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

NCT ID: NCT05020899

Last Updated: 2024-12-12

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

109 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-24

Study Completion Date

2023-08-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Smoking Cessation HIV Infections

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Quit for Life (QFL) Smoking cessation counselors WeChat messages Nicotine replacement therapy Self-help smoking cessation guide People living with HIV/AIDS (PLH)

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Sessions with a trained counselor

Intervention Type 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.

Cell phone messages

Intervention Type 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

Intervention Type OTHER

Participants will be offered nicotine replacement therapy (gum or patch, depending on which one is available).

Self-help guide for quitting smoking

Intervention Type OTHER

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.

Group Type ACTIVE_COMPARATOR

Offered nicotine replacement therapy

Intervention Type OTHER

Participants will be offered nicotine replacement therapy (gum or patch, depending on which one is available).

Self-help guide for quitting smoking

Intervention Type OTHER

Participants will be offered a self-help guide with information about quitting smoking.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BEHAVIORAL

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

Intervention Type OTHER

Offered nicotine replacement therapy

Participants will be offered nicotine replacement therapy (gum or patch, depending on which one is available).

Intervention Type OTHER

Self-help guide for quitting smoking

Participants will be offered a self-help guide with information about quitting smoking.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Boston Medical Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Lisa Quintiliani, PhD

Role: PRINCIPAL_INVESTIGATOR

Boston Medical Center

Hao Liang, PhD

Role: PRINCIPAL_INVESTIGATOR

Guangxi Medical University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Boston Medical Center

Boston, Massachusetts, United States

Site Status

Guangxi Medical University

Guangxi, Nanning, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States China

References

Explore related publications, articles, or registry entries linked to this study.

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 Jul 24. doi: 10.1007/s10461-025-04823-7. Online ahead of print.

Reference Type DERIVED
PMID: 40705206 (View on PubMed)

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1R21CA243835-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

H-41807

Identifier Type: -

Identifier Source: org_study_id