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Ending Tobacco Use Through Interactive Tailored Messaging for Cambodian People Living With HIV/AIDS (ProjectENDIT)

Primary Purpose

Smoking Cessation, HIV

Status
Recruiting
Phase
Not Applicable
Locations
Cambodia
Study Type
Interventional
Intervention
Smartphone-delivered Automated Messaging
Nicotine patch
Brief Advice to Quit and Smoking Cessation Self Help Materials
Diet Assessment
Sponsored by
H. Lee Moffitt Cancer Center and Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Smoking Cessation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 1) being aged ≥18 years 2) being HIV-positive 3) self-reporting as a current combustible cigarette smoker (smoked ≥100 cigarettes in lifetime and currently smoke ≥1 cigarettes/day) 4) willing to set a date for a quit attempt within 2 weeks of study enrollment 5) being able to provide written informed consent to participate 6) being able to read Khmer (score ≥4 points on the Rapid Estimate of Adult Literacy in Medicine-Short Form Exclusion Criteria: 1) history of a medical condition that precludes use of nicotine replacement therapy 2) physician/clinician deemed ineligible to participate based on medical or psychiatric condition 3) enrolled in another cessation program or use of other cessation medications.

Sites / Locations

  • National AIDS AuthorityRecruiting
  • National Center for HIV/AIDS, Dermatology and STDRecruiting
  • National Institute of Public HealthRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard Care Group

Automated Messaging Treatment Group

Arm Description

Participants will receive brief advice and education materials to quit smoking along with brief weekly assessments to be completed on a smartphone. They will also receive a 8 week supply of of nicotine replacement therapy in the form of nicotine patches.

Participants will receive brief advice and education materials to quit smoking, along with brief weekly assessments and an interactive phone-based treatment program delivered on a smartphone. They will also receive a 8 week supply of of nicotine replacement therapy in the form of nicotine patches.

Outcomes

Primary Outcome Measures

Self Reported 7 Day Abstinence Smoking Status
Participants will self report 7-day abstinence smoking status
Smoking Status by Expired Carbon Monoxide
Investigators will use a CO monitor to verify smoking status biochemically

Secondary Outcome Measures

Self Reported 7 Day Abstinence Smoking Status at 3 Months
Participants will self report 7-day abstinence smoking status
Smoking Status by Expired Carbon Monoxide at 3 Months
Investigators will use a CO monitor to verify smoking status biochemically
Self Reported 7 Day Abstinence Smoking Status at 6 Months
Participants will self report 7-day abstinence smoking status
Smoking Status by Expired Carbon Monoxide at 6 Months
Investigators will use a CO monitor to verify smoking status biochemically

Full Information

First Posted
February 16, 2023
Last Updated
June 14, 2023
Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Collaborators
National Cancer Institute (NCI), University of Oklahoma, M.D. Anderson Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT05746442
Brief Title
Ending Tobacco Use Through Interactive Tailored Messaging for Cambodian People Living With HIV/AIDS
Acronym
ProjectENDIT
Official Title
Ending Tobacco Use Through Interactive Tailored Messaging for Cambodian People Living With HIV/AIDS (Project END-IT)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 11, 2023 (Actual)
Primary Completion Date
March 2025 (Anticipated)
Study Completion Date
March 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Collaborators
National Cancer Institute (NCI), University of Oklahoma, M.D. Anderson Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The goal of this research study is to test how well an automated text messaging smoking treatment program helps smokers with HIV quit smoking.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Smoking Cessation, HIV

