IRB Award: 

National Institutes of Health – National Cancer Institute 

Title: Efficacy of two novel behavioral post-cessation weight gain interventions 

 Leveraging Community Pharmacists to Optimize Smoking Cessation Services for Rural Smokers in Appalachia 

1R01CA267963-01A1 

PI: Melissa Little, PhD, MPH  

Years: 2022-2027 

Award: $5,087,163  

Working study name: QuitAid 

IRB Finalization: 

Name: Leveraging Community Pharmacists to Optimize Smoking Cessation Services for Rural Smokers in Appalachia  

ID: HSR 220197 

Date: 09/13/2022 (yearly renewal) 

IRB Assurance Letter: 

ASSURANCE FORM 

University of Virginia 

Institutional Review Board for Health Sciences Research HIPAA Privacy Board  

UVA Study Tracking #HSR220197

Event: Approval Protocol Modification – Expedited  

Type: Protocol 

Sponsor(s):  National Cancer Institute (NCI-NIH) Sponsor Protocol #: 1 R01 CA267963-01A1 

Principal Investigator: Melissa Little

Title: Leveraging Community Pharmacists to Optimize Smoking Cessation Services for Rural Smokers in Appalachia 

Assurance:  Federal Wide Assurance (FWA)#: 00006183   UVa IRB #1 Registration IRB#00000447  

Certification of IRB Review: The IRB-HSR/HIPAA Privacy Board abides by 21CFR50, 21CFR56, 45CFR46, 45CFR160, 45CFR164, 32CFR219 and ICH guidelines as compatible with FDA and DHHS regulations. This activity has been reviewed in accordance with these regulations. 

Event Date:  04/11/23 Protocol Expiration Date:  09/12/23 Study Protocol :  03/16/23

Current Status: Open to Enrollment  

Consent Version Dates: Adult   09/01/22 

UVA Site Only Number of Subjects Approved to Enroll:   838 Study-Data Security Plan  07/28/22  Study-Application  04/03/23  

Committee Members (did not vote): 

Comments:   The IRB determined the modification met the criteria for approval per the federal regulations and was approved per 45CFR46.110(b)(2). Modification expedited: minimal risk/minor changes. The following revisions were applied: Change NRT gum to NRT lozenge. Participants favor NRT lozenge more than gum and there are lesscontraindications for using the lozenge, and thus the need for fewer protocol modifications for people who can not use the gum and need the lozenge. They also have similar efficacy. Updates Pharmacist and Participant (rural smokers) Surveys. Updated the measures in the pharmacistand participant surveys after reviewing the findings from the pilot feasibility trial (HSR210262).  Changed from cotinine verification of smoking abstinence as the primary biochemical verification tocarbon monoxide monitoring. Carbon monoxide monitoring was already approved for smokers who reported using other tobacco products such as e-cigarettes or smokeless tobacco. Given the growing number of dual users, all smokers who quit, verify their smoking abstinence using the Microport Smokelyzer carbon monoxide monitor. This will ensure uniformity across participants and avoid the need to collect saliva samples (which is required in the cotinine verification). 

• Removed the requirement for pharmacies to be in the Central and South Central sub-regions of 

Appalachia. The study team realized that some of the targeted areas of rural Appalachia are in North Central (they still fall within the other parameters that were previously approved, namely in rural Appalachian areas that include Virginia, Tennessee, Kentucky, North Carolina and West Virginia). 

• Include a participant referral program. In addition, following the baseline visit, participants will be madeaware of an opportunity to refer up to 3 non-household members to participate in the study. If the individual who is referred to the study completes a phone screen, the individual who made the referral will receive $15 per randomized participant. The maximum referral bonus per participant is $45. 

• Participants can complete the baseline survey now telephonically. Once consent is obtained, theparticipant will complete the baseline assessment (either by phone or a secure RedCap link or a mailed paper copy of the survey).  

