HIV Infections, Smoking Cessation
Conditions
Keywords
Quit for Life (QFL), Smoking cessation counselors, WeChat messages, Nicotine replacement therapy, Self-help smoking cessation guide, People living with HIV/AIDS (PLH)
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.
Interventions
BEHAVIORALSessions 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.
OTHERCell 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
OTHEROffered nicotine replacement therapy
Participants will be offered nicotine replacement therapy (gum or patch, depending on which one is available).
OTHERSelf-help guide for quitting smoking
Participants will be offered a self-help guide with information about quitting smoking.
Sponsors
National Cancer Institute (NCI)
Boston Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Intervention Satisfaction at 12 Weeks | 12 weeks | Participant satisfaction with the intervention will be assessed using an investigator-developed questionnaire |
| Intervention Satisfaction at 8 Weeks | 8 weeks | Participant satisfaction with the intervention will be assessed using an investigator-developed questionnaire |
Countries
China, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Quit for Life Group 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.
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.
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. | 54 |
| Control Group 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.
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. | 55 |
| Total | 109 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| 12 Week Follow-up | Death | 0 | 1 |
| 12 Week Follow-up | Lost to Follow-up | 1 | 0 |
| 8 Week Follow-up | Lost to Follow-up | 3 | 6 |
Baseline characteristics
| Characteristic | Quit for Life Group | Control Group | Total |
|---|---|---|---|
| Age, Continuous | 44 years STANDARD_DEVIATION 15 | 46 years STANDARD_DEVIATION 16 | 45 years STANDARD_DEVIATION 15 |
| Cigarettes Smoked in the Previous 30 Days | 502.2 cigarettes STANDARD_DEVIATION 242.3 | 579.3 cigarettes STANDARD_DEVIATION 218 | 541.1 cigarettes STANDARD_DEVIATION 232.6 |
| Race/Ethnicity, Customized Asian | 54 Participants | 55 Participants | 109 Participants |
| Region of Enrollment China | 54 participants | 55 participants | 109 participants |
| Sex: Female, Male Female | 2 Participants | 2 Participants | 4 Participants |
| Sex: Female, Male Male | 52 Participants | 53 Participants | 105 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 54 | 1 / 55 |
| other Total, other adverse events | 0 / 54 | 0 / 55 |
| serious Total, serious adverse events | 0 / 54 | 0 / 55 |
Outcome results
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
Time frame: 12 weeks
Population: Data are missing for 6 participants in the Quit for Life group and 9 participants in the Control group.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Quit for Life Group | Number of Participants With Biochemically Verified Smoking Cessation | 26 Participants |
| Control Group | Number of Participants With Biochemically Verified Smoking Cessation | 10 Participants |
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.
Time frame: 12 weeks
Population: Data are missing for 1 participant in the Control group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Quit for Life Group | Adherence to Antiretroviral Treatments (ART) at 12 Weeks | 9.42 units on a scale | Standard Deviation 1.43 |
| Control Group | Adherence to Antiretroviral Treatments (ART) at 12 Weeks | 9.02 units on a scale | Standard Deviation 2.2 |
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.
Time frame: 8 weeks
Population: Data are missing for 1 participant in the Control group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Quit for Life Group | Adherence to Antiretroviral Treatments (ART) at 8 Weeks | 9.65 units on a scale | Standard Deviation 0.59 |
| Control Group | Adherence to Antiretroviral Treatments (ART) at 8 Weeks | 9.10 units on a scale | Standard Deviation 1.79 |
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.
Time frame: baseline, 12 weeks
Population: Data are missing for 24 participants in the Quit for Life group and 10 participants in the Control group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Quit for Life Group | Change in Number of Cigarettes Smoked in the Previous 30 Days at 12 Weeks | -208.85 cigarettes | Standard Deviation 263.93 |
| Control Group | Change in Number of Cigarettes Smoked in the Previous 30 Days at 12 Weeks | -191.84 cigarettes | Standard Deviation 175.42 |
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.
Time frame: baseline, 8 weeks
Population: Data are missing for 23 participants in the Quit for Life group and 13 participants in the Control group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Quit for Life Group | Change in Number of Cigarettes Smoked in the Previous 30 Days at 8 Weeks | -169.29 cigarettes | Standard Deviation 287.08 |
| Control Group | Change in Number of Cigarettes Smoked in the Previous 30 Days at 8 Weeks | -170.83 cigarettes | Standard Deviation 163.66 |
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.
Time frame: 12 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Quit for Life Group | Number of Participants That Self Reported Smoking Cessation at 12 Weeks | 29 Participants |
| Control Group | Number of Participants That Self Reported Smoking Cessation at 12 Weeks | 40 Participants |
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.
Time frame: 8 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Quit for Life Group | Number of Participants That Self Reported Smoking Cessation at 8 Weeks | 29 Participants |
| Control Group | Number of Participants That Self Reported Smoking Cessation at 8 Weeks | 37 Participants |
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.
Time frame: 12 weeks
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Quit for Life Group | Number of Quit Attempts at 12 Weeks | No attempts | 1 Participants |
| Quit for Life Group | Number of Quit Attempts at 12 Weeks | 1 or more attempts | 49 Participants |
| Control Group | Number of Quit Attempts at 12 Weeks | No attempts | 10 Participants |
| Control Group | Number of Quit Attempts at 12 Weeks | 1 or more attempts | 38 Participants |
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.
Time frame: 8 weeks
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Quit for Life Group | Number of Quit Attempts at 8 Weeks | No attempts | 7 Participants |
| Quit for Life Group | Number of Quit Attempts at 8 Weeks | 1 or more attempts | 44 Participants |
| Control Group | Number of Quit Attempts at 8 Weeks | No attempts | 13 Participants |
| Control Group | Number of Quit Attempts at 8 Weeks | 1 or more attempts | 36 Participants |
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.
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Quit for Life Group | Quality of Life (QOL) in the Dimensions of Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression at 12 Weeks | 83.90 units on a scale | Standard Deviation 9.81 |
| Control Group | Quality of Life (QOL) in the Dimensions of Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression at 12 Weeks | 79.75 units on a scale | Standard Deviation 9.9 |
Other Pre-specified
Intervention Satisfaction at 12 Weeks
Participant satisfaction with the intervention will be assessed using an investigator-developed questionnaire
Time frame: 12 weeks
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Quit for Life Group | Intervention Satisfaction at 12 Weeks | Met all of your goal | 21 Participants |
| Quit for Life Group | Intervention Satisfaction at 12 Weeks | Met some/none of your goal | 29 Participants |
| Control Group | Intervention Satisfaction at 12 Weeks | Met all of your goal | 8 Participants |
| Control Group | Intervention Satisfaction at 12 Weeks | Met some/none of your goal | 40 Participants |
Other Pre-specified
Intervention Satisfaction at 8 Weeks
Participant satisfaction with the intervention will be assessed using an investigator-developed questionnaire
Time frame: 8 weeks
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Quit for Life Group | Intervention Satisfaction at 8 Weeks | Met all of your goal | 17 Participants |
| Quit for Life Group | Intervention Satisfaction at 8 Weeks | Met some/none of your goal | 34 Participants |
| Control Group | Intervention Satisfaction at 8 Weeks | Met all of your goal | 11 Participants |
| Control Group | Intervention Satisfaction at 8 Weeks | Met some/none of your goal | 38 Participants |