Tobacco Assessment and Intervention With Low-Income Persons Living With HIV-AIDS (PLWHA) in Community-Based AIDS Service Organizations
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ClinicalTrials.gov Identifier: NCT01482923 |
Recruitment Status
:
Active, not recruiting
First Posted
: December 1, 2011
Last Update Posted
: February 7, 2018
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Condition or disease | Intervention/treatment |
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Tobacco Cessation HIV AIDS | Behavioral: Treatment as usual Behavioral: AIR (Aspirations, Inspiration, Respiration) |
Study Type : | Observational |
Estimated Enrollment : | 60 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Feasibility of Tobacco Assessment and Intervention With Low-Income Persons Living With HIV-AIDS (PLWHA) in Community-Based AIDS Service Organizations |
Actual Study Start Date : | November 2011 |
Estimated Primary Completion Date : | November 2018 |
Estimated Study Completion Date : | November 2018 |

Group/Cohort | Intervention/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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Behavioral: Treatment as usual
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.
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Behavioral: AIR (Aspirations, Inspiration, Respiration)
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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- 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."
- 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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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01482923
United States, New York | |
City College of New York | |
New York, New York, United States, 10031 |
Principal Investigator: | Jamie Ostroff, PhD | Memorial Sloan Kettering Cancer Center |
Additional Information:
Responsible Party: | Memorial Sloan Kettering Cancer Center |
ClinicalTrials.gov Identifier: | NCT01482923 History of Changes |
Other Study ID Numbers: |
11-173 |
First Posted: | December 1, 2011 Key Record Dates |
Last Update Posted: | February 7, 2018 |
Last Verified: | May 2017 |
Keywords provided by Memorial Sloan Kettering Cancer Center:
Tobacco Use Assessment smoke tobacco quit smoking tobacco cessation |
HIV/AIDS Community-Based Service Organizations 11-173 Low-Income Persons Living with HIV/AIDS |