• Moved some of the demographic questions from the baseline to the screener. Historically, clinical trialshave included mostly white racial groups and women. Recently there has been a push to ensure that clinical trials have adequate representation of minority and underrepresented populations. In order to inform future clinical trials and ensure adequate representation of these underrepresented groups, it is important to collect demographics of individuals throughout the recruitment process to see if and where these underrepresented groups are getting screened out. By moving the demographics questions to the screener, the study team will be able to make informed decisions throughout the study regarding recruitment and marketing efforts to ensure adequate representation of the study sample in terms of race, ethnicity, gender and SES. 

• Removed OutcomesMTM to document billing and study documentation. The software was not going to capture enough of the study documentation needed for a clinical trial.  

• The follow-up assessments based on randomization instead of enrollment. This will ensure thatfollow-ups are based on completion of the baseline survey and when interventions begin. It has been the experience of the study team that some individuals can take a while to complete the baseline survey. Basing follow-ups off of the randomization eliminates any confounding based on time to complete the baseline survey. 

• Added incentives for pharmacies (non-humans subjects payments) for participating in the study.Previously, the study team reimbursed pharmacies for providing MTM, distributing NRT and administering the cotinine test. With this modification, adding in additional incentive payments to cover the costs associated with participating in a clinical trial. Will also reimburse pharmacies for any costs associated with providing the NRT study medications that are not covered by a participant’s insurance. Finally, to reimburse pharmacies for their support of the study, the study will provide them with a $2,000 compensation after they have recruited their first 20 subjects. For each additional 20 subjects, they will receive an additional $1,000. 

• Treatment Fidelity Guides. Developed documentation guides to document the implementation of thebehavioral treatment sessions for both QuitAid and QuitLine. These documentation guides will also ensure the fidelity of the implementation guides, which will be conducted by either tape review (for QuitLine) or a ‘secret shopper’ format (for Quitaid). This change is already outlined in the protocol and these guides are included in this modification for review. 

• Updated verbal consent script.  

• Separated out the screener from the consent process. 

Reconsent IS required for Pharmacist subjects if already recruited to participate.  

Reconsent NOT required for smoking cessation subjects as NO subjects have been enrolled.  

Included with Submission

1.Revised Protocol dated 3-16-23 2.Revised IRB application dated 4-3-23 Revised Telephone Verbal Consent Script dated 3-13-23 Revised Study Information Sheet 5.Pharmacist Baseline Assessment Form 6.Package Inserts for Nicotine Lozenges (replacing Nicotine Gum as a treatment) 7.Pharmacist Overview Booklet 8.Quit Aid 2 month survey 9.Quit Aid 6 month survey 9.Quit Aid Baseline Survey 10.Documentation Guides: a.MTM Intervention Day 1 b.MTM Intervention Day 7, 14, 21, 28 c.MTM Intervention 48 Hours d.Session 1 Telephone Counseling Documentation Guide e.Session 2 Telephone Counseling Documentation Guide f.Session 3 Telephone Counseling Documentation Guide g.Session 4 Telephone Counseling Documentation Guide 11.Fidelity Guides:  a.Fidelity QuitAid Session 1 b.Fidelity QuitAid Sessions 7, 14, 21, 28 c.Fidelity Telephone Counseling Session 1 d.Fidelity Telephone Counseling Session 2 e.Fidelity Telephone Counseling Session 3 f.Fidelity Telephone Counseling Session 4

The IRB-HSR official noted below certifies that the information provided above is correct and that, as required, future reviews will be performed and certification will be provided.   

Name: Eileen C. Sembrowich, BSc,BA,CCRP,CIP Title: Member, Institutional Review Board for Health Sciences Research 434.924.2620 Fax: 434-924-2932  

Name and Address of Institution: IRB for Health Sciences Research University of Virginia, PO Box 800483 Charlottesville, VA 22908  OR IRB for Health Sciences Research One Morton Drive, Suite 400 Charlottesville, VA 22903  

Approved by:  Eileen C. Sembrowich, BSc,BA,CCRP,CIP   From IP Address: 128.143.229.234  

Date:    04/11/23 at 10:06 AM