Smoking CessationQFLNCT05020899
Quit For Life (QFL): Smoking Cessation Among Chinese Smokers Living With HIV
A study testing Sessions with a trained counselor, Cell phone messages and Offered nicotine replacement therapy in people with Smoking Cessation and HIV Infections, run by Boston Medical Center at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking Cessation, HIV Infections
- What is being tested?
- Sessions with a trained counselor, Cell phone messages and Offered nicotine replacement therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 109 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 24 Feb 2022to 1 Aug 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Self-reported using other smoking cessation program or medication
- Having a serious health problem that may make them unsuitable to stay in the study
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
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.
Read more
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.
- Conditions
- Smoking Cessation, HIV Infections
- Being tested
- Sessions with a trained counselor, Cell phone messages, Offered nicotine replacement therapy, Self-help guide for quitting smoking
- Keywords
- Quit for Life (QFL), Smoking cessation counselors, WeChat messages, Nicotine replacement therapy, Self-help smoking cessation guide, People living with HIV/AIDS (PLH)
- Medical subject headings
- Smoking Cessation, HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sessions with a trained counselorBehavioural
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 messagesOther
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 therapyOther
Participants will be offered nicotine replacement therapy (gum or patch, depending on which one is available).
Self-help guide for quitting smokingOther
Participants will be offered a self-help guide with information about quitting smoking.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Sessions with a trained counselor; Other: Cell phone messages; Other: Offered nicotine replacement therapy; Other: Self-help guide for 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. Receives: Other: Offered nicotine replacement therapy; Other: Self-help guide for quitting smoking |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 weeks
Secondary outcomes (9)
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.
Measured: 8 weeks
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2021
- Study start24 Feb 2022
- Primary completion1 Aug 2023
- Study completion1 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by Boston Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Lisa Quintiliani, PhD, Principal investigator, Boston Medical CenterHao Liang, PhD, Principal investigator, Guangxi Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05020899
- Sponsor's protocol ID
- H-41807
- Other IDs
- 1R21CA243835-01A1
- Acronym
- QFL
- Status last verified
- Nov 2024
- First submitted
- 19 Aug 2021
- Last updated
- 12 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40705206
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quit For Life (QFL): Smoking Cessation Among Chinese Smokers Living With HIV
- ClinicalTrials.gov ID
- NCT05020899
- Acronym / sponsor ID
- QFL / H-41807
- Conditions
- 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)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 24 Feb 2022 (actual)
- Primary completion
- 1 Aug 2023 (actual)
- Study completion
- 1 Aug 2023 (actual)
- First posted
- 25 Aug 2021 (actual)
- Results
- Posted 5 Oct 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Quit for Life group | Experimental | Behavioral: Sessions with a trained counselor, Other: Cell phone messages, Other: Offered nicotine replacement therapy, Other: Self-help guide for quitting smokingParticipants 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 | Other: Offered nicotine replacement therapy, Other: Self-help guide for quitting smokingParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (2 listed)
- Self-reported using other smoking cessation program or medication
- Having a serious health problem that may make them unsuitable to stay in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sessions with a trained counselor4 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. | Behavioural | Quit for Life group |
| Cell phone messagesBrief 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 | Other | Quit for Life group |
| Offered nicotine replacement therapyParticipants will be offered nicotine replacement therapy (gum or patch, depending on which one is available). | Other | Control group, Quit for Life group |
| Self-help guide for quitting smokingParticipants will be offered a self-help guide with information about quitting smoking. | Other | Control group, Quit for Life group |
Primary outcome
Number of Participants With Biochemically Verified Smoking Cessation
Time frame: 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
9 secondary outcomes
Number of Participants That Self Reported Smoking Cessation at 8 Weeks
Time frame: 8 weeks
Number of Participants That Self Reported Smoking Cessation at 12 Weeks
Time frame: 12 weeks
Change in Number of Cigarettes Smoked in the Previous 30 Days at 8 Weeks
Time frame: baseline, 8 weeks
Change in Number of Cigarettes Smoked in the Previous 30 Days at 12 Weeks
Time frame: baseline, 12 weeks
Number of Quit Attempts at 8 Weeks
Time frame: 8 weeks
Number of Quit Attempts at 12 Weeks
Time frame: 12 weeks
Adherence to Antiretroviral Treatments (ART) at 8 Weeks
Time frame: 8 weeks
Adherence to Antiretroviral Treatments (ART) at 12 Weeks
Time frame: 12 weeks
Quality of Life (QOL) in the Dimensions of Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression at 12 Weeks
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40705206Huang 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lisa Quintiliani, PhD principal investigator
Boston Medical Center
Hao Liang, PhD principal investigator
Guangxi Medical University
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sessions with a trained counselor, Cell phone messages and Offered nicotine replacement therapy in people with Smoking Cessation and HIV Infections, run by Boston Medical Center at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Oct 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Biochemically Verified Smoking Cessation (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05020899, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2024.