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Evaluating Smoking Cessation Interventions for PWH in South Africa
Sponsor: Johns Hopkins University
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.
Official title: Evaluating Smoking Cessation Interventions for PWH in South Africa: Efficacy, Implementation, and Cost-effectiveness
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
660
Start Date
2023-11-27
Completion Date
2027-08-31
Last Updated
2025-06-27
Healthy Volunteers
No
Interventions
Varenicline
At enrolment, a 12-week course of varenicline in the commercially available package will be dispensed by a study clinician.
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.
Nicotine gum
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.
Intensive Behavioral Counselling
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.
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.
Locations (1)
Perinatal HIV Research Unit (PHRU)
Soweto, Gauteng, South Africa