Feasibility of a Medical-Legal Partnership Model to Connect Coal Miners QuitAid

Part of paid clinical trials in Charlottesville, Virginia.

Sponsor
University of Virginia
Study ID
NCT07694492
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

  • Nicotine Dependence
  • Smokeless Tobacco Use
  • Tobacco Use Cessation
  • Tobacco Use Disorder

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • QuitAid (pharmacist-delivered MTM) — BEHAVIORAL
    Six telephonic pharmacist coaching sessions over 4 weeks focused on setting a quit date and quitting TNPs. The first session (and subsequent proactive calls at \~days 2, 7, 14, 21, and 28) addresses negative beliefs about NRT, strengthens motivation and commitment to NRT use, monitors NRT use, provides feedback, and supports adherence. Includes the Pre-Quit Motivation Modules (up to three telephonic sessions) for participants not yet ready to quit.
  • Nicotine Replacement Therapy (NRT) — DRUG
    24 weeks of NRT dispensed under a standing order and mailed to participants, with standard use guidelines. Product is matched to TNP type: long-acting patch for smoked TNP users, short-acting gum for oral TNP users, patch for dual users.

Study Details

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.

Key Dates

First listed
Jul 10, 2026
Start date
Sep 1, 2026
Status verified
Jul 2026
Primary completion
Sep 30, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: QuitAid + NRT
    Participants receive the pharmacist-delivered QuitAid MTM program plus 24 weeks of NRT. Those ready to quit receive six telephonic coaching sessions over 4 weeks; those not ready to quit receive up to three Pre-Quit Motivation Modules and may transition to QuitAid upon reporting readiness at a weekly check-in (Weeks 1-4).
  • Active Comparator: NRT Only
    Participants receive 24 weeks of NRT beginning in Week 1 without the QuitAid MTM program. All follow-up assessments are conducted regardless of condition.

Primary Outcome Measure

Feasibility of Randomization [ Time Frame: Through study recruitment (approximately 6 months) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of VirginiaCharlottesvilleVirginia22903
Ashley N DeMoss, MPH
[email protected]
(304) 574-8073
Melissa A Little, PhD, MPH (PRINCIPAL_INVESTIGATOR)
Drew Harris, MD (PRINCIPAL_INVESTIGATOR)
Candace H Wood, PharmD (SUB_INVESTIGATOR)
Roger T Anderson, PhD (SUB_INVESTIGATOR)

Find similar trials in Charlottesville, VA

By research site
University of Virginia· Charlottesville, VA

Related Studies