SmokingPhase 4NCT03999411
Smartphone Intervention for Smoking Cessation and Improving Adherence to Treatment Among HIV Patients
A Phase 4 study testing Nicoderm C-Q Transdermal Product, Adherence to Antiretroviral Therapy Counseling and Behavioral Smoking Cessation Counseling in people with Smoking and Smoking Cessation, run by University of Miami at 1 site in United States.
Trial summary
The purpose of this study is to learn if a mindfulness-based smoking cessation smartphone app can help people quit smoking and stay on antiretroviral therapies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking, Smoking Cessation, HIV
- What is being tested?
- Nicoderm C-Q Transdermal Product, Adherence to Antiretroviral Therapy Counseling and Behavioral Smoking Cessation Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Sep 2019to 14 Oct 2020
- Phase
- Phase 4
- 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
- ≥ 18 years old
- Diagnosed with HIV
- Have been prescribed ART medication in the prior 6 months
- Have smoked ≥ 5 cigarettes/day in the past year
- Be interested in making a quit attempt in the next 30 days
- Own a smartphone (apple/android)and plan to keep it active for the following 3 months
Show all 10Show fewer
- Read/speak English
- Be able to provide consent
- Have no plans to move in the next 3 months
- Not pregnant or planning to be pregnant in the following 3 months
Who cannot join
- Adults unable to consent
- Individuals who are not yet adults (infants, children, teenagers)
- Pregnant women
- Prisoners
- Have contraindication to NRT (past month myocardial infarction, history of serious arrhythmias/or unstable angina pectoris, dermatological disorder)
- Currently being treated for a psychiatric condition
- Currently being treated for smoking cessation, alcoholism, or illicit drug use
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Novel Smartphone-based Intervention to Support Smoking Cessation and Adherence to Antiretroviral Therapy Among People Living With HIV: A Pilot Randomized Clinical Trial
The purpose of this study is to learn if a mindfulness-based smoking cessation smartphone app can help people quit smoking and stay on antiretroviral therapies.
Read the detailed description
The current study aims to test the feasibility of a three-arm randomized clinical trial testing the combined mindfulness training + Emocha apps intervention versus the mindfulness training app only with brief advice to improve ART adherence and usual care (UC; brief advice to quit and improve ART adherence). Our primary hypothesis is that the combination of mindfulness training + Emocha apps would be superior to the mindfulness training app with brief advice to improve ART adherence, and these two interventions would be superior to the UC in terms of the feasibility, acceptability, and potential efficacy (3-month smoking cessation; improvement in adherence to ART).
- Conditions
- Smoking, Smoking Cessation, HIV
- Being tested
- Nicoderm C-Q Transdermal Product, Adherence to Antiretroviral Therapy Counseling, Behavioral Smoking Cessation Counseling, "Crave-to-Quit" app, vDOT "emocha" app
- Keywords
- nicotine replacement therapy, antiretroviral, smartphone
- Medical subject headings
- Smoking, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nicoderm C-Q Transdermal ProductDrug
Also called NRT
6 weeks of GlaxoSmithKline Nicoderm CQ (NRT)
Adherence to Antiretroviral Therapy CounselingBehavioural
Brief counseling on adhering to antiretroviral therapy with self-help materials.
Behavioral Smoking Cessation CounselingBehavioural
One time face-to-face smoking cessation counseling and 2 follow-up phone calls.
"Crave-to-Quit" appBehavioural
Evidence-based mindfulness smoking cessation smartphone app ("Crave-to-Quit") adapted from an in-person mindfulness training relapse prevention smoking cessation intervention.
vDOT "emocha" appBehavioural
Video Directly Observed Therapy (vDOT) smartphone app ("emocha") that allows participants to take a video of themselves taking medication to ensure adherence.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | Placebo comparator | Participants will receive brief advice to adhere to ART brief advice to quit smoking, 6-week supplies of nicotine-replacement therapy (NRT), and self-help materials to quit smoking and adhere to ART. Receives: Drug: Nicoderm C-Q Transdermal Product; Behavioral: Adherence to Antiretroviral Therapy Counseling |
| Smoking cessation only intervention | Active comparator | Participants in this group will receive the usual care (UC) for adherence to ART, one in-person orientation sessions, 6-week supplies of NRT the "Crave-to-Quit" app, and two brief follow-up phone calls. Receives: Drug: Nicoderm C-Q Transdermal Product; Behavioral: Adherence to Antiretroviral Therapy Counseling; Behavioral: Behavioral Smoking Cessation Counseling; Behavioral: "Crave-to-Quit" app |
| Combined smoking cessation and HIV intervention | Experimental | Participants in this group will receive everything given in the Smoking Cessation Only arm and will also use the emocha app and will receive a tutorial explaining the app content and features. The study team will explain to participants that the app will help them in tracking dose-by-dose medication adherence by recording a video for themselves taking their medication. Receives: Drug: Nicoderm C-Q Transdermal Product; Behavioral: Adherence to Antiretroviral Therapy Counseling; Behavioral: Behavioral Smoking Cessation Counseling; Behavioral: "Crave-to-Quit" app; Behavioral: vDOT "emocha" app |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Smoking Cessation
Participants who self-report seven days of non-smoking.
Measured: Up to 3 months
Number of Participants With ≥ 95% Adherence to ART Medication Based on the Visual Analogue Scale
Number of participants with ≥ 95% Adherence to ART Medication Based on the Visual Analogue Scale ranging from 0 to 100%. The ART medication visual analogue scale is an instrument for patients to rate their dose taken percentages (≥ 95% of doses taken will be regarded as good adherence). Higher score (0 to 100%) indicates higher adherence to ART.
Measured: 3 months
Usability of Intervention Questionnaire Score
The usability of the Craving-to Quit and Emocha apps will be assessed via a questionnaire with scores ranging from 0-10 with the higher score indicating increased comfortability with using the app.
Measured: 3 months
Acceptability of Intervention Questionnaire Scores
The acceptability is be assessed by 3 items "How satisfied were you with the intervention?", "How likely are you to recommend this intervention to a friend?" and "How useful was the intervention?" Each question is scored from 0-10 with the higher score indicating increased acceptability.
Measured: 3 months
Number of Participants Reporting Engagement With the Intervention
Participant engagement is evaluated via self-reported use of the Craving-to-Quit and Emocha apps. Participants will complete a questionnaire indicating how often they used the apps. The response categories include: Everyday, often, some days, not often, not at all. We report the number of participants in each category or combination of categories.
Measured: Up to 3 months
Feasibility of Delivery
The feasibility of delivery will be assessed via evaluating the:
- eligible, defined as number of participants eligible out of total screened
- recruitment rate, defined as number of participants enrolled out of total screened
- total completing all study activities, defined as the number of participants completing all activities out of total enrolled
Measured: At screening through study completion (up to 3 months)
Secondary outcomes (2)
Number of Participants With Reported Relapse
Number of participants who have smoked at least once per week on two consecutive weeks after smoking cessation was confirmed.
Measured: Up to 3 months
Number of Cigarettes Smoked Per Day
Self-reported number of cigarettes smoked per day by each participant (Q. On average, how many cigarettes do you smoke per day?) at baseline assessment and at 3-month assessment.
Measured: At baseline and at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2019
- Study start9 Sep 2019
- Primary completion14 Oct 2020
- Study completion14 Oct 2020
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.
- Other trials for SmokingStudies of the same condition, open and under way.
- More trials run by University of MiamiThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Taghrid Asfar, University of Miami
- Investigators
- Taghrid Asfar, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03999411
- Sponsor's protocol ID
- 20190181
- Status last verified
- Mar 2024
- First submitted
- 24 Jun 2019
- Last updated
- 28 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Smartphone-based Intervention to Support Smoking Cessation and Adherence to Antiretroviral Therapy Among People Living With HIV: A Pilot Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03999411
- Acronym / sponsor ID
- 20190181
- Conditions
- Smoking, Smoking Cessation, HIV
- Keywords
- nicotine replacement therapy, antiretroviral, smartphone
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 9 Sep 2019 (actual)
- Primary completion
- 14 Oct 2020 (actual)
- Study completion
- 14 Oct 2020 (actual)
- First posted
- 26 Jun 2019 (actual)
- Results
- Posted 2 Dec 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to learn if a mindfulness-based smoking cessation smartphone app can help people quit smoking and stay on antiretroviral therapies.
