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Recruiting NCT05746442

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

No phase Interventional Smoking Cessation HIV

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Smartphone-delivered Automated Messaging, Nicotine patch, Brief Advice to Quit and Smoking Cessation Self Help Materials, Diet Assessment.
Who it may be relevant to
Registry conditions: Smoking Cessation, HIV. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Cambodia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

Interventions

  • Behavioral Smartphone-delivered Automated Messaging
    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.
  • Drug Nicotine patch
    Participants will be provided with a 8 week supply of nicotine patches
  • Behavioral Brief Advice to Quit and Smoking Cessation Self Help Materials
    Participants will receive self-help materials from Khmer Quit Now, a national smoking cessation campaign in Cambodia
  • Behavioral Diet Assessment
    Participants will be asked to complete brief weekly smartphone assessments about their diet for a 26-week period

Primary outcome measures

  • Self Reported 7 Day Abstinence Smoking Status [Time frame: 12 Month Follow-Up]
  • Smoking Status by Expired Carbon Monoxide [Time frame: 12 Month Follow-up]
Secondary outcome measures (4)
  • Self Reported 7 Day Abstinence Smoking Status at 3 Months [Time frame: At 3 Months]
  • Smoking Status by Expired Carbon Monoxide at 3 Months [Time frame: At 3 Months]
  • Self Reported 7 Day Abstinence Smoking Status at 6 Months [Time frame: At 6 Months]
  • Smoking Status by Expired Carbon Monoxide at 6 Months [Time frame: At 6 Months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Prevention

Study locations

Cambodia · 3 centers
  • National AIDS Authority — Phnom Penh
  • National Center for HIV/AIDS, Dermatology and STD — Phnom Penh
  • National Institute of Public Health — Phnom Penh

Publications

  • 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. d PMID 37384390

Identifiers

NCT: NCT05746442 · MCC-21528 · U01CA261598

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