[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Public Health Foundation Enterprises, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":72},{"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":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100564606","phase-2-prepsmart-2-1-1-pilot-100564606",false,"NCT06631365","PrEPsmart 2-1-1 Pilot","PrEPsmart Pilot: a Trial to Evaluate a Mobile App to Support the Safe and Effective Use of On-demand Pre-exposure Prophylaxis (PrEP) Among Sexual Minority Men in the US","Inclusion Criteria:\n\n* Age 18 years or older\n* Cisgender-male who reports sex with persons assigned male at birth\n* Willing and able to provide written informed consent\n* HIV-uninfected by negative 4th generation HIV test during screening (prescribed group)\n* Documentation of negative HIV test within the last 3 months by outside laboratory OR evidence of PrEP prescription within the last 6 months based on medical records or pharmacy\u002Fprovider communication\n* Owns an iOS or Android mobile phone with a camera and has private access to the internet\n* Able to understand, read, and speak English\n* Able to attend study visits at a local research site in San Francisco (Bridge HIV) (prescribed and non-prescribed groups) or virtual visits via a HIPAA-compliant teleconferencing platform (non-prescribed group)\n* Interested in starting or currently taking on-demand PrEP with TDF\u002FFTC\n* Report having anal sex at least once a month and expecting to maintain at least this frequency of anal sex during study participation by self-report\n* Creatinine clearance ≥60 mL\u002Fmin based on testing done during screening (prescribed group)\n* Have PrEP clinical and laboratory monitoring by another provider or clinic by self-report (non-prescribed group)\n* No contraindications to TDF\u002FFTC use\n* No evidence of chronic HBV infection based on testing done during screening (prescribed group)\n* Willing to self-collect urine samples weekly\n\nExclusion Criteria:\n\n* Repeatedly reactive HIV test at screening or enrollment or self-reported reactive HIV test (prescribed group)\n* Signs or symptoms of acute HIV infection at screening or enrollment\n* Currently enrolled in another PrEP intervention study.\n* Unable to commit to study participation for the duration of the study\n* Any medical, psychiatric, or social condition or other responsibilities that, in the judgment of the investigator, would make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.",true,"MALE","18 Years",{"count":20,"type":21},60,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This is a pilot study to assess the feasibility, acceptability, and preliminary effectiveness of pre-exposure prophylaxis (PrEP)smart among cisgender sexual minority males (SMM) taking on-demand PrEP over a 6-month period.\n\nUpon project completion, the investigators will have developed a highly innovative tool to support men who have sex with men (MSM) using on-demand PrEP ready for testing in a larger efficacy trial",[27],"HIV-1-infection","RECRUITING","2024-10-07",{"date":31,"type":32},"2024-10-08","ACTUAL",{"date":34,"type":32},"2023-10-02",{"date":36,"type":21},"2025-04-01",{"name":38,"class":39},"Public Health Foundation Enterprises, Inc.","OTHER",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":45,"acronym":46,"eligibilityCriteria":47,"healthyVolunteers":16,"sex":48,"minAge":49,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":22,"phases":52,"briefSummary":54,"conditions":55,"keywords":58,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":71},"100428187","comparing-mobile-health-strategies-to-improve-pre-exposure-prophylaxis-use-prep-for-hiv-prevention-100428187","NCT04855773","Comparing Mobile Health Strategies to Improve Pre-exposure Prophylaxis Use (PrEP) for HIV Prevention","PCORI PrEP","Inclusion Criteria:\n\n* Self-identifies as a cisgender man, transgender man (assigned female at birth, trans-masculine spectrum), or transgender woman (assigned male sex at birth, trans-feminine spectrum)\n* Report sex with a cisgender man or transgender woman or any individual assigned male sex at birth in the past 12 months\n* Age 15 years or older\n* Willing and able to provide written informed consent\n* Owns an iOS or Android mobile phone and able to access the internet and send and receive text messages\n* Able to understand, read, and speak English or Spanish\n* Newly initiated PrEP or currently on PrEP and at risk for PrEP discontinuation based on at least one of the following:\n\n  * Initiated PrEP within the past 6 months, or\n  * Has any of the following risk factors for PrEP discontinuation: missed clinic visits; age \\\u003C 30; African-American or Latino; transgender gender identity; or self-reported illicit substance use\n\nExclusion Criteria:\n\n* Currently enrolled in another PrEP intervention study\n* Unable to complete 12 month study participation\n* Any medical, psychiatric, or social condition or other responsibilities that, in the judgment of the investigator, would make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.","ALL","15 Years",{"count":51,"type":21},300,[53],"NA","The purpose of this study is to compare the effectiveness of two mobile health technologies (text messaging or a mobile app) designed to help people take HIV pre-exposure prophylaxis (PrEP) as directed by the clinic. PrEP is the use of a daily anti-HIV medications by HIV-negative people to help prevent HIV infection.",[56,57],"HIV Infections","Sexually Transmitted Diseases",[59,60,61,62],"Pre-exposure Prophylaxis (PrEP)","HIV Prevention","Mobile health (mHealth)","Medication adherence","2022-09-27",{"date":65,"type":32},"2022-09-28",{"date":67,"type":32},"2021-07-21",{"date":69,"type":21},"2023-08",{"name":38,"class":39},4,""]