[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"prep\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:prep":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,15,0,[8,49,79,106,136,159,184,210,224,248,268,290,318,344,373],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":32,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100053662","linking-youth-to-pre-exposure-prophylaxis-prep-services-100053662",false,"NCT07438041","Linking Youth to Pre-Exposure Prophylaxis (PrEP) Services","Linking Youth to Pre-Exposure Prophylaxis (PrEP) Services (LYPS): An Innovative Mobile Delivery and Mobile Health (mHealth) Intervention to Optimize PrEP Adherence and Persistence","LYPS","Inclusion Criteria:\n\n* Age 13-24 years, inclusive;\n* Reports anal or vaginal sex in the past year;\n* Is not living with HIV;\n* Weighs at least 35 kilograms (77 pounds);\n* Willing to receive PrEP care from a provider at a participating SC either in the clinic or at one of the designated places in the community being offered by the SC SC;\n* Has an Android-based smartphone or iPhone;\n* Has fluency in English (able to read, speak, and understand English); and\n* Willing to provide informed consent to participate in the study.\n\nExclusion Criteria:\n\n* Has counter-indications for PrEP according to guidelines and approved local label;\n* Has any clinically significant systemic disease (including but not limited to significant or uncontrolled liver disease, gastrointestinal disease, kidney disease, thyroid disease, osteoporosis, or bone disease) or diabetes;\n* Any other medical, behavioral, or other conditions that, in the opinion of the SC project lead or designee, could interfere with adherence to study procedures or compromise interpretation of study results;\n* Concurrent participation in ATN 166, ATN 170, or any other clinical trial providing HIV medications (PrEP, vaccine, etc.) or currently receiving any PrEP-adherence or persistence behavioral intervention; or\n* Is currently incarcerated or pending incarceration.",true,"ALL","13 Years","24 Years",{"count":22,"type":23},272,"ESTIMATED","INTERVENTIONAL",[26],"NA","The LYPS intervention is a multi-level intervention that combines: a) structural-level delivery of PrEP and PrEP services by a community health professional (CHP) at a designated place in the community being offered by the SC where PrEP is not yet provided (e.g., participant's home, community partner location, or traveling mobile van), with b) an individual-level mobile application (app) to support PrEP adherence and persistence between CHP visits.",[29,30,31],"HIV","PrEP","PrEP Adherence",[30,33,34,35],"Adherence","Oral PrEP","Injectable cabotegravir","NOT_YET_RECRUITING","2026-07-10",{"date":39,"type":40},"2026-07-13","ACTUAL",{"date":42,"type":23},"2026-07-27",{"date":44,"type":23},"2028-12-15",{"name":46,"class":47},"Westat","OTHER",4,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":17,"sex":18,"minAge":56,"maxAge":4,"enrollmentInfo":57,"targetDuration":4,"studyType":59,"phases":4,"briefSummary":60,"conditions":61,"keywords":64,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":78},"100638066","dynamic-decision-support-for-integrating-prep-in-clinics-for-young-people-in-alabama-and-botswana-100638066","NCT07597824","DYnamic decisioN Support for IntegrAting PrEP in Clinics for Young People in Alabama and Botswana","DYNAMIC PrEP","Group 1\n\n* Inclusion for Alabama site:\n\n  * 18 years of age or older\n  * Currently using or eligible for PrEP\n* Inclusion for Botswana site:\n\n  * 18 years of age or older\n  * Participated in the parent Tshireletso study in Botswana\n* Exclusion for both sites:\n\n  * Under the age of 18\n  * HIV positive\n\nGroup 2\n\n* Inclusion for both sites:\n\n  * 18 years of age or older\n  * Currently working as PrEP providers or clinic administrators at outpatient clinics\n* Exclusion for both sites:\n\n  * Under the age of 18\n\nGroup 3\n\n* Inclusion for both sites:\n\n  * 18 years of age or older\n  * Currently working as policy makers or program leaders at outpatient clinics\n* Exclusion for both sites:\n\n  * Under the age of 18","18 Years",{"count":58,"type":23},1000,"OBSERVATIONAL","This study evaluates strategies to improve access to HIV prevention through the integration of pre-exposure prophylaxis (PrEP) into existing healthcare settings, rather than limiting delivery to specialty clinics. The study addresses barriers to PrEP uptake, including limited awareness, stigma, and restricted access, and recognizes that availability alone may not ensure initiation or sustained use.