Improving smoking cessation and HIV/TB treatment outcomes in South Africa
Treatment Development for Smoking Cessation and Engagement in HIV/TB
This study is testing a new program to help people living with HIV and tuberculosis in Cape Town quit smoking to improve their overall health and treatment results.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 86 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Massachusetts General Hospital Academic / other |
| Locations | 1 site (Rondebosch) |
| Trial ID | NCT05842161 on ClinicalTrials.gov |
What this trial studies
This study aims to integrate existing interventions into a new program called QUIT-AD, which focuses on enhancing smoking cessation efforts among individuals living with HIV and/or tuberculosis (TB) in Cape Town, South Africa. The program seeks to address the high prevalence of smoking in this population, which exacerbates health issues related to HIV and TB. By demonstrating feasibility, acceptability, and preliminary efficacy, the intervention could pave the way for larger-scale effectiveness testing. The ultimate goal is to improve public health outcomes by increasing smoking quit rates and facilitating better treatment outcomes for HIV and TB patients.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals aged 18 or older who are living with HIV and/or TB, are current smokers, and are motivated to quit smoking.
Not a fit: Patients who are not daily smokers, have untreated mental health conditions, or are using other smoking cessation therapies may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve health outcomes for patients with HIV and TB by increasing smoking cessation rates.
How similar studies have performed: Other studies have shown success in integrating smoking cessation programs with HIV and TB treatment, indicating that this approach has potential.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Aged 18 or older 2. Willing and able to provide written informed consent 3. Living with HIV, confirmed via medical record, and on antiretroviral therapy (ART) AND/OR within 1 month of initiating or reinitiating TB treatment; positive GeneXpert test or sputum culture (5) Daily smoker operationalized as \> 5 cigarettes per day, (6) Motivation (\> 5/10) to quit smoking or \> 24 hour quit past yr Exclusion Criteria: 1. Habitual use of other tobacco products 2. Current interfering untreated/unstable mental health condition (e.g., psychosis, bipolar dx) 3. Current use of non-study pharmacotherapy for smoking cessation, 4. Cognitive Behavioral Therapy for smoking cessation initiated within the past year, 5. Diagnosed with extra-pulmonary or drug resistant (MDR or XDR) TB based upon chart review
Where this trial is running
Rondebosch
- University of Cape Town — Rondebosch, South Africa (Recruiting)
Study contacts
- Principal investigator: Amelia Stanton, PhD — Boston University
- Study coordinator: Conall O'Cleirigh, PhD
- Email: cocleirigh@mgh.harvard.edu
- Phone: 617-643-0385
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.