Evaluating Smoking Cessation Interventions for PWH in South Africa

PHASE2/PHASE3RecruitingINTERVENTIONAL
Enrollment

660

Participants

Timeline

Start Date

November 27, 2023

Primary Completion Date

August 31, 2027

Study Completion Date

August 31, 2027

Conditions
Smoking CessationHIVComorbidities and Coexisting Conditions
Interventions
DRUG

Varenicline

At enrolment, a 12-week course of varenicline in the commercially available package will be dispensed by a study clinician.

DRUG

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.

DRUG

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.

BEHAVIORAL

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.

BEHAVIORAL

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.

Trial Locations (1)

Unknown

RECRUITING

Perinatal HIV Research Unit (PHRU), Soweto

All Listed Sponsors
collaborator

Colorado State University

OTHER

collaborator

New York University

OTHER

collaborator

Perinatal HIV Research Unit of the University of the Witswatersrand

OTHER

collaborator

National Cancer Institute (NCI)

NIH

lead

Johns Hopkins University

OTHER

NCT05413122 - Evaluating Smoking Cessation Interventions for PWH in South Africa | Biotech Hunter | Biotech Hunter