Quit For Life (QFL): Smoking Cessation Among Chinese Smokers Living With HIV

HIV Infections Clinical Trial

— QFL  

Official title:

Quit For Life (QFL): Smoking Cessation Among Chinese Smokers Living With HIV

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05020899
• Other study ID #: H-41807
• Secondary ID: 1R21CA243835-01A
• Status: Completed
• Phase: N/A
• Start date: February 24, 2022
• Est. completion date: August 1, 2023

Study information

• Verified date: October 2023
• Source: Boston Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this two arm randomized clinical trial (RCT) is to test if a smoking cessation program called Quit for Life (QFL) which was developed by the investigators is effective for patients in China with HIV who smoke. This program is designed to suit the needs of people with HIV who smoke in China. Eligible participants who provide consent will be randomized into either the QFL or the Control group. The QFL group will receive a quit smoking program that lasts for 8 weeks with two parts- 1. 4 sessions with a trained counselor who will discuss the participants' smoking habits and strategies to help them quit. 2. Messages sent to the participants' cell phone using WeChat. The Control group will not have sessions with a trained counselor or receive messages sent to their cell phone. Both groups will be offered nicotine replacement therapy and a self-help guide with information about quitting smoking.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 109
• Est. completion date: August 1, 2023
• Est. primary completion date: August 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• HIV seropositive (by being at the HIV clinic and receiving care)
• Receiving ART treatment from the clinic (by being at the HIV clinic and receiving care)
• Smokes = 5 cigarettes per day
• Able to speak and read in Mandarin Chinese
• Self-reported anticipate to receive ART treatment from the clinic for at least 9 months
• Own a cell phone
• Be willing to set a quit date within 1 month after baseline assessment

Exclusion Criteria:

• Self-reported using other smoking cessation program or medication
• Having a serious health problem that may make them unsuitable to stay in the study

Related Conditions & MeSH terms

• HIV Infections
• Smoking Cessation

Intervention

Behavioral:
• Sessions with a trained counselor
4 sessions will be provided with a trained counselor who will discuss the participant's' smoking habits with them and strategies to help them quit. The first session is in-person, lasts for 20 minutes, and typically happens when the participant comes to the HIV clinic to pick up their medication. Sessions 2 through 4 are over the telephone and last for 15 minutes each. These occur 1 week, 4 weeks, and 8 weeks after the first session.

Other:
• Cell phone messages
Brief messages that give tips to help quit smoking will be sent to participants' cell phones using WeChat. 3 messages per day will be sent for the first week, 2 messages per day for the next 3 weeks, 1 message per day for the next 1 week, and 1-2 messages per week for the rest of the time
• Offered nicotine replacement therapy
Participants will be offered nicotine replacement therapy (gum or patch, depending on which one is available).
• Self-help guide for quitting smoking
Participants will be offered a self-help guide with information about quitting smoking.

Locations

Country	Name	City	State
China	Guangxi Medical University	Guangxi	Nanning
United States	Boston Medical Center	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Boston Medical Center	National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Intervention Satisfaction at 8 Weeks	Participant satisfaction with the intervention will be assessed using an investigator-developed questionnaire	8 weeks
Other	Intervention Satisfaction at 12 Weeks	Participant satisfaction with the intervention will be assessed using an investigator-developed questionnaire	12 weeks
Primary	Number of Participants With Biochemically Verified Smoking Cessation	Defined as not smoking during the previous 7 days, not even a puff, validated by measuring CO level (<8ppm) in the exhaled air	12 weeks
Secondary	Number of Participants That Self Reported Smoking Cessation at 8 Weeks	Participants will report if they did not smoke in the previous 7 days by answering questions in an interviewer-administered questionnaire.	8 weeks
Secondary	Number of Participants That Self Reported Smoking Cessation at 12 Weeks	Participants will report if they did not smoke in the previous 7 days by answering questions in an interviewer-administered questionnaire.	12 weeks
Secondary	Change in Number of Cigarettes Smoked in the Previous 30 Days at 8 Weeks	Participants will report the number of cigarettes they smoked in the previous 30 days by answering questions in an interviewer-administered questionnaire.	baseline, 8 weeks
Secondary	Change in Number of Cigarettes Smoked in the Previous 30 Days at 12 Weeks	Participants will report the number of cigarettes they smoked in the previous 30 days by answering questions in an interviewer-administered questionnaire.	baseline, 12 weeks
Secondary	Number of Quit Attempts at 8 Weeks	Participants will report the number of quit attempts since the study started by answering questions in an interviewer-administered questionnaire.	8 weeks
Secondary	Number of Quit Attempts at 12 Weeks	Participants will report the number of quit attempts since the study started by answering questions in an interviewer-administered questionnaire.	12 weeks
Secondary	Adherence to Antiretroviral Treatments (ART) at 8 Weeks	ART adherence will be assessed with the investigator developed, interviewer-administered 'Adherence to HIV medicine' questionnaire. This questionnaire assesses degree of adherence to taking HIV medicine on time by selecting a number between 0 and 10, where 0 = never on time [worse outcome] and 10 = always on time [best outcome]. Higher scores are more favorable.	8 weeks
Secondary	Adherence to Antiretroviral Treatments (ART) at 12 Weeks	ART adherence will be assessed with the investigator developed, interviewer-administered 'Adherence to HIV medicine' questionnaire. This questionnaire assesses degree of adherence to taking HIV medicine on time by selecting a number between 0 and 10, where 0 = never on time [worse outcome] and 10 = always on time [best outcome]. Higher scores are more favorable.	12 weeks
Secondary	Quality of Life (QOL) in the Dimensions of Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression at 12 Weeks	The EuroQol- 5 Dimension (EQ-5D) will be used to assess QOL. It is a questionnaire with five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and a scale of 0 to 100 where 0 means the worst health and 100 means the best health the participant can imagine.	12 weeks