Testing Quit-Smoking Treatments for People Living With HIV in South Africa
Tests quit-smoking drugs and counselling in adults living with HIV in South Africa.
Plain-language title generated from the registry record
Registry title: Evaluating Smoking Cessation Interventions for PWH in South Africa
Key facts
- Where
- Soweto, South AfricaSee the site
- Phase
- Phase 2/3
Where in South Africa
- Perinatal HIV Research Unit (PHRU)Soweto, South AfricaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Johns Hopkins University
- Trial code
- NCT05413122
- Record updated
- 19 October 2026
- Original description
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.Read full original descriptionShow less
Evaluating Smoking Cessation Interventions for PWH in South Africa: Efficacy, Implementation, and Cost-effectiveness
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.
Inclusion: ≥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; are current tobacco smokers (smoked at least 100 cigarettes in the subject's lifetime, smoked at least one cigarette daily in the past 30 days, have exhaled breath carbon monoxide (CO) ≥ 7 parts per million (ppm), and have a positive urine cotinine test), and; either own or have household access to a mobile phone, and; provide written informed consent.
Exclusion: 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 a history of adverse reactions to varenicline or nicotine patch, or; have generalized eczema or psoriasis, or; have cognitive dysfunction or psychosis as defined by the Mini-International Neuropsychiatric Interview (M.I.N.I.), or; have suicide risk as defined by the Columbia-Suicide Severity Rating Scale (C-SSRS), or; are pregnant, planning to become pregnant in the next four months, lactating, or are unwilling to use effective birth control, or; are not planning to continue to receive care at the clinic for the next 52 weeks, or; are a household member of a currently enrolled participant in this trial, or; In the opinion of the attending investigator are not a candidate for the clinical trail.