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

Primary Purpose

Smoking Cessation, HIV Infections

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Sessions with a trained counselor
Cell phone messages
Offered nicotine replacement therapy
Self-help guide for quitting smoking
Sponsored by
Boston Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Smoking Cessation focused on measuring Quit for Life (QFL), Smoking cessation counselors, WeChat messages, Nicotine replacement therapy, Self-help smoking cessation guide, People living with HIV/AIDS (PLH)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Boston Medical Center
  • Guangxi Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Quit for Life group

Control group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
August 19, 2021
Last Updated
October 3, 2023
Sponsor
Boston Medical Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT05020899
Brief Title
Quit For Life (QFL): Smoking Cessation Among Chinese Smokers Living With HIV
Acronym
QFL
Official Title
Quit For Life (QFL): Smoking Cessation Among Chinese Smokers Living With HIV
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
February 24, 2022 (Actual)
Primary Completion Date
August 1, 2023 (Actual)
Study Completion Date
August 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston Medical Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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- 4 sessions with a trained counselor who will discuss the participants' smoking habits and strategies to help them quit. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Smoking Cessation, HIV Infections
Keywords
Quit for Life (QFL), Smoking cessation counselors, WeChat messages, Nicotine replacement therapy, Self-help smoking cessation guide, People living with HIV/AIDS (PLH)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
109 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Quit for Life group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Sessions with a trained counselor
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Cell phone messages
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Offered nicotine replacement therapy
Intervention Description
Participants will be offered nicotine replacement therapy (gum or patch, depending on which one is available).
Intervention Type
Other
Intervention Name(s)
Self-help guide for quitting smoking
Intervention Description
Participants will be offered a self-help guide with information about quitting smoking.
Primary Outcome Measure Information:
Title
Number of Participants With Biochemically Verified Smoking Cessation
Description
Defined as not smoking during the previous 7 days, not even a puff, validated by measuring CO level (<8ppm) in the exhaled air
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Number of Participants That Self Reported Smoking Cessation at 8 Weeks
Description
Participants will report if they did not smoke in the previous 7 days by answering questions in an interviewer-administered questionnaire.
Time Frame
8 weeks
Title
Number of Participants That Self Reported Smoking Cessation at 12 Weeks
Description
Participants will report if they did not smoke in the previous 7 days by answering questions in an interviewer-administered questionnaire.
Time Frame
12 weeks
Title
Change in Number of Cigarettes Smoked in the Previous 30 Days at 8 Weeks
Description
Participants will report the number of cigarettes they smoked in the previous 30 days by answering questions in an interviewer-administered questionnaire.
Time Frame
baseline, 8 weeks
Title
Change in Number of Cigarettes Smoked in the Previous 30 Days at 12 Weeks
Description
Participants will report the number of cigarettes they smoked in the previous 30 days by answering questions in an interviewer-administered questionnaire.
Time Frame
baseline, 12 weeks
Title
Number of Quit Attempts at 8 Weeks
Description
Participants will report the number of quit attempts since the study started by answering questions in an interviewer-administered questionnaire.
Time Frame
8 weeks
Title
Number of Quit Attempts at 12 Weeks
Description
Participants will report the number of quit attempts since the study started by answering questions in an interviewer-administered questionnaire.
Time Frame
12 weeks
Title
Adherence to Antiretroviral Treatments (ART) at 8 Weeks
Description
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.
Time Frame
8 weeks
Title
Adherence to Antiretroviral Treatments (ART) at 12 Weeks
Description
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.
Time Frame
12 weeks
Title
Quality of Life (QOL) in the Dimensions of Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression at 12 Weeks
Description
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.
Time Frame
12 weeks
Other Pre-specified Outcome Measures:
Title
Intervention Satisfaction at 8 Weeks
Description
Participant satisfaction with the intervention will be assessed using an investigator-developed questionnaire
Time Frame
8 weeks
Title
Intervention Satisfaction at 12 Weeks
Description
Participant satisfaction with the intervention will be assessed using an investigator-developed questionnaire
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisa Quintiliani, PhD
Organizational Affiliation
Boston Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hao Liang, PhD
Organizational Affiliation
Guangxi Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Boston Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
Guangxi Medical University
City
Guangxi
State/Province
Nanning
ZIP/Postal Code
530021
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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