[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100566113":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":33,"centralContacts":40,"locations":50,"responsibleParty":69,"collaborators":72,"id":77,"slug":78,"hasResults":79,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":25,"eligibilityCriteria":83,"healthyVolunteers":84,"sex":85,"minAge":86,"maxAge":87,"enrollmentInfo":88,"targetDuration":25,"studyType":91,"phases":92,"briefSummary":94,"conditions":95,"keywords":104,"overallStatus":53,"whyStopped":25,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":120},{"fullName":5,"class":6},"Health Poverty Action","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention district","EXPERIMENTAL","The intervention provides HPV vaccinations to girls aged 10-13 and sexual and reproductive health (SRH) services to boys and girls aged 10-13 through three service delivery touch points: schools, health facilities, and community outreach. The vaccine in the intervention is a single dose of recombinant Human Papilloma virus quadrivalent types, 6, 11, 16, and 18. Schools will provide vaccinations and comprehensive sexuality education (CSE) sessions. Health facilities offer vaccinations and SRH education service. Community outreach delivers the integrated package to out-of-school girls and boys.",[13,14],"Other: Integrated HPV and SRH Service Package","Biological: Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant",{"label":16,"type":17,"description":18,"interventionNames":19},"Comparison District","ACTIVE_COMPARATOR","Standard HPV Vaccination (Comparison District) - In the comparison district, routine HPV vaccination services will be provided to girls aged 10-13 years. The vaccine is a single dose of recombinant Human Papilloma virus quadrivalent types, 6, 11, 16, and 18.; A school-based vaccination campaign will be conducted in 2024 November to promote and administer the HPV vaccine. Additionally, the vaccine will be available at health facilities starting in the same month. Outreach activities will also be conducted to ensure access to the vaccine for hard-to-reach populations and out-of-school girls. - Unlike the intervention district, there will be no additional training for nor service by healthcare providers on comprehensive sexuality education (CSE) or other sexual and reproductive health (SRH) services, and there will be no dedicated community outreach sessions on SRH topics.",[14],[21,26],{"type":6,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"Integrated HPV and SRH Service Package","1. Integrated Service Package combines HPV vaccination with sexual and reproductive health (SRH) education. The vaccine in the intervention package is a single dose of recombinant Human Papilloma virus quadrivalent types, 6, 11, 16, and 18.;\n2. The package will be delivered through multiple touch-points such as school-based programs, health facility services, and community outreach. i) In school, the intervention incorporates Comprehensive Sexuality Education, empowering boys and girls with knowledge about their bodies, health, and rights. This goes beyond simply providing information about HPV and vaccination. ii) At health facilities, the intervention package will also be delivered in adolescent-friendly ways, ensuring that boys and girls feel comfortable accessing SRH information. iii) Since not all boys and girls attend school, the intervention includes community outreach that ensures wider reach and accessibility for adolescents aged 10-13, including those not enrolled in school.",[9],null,{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"BIOLOGICAL","Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant","The vaccine itself is not the intervention of interest as this is delivered in both intervention and comparison arms. The vaccine is a single dose of recombinant Human Papilloma Virus Quadrivalent (Types 6, 11, 16, and 18). The administration of the vaccine is an intramuscular injection of 0.5 mili liter of suspension form.",[16,9],[32],"Gardasil",[34,37],{"name":35,"affiliation":5,"role":36},"Thet Lynn, MD, MMedSc Global Health","PRINCIPAL_INVESTIGATOR",{"name":38,"affiliation":39,"role":36},"Vanphanom Sychareun, MD, PhD","Health Sciences University, Laos",[41,46],{"name":42,"role":43,"phone":44,"phoneExt":25,"email":45},"Kongmany