Phase
Condition
Smoking Cessation
Diabetes Prevention
Hiv
Treatment
Varenicline
Nicotine gum
Nicotine patch
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
≥18 years of age, and
attend one of the selected study clinics, and
have a confirmed diagnosis of HIV (evidenced by one of: clinic or hospitalprescription for combination antiretroviral therapy (ART), or a current ARTmedication pack that has the patient's name documented thereon) and
have been taking ART for at least three consecutive months (to ensure engagement incare at the recruitment clinic), and
are current tobacco smokers (smoked at least 100 cigarettes in the subject'slifetime, have smoked daily for the past 30 days, have exhaled breath carbonmonoxide (CO) ≥ 7 parts per million (ppm), and have a positive urine cotinine test),and
either own or have household access to a mobile phone, and
provide written informed consent.
Exclusion
Exclusion Criteria:
Currently (within the previous 14 days) receiving or using smoking cessationcounselling or pharmacotherapy, or
are unable to participate due to severity of medical illness, guided by a Karnofskyscore of ≤ 40, or
have a history of seizures, cancer, heart disease, stroke, myocardial infarction,stomach ulcers, kidney failure, or liver failure, or
have generalized eczema or psoriasis, or
have cognitive dysfunction or psychosis as defined by the Mini-InternationalNeuropsychiatric Interview (M.I.N.I.), or
have suicide risk as defined by the Columbia-Suicide Severity Rating Scale (C-SSRS),or
are pregnant, planning to become pregnant in the next four months, lactating, or areunwilling to use effective birth control, or
have a history of adverse reactions to varenicline or nicotine patch, or
are not planning to continue to receive care at the clinic for the next 52 weeks.
In the opinion of the attending investigator are not a candidate for the clinicaltrail.
Study Design
Study Description
Connect with a study center
Perinatal HIV Research Unit (PHRU)
Soweto, Gauteng
South AfricaActive - Recruiting
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