\n\nThe study includes two components. First, a longitudinal cohort of current PrEP users will be followed to assess changes in access, preferences, and PrEP use over time in real-world settings. Second, a dynamic decision-support toolkit will be developed and evaluated to support patients and providers in PrEP-related decision-making. The toolkit will include patient- and provider-facing components to support clinical decision-making, improve risk understanding, and facilitate integration of PrEP into routine healthcare. The toolkit will be refined and beta-tested in selected healthcare facilities in Botswana and Alabama.",[62,63,30],"HIV Infections","Contraception",[65,30,66,67,68],"HIV adherence","young adults","Botswana","Alabama","2026-06-23",{"date":71,"type":40},"2026-06-25",{"date":73,"type":23},"2026-06",{"date":75,"type":23},"2031-12",{"name":77,"class":47},"University of Alabama at Birmingham",1,{"id":80,"slug":81,"hasResults":11,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":85,"eligibilityCriteria":86,"healthyVolunteers":17,"sex":18,"minAge":56,"maxAge":4,"enrollmentInfo":87,"targetDuration":4,"studyType":24,"phases":89,"briefSummary":90,"conditions":91,"keywords":93,"overallStatus":96,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":78},"100628513","hiv-pre-exposure-prophylaxis-prep-linkage-with-immediate-medications-in-the-emergency-department-study-100628513","NCT07462611","HIV Pre-Exposure Prophylaxis (PrEP) Linkage With Immediate Medications in the Emergency Department Study","HIV Pre-Exposure Prophylaxis (PrEP) Linkage With Immediate Medications in the Emergency Department (PrEP-ED) Study","PrEP ED","Primary study (ED patients):\n\nInclusion Criteria:\n\n* Able to comprehend and provide signed, written informed consent prior to initiation of study procedures.\n* Negative HIV rapid test\n* At least one of the following criteria:\n\n  * Requesting PrEP from their ED clinician\n  * Score \\>75% on the PCCI HIV Prediction Tool\n  * Prior bacterial STI diagnosis\n  * Seeking STI testing\n  * Referred by their ED clinician as someone who otherwise meets a CDC PrEP indication\n\nExclusion Criteria:\n\n* Known diagnosis of HIV\n* Positive HIV rapid test\n* Current use of PrEP, which is defined for purposes of this study as use of PrEP in the last 4 weeks\n* Known hypersensitivity or allergy to any PrEP modality\n* People who do not want to follow with Parkland ID clinic for ongoing PrEP care\n* Adults unable to consent, people under the age of 18, women who are known to be pregnant or breast feeding at time of study enrollment, or prisoners\n\nSub-study subjects (ED clinicians):\n\nInclusion criteria:\n\n• Clinician in the Parkland ED\n\nExclusion criteria:\n\n• People under the age of 18 or prisoners.",{"count":88,"type":23},250,[26],"Our primary objective is to increase HIV pre-exposure prophylaxis (PrEP) awareness and uptake among people who want, need, or would benefit from PrEP in Dallas, TX through a pilot program of immediate PrEP prescribing in the Parkland Memorial Hospital Emergency Department (ED) with linkage to PrEP clinic. Leveraging the previous work of the Parkland Center for Clinical Innovation (PCCI) which created an automated electronic health record (EHR) based HIV prediction tool and prior success with a robust ED HIV navigation program, a PrEP navigator would approach patients in the Parkland ED for PrEP initiation. Through standard care prescribing by their ED clinician, subjects would leave the ED with a prescription for rapid-start oral PrEP and a clinic appointment to persist on the PrEP modality of their choice which will include long-acting injectable options.",[92,30],"HIV Pre-exposure Prophylaxis",[30,94,95],"HIV pre-exposure prophylaxis","Emergency department","RECRUITING","2026-05-29",{"date":99,"type":40},"2026-06-02",{"date":101,"type":40},"2026-04-08",{"date":103,"type":23},"2028-04-01",{"name":105,"class":47},"University of Texas Southwestern Medical Center",{"id":107,"slug":108,"hasResults":11,"nctId":109,"briefTitle":110,"officialTitle":110,"acronym":111,"eligibilityCriteria":112,"healthyVolunteers":11,"sex":18,"minAge":56,"maxAge":4,"enrollmentInfo":113,"targetDuration":4,"studyType":59,"phases":4,"briefSummary":115,"conditions":116,"keywords":122,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":129,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":4},"100638250","prep-lana-pre-exposure-prophylaxis--long-acting-novel-antiviral-agent-100638250","NCT07620730","PrEP-LANA (Pre-exposure Prophylaxis- Long-acting Novel Antiviral Agent)","PrEP-LANA","Inclusion Criteria:\n\nParticipants of any gender, ethnicity or socio-economic group who meet all the following criteria are eligible for inclusion in this study:\n\n* Adults who are aged \\> 18 years at time of consent (including people of child-bearing capacity and age, non-pregnant or pregnant adults)\n* Attending a participating NHS sexual healthcare service\n* Prescribed LA CAB for PrEP according to NICE and NHS eligibility criteria (including those newly prescribed and those already using LA CAB)\n* Non-reactive \u002F negative HIV Antigen\u002FAntibody test and HIV RNA test at time of LA CAB for PrEP initiation (performed under routine care)\n* Able and willing and able to give informed consent to all study procedures prior to inclusion\n\nExclusion Criteria:\n\nPrEP user participants who meet any of the following criteria are ineligible for inclusion in this study:\n\n* One or more reactive or positive HIV test results at enrolment visit, even if HIV infection is not confirmed.