[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"people-living-with-hiv\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:people-living-with-hiv":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,45],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100512866","reset-for-the-treatment-of-stimulant-use-in-hiv-clinics-care-optimization-supporting-treatment-adherence-costa-100512866",false,"NCT05958017","reSET for the Treatment of Stimulant Use in HIV Clinics: Care Optimization Supporting Treatment Adherence (COSTA)","COSTA","Inclusion Criteria:\n\n1. Assigned male sex at birth and has not undergone any transgender hormonal treatment\n2. Reports having had sex with a male in the past 12 months\n3. Age 18 or older\n4. Is affiliated with a study referral source (e.g., AHF clinic, registry, other healthcare program or clinic) or resides in a city or county where a participating healthcare center or health program is located\n5. Screens positive for mild, moderate or severe stimulant use disorder in the last 12 months using the MINI\n6. Reports that he is not currently in drug treatment\n7. Is living with HIV\n8. Reports having an active antiretroviral prescription\n9. Have access to a smartphone or tablet with stable internet at least twice a week and can download applications to the smartphone or tablet\n10. Able to understand English\n11. Consents to participation in the study\n12. Provides sufficient locator information\n13. Identifies as non-Hispanic White, non-Hispanic Black\u002FAfrican American or Latinx\u002FHispanic\n14. Has been in stable housing for the past 3 months and intends to remain housed for the next 15 months\n\nExclusion Criteria:\n\n1. Patient appears to have diminished capacity to consent either because of cognitive impairment or severe psychiatric symptoms (e.g., mania, psychosis).\n2. Persons that meet criteria for prisoner status will be excluded at baseline.\n3. Patients who screen positive for moderate to severe opioid use disorder will be excluded from the study because effective pharmacological agents exist for the treatment of this disorder. These patients will be referred to community-based programs that provide specialized treatment for this disorder.\n4. Participants will be excluded prior to randomization, if they do not complete at baseline the Time-Line Follow-Back or the laboratory visit.","MALE","18 Years","90 Years",{"count":20,"type":21},260,"ESTIMATED","INTERVENTIONAL",[24],"NA","The purpose of this study is to find out if reSET, an FDA authorized mobile therapeutic, is effective in treating stimulant use disorder and helping keep HIV viral load suppression stable among men who have sex with men who are living with HIV and have a stimulant use disorder.",[27,28],"Stimulant Use Disorder","People Living With HIV",[30,31],"Substance use","Adherence to Anti-Retroviral Therapy","RECRUITING","2026-06-15",{"date":35,"type":36},"2026-06-17","ACTUAL",{"date":38,"type":36},"2025-03-04",{"date":40,"type":21},"2028-01-31",{"name":42,"class":43},"University of Miami","OTHER",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":53,"minAge":17,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":22,"phases":56,"briefSummary":58,"conditions":59,"keywords":67,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":80},"100562168","phase-2-covid-19-booster-and-iiv-schedule-in-immunocompromised-hosts-100562168","NCT06599658","COVID-19 Booster and IIV Schedule in Immunocompromised Hosts","The Immunogenicity and Safety of COVID-19 and Influenza Vaccine Co-administration and Interval in Immunocompromised Hosts","CO2I2","Inclusion Criteria:\n\n\\- All participants must meet ALL the following inclusion criteria: i. Adults (≥18 years) ii. Received the primary mRNA COVID-19 vaccine series (i.e., ≥3 doses) iii. Have at least one of the following immunocompromising conditions:\n\na) Received a solid organ transplant (SOT) ≥3-months ago, and treated with a conventional maintenance immunosuppression regimen; b) People living with HIV (PLWH) receiving ART for ≥6 months who meet at least one of the following conditions: i) AIDS-defining illness in the last 6 months, ii) TB diagnosis in the last 6-months, iii) CD4\\<200 cells\u002FµL in the last 6 months, iv) CD4%\\<15% in the last 6 months, or v) absence of HIV viral suppression in the last 6 months; c) Inflammatory bowel disease (IBD) treated with a conventional or biologic immunosuppressive agent for ≥3 months; d) Rheumatoid arthritis or systemic lupus erythematosus (herein referred to as rheumatological disease (RD)) treated with a conventional or biologic immunosuppressive agent for ≥3 months.\n\nExclusion Criteria:\n\n* Potential participants who meet ANY of the following criteria will be excluded:\n\n  i. Received any of the following:\n  1. Annual vaccination against influenza \\< 6 months ago\n  2. COVID-19 booster \\< 3 months ago ii. History of any of the following:\n\n  \u003C!-- -->\n\n  1. life-threatening reaction any component of the IIV or COVID-19 vaccines\n  2. Guillain-Barre syndrome or myocarditis within 6 weeks of a previous influenza or COVID-19 vaccination\n  3. Contraindication to intramuscular vaccines such as bleeding disorder, severe thrombocytopenia, etc; iii. Receiving intravenous immunoglobulins; iv. Have underlying primary inborn errors of immunity; v. Receiving chemotherapy such as cyclophosphamide \\< 6-months ago; vi. Unable to provide informed consent","ALL",{"count":55,"type":21},660,[57],"PHASE2","The goal of this pragmatic embedded open-label, 2 x 2 factorial phase II randomized controlled trial is to evaluate strategies to improve COVID-19 booster and influenza vaccine immunogenicity in people living with immunocompromising conditions (PLIC).\n\nThe main questions it aims to answer are:\n\n1. Is co-administration of seasonal inactivated influenza vaccine (IIV) with the most up-to-date recommended COVID-19 booster dose non-inferior in inducing a 1-month peak protective humoral response against COVID-19, compared to a strategy of sequential administration of COVID-19 booster dose followed by seasonal IIV given one month later?\n2. Is the administration of the most up-to-date recommended COVID-19 booster doses at 3-month intervals superior at maintaining a longer term protective humoral immune response, compared to booster doses administered at 6-month intervals?\n\nResearchers will compare (1) COVID-19 and Influenza vaccines administered at Day 0 + COVID-19 Booster at a 3-month interval, (2) COVID-19 vaccine administered at Day 0 and Influenza vaccine administered at Day 28 + COVID-19 Booster at a 3-month interval, (3) COVID-19 and Influenza vaccines administered at Day 0 + COVID-19 Booster at a 6-month interval, and (4) COVID-19 vaccine administered at Day 0 and Influenza vaccine administered at Day 28 + COVID-19 Booster at a 6-month interval to see if median neutralization capacity of patient sera is non-inferior in the co- vs. sequential administration arms at 1-month after the initial COVID-19 booster and superior in the 3-month interval arms vs. the 6-month interval arms at 12 months after the initial COVID-19 booster. These outcomes will also be compared at 2-months for question 1 and 6-months for question 2.\n\nPeople living with immunocompromising conditions who take part in the trial will have blood samples drawn to verify immune response, be monitored for changes in clinical events and therapies, and complete questionnaires to verify adverse effects, quality of life and economic impact.",[60,61,62,63,64,65,66,28],"COVID 19","Influenza","Rheumatoid Arthritis (RA)","Systemic Lupus Erthematosus","Inflammatory Bowel Disease","Solid Organ Transplant Recipients","Immunocompromised Host",[68,69,70],"Vaccine","Immunogenicity","Safety","2026-03-06",{"date":73,"type":36},"2026-03-10",{"date":75,"type":36},"2024-11-20",{"date":77,"type":21},"2027-03-31",{"name":79,"class":43},"McGill University Health Centre\u002FResearch Institute of the McGill University Health Centre",3]