NCT05020899

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. 1.4 sessions with a trained counselor who will discuss the participants' smoking habits and strategies to help them quit.
  2. 2.Messages sent to the participants' cell phone using WeChat.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
109

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2022

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 19, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 25, 2021

Completed
6 months until next milestone

Study Start

First participant enrolled

February 24, 2022

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2023

Completed
2 months until next milestone

Results Posted

Study results publicly available

October 5, 2023

Completed
Last Updated

December 12, 2024

Status Verified

November 1, 2024

Enrollment Period

1.4 years

First QC Date

August 19, 2021

Results QC Date

September 5, 2023

Last Update Submit

November 25, 2024

Conditions

Smoking CessationHIV Infections

Keywords

Quit for Life (QFL)Smoking cessation counselorsWeChat messagesNicotine replacement therapySelf-help smoking cessation guidePeople living with HIV/AIDS (PLH)

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (9)

  • Number of Participants That Self Reported Smoking Cessation at 8 Weeks

    8 weeks

  • Number of Participants That Self Reported Smoking Cessation at 12 Weeks

    12 weeks

  • Change in Number of Cigarettes Smoked in the Previous 30 Days at 8 Weeks

    baseline, 8 weeks

  • Change in Number of Cigarettes Smoked in the Previous 30 Days at 12 Weeks

    baseline, 12 weeks

  • Number of Quit Attempts at 8 Weeks

    8 weeks

  • +4 more secondary outcomes

Other Outcomes (2)

  • Intervention Satisfaction at 8 Weeks

    8 weeks

  • Intervention Satisfaction at 12 Weeks

    12 weeks

Study Arms (2)

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.

Behavioral: Sessions with a trained counselorOther: Cell phone messagesOther: Offered nicotine replacement therapyOther: 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.

Other: Offered nicotine replacement therapyOther: Self-help guide for quitting smoking

Interventions

Sessions with a trained counselorBEHAVIORAL

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.

Quit for Life group
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

Quit for Life group
Offered nicotine replacement therapyOTHER

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

Control groupQuit for Life group
Self-help guide for quitting smokingOTHER

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

Control groupQuit for Life group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Self-reported using other smoking cessation program or medication
  • Having a serious health problem that may make them unsuitable to stay in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Guangxi Medical University

Guangxi, Nanning, 530021, China

Location

Related Publications (1)

  • 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.

    PMID: 40705206DERIVED

MeSH Terms

Conditions

Smoking CessationHIV Infections

Condition Hierarchy (Ancestors)

Health BehaviorBehaviorBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Results Point of Contact

Title
Lisa Quintiliani, PhD
Organization
Boston Medical Center
lisa.quintiliani@bmc.org
617-638-2777

Study Officials

  • Lisa Quintiliani, PhD

    Boston Medical Center

    PRINCIPAL INVESTIGATOR

  • Hao Liang, PhD

    Guangxi Medical University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 19, 2021

First Posted

August 25, 2021

Study Start

February 24, 2022

Primary Completion

August 1, 2023

Study Completion

August 1, 2023

Last Updated

December 12, 2024

Results First Posted

October 5, 2023

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)US(1)