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

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

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

Conditions
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HIV, Smoking Cessation

Intervention / Treatment
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* Behavioral: Smartphone-delivered Automated Messaging
* Drug: Nicotine patch
* Behavioral: Brief Advice to Quit and Smoking Cessation Self Help Materials
* Behavioral: Diet Assessment


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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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 |