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

This study is currently recruiting participants.

Verified May 2013 by Memorial Sloan-Kettering Cancer Center

Sponsor:

Collaborators:

Gay Men’s Health Crisis

The City College of New York

AIDS Center of Queens County

Bronx AIDS Services

Bronx Community Pride Center

Brooklyn AIDS Task Force

Fortune Society

Harlem United Community AIDS Center

Iris House

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: May 17, 2013

Last verified: May 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

November 28, 2011

Last Updated Date

May 17, 2013

Start Date ^ICMJE

November 2011

Estimated Primary Completion Date

November 2014 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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."

Original Primary Outcome Measures ^ICMJE

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.

Change History

Complete list of historical versions of study NCT01482923 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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."

Original Secondary Outcome Measures ^ICMJE

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.

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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

Detailed Description

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Probability Sample

Study Population

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

Condition ^ICMJE

Tobacco Cessation
HIV
AIDS

Intervention ^ICMJE

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.

Study Group/Cohort (s)

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)

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

November 2014

Estimated Primary Completion Date

November 2014 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Jack Burkhalter, PhD	646-888-0040
Contact: Jamie Ostroff, PhD	646-888-0041

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01482923

Other Study ID Numbers ^ICMJE

11-173

Has Data Monitoring Committee

Not Provided

Responsible Party

Memorial Sloan-Kettering Cancer Center

Study Sponsor ^ICMJE

Memorial Sloan-Kettering Cancer Center

Collaborators ^ICMJE

Gay Men’s Health Crisis
The City College of New York
AIDS Center of Queens County
Bronx AIDS Services
Bronx Community Pride Center
Brooklyn AIDS Task Force
Fortune Society
Harlem United Community AIDS Center
Iris House
North Jersey Community Research Initiative

Investigators ^ICMJE

Principal Investigator:

Jack Burkhalter, PhD

Memorial Sloan-Kettering Cancer Center

Information Provided By

Memorial Sloan-Kettering Cancer Center

Verification Date

May 2013

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

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