660
Participants
Start Date
November 27, 2023
Primary Completion Date
August 31, 2027
Study Completion Date
August 31, 2027
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.
RECRUITING
Perinatal HIV Research Unit (PHRU), Soweto
Colorado State University
OTHER
New York University
OTHER
Perinatal HIV Research Unit of the University of the Witswatersrand
OTHER
National Cancer Institute (NCI)
NIH
Johns Hopkins University
OTHER