Evaluating Smoking Cessation Interventions for PWH in South Africa

Launched by JOHNS HOPKINS UNIVERSITY · Jun 3, 2022

Keywords

ClinConnect Summary

This clinical trial is looking at how to help people living with HIV (PWH) in South Africa quit smoking. The goal is to create a smoking cessation program that can be easily included in the regular care they receive for HIV. The study is currently recruiting participants who are at least 18 years old, have a confirmed HIV diagnosis, and are regular smokers. To join, they also need to be receiving HIV treatment for at least three months and have access to a mobile phone.

Participants in the trial can expect to receive support and resources designed to help them quit smoking, along with regular check-ins. It's important to know that some people may not be eligible, such as those who have recently received smoking cessation help, have certain medical conditions, or are pregnant. If you or someone you know meets the criteria and is interested in quitting smoking, this trial could be a great opportunity to get support tailored specifically for people living with HIV.

Gender

ALL

Eligibility criteria

• 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.