[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100277468":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":25,"locations":18,"responsibleParty":31,"collaborators":33,"id":37,"slug":38,"hasResults":39,"nctId":40,"briefTitle":41,"officialTitle":41,"acronym":18,"eligibilityCriteria":42,"healthyVolunteers":43,"sex":44,"minAge":45,"maxAge":46,"enrollmentInfo":47,"targetDuration":18,"studyType":50,"phases":51,"briefSummary":53,"conditions":54,"keywords":18,"overallStatus":56,"whyStopped":18,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":18},{"fullName":5,"class":6},"Hektoen Institute for Medical Research","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"ARM A: Proteus Sensor System (PSS) First","ACTIVE_COMPARATOR","ARM A will receive Proteus Sensor System (PSS) first. At 12-week intervals participants will crossover to the next condition.",[13],"Device: Proteus Sensor System",{"label":15,"type":16,"description":17,"interventionNames":18},"ARM B: SOC First","NO_INTERVENTION","ARM B will 12 weeks of FTC\u002FTDS standard of care (SOC) first. At 12-week intervals participants will crossover to the next condition.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"DEVICE","Proteus Sensor System","The Proteus Sensor System (PSS) intervention includes 12 weeks of daily FTC\u002FTDF with a weekly text messages transmitted to participants with estimated HIV risk reduction based upon the DBS algorithm.",[9],[26],{"name":27,"role":28,"phone":29,"phoneExt":18,"email":30},"Gregory Huhn, MD","CONTACT","(312) 572-4575","ghuhn@cookcountyhhs.org",{"type":32,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR",[34],{"name":35,"class":36},"National Institute of Allergy and Infectious Diseases (NIAID)","NIH","100277468","feasibility-of-an-ingestible-sensor-system-to-measure-prep-adherence-in-ymsm-100277468",false,"NCT02891720","Feasibility of an Ingestible Sensor System to Measure PrEP Adherence in YMSM","Inclusion Criteria\n\nYoung men who meet all of the following criteria are eligible for inclusion:\n\n* PrEP-eligible YMSM\n* Ages 18-24\n* Biologically born male\n* Report interest in PrEP\n* Intend to use PrEP for a full 6 month period\n* Eligible to be a PrEP patient at the CORE Center PrEP Clinic\n* Meet one the following sexual risk criteria:\n\n  * Have an HIV-positive sexual partner\n  * Had recent bacterial STI\n  * Report high numbers of sexual partners\n  * Report history of inconsistent or no condom use\n  * Report exchange\u002Ftransactional sex.\n\nExclusion Criteria\n\nYoung men who meet any of the following criteria will be excluded:\n\n* HIV+\n* Creatinine clearance \\\u003C60 cc\u002Fmin)\n* Allergy to topical adhesive\n* Acute gastrointestinal symptoms\n* History of major GI surgery\n* Presence of an implanted electronic medical device.\n* Subjects who are receiving any of the following medications:Nephrotoxic drugs (e.g., cidofovir, amphotericin, aminoglycosides, dapsone, tacrolimus, foscarnet, ACE inhibitors), all diuretics, drugs that may interfere with TFV excretion (e.g., (Val)ganciclovir, Cyclosporin A, Sirolimus, Antineoplastics), drugs (not including mineral and vitamin supplements) used for treatment of osteoporosis (e.g., alendronate and other bisphosphonates, teriparatide, denosumab, and calcitonin), chronic use of oral or systemic steroids (i.e., daily use for two weeks or more is not allowed), experimental medications that are not Food and Drug Administration (FDA)-approved, and FTC\u002FTDF (Truvada®) received outside of the study",true,"MALE","18 Years","24 Years",{"count":48,"type":49},100,"ESTIMATED","INTERVENTIONAL",[52],"NA","The goal of this study is to evaluate an integrated technology system that confirms ingestion of oral PrEP, monitors adherence both in real-time and longitudinally, and provides visual feedback mechanisms to promote enhanced adherence behaviors.",[55],"Human Immunodeficiency Virus","NOT_YET_RECRUITING","2016-09-01",{"date":59,"type":49},"2016-09-07",{"date":61,"type":18},"2017-06",{"date":63,"type":49},"2019-11",{"name":5,"class":6}]