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โ† Trials
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Evaluating Smoking Cessation Interventions for PWH in South Africa

RecruitingPhase 2, Phase 3Ages 18 Years - anyAllJohns Hopkins University
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. โ‰ฅ18 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 or evidence of taking ART for four of the past six 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, smoked at least one cigarette daily in the past 30 days, have exhaled breath carbon monoxide (CO) โ‰ฅ 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 โ‰ค 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, or 10. are a household member of a currently enrolled participant in this trial, or 11. In the opinion of the attending investigator are not a candidate for the clinical trail.
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What it tests

  • Varenicline
  • Nicotine patch
  • Nicotine gum
  • Intensive Behavioral Counselling
  • Peer Counselling
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Where

1 site
Perinatal HIV Research Unit (PHRU)
Soweto, South Africa
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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