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

H. Lee Moffitt Cancer Center and Research Institute

Status: Enrolling

Conditions: HIV; Smoking Cessation

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05746442

MCC-21528

U01CA261598 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Enrollment: 800 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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800 participants in 2 patient groups

Standard Care Group

Active Comparator group

Description:

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.

Treatment:

Behavioral: Brief Advice to Quit and Smoking Cessation Self Help Materials

Drug: Nicotine patch

Behavioral: Diet Assessment

Automated Messaging Treatment Group

Experimental group

Description:

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.

Treatment:

Behavioral: Smartphone-delivered Automated Messaging

Behavioral: Brief Advice to Quit and Smoking Cessation Self Help Materials

Drug: Nicotine patch