Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 1R21CA243835-01A1 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
Not provided
Not provided
Not provided
Not provided
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-
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Quit for Life group | Experimental | 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. |
|
| Control group | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sessions with a trained counselor | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Number of Participants That Self Reported Smoking Cessation at 12 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Intervention Satisfaction at 8 Weeks | Participant satisfaction with the intervention will be assessed using an investigator-developed questionnaire | 8 weeks |
| Intervention Satisfaction at 12 Weeks | Participant satisfaction with the intervention will be assessed using an investigator-developed questionnaire |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Lisa Quintiliani, PhD | Boston Medical Center | Principal Investigator |
| Hao Liang, PhD | Guangxi Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston Medical Center | Boston | Massachusetts | 02118 | United States | ||
| Guangxi Medical University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40705206 | Derived | Huang J, Yang S, Xie Z, Guo B, Lan Y, Li Y, Jiang Y, Forman LS, Lunze K, Liang B, Abdullah AS, Ye L, Liang H, Quintiliani LM. WeChat-based Messaging and Behavioral Counseling for Smoking Cessation for People with HIV in China: a Randomized Controlled Pilot Trial. AIDS Behav. 2025 Dec;29(12):3866-3876. doi: 10.1007/s10461-025-04823-7. Epub 2025 Jul 24. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 8 Week Follow-up |
|
| ||||||||||||||||||
| 12 Week Follow-up |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Data are missing for 6 participants in the Quit for Life group and 9 participants in the Control group. | Posted | Count of Participants | Participants | 12 weeks |
|
12 weeks
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lisa Quintiliani, PhD | Boston Medical Center | 617-638-2777 | lisa.quintiliani@bmc.org |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 21, 2024 | Nov 25, 2024 | Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 20, 2022 | Aug 29, 2023 | ICF_001.pdf |
Not provided
| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Cell phone messages | Other | 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 | Other | Participants will be offered nicotine replacement therapy (gum or patch, depending on which one is available). |
|
| Self-help guide for quitting smoking | Other | Participants will be offered a self-help guide with information about quitting smoking. |
|
Participants will report if they did not smoke in the previous 7 days by answering questions in an interviewer-administered questionnaire. |
| 12 weeks |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 12 weeks |
| Guangxi |
| Nanning |
| 530021 |
| China |
| NOT COMPLETED |
|
|
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Cigarettes Smoked in the Previous 30 Days | Mean | Standard Deviation | cigarettes |
|
| OG001 | 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. |
|
|
| 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. | Posted | Count of Participants | Participants | 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. | Posted | Count of Participants | Participants | 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. | Data are missing for 23 participants in the Quit for Life group and 13 participants in the Control group. | Posted | Mean | Standard Deviation | cigarettes | 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. | Data are missing for 24 participants in the Quit for Life group and 10 participants in the Control group. | Posted | Mean | Standard Deviation | cigarettes | 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. | Posted | Count of Participants | Participants | 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. | Posted | Count of Participants | Participants | 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. | Data are missing for 1 participant in the Control group. | Posted | Mean | Standard Deviation | units on a scale | 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. | Data are missing for 1 participant in the Control group. | Posted | Mean | Standard Deviation | units on a scale | 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. | Posted | Mean | Standard Deviation | units on a scale | 12 weeks |
|
|
|
| Other Pre-specified | Intervention Satisfaction at 8 Weeks | Participant satisfaction with the intervention will be assessed using an investigator-developed questionnaire | Posted | Count of Participants | Participants | 8 weeks |
|
|
|
| Other Pre-specified | Intervention Satisfaction at 12 Weeks | Participant satisfaction with the intervention will be assessed using an investigator-developed questionnaire | Posted | Count of Participants | Participants | 12 weeks |
|
|
|
| 0 |
| 54 |
| 0 |
| 54 |
| 0 |
| 54 |
| EG001 | 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. | 1 | 55 | 0 | 55 | 0 | 55 |
Not provided
Not provided
Not provided
| D007239 |
| Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |