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

NCT05746442 | Recruiting

• 2 other identifiers: MCC-21528U01CA261598
• Study Type: interventional
• Target: 800
• Locations: 1 country
• Sites: 3

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.

Conditions

Smoking Cessation; HIV

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Self Reported 7 Day Abstinence Smoking Status at 3 Months

  At 3 Months

• Smoking Status by Expired Carbon Monoxide at 3 Months

  At 3 Months

• Self Reported 7 Day Abstinence Smoking Status at 6 Months

  At 6 Months

• Smoking Status by Expired Carbon Monoxide at 6 Months

  At 6 Months

Study Arms (2)

Standard Care Group

ACTIVE COMPARATOR

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

Automated Messaging Treatment Group

EXPERIMENTAL

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; Drug: Nicotine patch; Behavioral: Brief Advice to Quit and Smoking Cessation Self Help Materials

Interventions

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.

Automated Messaging Treatment Group

Nicotine patch DRUG

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

Automated Messaging Treatment Group; Standard Care Group

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

Automated Messaging Treatment Group; Standard Care Group

Diet Assessment BEHAVIORAL

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

Standard Care Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) being aged ≥18 years
• \) being HIV-positive
• \) self-reporting as a current combustible cigarette smoker (smoked ≥100 cigarettes in lifetime and currently smoke ≥1 cigarettes/day)
• \) willing to set a date for a quit attempt within 2 weeks of study enrollment
• \) being able to provide written informed consent to participate
• \) being able to read Khmer (score ≥4 points on the Rapid Estimate of Adult Literacy in Medicine-Short Form

You may not qualify if:

• \) history of a medical condition that precludes use of nicotine replacement therapy
• \) physician/clinician deemed ineligible to participate based on medical or psychiatric condition
• \) enrolled in another cessation program or use of other cessation medications.

Sponsors & Collaborators

• National Cancer Institute (NCI): collaborator
• University of Oklahoma: collaborator
• M.D. Anderson Cancer Center: collaborator
• H. Lee Moffitt Cancer Center and Research Institute: lead

Study Sites (3)

National AIDS Authority

Phnom Penh, Cambodia

RECRUITING

National Center for HIV/AIDS, Dermatology and STD

Phnom Penh, Cambodia

RECRUITING

National Institute of Public Health

Phnom Penh, Cambodia

RECRUITING

Related Publications (1)

• Bui TC, Hoogland CE, Chhea C, Sopheab H, Ouk V, Samreth S, Hor B, Vidrine JI, Businelle MS, Shih YCT, Sutton SK, Jones SR, Shorey Fennell B, Cottrell-Daniels C, Frank-Pearce SG, Ngor C, Kulkarni S, Vidrine DJ. Ending Tobacco Use Through Interactive Tailored Messaging for Cambodian People With HIV (Project EndIT): Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2023 Jun 29;12:e48923. doi: 10.2196/48923.

  PMID: 37384390 DERIVED

MeSH Terms

Conditions

Smoking Cessation

Interventions

Tobacco Use Cessation Devices

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Damon Vidrine, Dr.PH

  Moffitt Cancer Center

  PRINCIPAL INVESTIGATOR

• Thanh Bui, Dr.PH

  Phnom Penh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah Jones

CONTACT

813-745-7525; Sarah.Jones@moffitt.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2023
• First Posted: February 27, 2023
• Study Start: January 11, 2023
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): February 28, 2027
• Last Updated: April 1, 2026

Record last verified: 2026-03

Locations

CA (3)