NCT05842161 South Africa Smoking Cessation and Engagement in HIV/TB Care Care
| NCT ID | NCT05842161 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Massachusetts General Hospital |
| Condition | HIV Infections |
| Study Type | INTERVENTIONAL |
| Enrollment | 86 participants |
| Start Date | 2024-03-12 |
| Primary Completion | 2026-05-01 |
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.
This trial targets 86 participants in total. It began in 2024-03-12 with a primary completion date of 2026-05-01.
⚠ 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 purpose of this study is to integrate elements from existing interventions developed by our team into a single intervention (QUIT-AD), designed to improve smoking cessation and favorable HIV/TB treatment outcomes among individuals with HIV and/or TB in Cape Town, South Africa. If feasibility, acceptability, and preliminary efficacy are demonstrated, the intervention will be ready for large-scale effectiveness/implementation testing. This program will has the potential to dramatically improve public health by increasing the smoking quit rate and facilitating favorable HIV/TB treatment outcomes among patients with HIV and/or TB in resource limited South African settings.
Eligibility 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
Contact & Investigator
Amelia Stanton, PhD
PRINCIPAL INVESTIGATOR
Boston University
Frequently Asked Questions
Who can join the NCT05842161 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying HIV Infections. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05842161 currently recruiting?
Yes, NCT05842161 is actively recruiting participants. Contact the research team at cocleirigh@mgh.harvard.edu for enrollment information.
Where is the NCT05842161 trial being conducted?
This trial is being conducted at Rondebosch, South Africa.
Who is sponsoring the NCT05842161 clinical trial?
NCT05842161 is sponsored by Massachusetts General Hospital. The principal investigator is Amelia Stanton, PhD at Boston University. The trial plans to enroll 86 participants.
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