Evaluating Smoking Cessation Interventions for PWH in South Africa

HIV Clinical Trial

— Tlogela  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05413122
• Other study ID #: IRB00299078
• Secondary ID: 1U01CA261626-01
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: November 27, 2023
• Est. completion date: November 27, 2029

Study information

• Verified date: November 2023
• Source: Johns Hopkins University
• Contact: Jonathan E Golub, PhD MPH
• Phone: 443-287-2969
• Email: jgolub[@]jhmi.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 660
• Est. completion date: November 27, 2029
• Est. primary completion date: November 27, 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Comorbidities and Coexisting Conditions
• HIV
• Smoking Cessation

Intervention

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

Country	Name	City	State
South Africa	Perinatal HIV Research Unit (PHRU)	Soweto	Gauteng

Sponsors (5)

Lead Sponsor	Collaborator
Johns Hopkins University	Colorado State University, National Cancer Institute (NCI), New York University, Perinatal HIV Research Unit of the University of the Witswatersrand

Country where clinical trial is conducted

South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	7-day point prevalence tobacco abstinence at 52 weeks	Verified by exhaled breath CO < 7ppm and a negative urine cotinine test.	52 weeks
Secondary	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.	26 weeks
Secondary	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.	12 weeks