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RECRUITING
NCT05413122
PHASE2/PHASE3

Evaluating Smoking Cessation Interventions for PWH in South Africa

Sponsor: Johns Hopkins University

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

660

Start Date

2023-11-27

Completion Date

2027-08-31

Last Updated

2025-06-27

Healthy Volunteers

No

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.

Locations (1)

Perinatal HIV Research Unit (PHRU)

Soweto, Gauteng, South Africa