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

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

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

Study Overview

• Status: Recruiting
• Conditions: Smoking Cessation; HIV
• Intervention / Treatment: Drug: Nicotine patch; Behavioral: Brief Advice to Quit and Smoking Cessation Self Help Materials; Behavioral: Diet Assessment; Behavioral: Smartphone-delivered Automated Messaging

• Study Type: Interventional
• Enrollment (Estimated): 800
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sarah Jones; Phone Number: 813-745-7525; Email: Sarah.Jones@moffitt.org

Study Locations

• Cambodia
  • Phnom Penh, Cambodia
    • Recruiting
    • National AIDS Authority
    • Contact: Leng Hor, MD, PhD
    • Principal Investigator: Leng Hor, MD, PhD
  • Phnom Penh, Cambodia
    • Recruiting
    • National Center for HIV/AIDS, Dermatology and STD
    • Contact: Ouk Vichea, MD
    • Principal Investigator: Ouk Vichea, MD
  • Phnom Penh, Cambodia
    • Recruiting
    • National Institute of Public Health
    • Contact: Chhorvann Chhea
    • Principal Investigator: Chhorvann Chhea

Participation Criteria

Eligibility Criteria

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

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.	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: 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: H. Lee Moffitt Cancer Center and Research Institute
• Collaborators: M.D. Anderson Cancer Center; National Cancer Institute (NCI); University of Oklahoma
• Investigators: Principal Investigator: Damon Vidrine, Dr.PH, Moffitt Cancer Center; Principal Investigator: Thanh Bui, Dr.PH, Phnom Penh

Study record dates

Study Major Dates

• Study Start (Actual): January 11, 2023
• Primary Completion (Estimated): March 1, 2025
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: February 16, 2023
• First Submitted That Met QC Criteria: February 16, 2023
• First Posted (Actual): February 27, 2023

Study Record Updates

• Last Update Posted (Estimated): June 16, 2023
• Last Update Submitted That Met QC Criteria: June 14, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases; Urogenital Diseases; Genital Diseases; HIV Infections; Acquired Immunodeficiency Syndrome; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Nicotine
• Other Study ID Numbers: MCC-21528; U01CA261598 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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