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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Gay Men’s Health Crisis
The City College of New York
AIDS Center of Queens County
Bronx AIDS Services
North Jersey Community Research Initiative
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT01482923
First received: November 28, 2011
Last updated: April 3, 2014
Last verified: April 2014
  Purpose

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


Condition Intervention
Tobacco Cessation
HIV
AIDS
Behavioral: Treatment as usual
Behavioral: AIR (Aspirations, Inspiration, Respiration)

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • Feasibility of a motivational tobacco cessation intervention [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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."


Secondary Outcome Measures:
  • Estimate the differences between the experimental intervention [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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."


Estimated Enrollment: 60
Study Start Date: November 2011
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01482923

Locations
United States, New York
City College of New York
New York, New York, United States, 10031
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Gay Men’s Health Crisis
The City College of New York
AIDS Center of Queens County
Bronx AIDS Services
North Jersey Community Research Initiative
Investigators
Principal Investigator: Jack Burkhalter, PhD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT01482923     History of Changes
Other Study ID Numbers: 11-173
Study First Received: November 28, 2011
Last Updated: April 3, 2014
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases

ClinicalTrials.gov processed this record on September 11, 2014