An Evidence Based Smoking Cessation Program for Persons Living With HIV/AIDS (Project Legacy)
1 other identifier
interventional
N/A
0 countries
N/A
Brief Summary
The goal of this research study is to compare 2 different phone-based programs for quitting smoking for people with HIV/AIDS.
Trial Health
Trial Health Score
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Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 19, 2013
CompletedFirst Posted
Study publicly available on registry
January 8, 2014
CompletedStudy Start
First participant enrolled
April 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2019
CompletedFebruary 28, 2014
February 1, 2014
5 years
November 19, 2013
February 27, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Smoking Abstinence
Smoking abstinence defined as biochemically confirmed 7-day abstinence. Expired CO will be used to biochemically verify abstinence.
3 months
Study Arms (2)
Group 1 - Phone Call Support
OTHERSmoking cessation telephone hotline phone number provided to participants, along with a 10 week supply of nicotine patches. Each participant counseled on quitting smoking at baseline. Questionnaires completed at baseline, 3 months, and at 6 months. Participant receives 11 phone calls from study staff over a 6-month period. Breath test performed at 3 month and 6 month visit.
Group 2 - Text Messaging Support
OTHERParticipants receive 10 week supply of nicotine patches. Each participant counseled on quitting smoking at baseline. Questionnaires completed at baseline, 3 months, and at 6 months. Participants receive text messages for support about quitting smoking over a 6 month period. Breath test performed at 3 month and 6 month visit.
Interventions
10 week supply of nicotine patches given to participants at baseline.
Each participant counseled on quitting smoking at baseline.
Questionnaires completed at baseline, 3 months, and at 6 months.
Breath test performed at 3 month and 6 month visit.
Participant receives 11 phone calls from study staff over a 6-month period.
Participants receive text messages for support about quitting smoking over a 6 month period.
Eligibility Criteria
You may qualify if:
- Receiving care for HIV/AIDS at a Legacy Community Health Services Clinic
- years of age or older
- Self-reported current smoker (smoked at least 100 cigarettes in lifetime and smoking every day or most days)
- Able to provide written informed consent to participate
- English or Spanish speaking
You may not qualify if:
- Positive history of a medical condition that precludes use of the nicotine patch
- Current use of nicotine replacement therapy (NRT)
- Current use of other smoking cessation medications (e.g., Chantix or Zyban)
- Pregnant or nursing
- Enrolled in another smoking cessation study
- Unwilling to set a target quit date
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Damon Vidrine, MS, DRPH, BA
M.D. Anderson Cancer Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 19, 2013
First Posted
January 8, 2014
Study Start
April 1, 2014
Primary Completion
April 1, 2019
Last Updated
February 28, 2014
Record last verified: 2014-02