Smoking CessationProjectENDITNCT05746442
Ending Tobacco Use Through Interactive Tailored Messaging for Cambodian People Living With HIV/AIDS
A study testing Smartphone-delivered Automated Messaging, Nicotine patch and Brief Advice to Quit and Smoking Cessation Self Help Materials in people with Smoking Cessation and HIV, run by H. Lee Moffitt Cancer Center and Research Institute at 3 sites in Cambodia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking Cessation, HIV
- What is being tested?
- Smartphone-delivered Automated Messaging, Nicotine patch and Brief Advice to Quit and Smoking Cessation Self Help Materials
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 3 sitesCambodia
- Study dates
- 11 Jan 2023to 30 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Cambodia3 sites, 3 recruiting
- Recruiting
National AIDS Authority
Phnom Penh
Leng Hor, MD, PhD
Leng Hor, MD, PhD
- Recruiting
National Center for HIV/AIDS, Dermatology and STD
Phnom Penh
Ouk Vichea, MD
Ouk Vichea, MD
- Recruiting
National Institute of Public Health
Phnom Penh
Chhorvann Chhea
Chhorvann Chhea
About this study
Official title: Ending Tobacco Use Through Interactive Tailored Messaging for Cambodian People Living With HIV/AIDS (Project END-IT)
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
- Being tested
- Smartphone-delivered Automated Messaging, Nicotine patch, Brief Advice to Quit and Smoking Cessation Self Help Materials, Diet Assessment
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smartphone-delivered Automated MessagingBehavioural
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 patchDrug
Participants will be provided with a 8 week supply of nicotine patches
Brief Advice to Quit and Smoking Cessation Self Help MaterialsBehavioural
Participants will receive self-help materials from Khmer Quit Now, a national smoking cessation campaign in Cambodia
Diet AssessmentBehavioural
Participants will be asked to complete brief weekly smartphone assessments about their diet for a 26-week period
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Smartphone-delivered Automated Messaging; Drug: Nicotine patch; Behavioral: Brief Advice to Quit and Smoking Cessation Self Help Materials |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self Reported 7 Day Abstinence Smoking Status
Participants will self report 7-day abstinence smoking status
Measured: 12 Month Follow-Up
Smoking Status by Expired Carbon Monoxide
Investigators will use a CO monitor to verify smoking status biochemically
Measured: 12 Month Follow-up
Secondary outcomes (4)
Self Reported 7 Day Abstinence Smoking Status at 3 Months
Participants will self report 7-day abstinence smoking status
Measured: At 3 Months
Smoking Status by Expired Carbon Monoxide at 3 Months
Investigators will use a CO monitor to verify smoking status biochemically
Measured: At 3 Months
Self Reported 7 Day Abstinence Smoking Status at 6 Months
Participants will self report 7-day abstinence smoking status
Measured: At 6 Months
Smoking Status by Expired Carbon Monoxide at 6 Months
Investigators will use a CO monitor to verify smoking status biochemically
Measured: At 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2023
- Study start11 Jan 2023
- Primary completion31 Aug 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by H. Lee Moffitt Cancer Center and Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Damon Vidrine, Dr.PH, Principal investigator, Moffitt Cancer CenterThanh Bui, Dr.PH, Principal investigator, Phnom Penh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05746442
- Sponsor's protocol ID
- MCC-21528
- Other IDs
- U01CA261598
- Acronym
- ProjectENDIT
- Status last verified
- Aug 2026
- First submitted
- 16 Feb 2023
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ending Tobacco Use Through Interactive Tailored Messaging for Cambodian People Living With HIV/AIDS (Project END-IT)
- ClinicalTrials.gov ID
- NCT05746442
- Acronym / sponsor ID
- ProjectENDIT / MCC-21528
- Conditions
- Smoking Cessation, HIV
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), University of Oklahoma, M.D. Anderson Cancer Center
- Study start
- 11 Jan 2023 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 27 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this research study is to test how well an automated text messaging smoking treatment program helps smokers with HIV quit smoking.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Care Group | Active comparator | Drug: Nicotine patch, Behavioral: Brief Advice to Quit and Smoking Cessation Self Help Materials, Behavioral: Diet AssessmentParticipants 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. |
| Automated Messaging Treatment Group | Experimental | Behavioral: Smartphone-delivered Automated Messaging, Drug: Nicotine patch, Behavioral: Brief Advice to Quit and Smoking Cessation Self Help MaterialsParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smartphone-delivered Automated MessagingAn 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. | Behavioural | Automated Messaging Treatment Group |
| Nicotine patchParticipants will be provided with a 8 week supply of nicotine patches | Drug | Automated Messaging Treatment Group, Standard Care Group |
| Brief Advice to Quit and Smoking Cessation Self Help MaterialsParticipants will receive self-help materials from Khmer Quit Now, a national smoking cessation campaign in Cambodia | Behavioural | Automated Messaging Treatment Group, Standard Care Group |
| Diet AssessmentParticipants will be asked to complete brief weekly smartphone assessments about their diet for a 26-week period | Behavioural | Standard Care Group |
Primary outcome
Self Reported 7 Day Abstinence Smoking Status
Time frame: 12 Month Follow-Up
Participants will self report 7-day abstinence smoking status
Smoking Status by Expired Carbon Monoxide
Time frame: 12 Month Follow-up
Investigators will use a CO monitor to verify smoking status biochemically
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
- Derived from this study: PubMed 37384390Bui 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Damon Vidrine, Dr.PH principal investigator
Moffitt Cancer Center
Thanh Bui, Dr.PH principal investigator
Phnom Penh
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smartphone-delivered Automated Messaging, Nicotine patch and Brief Advice to Quit and Smoking Cessation Self Help Materials in people with Smoking Cessation and HIV, run by H. Lee Moffitt Cancer Center and Research Institute at 3 sites in Cambodia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Cambodia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lindsey Sparrock, PhD (813-745-2893, Lindsey.Sparrock@moffitt.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self Reported 7 Day Abstinence Smoking Status (time frame: 12 Month Follow-Up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05746442, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026.