Status:
RECRUITING
Evaluating Smoking Cessation Interventions for PWH in South Africa
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
Colorado State University
New York University
Conditions:
Smoking Cessation
HIV
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
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.
Detailed Description
This project will evaluate the main and interaction effects of four evidence-based smoking cessation components integrated within HIV care in South Africa: (1) intensive behavioural counselling, (2) p...
Eligibility Criteria
Inclusion
- ≥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 hospital prescription for combination antiretroviral therapy (ART), or a current ART medication pack that has the patient's name documented thereon) and
- have been taking ART for at least three consecutive months (to ensure engagement in care at the recruitment clinic), and
- are current tobacco smokers (smoked at least 100 cigarettes in the subject's lifetime, have smoked daily for the past 30 days, have exhaled breath carbon monoxide (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
- Currently (within the previous 14 days) receiving or using smoking cessation counselling or pharmacotherapy, or
- are unable to participate due to severity of medical illness, guided by a Karnofsky score 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-International Neuropsychiatric 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 are unwilling 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 clinical trail.
Key Trial Info
Start Date :
November 27 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2027
Estimated Enrollment :
660 Patients enrolled
Trial Details
Trial ID
NCT05413122
Start Date
November 27 2023
End Date
August 31 2027
Last Update
June 27 2025
Active Locations (1)
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1
Perinatal HIV Research Unit (PHRU)
Soweto, Gauteng, South Africa