Clinical trial NCT05020899: Quit For Life (QFL): Smoking Cessation Among Chinese Smokers Living With HIV
Official title: Quit For Life (QFL): Smoking Cessation Among Chinese Smokers Living With HIV
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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)
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2021-08-25
Enrollment: 109
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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. 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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Biochemically Verified Smoking Cessation
timeFrame: 12 weeks
Secondary outcomes:
measure: Number of Participants That Self Reported Smoking Cessation at 8 Weeks
timeFrame: 8 weeks
measure: Number of Participants That Self Reported Smoking Cessation at 12 Weeks
timeFrame: 12 weeks
measure: Change in Number of Cigarettes Smoked in the Previous 30 Days at 8 Weeks
timeFrame: baseline, 8 weeks
measure: Change in Number of Cigarettes Smoked in the Previous 30 Days at 12 Weeks
timeFrame: baseline, 12 weeks
measure: Number of Quit Attempts at 8 Weeks
timeFrame: 8 weeks
measure: Number of Quit Attempts at 12 Weeks
timeFrame: 12 weeks
measure: Adherence to Antiretroviral Treatments (ART) at 8 Weeks
timeFrame: 8 weeks
measure: Adherence to Antiretroviral Treatments (ART) at 12 Weeks
timeFrame: 12 weeks
measure: Quality of Life (QOL) in the Dimensions of Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression at 12 Weeks
timeFrame: 12 weeks
Other outcomes:
measure: Intervention Satisfaction at 8 Weeks
timeFrame: 8 weeks
measure: Intervention Satisfaction at 12 Weeks
timeFrame: 12 weeks
Locations:
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
city: Guangxi
country: China
facility: Guangxi Medical University
state: Nanning
Study officials:
affiliation: Boston Medical Center
name: Lisa Quintiliani, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Guangxi Medical University
name: Hao Liang, PhD
role: PRINCIPAL_INVESTIGATOR
References: