Evaluating Smoking Cessation Interventions for PWH in South Africa (Tlogela)

Johns Hopkins University

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: HIV; Comorbidities and Coexisting Conditions; Smoking Cessation

Treatments: Drug: Varenicline; Behavioral: Peer Counselling; Drug: Nicotine gum; Behavioral: Intensive Behavioral Counselling; Drug: Nicotine patch

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05413122

IRB00335707

1U01CA261626-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

This project will evaluate the main and interaction effects of four evidence-based smoking cessation components integrated within HIV care in South Africa: (1) intensive behavioural counselling, (2) peer support, (3) combination nicotine replacement therapy (c-NRT), and (4) varenicline. The investigators will also evaluate the implementation and cost-effectiveness of these interventions. This study is a balanced full factorial randomised trial of 660 adults with HIV and will be implemented in two diverse sites in Gauteng, South Africa representing both peri-urban and urban settings.

Participants will be recruited via health care worker-referral or self-referral. Interested patients will be further screened for eligibility. Eligible participants will be administered written informed consent (see "Informed Consent and Assent" section below), and participants will be randomized into one of 16 study conditions for a 12-week intervention period. This will be an open-label trial; neither the participants nor study personnel will be blinded to treatment assignment post randomization, but randomization block assignment will be concealed from the study personnel who will be enrolling participants.

Enrollment: 660 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. ≥18 years of age, and
2. attend one of the selected study clinics, and
3. 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
4. have been taking ART for at least three consecutive months (to ensure engagement in care at the recruitment clinic), and
5. 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
6. either own or have household access to a mobile phone, and
7. provide written informed consent.

Exclusion criteria

1. Currently (within the previous 14 days) receiving or using smoking cessation counselling or pharmacotherapy, or
2. are unable to participate due to severity of medical illness, guided by a Karnofsky score of ≤ 40, or
3. have a history of seizures, cancer, heart disease, stroke, myocardial infarction, stomach ulcers, kidney failure, or liver failure, or
4. have generalized eczema or psoriasis, or
5. have cognitive dysfunction or psychosis as defined by the Mini-International Neuropsychiatric Interview (M.I.N.I.), or
6. have suicide risk as defined by the Columbia-Suicide Severity Rating Scale (C-SSRS), or
7. are pregnant, planning to become pregnant in the next four months, lactating, or are unwilling to use effective birth control, or
8. have a history of adverse reactions to varenicline or nicotine patch, or
9. are not planning to continue to receive care at the clinic for the next 52 weeks.
10. In the opinion of the attending investigator are not a candidate for the clinical trail.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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660 participants in 16 patient groups

Intensive Behavioral Counselling

Experimental group

Description:

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. \].

Treatment:

Behavioral: Intensive Behavioral Counselling

Peer Support

Experimental group

Description:

Participants randomized to receive Peer Support will be engaged by participants' own 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:

Behavioral: Peer Counselling

c-NRT

Experimental group

Description:

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. Participants will be provided with education on its use, including where and how to place a patch, strength of patches to use and how to taper, not smoking while using the patch, and using gum ad hoc; the investigators will also discuss possible side effects. Participants will be given a number to call should the participants require assistance, and weekly calls will be made to participants to screen for adverse events and monitor adherence; calls will taper to every other week after four weeks.

Treatment:

Drug: Nicotine patch

Drug: Nicotine gum

Varenicline

Experimental group

Description:

At enrolment, a 12-week course of varenicline in the commercially available package will be dispensed by a study clinician according to randomization into the varenicline condition and participants will be provided with education on its use. Participants will be instructed to begin taking varenicline one week prior to participants' quit date and for 11 weeks following quit date. Participants will be given a number to call should the participants require assistance, and weekly calls will be made to participants to screen for adverse events and to monitor adherence; calls will taper to every other week after four weeks.

Treatment:

Drug: Varenicline

Control

No Intervention group

Description:

No intervention

Varenicline & c-NRT

Experimental group

Description:

Varenicline \& c-NRT

Treatment:

Drug: Nicotine patch

Drug: Nicotine gum

Drug: Varenicline

Peer Support & Varenicline

Experimental group

Description:

Peer Support \& Varenicline

Treatment:

Behavioral: Peer Counselling

Drug: Varenicline

c-NRT & Peer Support

Experimental group

Description:

c-NRT \& Peer Support

Treatment:

Drug: Nicotine patch

Drug: Nicotine gum

Behavioral: Peer Counselling

c-NRT & Peer Support & Varenicline

Experimental group

Description:

c-NRT \& Peer Support \& Varenicline

Treatment:

Drug: Nicotine patch

Drug: Nicotine gum

Behavioral: Peer Counselling

Drug: Varenicline

Intensive Behavioral Counseling & Varenicline

Experimental group

Description:

Intensive Behavioral Counseling \& Varenicline

Treatment:

Behavioral: Intensive Behavioral Counselling

Drug: Varenicline

Intensive Behavioral Counseling & c-NRT

Experimental group

Description:

Intensive Behavioral Counseling \& c-NRT

Treatment:

Drug: Nicotine patch

Behavioral: Intensive Behavioral Counselling

Drug: Nicotine gum

Intensive Behavioral Counseling & Varenicline & c-NRT

Experimental group

Description:

Intensive Behavioral Counseling \& Varenicline \& c-NRT

Treatment:

Drug: Nicotine patch

Behavioral: Intensive Behavioral Counselling

Drug: Nicotine gum

Drug: Varenicline

Intensive Behavioral Counseling & Peer Support

Experimental group

Description:

Intensive Behavioral Counseling \& Peer Support

Treatment:

Behavioral: Intensive Behavioral Counselling

Behavioral: Peer Counselling

Intensive Behavioral Counseling & Peer Support & Varenicline

Experimental group

Description:

Intensive Behavioral Counseling \& Peer Support \& Varenicline

Treatment:

Behavioral: Intensive Behavioral Counselling

Behavioral: Peer Counselling

Drug: Varenicline

Intensive Behavioral Counseling & Peer Support & c-NRT

Experimental group

Description:

Intensive Behavioral Counseling \& Peer Support \& c-NRT

Treatment:

Drug: Nicotine patch

Behavioral: Intensive Behavioral Counselling

Drug: Nicotine gum

Behavioral: Peer Counselling

Intensive Behavioral Counseling & Peer Support & c-NRT & Varenicline

Experimental group

Description:

Intensive Behavioral Counseling \& Peer Support \& c-NRT \& Varenicline

Treatment:

Drug: Nicotine patch

Behavioral: Intensive Behavioral Counselling

Drug: Nicotine gum

Behavioral: Peer Counselling

Drug: Varenicline