[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100470996":3},{"organization":4,"armGroups":7,"interventions":79,"overallOfficials":104,"centralContacts":111,"locations":120,"responsibleParty":142,"collaborators":144,"id":154,"slug":155,"hasResults":156,"nctId":157,"briefTitle":158,"officialTitle":159,"acronym":160,"eligibilityCriteria":161,"healthyVolunteers":156,"sex":162,"minAge":163,"maxAge":34,"enrollmentInfo":164,"targetDuration":34,"studyType":167,"phases":168,"briefSummary":171,"conditions":172,"keywords":176,"overallStatus":122,"whyStopped":34,"lastUpdateSubmitDate":180,"lastUpdatePostDateStruct":181,"startDateStruct":184,"completionDateStruct":186,"leadSponsor":188,"locationsCount":189},{"fullName":5,"class":6},"Johns Hopkins University","OTHER",[8,14,19,25,30,35,39,43,47,51,55,59,63,67,71,75],{"label":9,"type":10,"description":11,"interventionNames":12},"Intensive Behavioral Counselling","EXPERIMENTAL","Participants randomized to the Intensive Behavioural Counselling condition will receive in-person intensive (\\~45 minutes) behavioural counselling in the clinic at enrolment\u002Fbaseline and at weeks 2, 4, 8, and 12. Additionally, on non-clinic visit weeks participants will receive (1) one phone call each week from the clinic counsellor, and (2) two text messages each week providing encouragement and advice. \\].",[13],"Behavioral: Intensive Behavioral Counselling",{"label":15,"type":10,"description":16,"interventionNames":17},"Peer Support","Participants randomized to receive Peer Support will be engaged by participants' own peer counsellor assigned from Day 0-12 weeks, with in-person visits at least at baseline, weeks 2, 4, 8 and 12. Peer counselling will follow a flexible framework for contact with participants, which will include in-person and phone-based check-ins, depending upon individual participant preference. Peer counsellors will visit the counsellors' assigned participant in-person at participants' home, workplace, or other setting based on participant preference at least during baseline, weeks 2, 4, 8 and 12; additional in-person contact will be provided upon participant request.",[18],"Behavioral: Peer Counselling",{"label":20,"type":10,"description":21,"interventionNames":22},"c-NRT","A 12-week course of nicotine patches and nicotine gum will be dispensed to the participant by the counsellor according to randomization into the c-NRT condition. c-NRT will be provided per label instructions given number of cigarettes the participant smokes per day and will be provided in the commercially available package. Participants will be provided with education on its use, including where and how to place a patch, strength of patches to use and how to taper, not smoking while using the patch, and using gum ad hoc; the investigators will also discuss possible side effects. Participants will be given a number to call should the participants require assistance, and weekly calls will be made to participants to screen for adverse events and monitor adherence; calls will taper to every other week after four weeks.",[23,24],"Drug: Nicotine patch","Drug: Nicotine gum",{"label":26,"type":10,"description":27,"interventionNames":28},"Varenicline","At enrolment, a 12-week course of varenicline in the commercially available package will be dispensed by a study clinician according to randomization into the varenicline condition and participants will be provided with education on its use. Participants will be instructed to begin taking varenicline one week prior to participants' quit date and for 11 weeks following quit date. Participants will be given a number to call should the participants require assistance, and weekly calls will be made to participants to screen for adverse events and to monitor adherence; calls will taper to every other week after four weeks.",[29],"Drug: Varenicline",{"label":31,"type":32,"description":33,"interventionNames":34},"Control","NO_INTERVENTION","No intervention",null,{"label":36,"type":10,"description":37,"interventionNames":38},"Varenicline & c-NRT","Varenicline \\& c-NRT",[29,23,24],{"label":40,"type":10,"description":41,"interventionNames":42},"Peer Support & Varenicline","Peer Support \\& Varenicline",[29,18],{"label":44,"type":10,"description":45,"interventionNames":46},"c-NRT & Peer Support","c-NRT \\& Peer Support",[23,24,18],{"label":48,"type":10,"description":49,"interventionNames":50},"c-NRT & Peer Support & Varenicline","c-NRT \\& Peer Support \\& Varenicline",[29,23,24,18],{"label":52,"type":10,"description":53,"interventionNames":54},"Intensive Behavioral Counseling & Varenicline","Intensive Behavioral Counseling \\& Varenicline",[29,13],{"label":56,"type":10,"description":57,"interventionNames":58},"Intensive Behavioral Counseling & c-NRT","Intensive Behavioral Counseling \\& c-NRT",[23,24,13],{"label":60,"type":10,"description":61,"interventionNames":62},"Intensive Behavioral Counseling & Varenicline & c-NRT","Intensive Behavioral Counseling \\& Varenicline \\& c-NRT",[29,23,24,13],{"label":64,"type":10,"description":65,"interventionNames":66},"Intensive Behavioral Counseling & Peer Support","Intensive Behavioral Counseling \\& Peer Support",[13,18],{"label":68,"type":10,"description":69,"interventionNames":70},"Intensive Behavioral Counseling & Peer Support & Varenicline","Intensive Behavioral Counseling \\& Peer Support \\& Varenicline",[29,13,18],{"label":72,"type":10,"description":73,"interventionNames":74},"Intensive Behavioral Counseling & Peer Support & c-NRT","Intensive Behavioral Counseling \\& Peer Support \\& c-NRT",[23,24,13,18],{"label":76,"type":10,"description":77,"interventionNames":78},"Intensive Behavioral Counseling & Peer Support & c-NRT & Varenicline","Intensive Behavioral Counseling \\& Peer Support \\& c-NRT \\& Varenicline",[29,23,24,13,18],[80,84,90,95,99],{"type":81,"name":26,"description":82,"armGroupLabels":83,"otherNames":34},"DRUG","At enrolment, a 12-week course of varenicline in the commercially available package will be dispensed by a study clinician.",[68,76,52,60,40,26,36,48],{"type":81,"name":85,"description":86,"armGroupLabels":87,"otherNames":88},"Nicotine patch","A 12-week course of nicotine patches and nicotine gum will be dispensed to the participant by the counsellor according to randomization into the c-NRT condition. c-NRT will be provided per label instructions given number of cigarettes the participant smokes per day and will be provided in the commercially available package.",[72,76,60,56,36,20,44,48],[89],"combination nicotine replacement therapy",{"type":81,"name":91,"description":86,"armGroupLabels":92,"otherNames":93},"Nicotine gum",[72,76,60,56,36,20,44,48],[94],"nicotine replacement",{"type":96,"name":9,"description":97,"armGroupLabels":98,"otherNames":34},"BEHAVIORAL","Participants randomized to the Intensive Behavioural Counselling condition will receive in-person intensive (\\~45 minutes) behavioural counselling in the clinic at screening and at weeks 2, 4, 8, and 12. Additionally, on non-clinic visit weeks participants will receive (1) one phone call each week from the clinic counsellor, and (2) two text messages each week providing encouragement and advice.",[64,68,72,76,52,60,56,9],{"type":96,"name":100,"description":101,"armGroupLabels":102,"otherNames":103},"Peer Counselling","Participants randomized to the Peer Support condition will be engaged by a peer counsellor over weeks -2 to 12. Peer counselling will follow a flexible framework for contact with participants, which will include in-person and phone-based check-ins, depending upon individual participant preference. Peer counsellors will visit the counsellors' assigned participant in-person at participants' home, workplace, or other setting based on participant preference at least during weeks -2, 2, 4, 8 and 12; additional in-person contact will be provided upon participant request.",[64,68,72,76,15,40,44,48],[15],[105,109],{"name":106,"affiliation":107,"role":108},"Neil Martison","Perinatal HIV Research Unit (PHRU)","PRINCIPAL_INVESTIGATOR",{"name":110,"affiliation":5,"role":108},"Jonathan E Golub, PhD