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NCT Number: NCT05746442

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

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

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Key information

Conditions

Smoking Cessation Behavior HIV Health Behavior

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National AIDS Authority, Phnom Penh, Cambodia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Smartphone-delivered Automated Messaging

Behavioral

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.

Nicotine patch

Drug

Participants will be provided with a 8 week supply of nicotine patches

Brief Advice to Quit and Smoking Cessation Self Help Materials

Behavioral

Participants will receive self-help materials from Khmer Quit Now, a national smoking cessation campaign in Cambodia

Diet Assessment

Behavioral

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

Primary outcomes

  1. Self Reported 7 Day Abstinence Smoking Status

    Time frame: 12 Month Follow-Up

    Participants will self report 7-day abstinence smoking status

  2. Smoking Status by Expired Carbon Monoxide

    Time frame: 12 Month Follow-up

    Investigators will use a CO monitor to verify smoking status biochemically

Secondary outcomes

  1. Self Reported 7 Day Abstinence Smoking Status at 3 Months

    Time frame: At 3 Months

    Participants will self report 7-day abstinence smoking status

  2. Smoking Status by Expired Carbon Monoxide at 3 Months

    Time frame: At 3 Months

    Investigators will use a CO monitor to verify smoking status biochemically

  3. Self Reported 7 Day Abstinence Smoking Status at 6 Months

    Time frame: At 6 Months

    Participants will self report 7-day abstinence smoking status

  4. Smoking Status by Expired Carbon Monoxide at 6 Months

    Time frame: At 6 Months

    Investigators will use a CO monitor to verify smoking status biochemically

Study contacts

Contact information is provided by the study sponsor or research team.

Sarah Jones

CONTACT

[email protected]

813-745-7525

Sponsors and collaborators

Lead sponsor

H. Lee Moffitt Cancer Center and Research Institute

Other

Collaborators

  • M.D. Anderson Cancer Center
  • National Cancer Institute (NCI)
  • University of Oklahoma

Registry information

Official study title

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

Acronym: ProjectENDIT

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Feb 27, 2023
Registry last updated
Jun 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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