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New treatment option for Smoking Cessation
Official title Evaluating Smoking Cessation Interventions for PWH in South Africa
ClinicalTrials.gov ID: NCT05413122
What this study is testing
What is Varenicline?
Varenicline is an investigational medicine, being studied as a potential treatment for smoking cessation.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- ≥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...
- 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...
- 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...
You likely can't join if
- 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
- 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
See the full eligibility 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 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...
- either own or have household access to a mobile phone, and
- provide written informed consent.
- 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
- 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
- have a history of adverse reactions to varenicline or nicotine patch, 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.
The study team makes the final eligibility decision.
Where it's taking place
- Soweto, Gauteng, South Africa
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Soweto, Gauteng, South Africa. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.