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Study Summary
No. 2003-0784:.......Psychosocial......Ellen R. Gritz......Behavioral Science
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Study Summary Title
Study Summary
Number:
2003-0784
Study Title:An Innovative Telephone Intervention for HIV-Positive Smokers
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Physician New Patient Referral
Name:Ellen R. GritzPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:Behavioral ScienceReferring MD
Call:
800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-792-8270
Contact us about clinical trials
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General Information
Disease Group:PsychosocialSupported By:N/A
Phase of Study:N/AReturn
Visit:
NA
Treatment
Agents:
NoneHome Care:NA
Treatment Loc:Independent Multicenter Arrangements
Estimated
Length of Stay
in Houston:
NA
Description/
Intervention:
The goal of this research study is to look at treatments that may help
individuals who have HIV/AIDS to stop smoking.
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Study Objectives / Outcomes
Within the HIV-positive population, an estimated 50-70%[1-3] of individuals smoke. Despite this alarmingly high rate, HIV-positive smokers have not been targeted for intervention due to the poor prognosis of their disease. However, with new antiretroviral regimens, HIV-positive individuals are now living longer. As longevity increases, HIV-positive individuals are more vulnerable to both the long- and short-term impact of cigarette smoking. Smoking is a significant factor in the course, management, and quality of life for patients with HIV/AIDS. Preliminary research suggests that 62% of HIV-positive smokers are considering quitting smoking [3]. Currently no published studies have explored the efficacy of a smoking cessation intervention for HIV-positive smokers who are interested in quitting smoking. Our goal is cto assess a smoking cessation intervention targeted to an HIV/AIDS patient population.

1. To compare a Cell Phone Intervention (CPI) - a targeted, proactive cellular telephone delivered smoking cessation treatment focused on the special needs and concerns of a low income, multi-ethnic, HIV-positive population - to a Recommended Standard of Care (RSOC) treatment in a randomized controlled trial.
    2. To evaluate the association of self-efficacy, negative affect, coping behavior, and quality of life with smoking status.
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    Study Status Information
    Study Activation / Registration Date:01/23/2004
    IRB Review and Approval Date:11/19/2003
    Study Type:Cancer Control
    Recruitment Status:Closed
    Projected Accrual:705
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    Enrollment Eligibility
    If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

    Inclusion Criteria:1) HIV-positive

    2) 18 years of age or older

    3) Current, regular smoker (> 5 cigarettes per day for the past 30 days, breath CO of > 7ppm)

    4) English or Spanish speaking

    5) Able to provide written informed consent to participate

    6) Willing to set a quit date within 1 week of baseline assessment

    Exclusion Criteria:1) Physician deemed ineligibility based on medical (HIV related or other condition) or psychiatric condition

    2) Current participation in another smoking cessation program

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    Links
    Registration Number: NCT00502827
    Study Information on Clinical Trials Registry (clinicaltrials.gov)

    Other Links:
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    Results


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