NCT05413122 Evaluating Smoking Cessation Interventions for PWH in South Africa
| NCT ID | NCT05413122 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Johns Hopkins University |
| Condition | Smoking Cessation |
| Study Type | INTERVENTIONAL |
| Enrollment | 660 participants |
| Start Date | 2023-11-27 |
| Primary Completion | 2027-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 660 participants in total. It began in 2023-11-27 with a primary completion date of 2027-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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 (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, 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 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. 10. In the opinion of the attending investigator are not a candidate for the clinical trail.
Contact & Investigator
Neil Martison
PRINCIPAL INVESTIGATOR
Perinatal HIV Research Unit (PHRU)
Frequently Asked Questions
Who can join the NCT05413122 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Smoking Cessation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05413122 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05413122 currently recruiting?
Yes, NCT05413122 is actively recruiting participants. Contact the research team at jgolub@jhmi.edu for enrollment information.
Where is the NCT05413122 trial being conducted?
This trial is being conducted at Soweto, South Africa.
Who is sponsoring the NCT05413122 clinical trial?
NCT05413122 is sponsored by Johns Hopkins University. The principal investigator is Neil Martison at Perinatal HIV Research Unit (PHRU). The trial plans to enroll 660 participants.