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

NCT01482923 | Completed

• 1 other identifier: 11-173
• Study Type: observational
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Outcome Measures

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."

  2 years

Secondary Outcomes (1)

• Estimate the differences between the experimental intervention

  2 years

Study Arms (2)

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

Treatment as usual BEHAVIORAL

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.

Treatment As Usual (TAU)

AIR (Aspirations, Inspiration, Respiration) BEHAVIORAL

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.

Aspiration, Inspiration Respiration, or AIR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

City College of New York

New York, New York, 10031, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Tobacco Use Cessation; Acquired Immunodeficiency Syndrome

Interventions

Therapeutics; Air; Inhalation; Respiration

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Atmosphere; Environment; Ecological and Environmental Phenomena; Biological Phenomena; Meteorological Concepts; Environment and Public Health; Respiratory Mechanics; Respiratory Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Officials

• Jamie Ostroff, PhD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2011
• First Posted: December 1, 2011
• Study Start: November 22, 2011
• Primary Completion: October 21, 2019
• Study Completion: October 21, 2019
• Last Updated: November 4, 2019

Record last verified: 2019-11

Locations

US (1)