\n* Currently enrolled in interventional trial of PrEP agents, HIV vaccine trial or experimental medication.\n* Plan to relocate out of the area during the study period. Note: \"Plan to relocate out of the area\" is defined as a stated intention at enrolment to move residence outside the catchment area of a participating study site during the study period, such that ongoing clinical management would likely transfer to a non-participating team.",{"count":114,"type":23},220,"The goal of this 12-month implementation science study is to generate the evidence required to ensure long-acting cabotegravir (LA CAB) as pre-exposure prophylaxis (PrEP) can be delivered in an equitable manner within the NHS. This study will recruit both PrEP users and healthcare professionals (HCPs).\n\nThe main questions it aims to answer are:\n\n* What do healthcare providers think about the feasibility of delivering LA CAB PrEP within sexual health services in the NHS?\n* How many participants stay on\u002Fremain consistent with LA CAB PrEP injections at Month 12 (PrEP persistence)?\n\nParticipants (200 PrEP users) will be followed for 12-months and asked to complete surveys at 3 study visits. A subset of 20 participants will also be asked to complete interviews about their experiences. We will also ask 20 HCPs at participating locations to complete surveys and interviews at both baseline and month 12.\n\nA core principle of equity (understanding any difference in impact on underserved populations) will be applied throughout the study. To ensure representation of a diverse group of participants that reflects the demographic groups most affected by incident HIV and most underserved by PrEP in the UK, enrolment targets will be applied and meticulously managed by the central study team, as follows:\n\n* A cap of 30% (n=60) will be applied to recruitment of White cisgender men who have sex with men who are not otherwise part of other under-represented groups (as defined below),\n* At least 70%% (n=140) of participants will represent groups currently underserved by PrEP and fall into one (or more) of the following socio-demographic categories: women (defined cisgender or transgender) OR as transgender men OR non-binary individuals OR age\\\u003C25 yrs, OR sex workers OR people who inject drugs OR racially minoritised heterosexual men.",[30,117,118,119,120,121],"PrEP Adherence Experiences","PrEP Adherence Perspectives","PrEP Uptake","Equity","Community Setting",[30,123,111,124,125,126,120,127],"Patient and public involvement and engagement","LA CAB","Cabotegravir","Long-acting PrEP","community setting","2026-05-28",{"date":99,"type":40},{"date":131,"type":23},"2026-10",{"date":133,"type":23},"2028-06",{"name":135,"class":47},"Queen Mary University of London",{"id":137,"slug":138,"hasResults":11,"nctId":139,"briefTitle":140,"officialTitle":141,"acronym":4,"eligibilityCriteria":142,"healthyVolunteers":17,"sex":18,"minAge":143,"maxAge":4,"enrollmentInfo":144,"targetDuration":4,"studyType":24,"phases":146,"briefSummary":147,"conditions":148,"keywords":149,"overallStatus":96,"whyStopped":4,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":153,"startDateStruct":154,"completionDateStruct":155,"leadSponsor":157,"locationsCount":78},"100587601","bringing-medicines-for-hiv-prevention-to-a-family-planning-clinic-100587601","NCT06930508","Bringing Medicines for HIV Prevention to a Family Planning Clinic","Implementing HIV Pre-Exposure Prophylaxis in a Family Planning Clinic: A Study of Feasibility and Acceptability (Aka The Pilot Fish Study)","This study will include patient participants who:\n\n* Are age 16 or older\n* Are presenting for care at the Women and Infants Hospital of Rhode Island Family Planning Clinic\n* Speak English or Spanish\n* Have decisional capacity\n\nThis study will exclude patient participants who:\n\n\\- Are currently seeking abortion care\n\nThis study will include physician participants who:\n\n\\- Provide care at the Women and Infants Hospital of Rhode Island Family Planning Clinic\n\nThis study will not have any specific exclusion criteria for physician participants.","16 Years",{"count":145,"type":23},83,[26],"The goal of this clinical trial is to understand what patients and physicians think about providing medications to prevent HIV transmission to patients in a family planning clinic. These medications are known as pre-exposure prophylaxis, or PrEP. The main questions to answer are:\n\n1. Do patients find it acceptable to be asked about, and offered, PrEP during their visit to a family planning clinic?\n2. What things make it easier or harder to ask about PrEP in a family planning clinic setting?\n3. What things make it easier or harder to begin PrEP in a family planning clinic setting?\n\nPatient participants:\n\n1. Will receive standardized counseling about PrEP.\n2. Will have the opportunity to begin PrEP as part of their routine, ongoing care.\n3. Will be asked to complete a survey about their experiences.