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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05746442
Other study ID # MCC-21528
Secondary ID U01CA261598
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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