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

HIV Clinical Trial

— ProjectENDIT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05746442
• Other study ID #: MCC-21528
• Secondary ID: U01CA261598
• Status: Recruiting
• Phase: N/A
• Start date: January 11, 2023
• Est. completion date: April 2025

Study information

• Verified date: June 2024
• Source: H. Lee Moffitt Cancer Center and Research Institute
• Contact: Sarah Jones
• Phone: 813-745-7525
• Email: Sarah.Jones[@]moffitt.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 800
• Est. completion date: April 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV
• HIV Infections
• Smoking Cessation

Intervention

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

Locations

Country	Name	City	State
Cambodia	National AIDS Authority	Phnom Penh
Cambodia	National Center for HIV/AIDS, Dermatology and STD	Phnom Penh
Cambodia	National Institute of Public Health	Phnom Penh

Sponsors (4)

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

Country where clinical trial is conducted

Cambodia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Self Reported 7 Day Abstinence Smoking Status	Participants will self report 7-day abstinence smoking status	12 Month Follow-Up
Primary	Smoking Status by Expired Carbon Monoxide	Investigators will use a CO monitor to verify smoking status biochemically	12 Month Follow-up
Secondary	Self Reported 7 Day Abstinence Smoking Status at 3 Months	Participants will self report 7-day abstinence smoking status	At 3 Months
Secondary	Smoking Status by Expired Carbon Monoxide at 3 Months	Investigators will use a CO monitor to verify smoking status biochemically	At 3 Months
Secondary	Self Reported 7 Day Abstinence Smoking Status at 6 Months	Participants will self report 7-day abstinence smoking status	At 6 Months
Secondary	Smoking Status by Expired Carbon Monoxide at 6 Months	Investigators will use a CO monitor to verify smoking status biochemically	At 6 Months