Evaluating Smoking Cessation Interventions for PWH in South Africa

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.

Conditions

• Smoking Cessation
• HIV
• Comorbidities 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.

Sponsors & Collaborators

• Colorado State University

  collaborator OTHER

• New York University

  collaborator OTHER

• Perinatal HIV Research Unit of the University of the Witswatersrand

  collaborator OTHER

• National Cancer Institute (NCI)

  collaborator NIH

• Johns Hopkins University

  lead OTHER

Principal Investigators

• Neil Martison · Perinatal HIV Research Unit (PHRU)

• Jonathan E Golub, PhD MPH · Johns Hopkins University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

FACTORIAL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-11-27

Primary Completion

2027-08-31

Completion

2027-08-31

Countries

• South Africa

Study Locations