Health TrialsbyHealthPanel

Evaluating Smoking Cessation Interventions for PWH in South Africa

ConditionsSmoking CessationHIVComorbidities and Coexisting Conditions
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorJohns Hopkins University

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

≥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 or evidence of taking ART for four of the past six months (to ensure engagement in care at the recruitment clinic), and

Disqualifiers

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

Trial design

Design model

Factorial

Treatments tested in this trial

  • Varenicline

    Drug

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

  • Nicotine patch

    Drug

    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.

  • Nicotine gum

    Drug

    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.

  • Intensive Behavioral Counselling

    Behavioral

    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.

  • Peer Counselling

    Behavioral

    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.

Treatment groups

660 Participants
are divided into 16 treatment groups

16

Treatment groups

See each treatment group below.

Group A: Intensive Behavioral CounsellingExperimental treatment 1 intervention
Group B: Peer SupportExperimental treatment 1 intervention
Group C: c-NRTExperimental treatment 2 interventions
Group D: VareniclineExperimental treatment 1 intervention
Group E: ControlNo intervention 0 interventions
Group F: Varenicline & c-NRTExperimental treatment 3 interventions
Group G: Peer Support & VareniclineExperimental treatment 2 interventions
Group H: c-NRT & Peer SupportExperimental treatment 3 interventions
Group I: c-NRT & Peer Support & VareniclineExperimental treatment 4 interventions
Group J: Intensive Behavioral Counseling & VareniclineExperimental treatment 2 interventions
Group K: Intensive Behavioral Counseling & c-NRTExperimental treatment 3 interventions
Group L: Intensive Behavioral Counseling & Varenicline & c-NRTExperimental treatment 4 interventions
Group M: Intensive Behavioral Counseling & Peer SupportExperimental treatment 2 interventions
Group N: Intensive Behavioral Counseling & Peer Support & VareniclineExperimental treatment 3 interventions
Group O: Intensive Behavioral Counseling & Peer Support & c-NRTExperimental treatment 4 interventions
Group P: Intensive Behavioral Counseling & Peer Support & c-NRT & VareniclineExperimental treatment 5 interventions

Trial outcomes

Primary outcomes

1

7-day point prevalence tobacco abstinence at 52 weeks

Verified by exhaled breath CO \< 7ppm and a negative urine cotinine test.

Time frame
52 weeks

Secondary outcomes

1

7-day point prevalence tobacco abstinence at 26 weeks

Verified by exhaled breath CO \< 7ppm and a negative urine cotinine test. Urine cotinine will be excluded as an indicator of abstinence for those self-reporting c-NRT use in the preceding week.

Time frame
26 weeks
2

7-day point prevalence tobacco abstinence at 12 weeks

Verified by exhaled breath CO \< 7ppm and a negative urine cotinine test. Urine cotinine will be excluded as an indicator of abstinence for those self-reporting c-NRT use in the preceding week.

Time frame
12 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Johns Hopkins University

Lead sponsor

Colorado State University

Collaborator

New York University

Collaborator

Perinatal HIV Research Unit of the University of the Witswatersrand

Collaborator

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov
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