\n\nPhysician participants:\n\n1. Will receive standardized education about PrEP.\n2. Will talk to patient participants about PrEP, and support patient participants who want to begin PrEP.\n3. Will be asked to complete pre-and post-study surveys about their experiences.\n4. May be asked to complete a post-study in-depth interview about their experiences.",[29,30],[150,151,152],"HIV PrEP screening","HIV PrEP initiation","ob\u002Fgyn",{"date":97,"type":40},{"date":128,"type":40},{"date":156,"type":23},"2026-07-31",{"name":158,"class":47},"Women and Infants Hospital of Rhode Island",{"id":160,"slug":161,"hasResults":11,"nctId":162,"briefTitle":163,"officialTitle":164,"acronym":165,"eligibilityCriteria":166,"healthyVolunteers":17,"sex":167,"minAge":56,"maxAge":4,"enrollmentInfo":168,"targetDuration":4,"studyType":24,"phases":169,"briefSummary":170,"conditions":171,"keywords":173,"overallStatus":96,"whyStopped":4,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":176,"startDateStruct":178,"completionDateStruct":180,"leadSponsor":182,"locationsCount":78},"100565185","using-prep-doing-it-for-ourselves-100565185","NCT06638892","Using PrEP, Doing It for Ourselves","Cluster Randomized Controlled Trial of Using PrEP, Doing it for Ourselves [UPDOs] Protective Styles: A Multi-level Intervention to Improve HIV Testing and PrEP Uptake Among At-risk Populations Living in the Southeastern Region of the United States","UPDOs","Inclusion Criteria:\n\n* Black\n* cisgender female\n* Ages 18+\n\nExclusion Criteria:\n\n* Under 18 years of age\n* Does not identify as Black\n* Not a cisgender female","FEMALE",{"count":58,"type":23},[26],"The goal of this clinical trial is to test a new online program called UPDOs Protective Styles to help people in the southeastern United States learn about and start using PrEP (pre-exposure prophylaxis), a medicine that helps prevent HIV. The study focuses on people who may be at higher risk for HIV and have not had equal access to PrEP.\n\nThe main questions it aims to answer are:\n\nDoes UPDOs help more people trust and understand PrEP? Does UPDOs increase the number of people who start and continue using PrEP?\n\nResearchers will compare two groups:\n\nOne group will use UPDOs, which includes six weekly videos, blog discussions, and access to telehealth services through Q Care Plus. The other group will receive standard HIV prevention materials from the CDC.\n\nParticipants will:\n\nBe recruited from 32 beauty salons in areas with high HIV rates. Complete surveys at the start of the study and again at 6, 12, 24, 32, and 52 weeks.\n\nHave access to HIV testing and PrEP prescriptions through Q Care Plus.\n\nThis study will also look at how well the program works in different communities and how easy it is to use and share.",[172,30],"HIV Prevention",[174,175],"Black Women","Community-based Research",{"date":177,"type":40},"2026-06-01",{"date":179,"type":40},"2026-02-13",{"date":181,"type":23},"2030-01",{"name":183,"class":47},"Duke University",{"id":185,"slug":186,"hasResults":11,"nctId":187,"briefTitle":188,"officialTitle":189,"acronym":190,"eligibilityCriteria":191,"healthyVolunteers":17,"sex":167,"minAge":56,"maxAge":4,"enrollmentInfo":192,"targetDuration":4,"studyType":59,"phases":4,"briefSummary":194,"conditions":195,"keywords":198,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":203,"lastUpdatePostDateStruct":204,"startDateStruct":206,"completionDateStruct":207,"leadSponsor":209,"locationsCount":78},"100632658","pharmacokinetic-study-of-long-acting-antiretrovirals-and-contraceptives-in-hiv-100632658","NCT07516548","Pharmacokinetic Study of Long-acting Antiretrovirals and Contraceptives in HIV","Pharmacokinetic Study of Long-acting Antiretrovirals and Contraceptive Options in HIV Prevention","PHARAOH","Parent Tshireletso Study Inclusion Criteria:\n\n1. Female 18 years of age or older and willing and able to provide an informed consent\n2. \\\u003C 14 days after delivery (calendar day of birth = day 0)\n3. Negative HIV screening test (conducted at the time of enrolment)\n4. Female \\\u003C30 years old or has had \\\u003C 3 prior pregnancies (Gravida 1, 2, or 3 including this pregnancy)\n5. Plan to stay and receive postpartum and pediatric care in the Gaborone or Molepolole region for 24 months\n\nParent Tshireletso Study Exclusion Criteria\n\n1. Receiving carbamazepine, phenobarbital, phenytoin, oxycarbazepine, rifampin, rifabutin, rifapentine, systemic dexamethasone (\\>1 dose oral\u002FIV), or St. John's wort\n2. Suspected to have, recently diagnosed with, or on treatment for TB (due to interaction with rifampicin)\n3. Previous hypersensitivity reaction to CAB or other INSTI\n4. Unstable medical or psychiatric condition making it unlikely they will be able to adhere to injections every 2 months\n5. Plan for pediatric and post-partum care outside the government system (private clinics)\n6. Inflammatory skin condition that compromises the safety of the intramuscular injection\n7. Weight \\\u003C35kg\n\nParent Doris Duke Study Inclusion Criteria Post-partum females