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

NCT ID: NCT05746442

Last Updated: 2026-01-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

800 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-11

Study Completion Date

2027-02-28

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.

Detailed Description

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Conditions

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Smoking Cessation HIV

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Standard Care Group

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.

Group Type ACTIVE_COMPARATOR

Nicotine patch

Intervention Type DRUG

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

Brief Advice to Quit and Smoking Cessation Self Help Materials

Intervention Type BEHAVIORAL

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

Diet Assessment

Intervention Type BEHAVIORAL

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

Automated Messaging Treatment Group

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.

Group Type EXPERIMENTAL

Smartphone-delivered Automated Messaging

Intervention Type 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

Intervention Type DRUG

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

Brief Advice to Quit and Smoking Cessation Self Help Materials

Intervention Type BEHAVIORAL

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

Interventions

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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.

Intervention Type BEHAVIORAL

Nicotine patch

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

Intervention Type DRUG

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

Intervention Type BEHAVIORAL

Diet Assessment

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

Intervention Type BEHAVIORAL

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

University of Oklahoma

OTHER

Sponsor Role collaborator

M.D. Anderson Cancer Center

OTHER

Sponsor Role collaborator

H. Lee Moffitt Cancer Center and Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Damon Vidrine, Dr.PH

Role: PRINCIPAL_INVESTIGATOR

Moffitt Cancer Center

Thanh Bui, Dr.PH

Role: PRINCIPAL_INVESTIGATOR

Phnom Penh

Locations

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National AIDS Authority

Phnom Penh, , Cambodia

Site Status RECRUITING

National Center for HIV/AIDS, Dermatology and STD

Phnom Penh, , Cambodia

Site Status RECRUITING

National Institute of Public Health

Phnom Penh, , Cambodia

Site Status RECRUITING

Countries

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Cambodia

Central Contacts

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Sarah Jones

Role: CONTACT

813-745-7525

Facility Contacts

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Leng Hor, MD, PhD

Role: primary

Ouk Vichea, MD

Role: primary

Chhorvann Chhea

Role: primary

References

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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.

Reference Type DERIVED
PMID: 37384390 (View on PubMed)

Other Identifiers

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U01CA261598

Identifier Type: NIH

Identifier Source: secondary_id

View Link

MCC-21528

Identifier Type: -

Identifier Source: org_study_id

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