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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
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The study team will conduct a feasibility, acceptability, and preliminary efficacy trial comparing Learn to Quit-HIV (n=30) to an app based on U.S. Clinical Practice Guidelines only (NCI QuitGuide; n=30) among HIV-positive smokers. Both apps will be integrated with NRT and ongoing HIV clinical care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Learn to Quit-HIV | Experimental | A smartphone app developed by the research team designed for people with HIV that provides Acceptance and Commitment Therapy skills to address smoking cessation. This app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches, along with technical smartphone coaching for the first 4 weeks of the study. |
|
| QuitGuide | Active Comparator | A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS (United States Department of Health and Human Services) Clinical Practice Guidelines. This app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches, along with technical smartphone coaching for the first 4 weeks of the study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Learn to Quit-HIV | Device | A smartphone app developed by the research team designed for people with HIV that provides Acceptance and Commitment Therapy skills to address smoking cessation. |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Daily App Use | Average duration of app use per arm over participants' 3 months of study participation | 3 months |
| Frequency of App Use as Measured by Interactions Per Day | Average frequency of app use per arm over participants' 3 months of study participation. | 3 months |
| Participant Attrition at One Month | Number of participants lost to follow-up at one month. | 1 month |
| Participant Attrition at Two Months | Number of participants lost-to-follow-up at two months. | 2 months |
| Participant Attrition at Three Months | Number of participants lost-to-follow-up at three months. | 3 month |
| Recruitment as Measured by the Proportion of Goal Participants Consented | Number of participants consented divided by goal of consenting 60 participants. | 1 year |
| App Usability as Measured by the Systems Usability Scale | Average app usability scores as measured by the Systems Usability Scale. The scale has a score range of 0 to 100 with higher scores representing better outcomes. | 1 month or next available time point if participant completed the measure at 3 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in Cigarettes Smoked Per Day | Change in cigarettes smoked per day from baseline to the 12-week follow up. Cigarettes smoked per day are measured with a self-report item at baseline and at the 3-month follow up. This outcome is calculated as the difference between cigarettes smoked per day at baseline and the cigarettes smoked per day at the 3 month timepoint. A positive and large values in this outcome indicate larger reductions in cigarettes smoked per day per group, indicating a more positive outcome. A negative and large value indicate an increase in cigarettes smoked per day per group, indicating a clinically negative outcome. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lauren Pacek, PhD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University | Durham | North Carolina | 27705 | United States |
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51 subjects completed the informed consent process at the screening visit. Eight of these subjects did not pass screen. Therefore, only 43 of these subjects had passed screen and started the study protocol by being assigned to one of the two condition arms.
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| ID | Title | Description |
|---|---|---|
| FG000 | Learn to Quit-HIV | A smartphone app developed by the research team designed for people with HIV that provides Acceptance and Commitment Therapy skills to address smoking cessation. This app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches, along with technical smartphone coaching for the first 4 weeks of the study. Learn to Quit-HIV: A smartphone app developed by the research team designed for people with HIV that provides Acceptance and Commitment Therapy skills to address smoking cessation. Nicotine patch: All participants will receive an 8-week course of nicotine patches. They will start off with 4 weeks of 21mg/24 hours patches, then move to 2 weeks of 14mg/24 hours patches, and finally end with 2 weeks of 7mg/24 hours patches. Smartphone coaching: All participants will partake in over-the-phone smartphone coaching lead by the PI or a research assistant. This will be a time for participants to bring up any technical issues they are experiencing with the study smartphone or app. |