included;\n\n1. if HIV-uninfected or unknown HIV status, willing to be tested for HIV\n2. if HIV-infected, documented to be on DTG as part of an antiretroviral treatment regimen\n3. maternal age \\>18 years,\n4. ability to speak English or Setswana\n5. intend to be available for follow up in Molepolole, Gaborone or Mochudi for 18 months post-delivery\n6. have access to a cell phone (including phone of friend or relative)\n\nParent Doris Duke Study Exclusion Criteria Post-partum females excluded if\n\n1. did not attend antenatal care or were not included in Tsepamo surveillance\n2. maternal age \\\u003C18,\n3. females who do not speak English or Setswana,\n4. unable or unwilling to give consent\n5. will not be able to attend follow up at a study site\n6. do not have access to any cell phone for follow up calls\n\nAdditional Inclusion Criteria for this PK Study\n\n1. For DMPA and ETG implant groups, intends to initiate or continue use of DMPA or ETG implant for at least another three or six months, respectively,\n2. For the CAB-LA groups, have received at least three consecutive CAB injections on time, including the one administered concurrently while starting a contraceptive method,\n3. Willing to undergo phlebotomy every 4 weeks for the duration of the sub-study period Additional Exclusion Criteria for this PK Study\n\n1\\) Use or anticipated use of nicotine-containing products (e.g., cigarettes or hookahs) known to interact with CAB-LA for the duration of the sub-study period 2) Use within the previous 90 days, current use, or planned future concomitant use of other hormonal contraceptives, including oral contraceptive methods 3) BMI≥35 4) Has any of the following laboratory abnormalities within the last year:\n\n1. Serum ALT\\>5x ULN at the time of screening,\n2. Serum creatinine \\>2.5x ULN at the time of screening. 5) Has any other condition that, in the opinion of the sub-study PI\u002Fdesignee, would preclude informed consent, make study participation unsafe, or complicate interpretation of study outcome 6) HIV infected females on the Doris Duke parent study",{"count":193,"type":23},105,"This study is being done to understand how long-acting injectable cabotegravir (CAB-LA) used for HIV pre-exposure prophylaxis (PrEP) and hormonal contraceptive methods affect each other when used at the same time. Women who are already using CAB-LA or not using PrEP will choose to join one of several groups based on whether they use injectable contraceptive (IM DMPA), an etonogestrel implant, or no hormonal contraceptive. Participants will have study visits every 4 to 12 weeks for up to 12 or 24 weeks after starting a contraceptive method to collect blood samples and measure levels of CAB-LA and hormone concentrations. The study will compare these levels to see if taking CAB-LA changes hormone concentrations or if using hormonal contraception changes CAB-LA drug levels. Safety, side effects, satisfaction, and continuation of CAB-LA PrEP and contraceptive methods will also be evaluated.",[62,63,196,30,197],"Drug-drug Interaction","Long-acting Injectable Cabotegravir for PrEP",[199,35,67,200,201,30,202],"Adolescent girls and young women","Long-acting injectable cabotegravir","Pharmacokinetic study","HIV prevention","2026-05-06",{"date":205,"type":40},"2026-05-08",{"date":177,"type":23},{"date":208,"type":23},"2026-12-31",{"name":77,"class":47},{"id":211,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":212,"targetDuration":4,"studyType":24,"phases":213,"briefSummary":27,"conditions":214,"keywords":215,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":216,"lastUpdatePostDateStruct":217,"startDateStruct":219,"completionDateStruct":221,"leadSponsor":223,"locationsCount":48},"100626623",{"count":22,"type":23},[26],[29,30,31],[30,33,34,35],"2026-04-15",{"date":218,"type":40},"2026-04-16",{"date":220,"type":23},"2026-05",{"date":222,"type":23},"2028-12",{"name":46,"class":47},{"id":225,"slug":226,"hasResults":11,"nctId":227,"briefTitle":228,"officialTitle":229,"acronym":230,"eligibilityCriteria":231,"healthyVolunteers":11,"sex":167,"minAge":56,"maxAge":4,"enrollmentInfo":232,"targetDuration":4,"studyType":24,"phases":234,"briefSummary":235,"conditions":236,"keywords":4,"overallStatus":96,"whyStopped":4,"lastUpdateSubmitDate":239,"lastUpdatePostDateStruct":240,"startDateStruct":242,"completionDateStruct":244,"leadSponsor":246,"locationsCount":78},"100570116","a-multi-level-trauma-informed-approach-to-increase-hiv-pre-exposure-prophylaxis-initiation-among-black-women-100570116","NCT06703060","A Multi-Level Trauma-Informed Approach to Increase HIV Pre-exposure Prophylaxis Initiation Among Black Women","Trauma-Informed HIV Prevention for Black Women in Baltimore","MATCH","Inclusion Criteria:\n\n* self-identified Black cisgender woman;\n* self-reported HIV-negative status, and\n* ≥18 years.