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

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.

Study Overview

• Status: Completed
• Conditions: HIV Infections; Smoking Cessation
• Intervention / Treatment: Behavioral: Sessions with a trained counselor; Other: Cell phone messages; Other: Offered nicotine replacement therapy; Other: Self-help guide for quitting smoking

• Study Type: Interventional
• Enrollment (Actual): 109
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Nanning
    • Guangxi, Nanning, China, 530021
      • Guangxi Medical University
• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Boston Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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.; Other: 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; Other: Offered nicotine replacement therapy; Participants will be offered nicotine replacement therapy (gum or patch, depending on which one is available).; Other: Self-help guide for quitting smoking; Participants will be offered a self-help guide with information about quitting smoking.
Active Comparator: 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.	Other: Offered nicotine replacement therapy; Participants will be offered nicotine replacement therapy (gum or patch, depending on which one is available).; Other: Self-help guide for quitting smoking; Participants will be offered a self-help guide with information about quitting smoking.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Other Outcome Measures

Outcome Measure	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	12 weeks

Collaborators and Investigators

• Sponsor: Boston Medical Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Lisa Quintiliani, PhD, Boston Medical Center; Principal Investigator: Hao Liang, PhD, Guangxi Medical University

Study record dates

Study Major Dates

• Study Start (Actual): February 24, 2022
• Primary Completion (Actual): August 1, 2023
• Study Completion (Actual): August 1, 2023

Study Registration Dates

• First Submitted: August 19, 2021
• First Submitted That Met QC Criteria: August 19, 2021
• First Posted (Actual): August 25, 2021

Study Record Updates

• Last Update Posted (Estimated): December 12, 2024
• Last Update Submitted That Met QC Criteria: November 25, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Nicotine replacement therapy; Quit for Life (QFL); Smoking cessation counselors; WeChat messages; Self-help smoking cessation guide; People living with HIV/AIDS (PLH)
• Additional Relevant MeSH Terms: Blood-Borne Infections; Urogenital Diseases; Genital Diseases; Immune System Diseases; Infections; RNA Virus Infections; Virus Diseases; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; HIV Infections; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Neurotransmitter Agents; Cholinergic Agents; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Nicotine
• Other Study ID Numbers: H-41807; 1R21CA243835-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No