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
800 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard Care Group
Arm Type
Active Comparator
Arm Description
Participants will receive brief advice and education materials to quit smoking along with brief weekly assessments to be completed on a smartphone. They will also receive a 8 week supply of of nicotine replacement therapy in the form of nicotine patches.
Arm Title
Automated Messaging Treatment Group
Arm Type
Experimental
Arm Description
Participants will receive brief advice and education materials to quit smoking, along with brief weekly assessments and an interactive phone-based treatment program delivered on a smartphone. They will also receive a 8 week supply of of nicotine replacement therapy in the form of nicotine patches.
Intervention Type
Behavioral
Intervention Name(s)
Smartphone-delivered Automated Messaging
Intervention Description
An interactive smartphone based intervention will provide weekly smoking-related assessments and personalized automated messages designed to increase motivation, self-efficacy, use of coping skills, social support and to reduce nicotine withdrawal symptoms and stress for a 26 week period.
Intervention Type
Drug
Intervention Name(s)
Nicotine patch
Intervention Description
Participants will be provided with a 8 week supply of nicotine patches
Intervention Type
Behavioral
Intervention Name(s)
Brief Advice to Quit and Smoking Cessation Self Help Materials
Intervention Description
Participants will receive self-help materials from Khmer Quit Now, a national smoking cessation campaign in Cambodia
Intervention Type
Behavioral
Intervention Name(s)
Diet Assessment
Intervention Description
Participants will be asked to complete brief weekly smartphone assessments about their diet for a 26-week period
Primary Outcome Measure Information:
Title
Self Reported 7 Day Abstinence Smoking Status
Description
Participants will self report 7-day abstinence smoking status
Time Frame
12 Month Follow-Up
Title
Smoking Status by Expired Carbon Monoxide
Description
Investigators will use a CO monitor to verify smoking status biochemically
Time Frame
12 Month Follow-up
Secondary Outcome Measure Information:
Title
Self Reported 7 Day Abstinence Smoking Status at 3 Months
Description
Participants will self report 7-day abstinence smoking status
Time Frame
At 3 Months
Title
Smoking Status by Expired Carbon Monoxide at 3 Months
Description
Investigators will use a CO monitor to verify smoking status biochemically
Time Frame
At 3 Months
Title
Self Reported 7 Day Abstinence Smoking Status at 6 Months
Description
Participants will self report 7-day abstinence smoking status
Time Frame
At 6 Months
Title
Smoking Status by Expired Carbon Monoxide at 6 Months
Description
Investigators will use a CO monitor to verify smoking status biochemically
Time Frame
At 6 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 1) being aged ≥18 years 2) being HIV-positive 3) self-reporting as a current combustible cigarette smoker (smoked ≥100 cigarettes in lifetime and currently smoke ≥1 cigarettes/day) 4) willing to set a date for a quit attempt within 2 weeks of study enrollment 5) being able to provide written informed consent to participate 6) being able to read Khmer (score ≥4 points on the Rapid Estimate of Adult Literacy in Medicine-Short Form Exclusion Criteria: 1) history of a medical condition that precludes use of nicotine replacement therapy 2) physician/clinician deemed ineligible to participate based on medical or psychiatric condition 3) enrolled in another cessation program or use of other cessation medications.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sarah Jones
Phone
813-745-7525
Email
Sarah.Jones@moffitt.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Damon Vidrine, Dr.PH
Organizational Affiliation
Moffitt Cancer Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Thanh Bui, Dr.PH
Organizational Affiliation
Phnom Penh
Official's Role
Principal Investigator
Facility Information:
Facility Name
National AIDS Authority
City
Phnom Penh
Country
Cambodia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Leng Hor, MD, PhD
First Name & Middle Initial & Last Name & Degree
Leng Hor, MD, PhD
Facility Name
National Center for HIV/AIDS, Dermatology and STD
City
Phnom Penh
Country
Cambodia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ouk Vichea, MD
First Name & Middle Initial & Last Name & Degree
Ouk Vichea, MD
Facility Name
National Institute of Public Health
City
Phnom Penh
Country
Cambodia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chhorvann Chhea
First Name & Middle Initial & Last Name & Degree
Chhorvann Chhea

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Ending Tobacco Use Through Interactive Tailored Messaging for Cambodian People Living With HIV/AIDS

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