[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100647731":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":31,"locations":40,"responsibleParty":61,"collaborators":63,"id":76,"slug":77,"hasResults":78,"nctId":79,"briefTitle":80,"officialTitle":80,"acronym":14,"eligibilityCriteria":81,"healthyVolunteers":78,"sex":82,"minAge":83,"maxAge":84,"enrollmentInfo":85,"targetDuration":12,"studyType":88,"phases":89,"briefSummary":91,"conditions":92,"keywords":96,"overallStatus":110,"whyStopped":12,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":120},{"fullName":5,"class":6},"Temple University","OTHER",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"Usual care","NO_INTERVENTION","During usual care, patient living with HIV with comorbid hypertension, diabetes, or hyperlipidemia do not interact with clinical pharmacists. The usual care phase of the intervention will be delivered by physicians, clinical officers, and nurses, with medications dispensed by pharmaceutical technologists.",null,{"label":14,"type":15,"description":16,"interventionNames":17},"INTEGRATE-RX","EXPERIMENTAL","INTEGRATE-RX intervention includes (1) integration of clinical pharmacists for CVD medication initiation and continuation, (2) pharmacist-coordinated access to CVD essential medicines, and (3) pharmacist-coordinated peer support for medication delivery and psychosocial counseling.",[18],"Behavioral: INTEGRATE-RX",[20],{"type":21,"name":14,"description":22,"armGroupLabels":23,"otherNames":12},"BEHAVIORAL","PLWH will be managed by the clinical pharmacist based on the established clinical care protocols that include comprehensive risk reduction strategies that incorporate counselling on diet and lifestyle, screening for, and management of other cardiovascular disease (CVD) risk factors, including but not limited to dyslipidemia and dysglycemia. The core components of the INTEGRATE-RX strategy will be: 1) integration of clinical pharmacists for CVD medication initiation and maintenance, (2) pharmacist-coordinated access to CVD essential medicines, and (3) pharmacist-coordinated peer support for medication delivery and psychosocial counselling.",[14],[25,29],{"name":26,"affiliation":27,"role":28},"Benson Njuguna, MPharm, MPH, MPP","Moi Teaching and Referral Hospital","PRINCIPAL_INVESTIGATOR",{"name":30,"affiliation":5,"role":28},"Dan Tran, PharmD",[32,36],{"name":30,"role":33,"phone":34,"phoneExt":12,"email":35},"CONTACT","215-707-6014","tran.nk.tina@temple.edu",{"name":37,"role":33,"phone":38,"phoneExt":12,"email":39},"Erica Maier, BA","215-707-9809","erica.maier@temple.edu",[41,53],{"facility":42,"status":12,"city":43,"state":44,"zip":12,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":12},"Kitale County Referral Hospital","Kitale","Trans Nzoia County","Kenya","KE",{"type":48,"coordinates":49},"Point",[50,51],35.00622,1.01572,{"lat":51,"lon":50},{"facility":27,"status":12,"city":54,"state":55,"zip":12,"country":45,"countryCode":46,"cosmosGeoPoint":56,"geoPoint":60,"contacts":12},"Eldoret","Uasin Gishu County",{"type":48,"coordinates":57},[58,59],35.26993,0.52036,{"lat":59,"lon":58},{"type":62,"investigatorFullName":12,"investigatorTitle":12,"investigatorAffiliation":12,"oldNameTitle":12,"oldOrganization":12},"SPONSOR",[64,67,69,71,73,75],{"name":65,"class":66},"National Heart, Lung, and Blood Institute (NHLBI)","NIH",{"name":68,"class":6},"Purdue University",{"name":70,"class":6},"Brown University",{"name":72,"class":6},"Duke University",{"name":74,"class":6},"NYU Langone Health",{"name":27,"class":6},"100647731","integrate-rx-integrating-clinical-pharmacists-in-hiv-care-to-mitigate-last-mile-challenges-and-reduce-cardiovascular-disease-burden-100647731",false,"NCT07711366","INTEGRATE-RX: Integrating Clinical Pharmacists in HIV Care to Mitigate Last-Mile Challenges and Reduce Cardiovascular Disease Burden","Inclusion Criteria:\n\n* Adult patients 18 years or above\n* Actively enrolled in the AMPATH HIV care program\n* Screen positive for and confirmed to have hypertension through repeated blood pressure measurement (SBP ≥ 140 or diastolic BP (DBP) ≥ 90), or those who are already in care for hypertension\n\nExclusion Criteria:\n\n* Hypertensive emergency requiring immediate medical attention\n* Terminal illness\n* Pregnancy\n* Inability to provide informed consent","ALL","18 Years","75 Years",{"count":86,"type":87},450,"ESTIMATED","INTERVENTIONAL",[90],"NA","The risk of heart attacks and stroke is two times higher among people living with HIV (PLWH), as compared to the general population. Prevention and treatment of cardiovascular disease (CVD) risk factors, such as high blood pressure, high cholesterol, and diabetes, are important in the overall management and CVD risk reduction among PLWH. Clinical pharmacists and their involvement in HIV care through comprehensive medication management have lead to improved medication adherence, undetectable HIV viral load, and continuity in care among PLWH. In addition, when pharmacists work with other health providers, they can also improve access to medications and management of major CVD risk factors like high blood pressure, high cholesterol, and diabetes. However, evaluation of the effectiveness, economic impact, and scalability of pharmacist-led interventions in combined HIV and CVD care in sub-Saharan Africa, where the burden of both HIV and CVD risk factors is high, are still understudied. Therefore, the objective of this study is to evaluate the effectiveness and cost-effectiveness of a pharmacist-led implementation strategy to prevent and manage cardiovascular disease in PLWH. The investigators hypothesize that a pharmacist-led intervention (INTEGRATE-RX) which includes - (1) integration of clinical pharmacists for CVD medication initiation and continuation, (2) pharmacist-coordinated access to CVD essential medicines, and (3) pharmacist-coordinated peer support for medication delivery and psychosocial counseling - will be clinically effective and cost-effective in improving CVD outcomes amongst PLWH.",[93,94,95],"HIV","Hypertension","Cardiovascular Disease Prevention",[97,98,99,93,100,101,102,103,104,105,106,107,108,109],"clinical pharmacist","integrated HIV and cardiovascular disease care","implementation science","cost effectiveness analysis","budget impact analysis","stepped-wedge cluster randomized trial","hybrid type 2 effectiveness-implementation trial","human centered design","clinical pharmacy","cardiovascular disease prevention","medication adherence","cardiovascular disease risk factors","peer navigators","NOT_YET_RECRUITING","2026-07-14",{"date":113,"type":114},"2026-07-17","ACTUAL",{"date":116,"type":87},"2026-10-01",{"date":118,"type":87},"2030-07-31",{"name":5,"class":6},2]