CClinicalTrials.gg
CompletedNCT01482923Updated Nov 4, 2019

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

An observational study in Tobacco Cessation, HIV and AIDS, sponsored by Memorial Sloan Kettering Cancer Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-11-04.

Sponsored by Memorial Sloan Kettering Cancer Center · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
65
Ages
18 Years and older
Sex
All
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Study summary

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

02

Conditions studied

  • Tobacco Cessation
  • HIV
  • AIDS

Keywords

  • Tobacco Use Assessment
  • smoke tobacco
  • quit smoking
  • tobacco cessation
  • HIV/AIDS
  • Community-Based Service Organizations
  • 11-173
  • Low-Income Persons Living with HIV/AIDS
03

In context

Lead sponsor

Memorial Sloan Kettering Cancer Center is the lead sponsor of 1,930 studies on the registry; 328 are open to participants now.

Of its 129 completed or terminated interventional studies of FDA-regulated products, 66 (51%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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

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

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
65 participants (actual)

Groups and cohorts

  • 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

  • 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)

Interventions

  • BehavioralTreatment 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.

  • BehavioralAIR (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.

06

What researchers measure

Primary outcomes

  1. 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."

    Time frame: 2 years

Secondary outcomes

  1. 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."

    Time frame: 2 years

07

Study locations

1 site
  • City College of New York
    New York, New York 10031, United States
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References and documents

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 4, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01482923
Lead sponsor
Memorial Sloan Kettering Cancer Center
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
Responsible party
Sponsor
First posted
Dec 1, 2011
Start date
Nov 22, 2011
Primary completion
Oct 21, 2019
Completion
Oct 21, 2019
Last update
Nov 4, 2019

Study contacts

Jamie Ostroff, PhD
principal investigator · Memorial Sloan Kettering Cancer Center
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.

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