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

Sponsor

H. Lee Moffitt Cancer Center and Research Institute (Other)

Overall Status

Recruiting

CT.gov ID

NCT05746442

Collaborator

National Cancer Institute (NCI) (NIH), University of Oklahoma (Other), M.D. Anderson Cancer Center (Other)

800

Enrollment

Locations

Arms

25.8

Anticipated Duration (Months)

266.7

Patients Per Site

10.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Smoking Cessation HIV	Behavioral: Smartphone-delivered Automated Messaging Drug: Nicotine patch Behavioral: Brief Advice to Quit and Smoking Cessation Self Help Materials Behavioral: Diet Assessment	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

800 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Prevention

Official Title:

Ending Tobacco Use Through Interactive Tailored Messaging for Cambodian People Living With HIV/AIDS (Project END-IT)

Actual Study Start Date :

Jan 5, 2023

Anticipated Primary Completion Date :

Mar 1, 2025

Anticipated Study Completion Date :

Mar 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Standard Care Group 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.	Drug: Nicotine patch Participants will be provided with a 8 week supply of nicotine patches Behavioral: Brief Advice to Quit and Smoking Cessation Self Help Materials Participants will receive self-help materials from Khmer Quit Now, a national smoking cessation campaign in Cambodia Behavioral: Diet Assessment Participants will be asked to complete brief weekly smartphone assessments about their diet for a 26-week period
Experimental: Automated Messaging Treatment Group 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.	Behavioral: Smartphone-delivered Automated Messaging 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. Drug: Nicotine patch Participants will be provided with a 8 week supply of nicotine patches Behavioral: Brief Advice to Quit and Smoking Cessation Self Help Materials Participants will receive self-help materials from Khmer Quit Now, a national smoking cessation campaign in Cambodia

Arm

Intervention/Treatment

Active Comparator: Standard Care Group

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.

Drug: Nicotine patch

Participants will be provided with a 8 week supply of nicotine patches

Behavioral: Brief Advice to Quit and Smoking Cessation Self Help Materials

Participants will receive self-help materials from Khmer Quit Now, a national smoking cessation campaign in Cambodia

Behavioral: Diet Assessment

Participants will be asked to complete brief weekly smartphone assessments about their diet for a 26-week period

Experimental: Automated Messaging Treatment Group

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.

Behavioral: Smartphone-delivered Automated Messaging

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.

Drug: Nicotine patch

Participants will be provided with a 8 week supply of nicotine patches

Behavioral: Brief Advice to Quit and Smoking Cessation Self Help Materials

Participants will receive self-help materials from Khmer Quit Now, a national smoking cessation campaign in Cambodia

Outcome Measures

Primary Outcome Measures

Self Reported 7 Day Abstinence Smoking Status [12 Month Follow-Up]
Participants will self report 7-day abstinence smoking status
Smoking Status by Expired Carbon Monoxide [12 Month Follow-up]
Investigators will use a CO monitor to verify smoking status biochemically

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

1. being aged ≥18 years
1. being HIV-positive
1. self-reporting as a current combustible cigarette smoker (smoked ≥100 cigarettes in lifetime and currently smoke ≥1 cigarettes/day)
1. willing to set a date for a quit attempt within 2 weeks of study enrollment
1. being able to provide written informed consent to participate
1. 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
1. physician/clinician deemed ineligible to participate based on medical or psychiatric condition
1. enrolled in another cessation program or use of other cessation medications.

Contacts and Locations

Locations

	Site	City	Country
1	National AIDS Authority	Phnom Penh	Cambodia
2	National Center for HIV/AIDS, Dermatology and STD	Phnom Penh	Cambodia
3	National Institute of Public Health	Phnom Penh	Cambodia

Sponsors and Collaborators

H. Lee Moffitt Cancer Center and Research Institute
National Cancer Institute (NCI)
University of Oklahoma
M.D. Anderson Cancer Center

Investigators

Principal Investigator: Damon Vidrine, Dr.PH, Moffitt Cancer Center
Principal Investigator: Thanh Bui, Dr.PH, Phnom Penh

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

H. Lee Moffitt Cancer Center and Research Institute

ClinicalTrials.gov Identifier:

NCT05746442

Other Study ID Numbers:

MCC-21528
U01CA261598

First Posted:

Feb 27, 2023

Last Update Posted:

Feb 27, 2023

Last Verified:

Feb 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Acquired Immunodeficiency Syndrome

HIV Infections

Nicotine

Study Results

No Results Posted as of Feb 27, 2023