Evaluating Smoking Cessation Interventions for PWH in South Africa: Efficacy, Implementation, and Cost-effectiveness
Status: Recruiting
Location: See location...
Intervention Type: Behavioral, Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• ≥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.
Locations
Other Locations
South Africa
Perinatal HIV Research Unit (PHRU)
RECRUITING
Soweto
Contact Information
Primary
Jonathan E Golub, PhD MPH
jgolub@jhmi.edu
443-287-2969
Backup
Laura Steiner, MSc
lsteine5@jhmi.edu
410-424-8445
Time Frame
Start Date: 2023-11-27
Estimated Completion Date: 2027-08-31
Participants
Target number of participants: 660
Treatments
Experimental: 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. \].
Experimental: Peer Support
Participants randomized to receive Peer Support will be engaged by participants' own 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.
Experimental: 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.
Experimental: 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.
No_intervention: Control
No intervention
Experimental: Varenicline & c-NRT
Varenicline \& c-NRT
Experimental: Peer Support & Varenicline
Peer Support \& Varenicline
Experimental: c-NRT & Peer Support
c-NRT \& Peer Support
Experimental: c-NRT & Peer Support & Varenicline
c-NRT \& Peer Support \& Varenicline
Experimental: Intensive Behavioral Counseling & Varenicline
Intensive Behavioral Counseling \& Varenicline
Experimental: Intensive Behavioral Counseling & c-NRT
Intensive Behavioral Counseling \& c-NRT
Experimental: Intensive Behavioral Counseling & Varenicline & c-NRT
Intensive Behavioral Counseling \& Varenicline \& c-NRT
Experimental: Intensive Behavioral Counseling & Peer Support
Intensive Behavioral Counseling \& Peer Support
Experimental: Intensive Behavioral Counseling & Peer Support & Varenicline
Intensive Behavioral Counseling \& Peer Support \& Varenicline
Experimental: Intensive Behavioral Counseling & Peer Support & c-NRT
Intensive Behavioral Counseling \& Peer Support \& c-NRT
Experimental: Intensive Behavioral Counseling & Peer Support & c-NRT & Varenicline
Intensive Behavioral Counseling \& Peer Support \& c-NRT \& Varenicline
Related Therapeutic Areas
Sponsors
Collaborators: Perinatal HIV Research Unit of the University of the Witswatersrand, Colorado State University, National Cancer Institute (NCI), New York University
Leads: Johns Hopkins University