ClinicalTrials.gg
RecruitingNCT05746442ProjectENDITUpdated Aug 13, 2026

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

An interventional study of Smartphone-delivered Automated Messaging and Nicotine patch in Smoking Cessation and HIV, sponsored by H. Lee Moffitt Cancer Center and Research Institute. Recruiting at 3 sites in Cambodia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-13.

Sponsored by H. Lee Moffitt Cancer Center and Research Institute · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Started Jan 2023; still recruiting 3 years 10 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
800
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Smoking Cessation
  • HIV

Browse trials for

03

In context

Smoking Cessation

1,581 studies on the registry are indexed under Smoking Cessation; 198 are open to participants now.

This study's planned enrollment of 800 is above the median of 164 across 1,423 interventional studies indexed under Smoking Cessation.

Browse Smoking Cessation studies →

Lead sponsor

H. Lee Moffitt Cancer Center and Research Institute is the lead sponsor of 540 studies on the registry; 75 are open to participants now.

Of its 99 completed or terminated interventional studies of FDA-regulated products, 57 (58%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 1) being aged ≥18 years
  • 2) being -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 to participate
  • 6) being able to read Khmer (score ≥4 points on the Rapid Estimate of Adult Literacy in Medicine-Short Form

Exclusion criteria

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.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
800 participants (estimated)

Study arms

  • Active comparator
    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.

    Drug: Nicotine patch · Behavioral: Brief Advice to Quit and Smoking Cessation Self Help Materials · Behavioral: Diet Assessment

  • Experimental
    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.

    Behavioral: Smartphone-delivered Automated Messaging · Drug: Nicotine patch · Behavioral: Brief Advice to Quit and Smoking Cessation Self Help Materials

Interventions

  • BehavioralSmartphone-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.

  • 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

06

What researchers measure

Primary outcomes

  1. Self Reported 7 Day Abstinence Smoking Status

    Participants will self report 7-day abstinence smoking status

    Time frame: 12 Month Follow-Up

  2. Smoking Status by Expired Carbon Monoxide

    Investigators will use a CO monitor to verify smoking status biochemically

    Time frame: 12 Month Follow-up

Secondary outcomes

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

    Participants will self report 7-day abstinence smoking status

    Time frame: At 3 Months

  2. Smoking Status by Expired Carbon Monoxide at 3 Months

    Investigators will use a CO monitor to verify smoking status biochemically

    Time frame: At 3 Months

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

    Participants will self report 7-day abstinence smoking status

    Time frame: At 6 Months

  4. Smoking Status by Expired Carbon Monoxide at 6 Months

    Investigators will use a CO monitor to verify smoking status biochemically

    Time frame: At 6 Months

07

Study locations

3 of 3 sites recruiting
  • National AIDS Authority
    Phnom Penh, Cambodia
    Recruiting
    • Leng Hor, MD, PhD · Contact
    • Leng Hor, MD, PhD · Principal investigator
  • National Center for HIV/AIDS, Dermatology and STD
    Phnom Penh, Cambodia
    Recruiting
    • Ouk Vichea, MD · Contact
    • Ouk Vichea, MD · Principal investigator
  • National Institute of Public Health
    Phnom Penh, Cambodia
    Recruiting
    • Chhorvann Chhea · Contact
    • Chhorvann Chhea · Principal investigator
08

References and documents

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. doi: 10.2196/48923. PubMed 37384390 ↗

Individual participant data

Plan to share: Undecided

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jan 2023 (actual). Primary completion is estimated for Aug 2027, 55 months after the start.

Of 546 non-industry interventional studies with no phase under Smoking Cessation, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 45. This study's planned 55 months is above that.

Counting every sponsor, half of 563 studies reached it within 24 months; a quarter within 12 and three quarters within 44.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 16, 2023
First posted
Feb 27, 2023
StartActual
Jan 11, 2023
Primary completionEst.
Aug 31, 2027
CompletionEst.
Sep 30, 2027
Last update
Aug 13, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05746442
Responsible party
Sponsor
First posted
Feb 27, 2023
Start date
Jan 11, 2023
Primary completion
Aug 31, 2027 (estimated)
Completion
Sep 30, 2027 (estimated)
Last update
Aug 13, 2026

Study contacts

Lindsey Sparrock, PhD
Contact
Lindsey.Sparrock@moffitt.org
813-745-2893
Damon Vidrine, Dr.PH
principal investigator · Moffitt Cancer Center
Thanh Bui, Dr.PH
principal investigator · Phnom Penh

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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