[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"prep-adherence-monitoring\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:prep-adherence-monitoring":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,41],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":4},"100648673","a-hybrid-effectiveness-implementation-trial-of-urine-point-of-care-assay-to-increase-prep-adherence-among-women-in-kenya-100648673",false,"NCT07725679","A Hybrid Effectiveness-Implementation Trial of Urine Point-of-Care Assay to Increase PrEP Adherence Among Women in Kenya","A Hybrid Effectiveness-Implementation Trial of a Urine Point-of-Care Assay to Increase PrEP Adherence Among Women in Kenya","Inclusion Criteria:\n\n* HIV uninfected\n* Received daily oral PrEP one month prior, with a negative result on a urine assay one-month post PrEP initiation\n* Currently attending or willing to attend one of the study clinics for PrEP refills\n* Interest in continuing on oral PrEP despite adherence challenges\n* No known sero-discordant relationships\n* Living in Kiambu County and not planning to relocate for the next year\n\nExclusion Criteria:\n\n* Inadequate capacity to consent or complete planned study procedures\n* Do not speak English or Kiswahili\n* Test positive for HIV at screening\n* Concomitant participation in another PrEP adherence support study",true,"FEMALE","18 Years","29 Years",{"count":21,"type":22},400,"ESTIMATED","INTERVENTIONAL",[25],"NA","The goal of this randomized trial study is to learn if drug-level feedback counseling works to improve oral PrEP adherence in adolescent girls and young women.\n\nResearchers will compare urine TFV assay positivity between arms. All participants will attend visits on the same schedule, and receive the same SOC counseling for PrEP adherence. Participants in the intervention arm will additionally take POC urine TFV tests and receive drug-level feedback as part of that counseling.",[28],"PrEP Adherence Monitoring","NOT_YET_RECRUITING","2026-07-21",{"date":32,"type":33},"2026-07-24","ACTUAL",{"date":35,"type":22},"2027-02-01",{"date":37,"type":22},"2031-08-01",{"name":39,"class":40},"University of Washington","OTHER",{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":16,"sex":49,"minAge":18,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":53,"conditions":54,"keywords":60,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":71},"100607260","prevention-icona-dedicated-ensemble-100607260","NCT07186244","Prevention ICONA Dedicated Ensemble","Implementation of an Italian Cohort of People on HIV-1 Pre-exposure Prophylaxis Within the ICONA Network: PrIDE (Prevention ICONA Dedicated Ensemble)","PrIDE","Inclusion Criteria:\n\n* Age \\>18 years\n* Negative HIV Ab\u002FAg test (4th generation or higher) at the enrollment visit\n* Request and\u002For willingness to take PrEP, or already on PrEP\n* Ability to understand the study procedures and to sign informed consent\n\nExclusion Criteria:\n\n* Individuals with HIV infection or with strong clinical\u002Fepidemiological suspicion of HIV infection\n* Individuals with contraindications to the use of medications included in the PrEP regimen (as per the product information)\n* Documented allergy to one or more pharmacological components of the proposed PrEP regimen\n* Lack of willingness to adhere to the required procedures and follow-up assessments","ALL",{"count":51,"type":22},5000,"OBSERVATIONAL","Despite significant advances in HIV treatment, transmission remains a public health concern. In 2022, there were 1.3 million new HIV infections worldwide and 1,888 new diagnoses in Italy, with sexual transmission being the predominant route. Many individuals are still diagnosed late, and a portion of people living with HIV are unaware of their status. Pre-Exposure Prophylaxis (PrEP) has emerged as an effective biomedical strategy to prevent new infections, especially when integrated into comprehensive prevention efforts.\n\nStudy Objectives The primary objective of this observational study is to establish a large prospective cohort of individuals using PrEP in Italy. The study aims to assess PrEP's effectiveness, tolerability, adherence, and barriers to long-term use in a real-world setting. These data will be instrumental in guiding future strategic interventions to optimize PrEP management and move toward the goal of zero new HIV infections in Italy.\n\nPrimary Objective\n\n* To assess the incidence of new HIV infections among PrEP users in Italy. Secondary Objectives\n* Incidence of other sexually transmitted infections (STIs);\n* Tolerability of PrEP;\n* Psychological and behavioral aspects related to PrEP use;\n* Adherence and persistence in care;\n* Use of therapies and prophylaxis for STIs during PrEP use. Study Design and Coordination This is a prospective observational study, promoted by Fondazione ICONA in collaboration with clinical centers and community-based organizations. The coordinating enrolling center is INMI \"L. Spallanzani\" IRCCS in Rome.\n\nParticipating Centers:\n\n* 49 university and hospital-based centers across Italy;\n* 4 non-clinical checkpoints offering PrEP screening, prescription, and follow-up.\n\nStudy Population Adults (≥18 years) who are HIV-negative, sexually active, and considered eligible for PrEP per national or international guidelines, including both new and current PrEP users.\n\nInclusion Criteria\n\n* Age ≥18 years;\n* Negative HIV test at enrollment;\n* Willingness to initiate or continue PrEP;\n* Informed consent provided. Exclusion Criteria\n* HIV infection or strong suspicion of infection;\n* Contraindications to PrEP medications; Known allergy to PrEP components; Refusal to comply with study procedures.",[55,28,56,57,58,59],"PrEP","HIV","HIV -1 Infection","STI","STI Prevention",[55,56,58,59],"RECRUITING","2025-09-15",{"date":64,"type":33},"2025-09-22",{"date":66,"type":33},"2024-09-09",{"date":68,"type":22},"2033-12-31",{"name":70,"class":40},"Fondazione ICONA",53]