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

Plain Language Summary

Simplified for easier understanding

This study is testing different interventions to help people living with HIV (PWH) in South Africa quit smoking. People with HIV are disproportionately affected by tobacco-related diseases, and this study aims to find more effective cessation strategies for this population. **You may be eligible if...** - You are 18 or older - You attend one of the study clinics in South Africa - You have a confirmed HIV diagnosis and have been taking antiretroviral therapy (ART) for at least 3 consecutive months - You are a current daily smoker (smoked at least 100 cigarettes in your lifetime and smoked every day for the past 30 days) **You may NOT be eligible if...** - You are not currently living with HIV - You have not been consistently on ART - You are not a regular smoker Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.