Smoking CessationNCT05014282
Automated Video-Assisted Smoking Treatment for People Living With HIV
A study testing Nicotine patch, Counseling and Nicotine lozenge in people with Smoking Cessation, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
Trial summary
This study evaluates whether Automated Treatment performed better, in terms of facilitating long-term smoking abstinence, than the more resource-intensive Standard Treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Nicotine patch, Counseling and Nicotine lozenge
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 512 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Dec 2021to 23 Sep 2026
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- smoked >/=100 cigarettes in lifetime
- English or Spanish speaking
- Currently smoke > 5 cigarettes/day
- Willing to make a quit attempt within 1 week of enrollment
- HIV positive
- Process a smartphone compatible with the project app
- Have a valid email address
Who cannot join
- Currently pregnant or breastfeeding
- Current use of smoking cessation medications
- Enrolled in a smoking cessation study
- Household member enrolled in the study
- Failure to electronically confirm participation within 14 days of randomization via electronic link sent to participant's smartphone
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Trial of Automated Video-Assisted Smoking Treatment for People Living With HIV (Project RESOURCE)
This study evaluates whether Automated Treatment performed better, in terms of facilitating long-term smoking abstinence, than the more resource-intensive Standard Treatment.
- Conditions
- Smoking Cessation
- Being tested
- Nicotine patch, Counseling, Nicotine lozenge, Smartphone-delivered automated treatment
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nicotine patchDrug
Participants were provided with a 10-week supply of nicotine patches.
CounselingBehavioural
Phone counseling with the state tobacco quitline.
Nicotine lozengeDrug
Participants were provided with a 10-week supply of nicotine lozenges.
Smartphone-delivered automated treatmentBehavioural
An interactive smartphone-based intervention that comprised content delivered via audio/video clips and text content automatically each week for 12 weeks and on demand for 26 weeks to participants.
| Study group | Role | What they receive |
|---|---|---|
| Standard Treatment | Active comparator | Participants randomized to Standard Treatment (ST) were provided with a 10-week supply of nicotine patches and lozenges. ST participants were connected with their state's Quitline services to receive smoking cessation treatment. Receives: Drug: Nicotine patch; Behavioral: Counseling; Drug: Nicotine lozenge |
| Automated Treatment | Experimental | Participants randomized to Automated Treatment (AT) were given a 10-week supply of nicotine patches and lozenges. AT comprised: 1) 12 proactive video-based treatment sessions, delivered weekly, that were tailored on smoking status, motivation, agency, and negative affect/stress; 2) 26 weeks of on-demand access to treatment content tailored on smoking status, motivation, agency, and negative affect/stress; 3) 26 weeks of text content. Receives: Drug: Nicotine patch; Drug: Nicotine lozenge; Behavioral: Smartphone-delivered automated treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-Reported 7-Day Point-Prevalence Smoking Abstinence
Participants who reported no smoking, not even a puff, within the past 7 days.
Measured: 12 Month Follow-Up
Secondary outcomes (3)
Biochemical Verification Via Salivary Cotinine
Investigators biochemically verified smoking status by collecting cotinine samples via salivary cotinine kit.
Measured: 12 Month Follow-Up
Self Reported 24 Hours Smoking Abstinence
Number of participants who reported no smoking, not even a puff, within the past 24 hours.
Measured: 12 Month Follow-Up
Self-Reported 30-Day Point-Prevalence Smoking Abstinence
Number of participants who reported no smoking, not even a puff, within the past 30 days.
Measured: 12 Month Follow-Up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2021
- Study start15 Dec 2021
- Primary completion23 Sep 2025
- Study completion23 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- None (open label)
- Enrolment
- 512 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Damon J Vidrine, Dr.PH, Principal investigator, Moffitt Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05014282
- Sponsor's protocol ID
- MCC-20262
- Other IDs
- R01CA243552
- Status last verified
- Sep 2026
- First submitted
- 13 Aug 2021
- Last updated
- 25 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Vidrine DJ, Bui TC, Businelle MS, Shih YT, Sutton SK, Shahani L, Hoover DS, Bowles K, Vidrine JI. Evaluating the Efficacy of Automated Smoking Treatment for People With HIV: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2021 Nov 17;10(11):e33183. doi: 10.2196/33183.
