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

Not Applicable

Completed

Conditions: Smoking Cessation
HIV Infections

Interventions: Other: Offered nicotine replacement therapy
Behavioral: Sessions with a trained counselor
Other: Self-help guide for quitting smoking
Other: Cell phone messages

Registration Number: NCT05020899

Lead Sponsor: Boston Medical Center

Brief 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 109

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Self-help guide for quitting smoking	Participants randomized to this arm will be offered nicotine replacement therapy (gum or patch, depending on which one is available) and a self-help guide with information about quitting smoking.
Control group	Offered nicotine replacement therapy	Participants randomized to this arm will be offered nicotine replacement therapy (gum or patch, depending on which one is available) and a self-help guide with information about quitting smoking.
Quit for Life group	Cell phone messages	Participants randomized to this arm will receive a 8 week quit smoking program delivered by trained counselors and messages to their cell phones. Participants will also be offered nicotine replacement therapy (gum or patch, depending on which one is available) and a self-help guide with information about quitting smoking.
Quit for Life group	Sessions with a trained counselor	Participants randomized to this arm will receive a 8 week quit smoking program delivered by trained counselors and messages to their cell phones. Participants will also be offered nicotine replacement therapy (gum or patch, depending on which one is available) and a self-help guide with information about quitting smoking.
Quit for Life group	Self-help guide for quitting smoking	Participants randomized to this arm will receive a 8 week quit smoking program delivered by trained counselors and messages to their cell phones. Participants will also be offered nicotine replacement therapy (gum or patch, depending on which one is available) and a self-help guide with information about quitting smoking.
Quit for Life group	Offered nicotine replacement therapy	Participants randomized to this arm will receive a 8 week quit smoking program delivered by trained counselors and messages to their cell phones. Participants will also be offered nicotine replacement therapy (gum or patch, depending on which one is available) and a self-help guide with information about quitting smoking.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Biochemically Verified Smoking Cessation	12 weeks	Defined as not smoking during the previous 7 days, not even a puff, validated by measuring CO level (\<8ppm) in the exhaled air

Secondary Outcome Measures

Name	Time	Method
Change in Number of Cigarettes Smoked in the Previous 30 Days at 8 Weeks	baseline, 8 weeks	Participants will report the number of cigarettes they smoked in the previous 30 days by answering questions in an interviewer-administered questionnaire.
Number of Quit Attempts at 8 Weeks	8 weeks	Participants will report the number of quit attempts since the study started by answering questions in an interviewer-administered questionnaire.
Change in Number of Cigarettes Smoked in the Previous 30 Days at 12 Weeks	baseline, 12 weeks	Participants will report the number of cigarettes they smoked in the previous 30 days by answering questions in an interviewer-administered questionnaire.
Adherence to Antiretroviral Treatments (ART) at 8 Weeks	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.
Quality of Life (QOL) in the Dimensions of Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression at 12 Weeks	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.
Number of Quit Attempts at 12 Weeks	12 weeks	Participants will report the number of quit attempts since the study started by answering questions in an interviewer-administered questionnaire.
Number of Participants That Self Reported Smoking Cessation at 8 Weeks	8 weeks	Participants will report if they did not smoke in the previous 7 days by answering questions in an interviewer-administered questionnaire.
Number of Participants That Self Reported Smoking Cessation at 12 Weeks	12 weeks	Participants will report if they did not smoke in the previous 7 days by answering questions in an interviewer-administered questionnaire.
Adherence to Antiretroviral Treatments (ART) at 12 Weeks	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.