Optimizing smoking cessation treatments for people with HIV in South Africa

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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.

Where it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Proactive pharmacist e-consults to optimize lung health for people with HIV

  This trial tests whether proactive pharmacist-led e-consults can help people with HIV improve lung-health medications, vaccinations, smoking cessation, and deprescribing of certain inhaled medicines or PPIs.

  Recruiting Seattle Institute for Biomedical and Clinical Research · Boise, Idaho and 2 other locations · NCT07507435

• Quitting Matters: a smoking quit program for people living with HIV

  This 6-month program will test whether a tailored smartphone app plus nicotine patches and gum helps people living with HIV quit smoking better than a standard quit app.

  Recruiting Wake Forest University Health Sciences · Winston-Salem, North Carolina · NCT06883097

• Helping Cambodian people with HIV quit smoking using text messages

  This study is testing if sending text messages can help people in Cambodia who have HIV quit smoking by providing support and resources.

  Recruiting at 3 sites H. Lee Moffitt Cancer Center and Research Institute · Phnom Penh and 2 other locations · NCT05746442

• Personalized wellness intervention for smoking cessation in adults living with HIV

  This study tests a personalized program to help adults with HIV quit smoking and see if it works better than standard methods.

  Recruiting at 2 sites University of Arizona · Phoenix, Arizona and 1 other locations · NCT04725617

• Smoky Futures: Danish Adolescent Nicotine Use over Time

  This observational cohort follows Danish youths ages 15–25 to see how cigarette, e-cigarette, and other nicotine use begin, change, and affect health and education over several years.

  Recruiting University of Southern Denmark · Copenhagen · NCT07910331

• Nicotine Orodispersible Tablet to Relieve Cravings in Smokers

  A nicotine mint orodispersible tablet is tested vs placebo to see if it quickly eases the urge to smoke in adult cigarette smokers.

  Recruiting Phase 2 Kenvue Brands LLC · Mississauga, Ontario · NCT07893158

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.