PubMed 34787590
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of Automated Video-Assisted Smoking Treatment for People Living With HIV (Project RESOURCE)
- ClinicalTrials.gov ID
- NCT05014282
- Acronym / sponsor ID
- MCC-20262
- Conditions
- Smoking Cessation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 512 participants (actual)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 15 Dec 2021 (actual)
- Primary completion
- 23 Sep 2025 (actual)
- Study completion
- 23 Sep 2026 (estimated)
- First posted
- 20 Aug 2021 (actual)
- Results
- Posted 25 Sep 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates whether Automated Treatment performed better, in terms of facilitating long-term smoking abstinence, than the more resource-intensive Standard Treatment.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Treatment | Active comparator | Drug: Nicotine patch, Behavioral: Counseling, Drug: Nicotine lozengeParticipants randomized to Standard Treatment (ST) were provided with a 10-week supply of nicotine patches and lozenges. ST participants were connected with their state's Quitline services to receive smoking cessation treatment. |
| Automated Treatment | Experimental | Drug: Nicotine patch, Drug: Nicotine lozenge, Behavioral: Smartphone-delivered automated treatmentParticipants randomized to Automated Treatment (AT) were given a 10-week supply of nicotine patches and lozenges. AT comprised: 1) 12 proactive video-based treatment sessions, delivered weekly, that were tailored on smoking status, motivation, agency, and negative affect/stress; 2) 26 weeks of on-demand access to treatment content tailored on smoking status, motivation, agency, and negative affect/stress; 3) 26 weeks of text content. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- smoked >/=100 cigarettes in lifetime
- English or Spanish speaking
- Currently smoke > 5 cigarettes/day
- Willing to make a quit attempt within 1 week of enrollment
- HIV positive
Key exclusion criteria (5 listed)
- Currently pregnant or breastfeeding
- Current use of smoking cessation medications
- Enrolled in a smoking cessation study
- Household member enrolled in the study
- Failure to electronically confirm participation within 14 days of randomization via electronic link sent to participant's smartphone
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 |
|---|---|---|
| Nicotine patchParticipants were provided with a 10-week supply of nicotine patches. | Drug | Automated Treatment, Standard Treatment |
| CounselingPhone counseling with the state tobacco quitline. | Behavioural | Standard Treatment |
| Nicotine lozengeParticipants were provided with a 10-week supply of nicotine lozenges. | Drug | Automated Treatment, Standard Treatment |
| Smartphone-delivered automated treatmentAn interactive smartphone-based intervention that comprised content delivered via audio/video clips and text content automatically each week for 12 weeks and on demand for 26 weeks to participants. | Behavioural | Automated Treatment |
Primary outcome
Self-Reported 7-Day Point-Prevalence Smoking Abstinence
Time frame: 12 Month Follow-Up
Participants who reported no smoking, not even a puff, within the past 7 days.
3 secondary outcomes
Biochemical Verification Via Salivary Cotinine
Time frame: 12 Month Follow-Up
Self Reported 24 Hours Smoking Abstinence
Time frame: 12 Month Follow-Up
Self-Reported 30-Day Point-Prevalence Smoking Abstinence
Time frame: 12 Month Follow-Up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34787590Vidrine DJ, Bui TC, Businelle MS, Shih YT, Sutton SK, Shahani L, Hoover DS, Bowles K, Vidrine JI. Evaluating the Efficacy of Automated Smoking Treatment for People With HIV: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2021 Nov 17;10(11):e33183. doi: 10.2196/33183.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Damon J Vidrine, Dr.PH principal investigator
Moffitt Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nicotine patch, Counseling and Nicotine lozenge in people with Smoking Cessation, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
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 7 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Yes. Results are posted in the registry (first posted 25 Sep 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-Reported 7-Day Point-Prevalence Smoking Abstinence (time frame: 12 Month Follow-Up). 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 NCT05014282, 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 25 Sep 2026.