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Completed

NCT Number: NCT05020899

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

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.

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Key information

Conditions

Smoking Cessation Behavior Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Health Behavior Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Guangxi Medical University, Guangxi, Nanning, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sessions with a trained counselor

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

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

Other

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

Self-help guide for quitting smoking

Other

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

Primary outcomes

  1. 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

Secondary outcomes

  1. Number of Participants That Self Reported Smoking Cessation at 8 Weeks

    Time frame: 8 weeks

    Participants will report if they did not smoke in the previous 7 days by answering questions in an interviewer-administered questionnaire.

  2. Number of Participants That Self Reported Smoking Cessation at 12 Weeks

    Time frame: 12 weeks

    Participants will report if they did not smoke in the previous 7 days by answering questions in an interviewer-administered questionnaire.

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

    Time frame: baseline, 8 weeks

    Participants will report the number of cigarettes they smoked in the previous 30 days by answering questions in an interviewer-administered questionnaire.

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

    Time frame: baseline, 12 weeks

    Participants will report the number of cigarettes they smoked in the previous 30 days by answering questions in an interviewer-administered questionnaire.

  5. Number of Quit Attempts at 8 Weeks

    Time frame: 8 weeks

    Participants will report the number of quit attempts since the study started by answering questions in an interviewer-administered questionnaire.

  6. Number of Quit Attempts at 12 Weeks

    Time frame: 12 weeks

    Participants will report the number of quit attempts since the study started by answering questions in an interviewer-administered questionnaire.

  7. Adherence to Antiretroviral Treatments (ART) at 8 Weeks

    Time frame: 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. Adherence to Antiretroviral Treatments (ART) at 12 Weeks

    Time frame: 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.

  9. 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

    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.

Other outcomes

  1. Intervention Satisfaction at 8 Weeks

    Time frame: 8 weeks

    Participant satisfaction with the intervention will be assessed using an investigator-developed questionnaire

  2. Intervention Satisfaction at 12 Weeks

    Time frame: 12 weeks

    Participant satisfaction with the intervention will be assessed using an investigator-developed questionnaire

Sponsors and collaborators

Lead sponsor

Boston Medical Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Acronym: QFL

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 25, 2021
Registry last updated
Dec 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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