\n* reports unprotected vaginal or anal sex in the past 6 months with a male sexual partner,\n* have at least one substantial HIV risk factor in the past 6 months according to the 2021 Centers for Disease Control (CDC) PrEP Eligibility Guidelines (i.e., HIV-positive sexual partner, recent bacterial Sexually Transmitted Disease (STD), 2+ sex partners, history of inconsistent or no condom use, commercial sex work, and residing in high HIV prevalence area or network), and\n* never taken PrEP\n\nExclusion Criteria:\n\n* non-English speaking and\n* currently living with HIV",{"count":233,"type":23},300,[26],"U.S. epidemiological data indicates that Black women are a high-risk HIV disparity group, yet initiation of novel prevention strategies like pre-exposure prophylaxis (PrEP) among this group is stagnant. Socio-structural challenges like intimate partner violence and gendered racism can constrain PrEP access among Black women, but few implementation studies have mitigated these challenges to improve PrEP initiation. The proposed research aims to implement and assess the effectiveness, implementation, and sustainability of a multilevel intervention to increase PrEP initiation among Black women with and without intimate partner violence in Baltimore.",[172,30,237,238],"Women","Intimate Partner Violence (IPV)","2026-03-19",{"date":241,"type":40},"2026-03-23",{"date":243,"type":40},"2025-02-28",{"date":245,"type":23},"2028-02",{"name":247,"class":47},"Johns Hopkins Bloomberg School of Public Health",{"id":249,"slug":250,"hasResults":11,"nctId":251,"briefTitle":252,"officialTitle":252,"acronym":253,"eligibilityCriteria":254,"healthyVolunteers":11,"sex":18,"minAge":56,"maxAge":4,"enrollmentInfo":255,"targetDuration":4,"studyType":24,"phases":257,"briefSummary":258,"conditions":259,"keywords":4,"overallStatus":96,"whyStopped":4,"lastUpdateSubmitDate":260,"lastUpdatePostDateStruct":261,"startDateStruct":263,"completionDateStruct":265,"leadSponsor":267,"locationsCount":78},"100610750","protect-al-prep-optimization-through-enhanced-continuum-tracking-100610750","NCT07231640","PrOTECT AL: PrEP Optimization Through Enhanced Continuum Tracking","PrOTECT AL","Inclusion Criteria:\n\n* currently practicing providers (either a clinician, nurse or medical assistant), OR 2) clinical administrator (e.g., someone in a leadership role within the PrEP clinic), OR 3) a data manager (i.e., someone who collects, enters and or manages data within the clinic) AND\n* English speaking\n* Age ≥ 18.\n\nExclusion Criteria:\n\n* Not one of the seven participating sites",{"count":256,"type":23},56,[26],"The purpose of this study is to enhance and evaluate the implementation of a PrEP Care Continuum data dashboard across seven distinct clinical sites in Alabama. By leveraging real-time data and fostering collaborative partnerships, this project aims to accurately visualize care disparities, allocate resources strategically, identify and address care gaps in the delivery of PrEP services, and gauge its impact on HIV prevention efforts.",[29,30,119,172],"2026-02-19",{"date":262,"type":40},"2026-02-20",{"date":264,"type":40},"2026-02-09",{"date":266,"type":23},"2030-04",{"name":77,"class":47},{"id":269,"slug":270,"hasResults":11,"nctId":271,"briefTitle":272,"officialTitle":273,"acronym":274,"eligibilityCriteria":275,"healthyVolunteers":17,"sex":18,"minAge":56,"maxAge":4,"enrollmentInfo":276,"targetDuration":4,"studyType":24,"phases":278,"briefSummary":279,"conditions":280,"keywords":4,"overallStatus":96,"whyStopped":4,"lastUpdateSubmitDate":282,"lastUpdatePostDateStruct":283,"startDateStruct":285,"completionDateStruct":287,"leadSponsor":289,"locationsCount":78},"100586749","hotspot-study-implement-and-evaluate-the-prep-pre-exposure-prophylaxis-implementation-strategy-100586749","NCT06919419","HOTSPOT Study: Implement and Evaluate the PrEP (Pre-exposure Prophylaxis) Implementation Strategy","The HOTSPOT Study Hybrid Implementation-effectiveness Study to Optimize HIV Testing and PrEP in a Southern Jail","Hotspot","Inclusion Criteria:\n\n* 18 years of age or older\n* Incarcerated in Dallas County Jail\n\nExclusion Criteria:\n\n* Severe medical or psychiatric disability making participation unsafe\n* Unable to provide consent\n* Not remaining in the local area after release from custody",{"count":277,"type":23},3600,[26],"The goal of this study is to measure the implementation and effectiveness of a multicomponent strategy for PrEP for people who are incarcerated at the Dallas County Jail. Specifically, based on a patients risk score on an electronic medical record HIV prediction model, referrals from providers and\u002For patient self-referrals, a PrEP patient navigator will meet with individuals at the jail to discuss HIV risk, offer HIV\u002FSTI testing if not yet completed and offer education around PrEP with referrals to community-based PrEP