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

HIV Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01482923
• Other study ID #: 11-173
• Status: Completed
• Start date: November 22, 2011
• Est. completion date: October 21, 2019

Study information

• Verified date: November 2019
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: October 21, 2019
• Est. primary completion date: October 21, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• AIDS
• HIV
• Tobacco Cessation

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	City College of New York	New York	New York

Sponsors (6)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	AIDS Center of Queens County, Bronx AIDS Services, Gay Men’s Health Crisis, North Jersey Community Research Initiative, The City College of New York

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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."	2 years

External Links

•   Memorial Sloan Kettering Cancer Center