MPH",[112,116],{"name":110,"role":113,"phone":114,"phoneExt":34,"email":115},"CONTACT","443-287-2969","jgolub@jhmi.edu",{"name":117,"role":113,"phone":118,"phoneExt":34,"email":119},"Laura Steiner, MSc","410-424-8445","lsteine5@jhmi.edu",[121],{"facility":107,"status":122,"city":123,"state":124,"zip":34,"country":125,"countryCode":126,"cosmosGeoPoint":127,"geoPoint":132,"contacts":133},"RECRUITING","Soweto","Gauteng","South Africa","ZA",{"type":128,"coordinates":129},"Point",[130,131],27.85849,-26.26781,{"lat":131,"lon":130},[134,138],{"name":135,"role":113,"phone":136,"phoneExt":34,"email":137},"Neil Martinson, MD PHD","+27 11 989 9836","martinson@phru.co.za",{"name":139,"role":113,"phone":140,"phoneExt":34,"email":141},"Leisha Genade, MPH","27 11 989 9714","genadel@phru.co.za",{"type":143,"investigatorFullName":34,"investigatorTitle":34,"investigatorAffiliation":34,"oldNameTitle":34,"oldOrganization":34},"SPONSOR",[145,147,149,151],{"name":146,"class":6},"Colorado State University",{"name":148,"class":6},"New York University",{"name":150,"class":6},"Perinatal HIV Research Unit of the University of the Witswatersrand",{"name":152,"class":153},"National Cancer Institute (NCI)","NIH","100470996","phase-2-evaluating-smoking-cessation-interventions-for-pwh-in-south-africa-100470996",false,"NCT05413122","Evaluating Smoking Cessation Interventions for PWH in South Africa","Evaluating Smoking Cessation Interventions for PWH in South Africa: Efficacy, Implementation, and Cost-effectiveness","Tlogela","Inclusion Criteria:\n\n1. ≥18 years of age, and\n2. attend one of the selected study clinics, and\n3. have a confirmed diagnosis of HIV (evidenced by one of: clinic or hospital prescription for combination antiretroviral therapy (ART), or a current ART medication pack that has the patient's name documented thereon) and\n4. have been taking ART for at least three consecutive months or evidence of taking ART for four of the past six months (to ensure engagement in care at the recruitment clinic), and\n5. are current tobacco smokers (smoked at least 100 cigarettes in the subject's lifetime, smoked at least one cigarette daily in the past 30 days, have exhaled breath carbon monoxide (CO) ≥ 7 parts per million (ppm), and have a positive urine cotinine test), and\n6. either own or have household access to a mobile phone, and\n7. provide written informed consent.\n\nExclusion Criteria:\n\n1. Currently (within the previous 14 days) receiving or using smoking cessation counselling or pharmacotherapy, or\n2. are unable to participate due to severity of medical illness, guided by a Karnofsky score of ≤ 40, or\n3. have a history of seizures, cancer, heart disease, stroke, myocardial infarction, stomach ulcers, kidney failure, or liver failure, or\n4. have generalized eczema or psoriasis, or\n5. have cognitive dysfunction or psychosis as defined by the Mini-International Neuropsychiatric Interview (M.I.N.I.), or\n6. have suicide risk as defined by the Columbia-Suicide Severity Rating Scale (C-SSRS), or\n7. are pregnant, planning to become pregnant in the next four months, lactating, or are unwilling to use effective birth control, or\n8. have a history of adverse reactions to varenicline or nicotine patch, or\n9. are not planning to continue to receive care at the clinic for the next 52 weeks, or\n10. are a household member of a currently enrolled participant in this trial, or\n11. In the opinion of the attending investigator are not a candidate for the clinical trail.","ALL","18 Years",{"count":165,"type":166},660,"ESTIMATED","INTERVENTIONAL",[169,170],"PHASE2","PHASE3","The overall objective of the study is to optimize a smoking cessation treatment package for people with HIV (PWH) that can be integrated into existing HIV care in South Africa.",[173,174,175],"Smoking Cessation","HIV","Comorbidities and Coexisting Conditions",[173,177,26,178,179],"Combination NRT","Behavioral Counselling","Peer Counseling","2026-06-05",{"date":182,"type":183},"2026-06-09","ACTUAL",{"date":185,"type":183},"2023-11-27",{"date":187,"type":166},"2027-08-31",{"name":5,"class":6},1]