Detailed description
The current study aims to test the feasibility of a three-arm randomized clinical trial testing the combined mindfulness training + Emocha apps intervention versus the mindfulness training app only with brief advice to improve ART adherence and usual care (UC; brief advice to quit and improve ART adherence). Our primary hypothesis is that the combination of mindfulness training + Emocha apps would be superior to the mindfulness training app with brief advice to improve ART adherence, and these two interventions would be superior to the UC in terms of the feasibility, acceptability, and potential efficacy (3-month smoking cessation; improvement in adherence to ART).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Usual Care | Placebo comparator | Drug: Nicoderm C-Q Transdermal Product, Behavioral: Adherence to Antiretroviral Therapy CounselingParticipants will receive brief advice to adhere to ART brief advice to quit smoking, 6-week supplies of nicotine-replacement therapy (NRT), and self-help materials to quit smoking and adhere to ART. |
| Smoking cessation only intervention | Active comparator | Drug: Nicoderm C-Q Transdermal Product, Behavioral: Adherence to Antiretroviral Therapy Counseling, Behavioral: Behavioral Smoking Cessation Counseling, Behavioral: "Crave-to-Quit" appParticipants in this group will receive the usual care (UC) for adherence to ART, one in-person orientation sessions, 6-week supplies of NRT the "Crave-to-Quit" app, and two brief follow-up phone calls. |
| Combined smoking cessation and HIV intervention | Experimental | Drug: Nicoderm C-Q Transdermal Product, Behavioral: Adherence to Antiretroviral Therapy Counseling, Behavioral: Behavioral Smoking Cessation Counseling, Behavioral: "Crave-to-Quit" app, Behavioral: vDOT "emocha" appParticipants in this group will receive everything given in the Smoking Cessation Only arm and will also use the emocha app and will receive a tutorial explaining the app content and features. The study team will explain to participants that the app will help them in tracking dose-by-dose medication adherence by recording a video for themselves taking their medication. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- ≥ 18 years old
- Diagnosed with HIV
- Have been prescribed ART medication in the prior 6 months
- Have smoked ≥ 5 cigarettes/day in the past year
- Be interested in making a quit attempt in the next 30 days
Key exclusion criteria (7 listed)
- Adults unable to consent
- Individuals who are not yet adults (infants, children, teenagers)
- Pregnant women
- Prisoners
- Have contraindication to NRT (past month myocardial infarction, history of serious arrhythmias/or unstable angina pectoris, dermatological disorder)
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 |
|---|---|---|
| Nicoderm C-Q Transdermal ProductAlso: NRT6 weeks of GlaxoSmithKline Nicoderm CQ (NRT) | Drug | Combined smoking cessation and HIV intervention, Smoking cessation only intervention, Usual Care |
| Adherence to Antiretroviral Therapy CounselingBrief counseling on adhering to antiretroviral therapy with self-help materials. | Behavioural | Combined smoking cessation and HIV intervention, Smoking cessation only intervention, Usual Care |
| Behavioral Smoking Cessation CounselingOne time face-to-face smoking cessation counseling and 2 follow-up phone calls. | Behavioural | Combined smoking cessation and HIV intervention, Smoking cessation only intervention |
| "Crave-to-Quit" appEvidence-based mindfulness smoking cessation smartphone app ("Crave-to-Quit") adapted from an in-person mindfulness training relapse prevention smoking cessation intervention. | Behavioural | Combined smoking cessation and HIV intervention, Smoking cessation only intervention |
| vDOT "emocha" appVideo Directly Observed Therapy (vDOT) smartphone app ("emocha") that allows participants to take a video of themselves taking medication to ensure adherence. | Behavioural | Combined smoking cessation and HIV intervention |
Primary outcome
Number of Participants With Smoking Cessation
Time frame: Up to 3 months
Participants who self-report seven days of non-smoking.
Number of Participants With ≥ 95% Adherence to ART Medication Based on the Visual Analogue Scale
Time frame: 3 months
Number of participants with ≥ 95% Adherence to ART Medication Based on the Visual Analogue Scale ranging from 0 to 100%. The ART medication visual analogue scale is an instrument for patients to rate their dose taken percentages (≥ 95% of doses taken will be regarded as good adherence). Higher score (0 to 100%) indicates higher adherence to ART.
Usability of Intervention Questionnaire Score
Time frame: 3 months
The usability of the Craving-to Quit and Emocha apps will be assessed via a questionnaire with scores ranging from 0-10 with the higher score indicating increased comfortability with using the app.
Acceptability of Intervention Questionnaire Scores
Time frame: 3 months
The acceptability is be assessed by 3 items "How satisfied were you with the intervention?", "How likely are you to recommend this intervention to a friend?" and "How useful was the intervention?" Each question is scored from 0-10 with the higher score indicating increased acceptability.
Number of Participants Reporting Engagement With the Intervention
Time frame: Up to 3 months
Participant engagement is evaluated via self-reported use of the Craving-to-Quit and Emocha apps. Participants will complete a questionnaire indicating how often they used the apps. The response categories include: Everyday, often, some days, not often, not at all. We report the number of participants in each category or combination of categories.
Feasibility of Delivery
Time frame: At screening through study completion (up to 3 months)
The feasibility of delivery will be assessed via evaluating the: 1. eligible, defined as number of participants eligible out of total screened 2. recruitment rate, defined as number of participants enrolled out of total screened 3. total completing all study activities, defined as the number of participants completing all activities out of total enrolled
2 secondary outcomes
Number of Participants With Reported Relapse
Time frame: Up to 3 months
Number of Cigarettes Smoked Per Day
Time frame: At baseline and at 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Taghrid Asfar, MD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nicoderm C-Q Transdermal Product, Adherence to Antiretroviral Therapy Counseling and Behavioral Smoking Cessation Counseling in people with Smoking and Smoking Cessation, run by University of Miami 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 10 inclusion and 7 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: finished, as of the sponsor's last update on 28 Mar 2024. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Dec 2021). 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?
Number of Participants With Smoking Cessation (time frame: Up to 3 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Mar 2024.