providers.",[30,29,281],"Incarceration","2026-02-06",{"date":284,"type":40},"2026-02-10",{"date":286,"type":40},"2025-03-01",{"date":288,"type":23},"2027-08-31",{"name":105,"class":47},{"id":291,"slug":292,"hasResults":11,"nctId":293,"briefTitle":294,"officialTitle":294,"acronym":295,"eligibilityCriteria":296,"healthyVolunteers":17,"sex":18,"minAge":56,"maxAge":4,"enrollmentInfo":297,"targetDuration":4,"studyType":24,"phases":299,"briefSummary":300,"conditions":301,"keywords":303,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":309,"lastUpdatePostDateStruct":310,"startDateStruct":312,"completionDateStruct":314,"leadSponsor":316,"locationsCount":78},"100577906","academic-detailing-to-optimize-prep-implementation-in-pediatric-primary-care-settings-adopt-prep-100577906","NCT06804382","Academic Detailing to Optimize PrEP Implementation in Pediatric Primary Care Settings: ADOPT-PrEP","ADOPT-PrEP","Inclusion Criteria:\n\n* Primary care provider at one of our 3 study sites (Boston Children's Hospital Adolescent\u002FYoung Adult Medicine, Martha Eliot Health Center, Children's Hospital Primary Care Center)\n\nExclusion Criteria:\n\n* None",{"count":298,"type":23},50,[26],"In this study, 50 pediatricians will participate in academic detailing, an evidence-based, 1-on-1 outreach education technique intended to promote clinician behavior change through brief, highly interactive, and individualized dialogues with trained educators, or \"detailers\". The goals of this study are to learn about whether this is a practical and acceptable technique, and whether it changes how pediatricians prescribe pre-exposure prophylaxis (PrEP) to adolescents and young adults (AYA) and how patients take it.",[30,302],"HIV Prevention Program",[30,304,305,306,307,308],"STI","AYA","adolescent","hiv prevention","academic detailing","2026-01-23",{"date":311,"type":40},"2026-01-26",{"date":313,"type":23},"2027-04-01",{"date":315,"type":23},"2030-03-30",{"name":317,"class":47},"Boston Children's Hospital",{"id":319,"slug":320,"hasResults":11,"nctId":321,"briefTitle":322,"officialTitle":323,"acronym":324,"eligibilityCriteria":325,"healthyVolunteers":17,"sex":18,"minAge":56,"maxAge":4,"enrollmentInfo":326,"targetDuration":4,"studyType":59,"phases":4,"briefSummary":328,"conditions":329,"keywords":333,"overallStatus":96,"whyStopped":4,"lastUpdateSubmitDate":334,"lastUpdatePostDateStruct":335,"startDateStruct":337,"completionDateStruct":339,"leadSponsor":341,"locationsCount":343},"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",{"count":327,"type":23},5000,"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.",[30,330,29,331,304,332],"PrEP Adherence Monitoring","HIV -1 Infection","STI Prevention",[30,29,304,332],"2025-09-15",{"date":336,"type":40},"2025-09-22",{"date":338,"type":40},"2024-09-09",{"date":340,"type":23},"2033-12-31",{"name":342,"class":47},"Fondazione ICONA",53,{"id":345,"slug":346,"hasResults":11,"nctId":347,"briefTitle":348,"officialTitle":349,"acronym":4,"eligibilityCriteria":350,"healthyVolunteers":17,"sex":351,"minAge":56,"maxAge":4,"enrollmentInfo":352,"targetDuration":4,"studyType":24,"phases":354,"briefSummary":355,"conditions":356,"keywords":359,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":364,"lastUpdatePostDateStruct":365,"startDateStruct":367,"completionDateStruct":369,"leadSponsor":371,"locationsCount":4},"100587647","behavioral-intervention-for-prep-service-utilization-among-chinese-msm-a-hapa-and-cei-integrated-model-100587647","NCT06931106","Behavioral Intervention for PrEP Service Utilization Among Chinese MSM: A HAPA and CEI Integrated Model","Behavioral Intervention to Enhance HIV Pre-Exposure Prophylaxis Service Utilization Among Men Who Have Sex With Men in China Based on Health Action Process Approach and Conditional Economic Incentives","Inclusion Criteria:\n\n* ≥18 years at enrollment;\n* Assigned male at birth with a history of ≥1 male-male sexual encounter (anal or oral intercourse);\n* HIV-negative confirmed by antibody testing at baseline;\n* No prior use of PrEP;\n* Expressed interest in PrEP intervention and commitment to complete scheduled follow-ups and data collection procedures;\n* Mentally competent to provide informed consent and participate in decision-making;\n* High HIV risk (meeting ≥1 of the following in the past 6 months): (1) Condomless anal\u002Fpenile-vaginal intercourse; (2)Shared needle use during illicit drug injection; (3) Sexual contact with HIV-positive partner(s); (4) Newly diagnosed STI; (5) Repeated use of PEP for HIV prevention; or (6) Self-identified as PrEP candidate through voluntary request.\n\nExclusion Criteria:\n\n* Confirmed HIV-positive status or unknown serostatus with refusal of HIV testing;\n* Clinically significant health conditions contraindicating PrEP use (e.g., creatinine clearance \\\u003C60 mL\u002Fmin, documented hypersensitivity to PrEP components);\n* Severe mental illness or neurological disorders impairing informed consent process.","MALE",{"count":353,"type":23},360,[26],"The goal of this clinical trial is to evaluate the effectiveness of a novel, intelligent intervention platform in bridging the \"intention-behavior gap\" for pre-exposure prophylaxis (PrEP) uptake among men who have sex with men (MSM) in China, a population at high risk for HIV infection. The study aims to address the following main questions:\n\n* Can the intervention platform, guided by the Health Action Process Approach (HAPA) and Conditional Economic Incentive (CEI) dual-track theoretical framework, significantly increase PrEP initiation rates among MSM?