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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05746442
Acronym
ProjectENDIT
Enrollment
800
Registered
2023-02-27
Start date
2023-01-11
Completion date
2027-09-30
Last updated
2026-08-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV, Smoking Cessation

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.

Interventions

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.

DRUGNicotine patch

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

BEHAVIORALBrief 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

BEHAVIORALDiet Assessment

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

Sponsors

H. Lee Moffitt Cancer Center and Research Institute
Lead SponsorOTHER
National Cancer Institute (NCI)
CollaboratorNIH
University of Oklahoma
CollaboratorOTHER
M.D. Anderson Cancer Center
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Self Reported 7 Day Abstinence Smoking Status12 Month Follow-UpParticipants will self report 7-day abstinence smoking status
Smoking Status by Expired Carbon Monoxide12 Month Follow-upInvestigators will use a CO monitor to verify smoking status biochemically

Secondary

MeasureTime frameDescription
Self Reported 7 Day Abstinence Smoking Status at 3 MonthsAt 3 MonthsParticipants will self report 7-day abstinence smoking status
Smoking Status by Expired Carbon Monoxide at 3 MonthsAt 3 MonthsInvestigators will use a CO monitor to verify smoking status biochemically
Self Reported 7 Day Abstinence Smoking Status at 6 MonthsAt 6 MonthsParticipants will self report 7-day abstinence smoking status
Smoking Status by Expired Carbon Monoxide at 6 MonthsAt 6 MonthsInvestigators will use a CO monitor to verify smoking status biochemically

Countries

Cambodia

Contacts

CONTACTLindsey Sparrock, PhD
Lindsey.Sparrock@moffitt.org813-745-2893
PRINCIPAL_INVESTIGATORDamon Vidrine, Dr.PH

Moffitt Cancer Center

PRINCIPAL_INVESTIGATORThanh Bui, Dr.PH

Phnom Penh

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 14, 2026