Feasibility of a Medical-Legal Partnership Model to Connect Coal Miners QuitAid (NCT07694492)
Determining the Feasibility of Utilizing a Medical-Legal Partnership Model to Reach Coal Miners Who Use Tobacco and Nicotine Products and Connect Them to a Pharmacy-based Cessation Program
🩺 Plain-English Summary (8th-Grade Level)
Coal miners in Central Appalachia have among the highest rates of tobacco and nicotine product (TNP) use of any occupational group and face elevated rates of lung cancer and coal workers' pneumoconiosis ("black lung"). This study tests a novel medical-legal partnership (MLP) that "flips" the traditional referral direction: lawyers representing coal miners in black-lung workers' compensation cases identify clients who use TNPs and, through an ask-advise-connect process, connect them to community pharmacists who deliver QuitAid, a pharmacist-delivered medication therapy management (MTM) program, together with nicotine replacement therapy (NRT). The study has two aims: (1) an implementation-science evaluation of the ask-advise-connect process in black-lung law offices, and (2) a randomized feasibility pilot in which coal miners who use TNPs are randomized to receive QuitAid or not, with all participants receiving 24 weeks of NRT. As a feasibility pilot, the study is designed to estimate recruitment, randomization, retention, fidelity, and dose parameters to inform a future NCI R01, and is not powered to detect differences between conditions.
Who can join: Review the eligibility criteria below.
Location: University of Virginia — Charlottesville, Virginia
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (1 Sites)
- University of Virginia — Charlottesville, Virginia
📞 Contact the Study Coordinator
Phone: (304) 574-8073
Email: fzv3nn@virginia.edu
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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- Reward Sensitivity and Pharmacotherapy for Smoking Cessation — Houston, Texas
- Mi QUIT CARE (Mile Square QUIT Community-Access-Referral-Expansion) — Chicago, Illinois
- Feasibility of Delivering VergeRx at FQHCs — Charlottesville, Virginia
Explore by condition: All Tobacco Use Cessation clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.