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
NCT number | NCT01482923 |
Other study ID # | 11-173 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | November 22, 2011 |
Est. completion date | October 21, 2019 |
Verified date | November 2019 |
Source | Memorial Sloan Kettering Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
"A treatment session especially for PLWHA to help them discuss and take action about their smoking may be useful."
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. |
Country | Name | City | State |
---|---|---|---|
United States | City College of New York | New York | New York |
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 |
United States,
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 |
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