Tobacco Assessment and Intervention With Low-Income Persons Living With HIV-AIDS (PLWHA) in Community-Based AIDS Service Organizations
Feasibility of Tobacco Assessment and Intervention With Low-Income Persons Living With HIV-AIDS (PLWHA) in Community-Based AIDS Service Organizations
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Actual)
Enrollment
Contacts and Locations
Study Locations
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New York
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New York, New York, United States, 10031
- City College of New York
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-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Number of groups / cohorts
Cohorts and Interventions
Group / CohortGroup / Cohort |
Intervention / TreatmentIntervention / Treatment |
|---|---|
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Treatment As Usual (TAU)
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.
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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.
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Aspiration, Inspiration Respiration, or AIR
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.
|
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.
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What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Feasibility of a motivational tobacco cessation intervention
Time Frame: 2 years
|
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."
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2 years
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Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Estimate the differences between the experimental intervention
Time Frame: 2 years
|
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."
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2 years
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Collaborators and Investigators
Sponsor
Sponsor
Collaborators
Collaborators
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Estimate)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
Other Study ID Numbers
- 11-173
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