[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100639390":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":34,"centralContacts":38,"locations":48,"responsibleParty":65,"collaborators":68,"id":72,"slug":73,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":43,"eligibilityCriteria":78,"healthyVolunteers":79,"sex":80,"minAge":81,"maxAge":82,"enrollmentInfo":83,"targetDuration":43,"studyType":86,"phases":87,"briefSummary":89,"conditions":90,"keywords":92,"overallStatus":102,"whyStopped":43,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":112},{"fullName":5,"class":6},"Seattle Children's Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Copper T-380 intrauterine device (Cu-IUD)","ACTIVE_COMPARATOR","The Cu-IUD will be Model TCu 380A used in public sector services in Kiambu County. Each T-shaped plastic frame has 176 mg of copper wire coiled around its vertical arm and a copper collar of 68 mg of copper on each of its transverse arms for a total copper surface area on the device of 380 mm2.\n\nThe product will be sterile and will be inserted as described in the package insert.",[13],"Device: Copper T Intrauterine device (Cu-IUD)",{"label":15,"type":10,"description":16,"interventionNames":17},"Levonorgestrel intrauterine system (LNG IUS)","The LNG-IUD consists of a T-shaped polyethylene frame with a steroid reservoir containing 52 mg levonorgestrel packaged with a sterile inserter.\n\nThe product will be sterile and will be inserted as described in the package insert",[18],"Drug: Levonorgesterel Intrauterine system (LNG IUS)",[20,28],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Levonorgesterel Intrauterine system (LNG IUS)","Product will be used as labeled for approximately 12 months.",[15],[26,27],"Mirena®, manufactured by Bayer Healthcare","Avibela, manufactured by DKT WomenGloba",{"type":29,"name":30,"description":23,"armGroupLabels":31,"otherNames":32},"DEVICE","Copper T Intrauterine device (Cu-IUD)",[9],[33],"Model TCu 380A, manufactured by the SMB Corporation of India or by Bayer Pharmaceuticals",[35],{"name":36,"affiliation":5,"role":37},"Heather Jaspan, MD, PhD","PRINCIPAL_INVESTIGATOR",[39,45],{"name":40,"role":41,"phone":42,"phoneExt":43,"email":44},"Laura Stueckle, MPH","CONTACT","1-206-884-1254",null,"laura.stueckle@seattlechildrens.org",{"name":46,"role":41,"phone":43,"phoneExt":43,"email":47},"Study PI, Dr. Jaspan, MD, PhD","heather.jaspan@seattlechildrens.org",[49],{"facility":50,"status":43,"city":51,"state":43,"zip":43,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"Partners in Health and Research Development","Thika","Kenya","KE",{"type":55,"coordinates":56},"Point",[57,58],37.06933,-1.03326,{"lat":58,"lon":57},[61],{"name":62,"role":41,"phone":63,"phoneExt":43,"email":64},"Prof. Nelly R. Mugo","+254723914057","rwamba@uw.edu",{"type":37,"investigatorFullName":66,"investigatorTitle":67,"investigatorAffiliation":5,"oldNameTitle":43,"oldOrganization":43},"Heather Jaspan","MD, PhD",[69],{"name":70,"class":71},"Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)","NIH","100639390","effects-of-copper-versus-levonorgestrel-intrauterine-devices-on-mucosal-microbiota-and-barrier-function-among-young-african-women-100639390",false,"NCT07627958","Effects of Copper Versus Levonorgestrel Intrauterine Devices on Mucosal Microbiota and Barrier Function Among Young African Women","Effects of Copper Versus Levonorgestrel Intrauterine Devices on Mucosal Microbiota and Barrier Function: a Randomized Trial Among Young African Women","Inclusion Criteria:\n\n* Willing and able to provide written informed consent for screening and trial participation\n* Desire and willingness to use either IUD or IUS for contraception for at least one year\n* Clear understanding of study randomization and commitment to use the assigned IUD\n* Between 18 and 40 years of age (inclusive)\n* Willing and able to actively participate in the study for 12 months\n* Willing to be tested for HIV\n* Sexually active\n* HIV-negative\n* Would benefit from STI prevention\n\nExclusion Criteria:\n\n* Living with HIV or HIV screening results that are not definitively negative\n* Currently pregnant or planning to become pregnant within the next 12 months\n* Documented or known history of infertility or sterilization\n* Prior history of ectopic pregnancy\n* Use of contraceptive implant, IUD or injectable progestin in the past 3 months\n* Use of oral contraceptives in the past 30 days\n* Planning to use alternative contraception except condoms for the trial duration\n* 0-6 weeks postpartum\n* Has had a hysterectomy or sterilization\n* History of challenges using and IUD\u002FIUS, including frequent expulsion\n* Medical contraindications (Category 3 or 4 criteria as detailed in the WHO MEC1 to copper IUDs or LNG-IUS, including:\n\n  * Endometrial, ovarian, or cervical cancer\n  * Unexplained vaginal bleeding between menstrual periods or bleeding after intercourse\n  * History of pelvic tuberculosis\n  * Anatomical abnormality of the uterus incompatible with IUD insertion\n  * A recent septic abortion\n  * Untreated mucopurulent cervicitis on exam, untreated pelvic inflammatory disease (PID), or untreated known gonorrhoea or chlamydia\n* Has any condition (social or medical), which in the opinion of the investigator, would make study participation unsafe or complicate data interpretation",true,"FEMALE","18 Years","40 Years",{"count":84,"type":85},120,"ESTIMATED","INTERVENTIONAL",[88],"NA","The goal of this clinical trial is to definitively determine whether copper intrauterine device (IUD) or hormonal intrauterine system (IUS) results in greater vaginal microbial diversity after 1 year in women (n= approximately 120) aged 18-40 years, who desire to use a copper IUD or hormonal IUS as contraception, are HIV-negative and could benefit from STI prevention.\n\nThe main questions it aims to answer are:\n\n1. Whether women assigned to copper IUD vs hormonal IUS have differences in vaginal microbial diversity after 1 year of use\n2. Whether women randomized to Copper IUD have reduced genital mucosal barrier integrity as indicated by proteomic signatures\n3. Whether women randomized to Copper IUD have greater incidence of high-risk HPV or curable STIs (Ct, Ng, Tv)\n\nParticipants will be assigned to have either the copper IUD or the hormonal IUS inserted as contraception. After that, they will have blood and vaginal fluids collected every 3 months for one year to look at the bacteria in their vagina, test for sexually transmitted infections, and examine markers of vaginal health.\n\nAfter enrolment, each participant will be followed for 12 months, and at the end of the trial, the participant can continue to use the IUD\u002FIUS or the study clinician can remove it.",[91],"Vaginal Microbial Diversity",[93,94,95,96,97,98,99,100,101],"IUD","IUS","intrauterine devices","Copper intrauterine device","Long-acting reversible contraception","contraception","Women","STI prevention","STI","NOT_YET_RECRUITING","2026-06-02",{"date":105,"type":106},"2026-06-04","ACTUAL",{"date":108,"type":85},"2026-07",{"date":110,"type":85},"2030-07",{"name":5,"class":6},1]