Overview

This trial is active, not recruiting.

Conditions tobacco cessation, hiv, aids
Treatments treatment as usual, air (aspirations, inspiration, respiration)
Sponsor Memorial Sloan Kettering Cancer Center
Collaborator Gay Men’s Health Crisis
Start date November 2011
End date November 2017
Trial size 60 participants
Trial identifier NCT01482923, 11-173

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
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.
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.
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.
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.

Primary Outcomes

Measure
Feasibility of a motivational tobacco cessation intervention
time frame: 2 years

Secondary Outcomes

Measure
Estimate the differences between the experimental intervention
time frame: 2 years

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title Feasibility of Tobacco Assessment and Intervention With Low-Income Persons Living With HIV-AIDS (PLWHA) in Community-Based AIDS Service Organizations
Principal investigator Jack Burkhalter, PhD
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center.