker in Queens, who is at least 18 years old, and has provided sexual services in the past 12 months, will be eligible.","Community advisory board (CAB) members: self identifies as a community member providing services to immigrant Chinese women and is at least 18 years old.","Peer Advocates: self identifies as current or previous sex worker, is a Chinese adult woman, and speaks both Mandarin and English.","Medical Providers: self identifies as a current medical provider who works with Chinese immigrant adults and speaks English.",[59,60,61,62],"Female Sex Workers: Because completion of HIV testing is our primary study outcome, women who received an HIV test in the previous 3 months or who know they are HIV-positive will be excluded from the study.","Community advisory board (CAB) members: Does not speak English or is under the age of 18.","Peer Advocates: Does not speak English\u002FMandarin or is under the age of 18.","Medical Providers: Does not speak English or does not provide care to Chinese immigrant adults (e.g., pediatricians).","Inclusion Criteria:\n\n* Female Sex Workers: A person who identifies as a woman, Chinese, a massage parlor (MP) worker in Queens, who is at least 18 years old, and has provided sexual services in the past 12 months, will be eligible.\n* Community advisory board (CAB) members: self identifies as a community member providing services to immigrant Chinese women and is at least 18 years old.\n* Peer Advocates: self identifies as current or previous sex worker, is a Chinese adult woman, and speaks both Mandarin and English.\n* Medical Providers: self identifies as a current medical provider who works with Chinese immigrant adults and speaks English.\n\nExclusion Criteria:\n\n* Female Sex Workers: Because completion of HIV testing is our primary study outcome, women who received an HIV test in the previous 3 months or who know they are HIV-positive will be excluded from the study.\n* Community advisory board (CAB) members: Does not speak English or is under the age of 18.\n* Peer Advocates: Does not speak English\u002FMandarin or is under the age of 18.\n* Medical Providers: Does not speak English or does not provide care to Chinese immigrant adults (e.g., pediatricians).",[65,66],"ADULT","OLDER_ADULT",[68,79,86],{"facility":13,"city":69,"state":69,"zip":70,"country":71,"contacts":72,"geoPoint":76},"New York","10016","United States",[73],{"name":74,"role":75},"Sahnah Lim, PhD","PRINCIPAL_INVESTIGATOR",{"lat":77,"lon":78},40.71427,-74.00597,{"facility":80,"city":69,"state":69,"zip":81,"country":71,"contacts":82,"geoPoint":85},"Columbia University Irving Medical Center","10032",[83],{"name":84,"role":75},"Chiaying Wei, PhD",{"lat":77,"lon":78},{"facility":87,"city":69,"state":69,"zip":88,"country":71,"contacts":89,"geoPoint":92},"CUNY-Hunter College","10065",[90],{"name":91,"role":75},"John Chin, PhD",{"lat":77,"lon":78},[94,98],{"name":74,"role":95,"phone":96,"email":97},"CONTACT","917-214-9070","Sahnah.lim@nyulangone.org",{"name":99,"role":95,"phone":100,"email":101},"Jiepin Cao","919-717-7093","Jiepin.cao@nyulangone.org",[103],{"name":74,"affiliation":13,"role":75},[],[],{"nct_id":4,"conditions":107,"biomarkers":109},[108,20],"Stroke prevention",[],{"nct_id":4,"found":15,"summary":111,"prompt_version":121},{"design":112,"status":113,"heading":114,"summary":115,"follow_up":116,"word_count":117,"commitments":118,"compensation":119,"drugs_mentioned":120},"This is an interventional pilot randomized controlled trial with 70 participants, split into two groups of 35 each.","completed","INSPIRE Initiative for HIV Prevention and Wellbeing in Chinese Sex Workers","This study, called the INSPIRE Initiative, is testing a new behavioral program to help prevent HIV and improve wellbeing among Chinese women who are sex workers. The program aims to reduce stigma (negative attitudes or beliefs) that can make it harder for women to get HIV testing. You might be able to join if you are a Chinese woman, at least 18 years old, work in a massage parlor in Queens, and have provided sexual services in the past year. The study will compare the INSPIRE Initiative, which involves four phone conversations with peer advocates, to standard HIV prevention information. Researchers will measure how many participants complete HIV testing about six weeks after starting the program. The current recruitment status is unclear.","Your participation will be followed up to approximately Week 6 to measure HIV testing completion.",122,"If you join the INSPIRE Initiative group, you will have four 45-minute phone conversations over six weeks. If you join the Standard of Care group, you will have one phone conversation.","Not stated in the trial record.",[32],"v2"]