RecruitingPhase 2Phase 3NCT05413122

Evaluating Smoking Cessation Interventions for PWH in South Africa

Evaluating Smoking Cessation Interventions for PWH in South Africa: Efficacy, Implementation, and Cost-effectiveness

Sponsor

Johns Hopkins University

Enrollment

660 participants

Start Date

Nov 27, 2023

Study Type

INTERVENTIONAL

Conditions

Comorbidities and Coexisting Conditions Smoking Cessation HIV

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

Min Age: 18 Years

Inclusion Criteria7

≥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 Criteria10

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.

Interventions

DRUGVarenicline

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

DRUGNicotine 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.

DRUGNicotine gum

BEHAVIORALIntensive 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.

BEHAVIORALPeer 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.