Tobacco Assessment and Intervention With Low-Income Persons Living With HIV-AIDS (PLWHA) in Community-Based AIDS Service Organizations

Study Overview
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Brief Summary
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A treatment session especially for PLWHA to help them discuss and take action about their smoking may be useful.

Official Title
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Feasibility of Tobacco Assessment and Intervention With Low-Income Persons Living With HIV-AIDS (PLWHA) in Community-Based AIDS Service Organizations

Conditions
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HIV, Tobacco Cessation, AIDS

Intervention / Treatment
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* Behavioral: Treatment as usual
* Behavioral: AIR (Aspirations, Inspiration, Respiration)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 years or older as per self-report; English speaking; New York or New Jersey State resident; HIV-positive serostatus direct referral from a CAB agency staff member, which verifies that the person is an HIV+ client, or by as verified by presentation of medical evidence (i.e.,confirmatory test result, ARV prescription, M11Q form, or lab results); Self-report of smoking > or = to 20 cigarettes (> or = to one pack) within the prior 7 days; To confirm smoking status, the carbon monoxide alveolar breath test must be > or = to 10 ppm; To confirm cognitive functioning, score on the in-person BLESSED Exam must be < or = to 10; Low income, defined by either: 1) Proof of Medicaid insurance, or 2) Self-report of income at 50% or below median income for New York State for New York State residents, or if a New Jersey resident, at or below 50% median income for New Jersey Exclusion Criteria: Presence of current severe psychopathology that would limit study participation (e.g., unstable schizophrenia, bipolar disorder recent changes to medication noncompliance); Currently receiving smoking cessation treatment elsewhere.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Treatment As Usual (TAU)<br>This study is a pilot intervention trial examining the feasibility of a motivational smoking cessation intervention using respiratory biomarker feedback in low income PLWHA. The plan is to recruit a pilot sample of 50 eligible and consented participants, randomized at a 1:1 ratio into either the Treatment As Usual (TAU) condition or the experimental (Aspiration, Inspiration Respiration, or AIR) intervention condition. | Behavioral: Treatment as usual<br>* Participants in the Treatment as Usual study arm will be provided with the following: 1) brief smoking cessation counseling as recommended in the Public Health Service treatment guidelines; 2) direct referral to the NY/NJ State Quitline; 3) a brochure that describes the Quitline services and provides contact information via telephone or internet; 4) a NY State brochure on HIV and smoking that identifies the specific risks of smoking for PLWHA; and 5) referral assistance to participants who present with untreated co-morbid conditions.<br>|
| Aspiration, Inspiration Respiration, or AIR<br>This study is a pilot intervention trial examining the feasibility of a motivational smoking cessation intervention using respiratory biomarker feedback in low income PLWHA. The plan is to recruit a pilot sample of 50 eligible and consented participants, randomized at a 1:1 ratio into either the Treatment As Usual (TAU) condition or the experimental (Aspiration, Inspiration Respiration, or AIR) intervention condition. | Behavioral: AIR (Aspirations, Inspiration, Respiration)<br>* Participants in the Aspirations, Inspiration, and Respiration study arm will receive all of the components of Treatment as Usual along with these additional components: 1) a lung age test to determine the ability and functioning of their lungs; 2) a personal lung health report with their lung age, the CO level of their breath, and a summary of their respiratory symptom assessment; 3) a review of this personal lung health report with a study counselor, 4) motivational interviewing techniques guided by Self-Determination Theory concepts to explicitly elicit at least one life aspiration of the patient and encourage discussion of such aspirations using an autonomy-supportive approach.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of a motivational tobacco cessation intervention | The study will test whether the percentage of eligible and enrolled study participants who complete the assigned intervention is significantly different from a population of percentages centered at 45%, i.e., the null population percentage, considered a percentage too low to be compatible with feasibility. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Estimate the differences between the experimental intervention | Assess potential factors influencing study participation by community organizations and, as the description, Descriptive statistics will be summarized by participating community organizations on each organization's Implementation Factors assessment, an agency study participation measure developed for this project. The measure assesses how many clients the agency has referred, what means were used to recruit, and what barriers to recruitment were encountered, and an open-ended question is provided for additional input. | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tobacco Use Assessment, smoke tobacco, quit smoking, tobacco cessation, HIV/AIDS, Community-Based Service Organizations, 11-173, Low-Income Persons Living with HIV/AIDS