Evaluating Smoking Cessation Interventions for PWH in South Africa (NCT05413122) | Clinical Trial Compass
RecruitingPhase 2/3
Evaluating Smoking Cessation Interventions for PWH in South Africa
South Africa660 participantsStarted 2023-11-27
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. ≥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 (to ensure engagement in care at the recruitment clinic), and
✓. 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
✓. either own or have household access to a mobile phone, and
✓. provide written informed consent.
Exclusion criteria
✕. 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 generalized eczema or psoriasis, or
✕
What they're measuring
1
7-day point prevalence tobacco abstinence at 52 weeks