New study aims to help people with HIV quit smoking in south africa
NCT ID NCT05413122
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests two smoking cessation methods—varenicline pills and nicotine patches with gum—in 660 people with HIV in South Africa. Participants will receive one of these treatments for 12 weeks, along with counseling. The goal is to see which approach works best to help them quit smoking long-term, with follow-up at 26 and 52 weeks.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Varenicline and nicotine replacement therapy (patches and gum)
- What this could lead to
- If successful, this could provide an effective, scalable smoking cessation program integrated into HIV care, reducing smoking-related diseases in this population.
- What could go wrong
- This is a Phase 2/3 trial, so results are not yet proven. The interventions may not work as well in real-world settings, and side effects like nausea or skin irritation are possible.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2/3
Runs two stages together: whether the treatment works, then large-scale confirmation.
- Participants
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About 660 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2023
- Expected to finish
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Aug 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 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) ≥ 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, 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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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Perinatal HIV Research Unit (PHRU)
RECRUITINGSoweto, Gauteng, South Africa
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