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

Not Applicable

Recruiting

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

• Registration Number: NCT05746442
• Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-11
• Study First Submitted: 2023-02-16
• Study First Submitted QC: 2023-02-16
• Study First Posted: 2023-02-27
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-13
• Last Update Posted: 2025-03-17
• Primary Completion: 2027-02-28
• Study Completion: 2027-02-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 800

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Care Group	Brief Advice to Quit and Smoking Cessation Self Help Materials	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.
Standard Care Group	Diet Assessment	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.
Automated Messaging Treatment Group	Smartphone-delivered Automated Messaging	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.
Automated Messaging Treatment Group	Brief Advice to Quit and Smoking Cessation Self Help Materials	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.
Standard Care Group	Nicotine patch	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.
Automated Messaging Treatment Group	Nicotine patch	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (3)

National AIDS Authority; 🇰🇭 Phnom Penh, Cambodia

National Institute of Public Health; 🇰🇭 Phnom Penh, Cambodia

National Center for HIV/AIDS, Dermatology and STD; 🇰🇭 Phnom Penh, Cambodia