\n* What are the key mechanisms and pathways underlying the transition from PrEP intention to actual usage behavior?\n\nResearchers will compare participants receiving the intelligent intervention platform (intervention group) with those receiving basic PrEP information (control group) to determine the platform's impact on PrEP initiation rates. Participants will:\n\n* Use a mobile health platform equipped with personalized HIV risk assessments, PrEP knowledge resources, action planning tools, peer support features, and economic incentives.\n* Complete baseline and follow-up surveys at 3 months and 6 months to assess PrEP initiation, adherence, and related behaviors.\n* Engage in peer group activities and receive tailored feedback based on their progress.\n\nThis study seeks to provide evidence for scalable and sustainable strategies to improve PrEP uptake and contribute to HIV prevention efforts in high-risk populations.",[29,30,357,358],"MSM","Behavior Changes",[29,360,361,362,363],"pre-exposure prophylaxis","men who have sex with men","health action process approach","economic incentive","2025-05-30",{"date":366,"type":40},"2025-06-04",{"date":368,"type":23},"2025-07",{"date":370,"type":23},"2026-08",{"name":372,"class":47},"Peking University",{"id":374,"slug":375,"hasResults":11,"nctId":376,"briefTitle":377,"officialTitle":377,"acronym":378,"eligibilityCriteria":379,"healthyVolunteers":17,"sex":18,"minAge":143,"maxAge":4,"enrollmentInfo":380,"targetDuration":382,"studyType":59,"phases":4,"briefSummary":383,"conditions":384,"keywords":386,"overallStatus":96,"whyStopped":4,"lastUpdateSubmitDate":243,"lastUpdatePostDateStruct":391,"startDateStruct":393,"completionDateStruct":395,"leadSponsor":397,"locationsCount":399},"100582256","development-of-a-predictive-model-for-sexually-transmitted-infections-in-individuals-using-pre-exposure-prophylaxis-for-hiv-in-spain-100582256","NCT06860945","Development of a Predictive Model for Sexually Transmitted Infections in Individuals Using Pre-Exposure Prophylaxis for HIV in Spain","STI_PrEPare","Inclusion Criteria:\n\n* All individuals with documented initiation of oral PrEP (daily or event-driven regimens), who have collected the medication at least once and have taken at least one pill, will be included in the study.\n\nThe approved criteria for the use of oral PrEP in Spain, as recommended by the Spanish Gesida guidelines (GeSIDA. Recomendaciones sobre la Profilaxis Pre-Exposición para la Prevención de la Infección por VIH en España. Marzo 2023. Available at http:\u002F\u002F.gesida-seimc.org\u002Fcategory\u002Fguias-clinicas\u002Fotras-guias-vigentes\u002F), are as follows:\n\n* People without HIV infection at the time of cohort inclusion\n* Age ≥ 16 yr who meet the following criteria:\n* MSM and transgender women with at least two of the following criteria during the last year: \\> 10 sexual partners; Condomless anal sex; Chemsex; PEP; ≥ 1 STI\n* Sex worker women who report non-habitual use of condoms.\n* Cisgender males\u002Ffemales, who report condomless and present at least two of the same criteria as MSM and transgender.\n* PWID with unsafe injection practices\n\nExclusion Criteria: none\n\n\\-",{"count":381,"type":23},9000,"5 Years","Objective: To develop and validate a predictive model for acquiring sexually transmitted infections (STIs) in individuals using HIV pre-exposure prophylaxis (PrEP) within the national program providing this strategy.\n\nMethods: Ambispective cohort study, multicentric (23 Spanish hospitals). All PrEP users, with follow-up within the program, will be included. Entry into the program will be considered as the baseline visit. From there, patients are followed quarterly, following the national protocols for monitoring PrEP users in Spain. At each visit, diagnosis of different STIs (serum, pharyngeal swab, urethral or urine sample, rectal swab, endocervical\u002Fvaginal swab, ulcer) is performed. Primary outcome variable: development of an STI (Yes\u002FNo). The following STIs will be considered: syphilis, Neisseria gonorrhoeae (NG) infection, Chlamydia trachomatis (CT) infection, lymphogranuloma venereum (LGV), Mycoplasma genitalium (MG) infection, genital herpes, hepatitis A, hepatitis B, hepatitis C, HIV infection, and MPOX. Secondary outcome variable: number of diagnosed STIs. In order to determine factors associated with acquiring an STI, multivariate analyses will be conducted using logistic regression. The best models will be analyzed in the validation population. To compare the models, we will follow the Bayesian approach suggested by Benavoli et al.",[385,29,30],"Sexually Transmitted Infections (STIs)",[304,29,30,387,388,389,390],"modelling","machine learning","adherence","persistence",{"date":392,"type":40},"2025-03-06",{"date":394,"type":40},"2025-01-01",{"date":396,"type":23},"2026-01-01",{"name":398,"class":47},"Hospital Universitario de Valme",26]