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

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

Study Overview

• Status: Completed
• Conditions: Tobacco Cessation; HIV; AIDS
• Intervention / Treatment: Behavioral: Treatment as usual; Behavioral: AIR (Aspirations, Inspiration, Respiration)

• Study Type: Observational
• Enrollment (Actual): 65

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10031
      • City College of New York

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

"Low-income smokers living with HIV/AIDS being served at community-based organizations."

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?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	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.
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.	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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborators: The City College of New York; North Jersey Community Research Initiative; Gay Men's Health Crisis; AIDS Center of Queens County; Bronx AIDS Services

Publications and helpful links

Helpful Links

• Memorial Sloan Kettering Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): November 22, 2011
• Primary Completion (Actual): October 21, 2019
• Study Completion (Actual): October 21, 2019

Study Registration Dates

• First Submitted: November 28, 2011
• First Submitted That Met QC Criteria: November 30, 2011
• First Posted (Estimate): December 1, 2011

Study Record Updates

• Last Update Posted (Actual): November 4, 2019
• Last Update Submitted That Met QC Criteria: November 1, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: quit smoking; HIV/AIDS; tobacco cessation; Tobacco Use Assessment; smoke tobacco; Community-Based Service Organizations; 11-173; Low-Income Persons Living with HIV/AIDS
• Other Study ID Numbers: 11-173