Chaleunvong, MD, PhD","CONTACT","+8562022200650","kchaluenvong@gmail.com",{"name":47,"role":43,"phone":48,"phoneExt":25,"email":49},"Viengnakhone Vongxay, MD, PhD","+856 20 95 665 699","viengnakhone_poom@yahoo.com",[51],{"facility":52,"status":53,"city":54,"state":55,"zip":25,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"Sing District, Luang Namtha Province","RECRUITING","Muang Sing","Province","Laos","LA",{"type":59,"coordinates":60},"Point",[61,62],101.14789,21.19206,{"lat":62,"lon":61},[65],{"name":66,"role":43,"phone":67,"phoneExt":25,"email":68},"Khamsook Phommavongsa","+856 20 22 233 383","K.phommavongsa@healthpovertyaction.org",{"type":36,"investigatorFullName":70,"investigatorTitle":71,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Dr. Thet Lynn","Program Development and Quality Manager - Asia Region",[73,75],{"name":74,"class":6},"Gavi, The Vaccine Alliance",{"name":39,"class":76},"UNKNOWN","100566113","integration-to-improve-adolescent-health-and-hpv-vaccination-in-laos-100566113",false,"NCT06650956","Integration to Improve Adolescent Health and HPV Vaccination in Laos","Integrated Service Delivery to Improve Adolescent Health and HPV Vaccination in Lao PDR: a Quasi-Experimental Mixed-Methods Study","Inclusion Criteria:\n\n* Female aged 10-13 years for HPV vaccination and SRH education\n* Male aged 10-13 years for SRH education\n* 10-13-year-old male and female students in randomly selected schools with at least 100 students in target classes (year-5 primary, year-1, 2 and 3 secondary)\n* 10-13-year-old males and females who are out-of-school and living in 2 remote villages each from four randomly selected health centers located around the selected schools\n\nExclusion Criteria:\n\n* males and females younger than 10 years or older than 13 years",true,"ALL","10 Years","13 Years",{"count":89,"type":90},700,"ESTIMATED","INTERVENTIONAL",[93],"NA","The goal of this study is to find out if adding HPV vaccination to adolescent health services works to increase HPV vaccine uptake in 10-13-year-old girls in Laos. The study will also look at the effects of adding HPV vaccination on the use of other health services in 10-13-year-old boys and girls.\n\nThe main questions the study aims to answer are:\n\n1. Does adding HPV vaccination to adolescent health services increase HPV vaccine uptake in girls aged 10-13 years compared to girls who only receive standard HPV vaccination services?\n2. Does adding HPV vaccination to adolescent health services increase the use of other health services in 10-13-year-old adolescent boys and girls compared to adolescents who only receive standard HPV vaccination services?\n3. What are the barriers and facilitators to using the combined intervention in Laos?\n4. What are the opinions of adolescents, caregivers, healthcare providers, and other stakeholders on the combined intervention?\n5. How much does it cost and how well it works to combine HPV vaccination with adolescent health services, as opposed to providing HPV vaccination alone?\n\nResearchers will compare a combined intervention to standard HPV vaccination services to see if the combined intervention works to increase HPV vaccination uptake and the use of other health services. The combined intervention includes HPV vaccination given at schools, health facilities, and through community outreach. It also includes education on sexual and reproductive health, counseling, and other health services. Participants in the combined intervention group will:\n\n1. Receive the HPV vaccine at school or at a health facility.\n2. Take part in group discussions about sexual and reproductive health.\n3. Take part in individual counseling sessions.\n4. Use other health services as needed.\n\nParticipants in the comparison group will receive standard HPV vaccination services, including:\n\n• HPV vaccination given at schools, health facilities, and through community outreach.",[96,97,98,99,100,101,102,103],"Healthy","Adolescents","Integrated, Community-Health Systems","HPV Vaccines","Sexual and Reproductive Health","Knowledge","Attitude","Health Workers",[105,106,107,108,109,110],"hpv vaccination","adolescent health","integration","lao pdr","cervical cancer prevention","sexual and reproductive health","2025-03-10",{"date":113,"type":114},"2025-03-12","ACTUAL",{"date":116,"type":114},"2024-11-01",{"date":118,"type":90},"2025-05",{"name":5,"class":6},1]