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

November 28, 2011
April 3, 2014
November 2011
November 2015   (final data collection date for primary outcome measure)
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."
feasibility of a motivational tobacco cessation intervention [ Time Frame: 2 years ] [ Designated as safety issue: No ]
using respiratory biomarker feedback and facilitated uptake of public health cessation services in low-income PLWHA who smoke and are being served in communitybased HIV/AIDS organizations. The primary feasibility indicator will be participant acceptance of the intervention as measured by the percentage of eligible and consented participants completing the assigned interventions and one month follow-up assessment.
Complete list of historical versions of study NCT01482923 on ClinicalTrials.gov Archive Site
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."
Estimate the differences between the experimental intervention [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Descriptive statistics will be sought on: 1) participants' self-reported motivation to quit smoking (as measured by the mean of the 4 motivation items); 2) the percentage of participants who accept referral to the NYS Quitline and 3) participant self-reported satisfaction with intervention measures developed for this study.
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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."

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
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Probability Sample

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

  • Tobacco Cessation
  • HIV
  • AIDS
  • 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.
  • 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.
  • 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.
    Intervention: Behavioral: Treatment as usual
  • 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.
    Intervention: Behavioral: AIR (Aspirations, Inspiration, Respiration)
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
60
November 2015
November 2015   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01482923
11-173
Not Provided
Memorial Sloan-Kettering Cancer Center
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
Principal Investigator: Jack Burkhalter, PhD Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP