Trial Outcomes & Findings for Quit For Life (QFL): Smoking Cessation Among Chinese Smokers Living With HIV (NCT NCT05020899)
NCT ID: NCT05020899
Last Updated: 2024-12-12
Results Overview
Defined as not smoking during the previous 7 days, not even a puff, validated by measuring CO level (\<8ppm) in the exhaled air
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
109 participants
Primary outcome timeframe
12 weeks
Results posted on
2024-12-12
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
8 Week Follow-up
STARTED
|
54
|
55
|
|
8 Week Follow-up
COMPLETED
|
51
|
49
|
|
8 Week Follow-up
NOT COMPLETED
|
3
|
6
|
|
12 Week Follow-up
STARTED
|
51
|
49
|
|
12 Week Follow-up
COMPLETED
|
50
|
48
|
|
12 Week Follow-up
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
8 Week Follow-up
Lost to Follow-up
|
3
|
6
|
|
12 Week Follow-up
Lost to Follow-up
|
1
|
0
|
|
12 Week Follow-up
Death
|
0
|
1
|
Baseline Characteristics
Quit For Life (QFL): Smoking Cessation Among Chinese Smokers Living With HIV
Baseline characteristics by cohort
| Measure |
Quit for Life Group
n=54 Participants
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.
|
Control Group
n=55 Participants
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.
|
Total
n=109 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
44 years
STANDARD_DEVIATION 15 • n=5 Participants
|
46 years
STANDARD_DEVIATION 16 • n=7 Participants
|
45 years
STANDARD_DEVIATION 15 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
52 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
105 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
54 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
109 Participants
n=5 Participants
|
|
Region of Enrollment
China
|
54 participants
n=5 Participants
|
55 participants
n=7 Participants
|
109 participants
n=5 Participants
|
|
Cigarettes Smoked in the Previous 30 Days
|
502.2 cigarettes
STANDARD_DEVIATION 242.3 • n=5 Participants
|
579.3 cigarettes
STANDARD_DEVIATION 218.0 • n=7 Participants
|
541.1 cigarettes
STANDARD_DEVIATION 232.6 • n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: Data are missing for 6 participants in the Quit for Life group and 9 participants in the Control group.
Defined as not smoking during the previous 7 days, not even a puff, validated by measuring CO level (\<8ppm) in the exhaled air
Outcome measures
| Measure |
Quit for Life Group
n=44 Participants
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.
|
Control Group
n=39 Participants
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.
|
|---|---|---|
|
Number of Participants With Biochemically Verified Smoking Cessation
|
26 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: 8 weeksParticipants will report if they did not smoke in the previous 7 days by answering questions in an interviewer-administered questionnaire.
Outcome measures
| Measure |
Quit for Life Group
n=51 Participants
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.
|
Control Group
n=49 Participants
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.
|
|---|---|---|
|
Number of Participants That Self Reported Smoking Cessation at 8 Weeks
|
29 Participants
|
37 Participants
|
SECONDARY outcome
Timeframe: 12 weeksParticipants will report if they did not smoke in the previous 7 days by answering questions in an interviewer-administered questionnaire.
Outcome measures
| Measure |
Quit for Life Group
n=50 Participants
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.
|
Control Group
n=48 Participants
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.
|
|---|---|---|
|
Number of Participants That Self Reported Smoking Cessation at 12 Weeks
|
29 Participants
|
40 Participants
|
SECONDARY outcome
Timeframe: baseline, 8 weeksPopulation: Data are missing for 23 participants in the Quit for Life group and 13 participants in the Control group.
Participants will report the number of cigarettes they smoked in the previous 30 days by answering questions in an interviewer-administered questionnaire.
Outcome measures
| Measure |
Quit for Life Group
n=28 Participants
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.
|
Control Group
n=36 Participants
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.
|
|---|---|---|
|
Change in Number of Cigarettes Smoked in the Previous 30 Days at 8 Weeks
|
-169.29 cigarettes
Standard Deviation 287.08
|
-170.83 cigarettes
Standard Deviation 163.66
|
SECONDARY outcome
Timeframe: baseline, 12 weeksPopulation: Data are missing for 24 participants in the Quit for Life group and 10 participants in the Control group.
Participants will report the number of cigarettes they smoked in the previous 30 days by answering questions in an interviewer-administered questionnaire.
Outcome measures
| Measure |
Quit for Life Group
n=26 Participants
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.
|
Control Group
n=38 Participants
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.
|
|---|---|---|
|
Change in Number of Cigarettes Smoked in the Previous 30 Days at 12 Weeks
|
-208.85 cigarettes
Standard Deviation 263.93
|
-191.84 cigarettes
Standard Deviation 175.42
|
SECONDARY outcome
Timeframe: 8 weeksParticipants will report the number of quit attempts since the study started by answering questions in an interviewer-administered questionnaire.
Outcome measures
| Measure |
Quit for Life Group
n=51 Participants
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.
|
Control Group
n=49 Participants
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.
|
|---|---|---|
|
Number of Quit Attempts at 8 Weeks
No attempts
|
7 Participants
|
13 Participants
|
|
Number of Quit Attempts at 8 Weeks
1 or more attempts
|
44 Participants
|
36 Participants
|
SECONDARY outcome
Timeframe: 12 weeksParticipants will report the number of quit attempts since the study started by answering questions in an interviewer-administered questionnaire.
Outcome measures
| Measure |
Quit for Life Group
n=50 Participants
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.
|
Control Group
n=48 Participants
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.
|
|---|---|---|
|
Number of Quit Attempts at 12 Weeks
No attempts
|
1 Participants
|
10 Participants
|
|
Number of Quit Attempts at 12 Weeks
1 or more attempts
|
49 Participants
|
38 Participants
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: Data are missing for 1 participant in the Control group.
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.
Outcome measures
| Measure |
Quit for Life Group
n=51 Participants
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.
|
Control Group
n=48 Participants
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.
|
|---|---|---|
|
Adherence to Antiretroviral Treatments (ART) at 8 Weeks
|
9.65 units on a scale
Standard Deviation 0.59
|
9.10 units on a scale
Standard Deviation 1.79
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Data are missing for 1 participant in the Control group.
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.
Outcome measures
| Measure |
Quit for Life Group
n=50 Participants
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.
|
Control Group
n=47 Participants
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.
|
|---|---|---|
|
Adherence to Antiretroviral Treatments (ART) at 12 Weeks
|
9.42 units on a scale
Standard Deviation 1.43
|
9.02 units on a scale
Standard Deviation 2.20
|
SECONDARY outcome
Timeframe: 12 weeksThe 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.
Outcome measures
| Measure |
Quit for Life Group
n=50 Participants
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.
|
Control Group
n=48 Participants
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.
|
|---|---|---|
|
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
|
79.75 units on a scale
Standard Deviation 9.90
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 8 weeksParticipant satisfaction with the intervention will be assessed using an investigator-developed questionnaire
Outcome measures
| Measure |
Quit for Life Group
n=51 Participants
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.
|
Control Group
n=49 Participants
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.
|
|---|---|---|
|
Intervention Satisfaction at 8 Weeks
Met all of your goal
|
17 Participants
|
11 Participants
|
|
Intervention Satisfaction at 8 Weeks
Met some/none of your goal
|
34 Participants
|
38 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 weeksParticipant satisfaction with the intervention will be assessed using an investigator-developed questionnaire
Outcome measures
| Measure |
Quit for Life Group
n=50 Participants
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.
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Control Group
n=48 Participants
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.
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Intervention Satisfaction at 12 Weeks
Met all of your goal
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21 Participants
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8 Participants
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Intervention Satisfaction at 12 Weeks
Met some/none of your goal
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29 Participants
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40 Participants
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Adverse Events
Quit for Life Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place