Optimizing smoking cessation treatments for people with HIV in South Africa
Evaluating Smoking Cessation Interventions for PWH in South Africa: Efficacy, Implementation, and Cost-effectiveness
This study is testing a new way to help people with HIV in South Africa quit smoking by using a combination of counseling, support from peers, and medications to see if it works better than what’s currently available.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 660 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Johns Hopkins University Academic / other |
| Locations | 1 site (Soweto, Gauteng) |
| Trial ID | NCT05413122 on ClinicalTrials.gov |
What this trial studies
This project aims to enhance smoking cessation strategies for individuals living with HIV by integrating four evidence-based components into existing HIV care in South Africa. The study will assess the effectiveness of intensive behavioral counseling, peer support, combination nicotine replacement therapy, and varenicline in a randomized trial involving 660 adults. Participants will be recruited from selected clinics and will undergo a 12-week intervention period. The trial will also evaluate the implementation and cost-effectiveness of these interventions across diverse settings in Gauteng.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who are HIV-positive, current tobacco smokers, and engaged in HIV care.
Not a fit: Patients who are currently receiving smoking cessation counseling or pharmacotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve smoking cessation rates among people living with HIV, leading to better health outcomes.
How similar studies have performed: Other studies have shown success with integrated smoking cessation interventions in similar populations, indicating a promising approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Soweto, Gauteng
- Perinatal HIV Research Unit (PHRU) — Soweto, Gauteng, South Africa (Recruiting)
Study contacts
- Principal investigator: Neil Martison — Perinatal HIV Research Unit (PHRU)
- Study coordinator: Jonathan E Golub, PhD MPH
- Email: jgolub@jhmi.edu
- Phone: 443-287-2969
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.