Tailoring Shared Decision Making for Lung Cancer Screening in Persons Living With HIV

Study Overview
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Brief Summary
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This study tailors a shared decision making intervention for lung cancer screening in persons living with human immunodeficiency virus (HIV). Information collected in this study may help doctors better understand how to perform lung cancer screening in persons living with HIV, so as to enhance shared decision making in persons living with HIV.

Detailed Description
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OUTLINE: AIM I: Participants attend a focus group over 1-1.5 hours providing feedback on refining potential methods of shared decision making (SDM). AIM II: Participants receive the SDM intervention developed in Aim I and provide feedback. Participants may attend a telephone interview over 45 minutes 1 month later.

Official Title
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Tailoring Shared Decision Making for Lung Cancer Screening in Persons With HIV (PWH)

Conditions
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Lung Carcinoma

Intervention / Treatment
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* Behavioral: Behavioral Intervention
* Other: Discussion (focus group)
* Other: Discussion (feedback on SDM)
* Other: Interview
* Other: Survey Administration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: AIM I: Patients with human immunodeficiency virus (PWH) enrolled in the local UW HIV cohort and primary providers at Madison Clinic and other Seattle-based clinics serving PWH AIM I: Using proposed United States Preventive Services Task Force (USPSTF) guidelines, participants enrolled in the registry who are current or former smokers, report >= 20 pack-years smoking history, and >= 50 years old (n=165) will be eligible for recruitment AIM I: Clinicians (medical doctors, physicians assistants and nurse practitioners) who provide primary care for PWH (n=48) will be eligible AIM II: PWH who are eligible for lung cancer screening (LCS) based on proposed USPSTF criteria Exclusion Criteria: Those found to be ineligible for LCS on coordinator review Are non-English speaking or have cognitive dysfunction that would prevent participation in SDM

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Observational (focus group, interview)<br>AIM I: Participants attend a focus group over 1-1.5 hours providing feedback on refining potential methods of SDM. AIM II: Participants receive the SDM intervention developed in Aim I and provide feedback. Participants may attend a telephone interview over 45 minutes 1 month later. | Behavioral: Behavioral Intervention<br>* Receive SDM intervention<br>* Other names: Behavioral Treatments;Other: Discussion (focus group)<br>* Attend focus group<br>* Other names: Discuss;Other: Discussion (feedback on SDM)<br>* Provide feedback on SDM<br>* Other names: Discuss;Other: Interview<br>* Attend a telephone interview<br>Other: Survey Administration<br>* Ancillary studies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Focus group analysis (Aim I) | All focus groups will be recorded and transcribed. Will use a framework analysis approach which combines both inductive and deductive methods where generated themes are mapped onto an implementation framework, specifically the Tailored Implementation of Chronic Diseases (TICD) checklist. Codes will then be analyzed through a constant comparison method to determine key themes. Will analyze all focus groups in real time to make iterative changes to the focus group guide based on feedback and refining potential methods of shared decision making (SDM). Pre-/post-SDM survey data will be collected via tablet, with a paper option if desired. | 10 months | 
| Lung cancer screening knowledge (LKS) responses (Aim II) | Pre- and post-intervention LKS responses will be compared via Chochran-Mantel-Haenszel or Friedman test based on data type. A Chochran-Mantel-Haenszel test will be used with categorical data and a Friedman test will be used with non-categorical data. | 14 months | 
| Decision of cancer screening (DCS) (Aim II) | The DCS will be summarized as the median of scores for participants from 0 (extreme certainty) to 100 (extreme uncertainty). | 14 months | 
| Acceptability of Intervention Measure (AIM) (Aim II) | Will be summarized and presented as range of scores from 1 (low acceptability/appropriateness) to 5 (high acceptability/appropriateness). | 14 months | 
| Intervention Appropriateness Measure (Aim II) | Will be summarized and presented as range of scores from 1 (low acceptability/appropriateness) to 5 (high acceptability/appropriateness). | 14 months | 
| Fidelity (Aim II) | Will be summarized as median percent of checklist items completed. Joint displays consistent with a mixed-methods convergent design will be used to analyze and interpret the data. | 14 months |