Mobile Contingency Management for Smoking Cessation (R01 Supplement) (PrevailGO)
Condition: Smoking Cessation
Study type: Interventional

Summary: 
      Smoking prevalence rates are disproportionately high among individuals living below the
      poverty threshold, those living in rural areas, and Oklahomans. Nearly 1.3 million Oklahomans
      live in rural areas and the prevalence of poverty is elevated relative to the U.S. Our
      preliminary work has indicated that offering small escalating financial incentives for
      smoking abstinence (i.e., Contingency Management [CM]) dramatically increases short-term
      cessation rates among socioeconomically disadvantaged smokers when incentives are included as
      an adjunct to clinic-based smoking cessation treatment. However, other approaches are needed
      for socioeconomically disadvantaged individuals who are unable to attend clinic visits due to
      rural residence or other limitations. Internet and mobile phone-based CM approaches have been
      developed to reduce or eliminate the need for in-person visits. The goal of the current
      project is to improve upon existing mobile CM approaches by fully automating the process to
      make financial incentives interventions for smoking cessation feasible and accessible to
      individuals across the state. The aims of the proposed project are to 1) develop a fully
      automated, mobile phone-based CM approach to remotely verify smoking abstinence, confirm
      participant identity, and deliver financial incentives for smoking cessation, and 2) evaluate
      the feasibility and preliminary effectiveness of using fully automated mobile CM as an
      adjunct to telephone counseling and nicotine replacement therapy among 20 socioeconomically
      disadvantaged adults. The current project extends the scope of the parent study by increasing
      the reach of the CM approach to socioeconomically disadvantaged individuals who may be unable
      to attend in-person visits.
    

Detailed description: 
      Tobacco Cessation Treatment. Participants referred to the Tobacco Treatment Research Program
      (TTRP) for smoking cessation treatment who are interested and eligible for the current study
      will be offered weekly telephone counseling/support sessions led by a staff counselor. Six
      unique sessions covering the following topics will be offered: 1) quit planning 2) the impact
      of tobacco on health/benefits of quitting, 2) stress management strategies, 3) making
      positive lifestyle changes, 4) developing coping skills, and 5) relapse prevention. The
      counselor will check in with participants each week about the difficulties and successes they
      have experienced, and plan for any challenging situations that are anticipated. Advice and
      support will be provided as needed. A two-week supply of nicotine replacement therapy
      (patches and gum) will be offered during the first session for medically eligible
      participants. Additional patches and gum will be mailed out for participants who wish to
      continue using pharmacotherapy (for up to 12 weeks).

      Financial Incentives. Participants will be provided with a smartphone that has the PrevailGO
      EMA app preloaded, as well as a Smokerlyzer iCO monitor. Participants will be randomly
      prompted 4 times daily during waking hours to complete smartphone-based EMAs. During random
      prompts, participants who self-report abstinence will be asked to provide a CO breath sample
      on 5 randomly selected days out of the week. Participants will be prompted to provide a CO
      breath sample at the last random assessment of the day, Participants will be reminded 2
      additional times on the same day during their normal waking hours to provide a CO breath
      sample if they miss the initial assessment. A gift card credit may be earned following a
      self-report of abstinence during the past 24 hours combined with a breath CO sample of ≤ 6
      ppm.

      Recruitment/Screening (Visit 1, Part 1; Screening). Individuals who are referred to the TTRP
      for smoking cessation treatment and report that they are uninsured or receiving Medicaid
      benefits will be sent an informational handout with their TTRP information packet (prior to
      their first visit). Participants will be reminded of all future in-person appointments via
      telephone, mail, email, and/or text. Additionally, research staff may attempt to collect
      smoking cessation status with each reminder. Participants with transportation difficulties
      living in the Oklahoma City metro area may be scheduled for pick-up and drop-off for key
      visits with SendaRide through their secure dashboard. At the first visit, study staff will
      inquire about their interest in finding out more about the study. Study staff will review the
      consent form with interested participants, and they will be screened for eligibility on-site
      in a private room in the clinic. Participant eligibility for the current study will not
      influence eligibility for the TTRP. The Rapid Estimate of Adult Literacy in Medicine (REALM;
      see Appendix A) will be administered to ensure that all participants are able to read at ≥
      sixth grade level (i.e., required to complete EMA and self-report questionnaires). Expired
      carbon monoxide (CO) will be measured and participants will be questioned about their 1)
      insurance status 2) age, 3) current level of smoking, 4) willingness to quit smoking, 5)
      willingness/ability to complete 6 weekly counseling sessions (including the first visit), 6)
      pregnancy/breastfeeding status, 7) computer/internet access, and 8) contraindications for
      nicotine replacement therapy. Expired CO will be measured. Eligible participants may complete
      the assessment portion of the visit.

      Pre-Quit (Visit 1, Part 2; Assessment). Participants will complete self-report questionnaires
      on a laptop computer; weight and height will be measured in a private room to ensure
      confidentiality. Visit 1 will be 1 of 2 in-person visits. Participants will be provided with
      an Android smartphone and a Smokerlyzer iCO breathe monitor. They will be instructed
      regarding the use of the phone (participants may make personal calls), the EMA procedures,
      and use of the portable CO monitor. Participants will receive 4 random prompts and 1 daily
      diary prompt (in the morning) during the normal waking hours each day for five consecutive
      weeks. Participants will be instructed to quit smoking at bedtime or 10:00 pm (whichever
      occurs first) 7 days after enrollment.

      Quit Day. Participants will remotely complete web-based self-report questionnaires and
      provide a smartphone-based CO measurement.

      One Week Post-Quit. Participants will remotely complete web-based self-report questionnaires
      and provide a smartphone-based CO measurement.

      Two Weeks Post-Quit. Participants will remotely complete web-based self-report questionnaires
      and provide a smartphone-based CO measurement.

      Three Weeks Post-Quit. Participants will remotely complete web-based self-report
      questionnaires and provide a smartphone-based CO measurement.

      Four Weeks Post-Quit. Participants will remotely complete web-based self-report
      questionnaires and provide a smartphone-based CO measurement.

      Eight Weeks Post-Quit. Participants will remotely complete web-based self-report
      questionnaires and provide a smartphone-based CO measurement.

      Twelve Weeks Post-Quit. Participants will return to the TTRP and complete self-report
      questionnaires on a tablet or laptop computer and provide a CO measurement.
    

Intervention name(s): Mobile Contingency Management
Intervention type(s): Behavioral
Intervention description(s): Participants will be offered 6 counseling sessions, nicotine replacement therapy, and a smartphone app that remotely verifies participant identity and smoking abstinence and automatically credits a gift card account for evidence of smoking abstinence.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Smoking Cessation; Socioeconomic Disadvantage; Contingency Management; Financial Incentives; Mobile Health; Biochemical Verification