Evaluating Smoking Cessation Interventions for PWH in South Africa

• Status: Not yet recruiting
• Trial end date: 2028-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johns Hopkins University
• Collaborators: Colorado State University; National Cancer Institute (NCI); New York University; Perinatal HIV Research Unit of the University of the Witswatersrand
• Treatments: Nicotine; Varenicline

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 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.