NCT02029612

An Evidence Based Smoking Cessation Program for Persons Living With HIV/AIDS (Project Legacy)

An Evidence Based Smoking Cessation Program for Persons Living With HIV/AIDS

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The goal of this research study is to compare 2 different phone-based programs for quitting smoking for people with HIV/AIDS.

Detailed description

If participant agrees to take part in this study, the following will be done at the first visit (called the Baseline Visit): * The study staff will give participant advice about quitting smoking. Participant will then set a quit date, after which they will plan to not smoke anymore. * Participant will receive a 10-week supply of nicotine patches and instructions on how to use them. * Participant will complete questionnaires on a laptop computer about their smoking habits, how much tobacco they use, how many times they have tried to quit, how ready they are to quit, and how dependent they are on nicotine. The questionnaires will take about 30 minutes to complete. Participant will then be assigned to 1 of 2 study groups. Participant will have a 1 in 5 (20%) chance of being assigned to Group 1, and a 4 in 5 (80%) chance of being assigned to Group 2. If participant is in Group 1: * Participant will receive a telephone number to a hotline for them to use to call and talk to someone about quitting. Participant can call the hotline anytime they need support in their effort to quit smoking. * Participant will also receive 11 phone calls from the study staff over a 6-month period. During each call, participant will be given support to help them quit. Each call will last about 15 minutes. If participant is in Group 2: * Participant will receive text messages for support about quitting smoking. In the first week, participant will get about 20 text messages. Each week, participant will receive fewer text messages, until they get 1 message per week by week 4. Participant will then get 1 message each week after that through month 6. * Participant will also receive another text message 1 time each week from the study staff asking if they have smoked within the past 24 hours. Participant will be asked to respond to this text message either by sending a text back to the study staff or calling the study staff. If the study staff does not receive participant's response they may receive a phone call from the staff asking about their smoking status over the past 24 hours. Follow-Up Visits (Both Groups): Three (3) and 6 months after the Baseline Visit, you will complete questionnaires on a laptop computer and participant will be asked for more information about their smoking status. At this visit, participant will also be asked to blow into a cardboard tube to check for byproducts of smoking. These visits will last about 20 minutes each. Length of Study: Participant will be on study for about 6 months. This is an investigational study. Up to 1000 patients will take part in this study. All will be enrolled at Legacy Community Health Services Clinic.

Conditions

• Tobacco Use Cessation

Interventions

Type	Name	Description
DRUG	Nicotine Patch	10 week supply of nicotine patches given to participants at baseline.
BEHAVIORAL	Phone Counseling	Each participant counseled on quitting smoking at baseline.
BEHAVIORAL	Questionnaires	Questionnaires completed at baseline, 3 months, and at 6 months.
BEHAVIORAL	Breath Test	Breath test performed at 3 month and 6 month visit.
BEHAVIORAL	Proactive Cell Phone Smoking Cessation Counseling	Participant receives 11 phone calls from study staff over a 6-month period.
BEHAVIORAL	Text Message Smoking Cessation Support	Participants receive text messages for support about quitting smoking over a 6 month period.

Timeline

• Start date: 2014-04-01
• Primary completion: 2019-04-01
• First posted: 2014-01-08
• Last updated: 2014-02-28