| FG001 | QuitGuide | A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS Clinical Practice Guidelines. This app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches, along with technical smartphone coaching for the first 4 weeks of the study. QuitGuide: A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS Clinical Practice Guidelines. Nicotine patch: All participants will receive an 8-week course of nicotine patches. They will start off with 4 weeks of 21mg/24 hours patches, then move to 2 weeks of 14mg/24 hours patches, and finally end with 2 weeks of 7mg/24 hours patches. Smartphone coaching: All participants will partake in over-the-phone smartphone coaching lead by the PI or a research assistant. This will be a time for participants to bring up any technical issues they are experiencing with the study smartphone or app. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Learn to Quit-HIV | A smartphone app developed by the research team designed for people with HIV that provides Acceptance and Commitment Therapy skills to address smoking cessation. This app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches, along with technical smartphone coaching for the first 4 weeks of the study. Learn to Quit-HIV: A smartphone app developed by the research team designed for people with HIV that provides Acceptance and Commitment Therapy skills to address smoking cessation. Nicotine patch: All participants will receive an 8-week course of nicotine patches. They will start off with 4 weeks of 21mg/24 hours patches, then move to 2 weeks of 14mg/24 hours patches, and finally end with 2 weeks of 7mg/24 hours patches. Smartphone coaching: All participants will partake in over-the-phone smartphone coaching lead by the PI or a research assistant. This will be a time for participants to bring up any technical issues they are experiencing with the study smartphone or app. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Duration of Daily App Use | Average duration of app use per arm over participants' 3 months of study participation | 7 participants from LTQ arm were excluded from the dataset due to technical/mechanical failure to provide Firebase data. 2 participants were removed from the NCI Quit guide arm due to PI withdrawal. | Posted | Mean | Full Range | minutes | 3 months |
|
12 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Learn to Quit-HIV | A smartphone app developed by the research team designed for people with HIV that provides Acceptance and Commitment Therapy skills to address smoking cessation. This app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches, along with technical smartphone coaching for the first 4 weeks of the study. Learn to Quit-HIV: A smartphone app developed by the research team designed for people with HIV that provides Acceptance and Commitment Therapy skills to address smoking cessation. Nicotine patch: All participants will receive an 8-week course of nicotine patches. They will start off with 4 weeks of 21mg/24 hours patches, then move to 2 weeks of 14mg/24 hours patches, and finally end with 2 weeks of 7mg/24 hours patches. Smartphone coaching: All participants will partake in over-the-phone smartphone coaching lead by the PI or a research assistant. This will be a time for participants to bring up any technical issues they are experiencing with the study smartphone or app. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cough | Infections and infestations | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Roger Vilardaga Viera, PhD | Duke University | 919-684-3441 | roger.vilardaga@duke.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 1, 2020 | Jun 1, 2023 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 25, 2022 | Jul 12, 2022 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| D016540 | Smoking Cessation |
| D014029 | Tobacco Use Disorder |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D061485 | Tobacco Use Cessation Devices |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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|
| QuitGuide | Behavioral | A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS Clinical Practice Guidelines. |
|
|
| Nicotine patch | Drug | All participants will receive an 8-week course of nicotine patches. They will start off with 4 weeks of 21mg/24 hours patches, then move to 2 weeks of 14mg/24 hours patches, and finally end with 2 weeks of 7mg/24 hours patches. |
|
| Smartphone coaching | Behavioral | All participants will partake in over-the-phone smartphone coaching lead by the PI or a research assistant. This will be a time for participants to bring up any technical issues they are experiencing with the study smartphone or app. |
|
| 3 months |
| Number of Quit Attempts | Quit attempts defined as self-reported no smoking at all for 24 hours; assessed via a Timeline Followback procedure. | 1 month |
| Number of Quit Attempts | Quit attempts defined as self-reported no smoking at all for 24 hours; assessed via a Timeline Followback procedure. | 3 months |
| 7-day Point Prevalence Abstinence | Percent of subjects in each group reporting 7-day point prevalence abstinence. Abstinence is determined by a self-report of not smoking any tobacco product at all during the corresponding time frame period, AND by a result of less than 5 ppm in carbon monoxide breath testing. If the participant does not meet both criteria, or if they do not provide data at the time-point they are not considered abstinent. | 1 month |
| 7-day Point Prevalence Abstinence | Percent of subjects in each group reporting 7-day point prevalence abstinence. Abstinence is determined by a self-report of not smoking any tobacco product at all during the corresponding time frame period, AND by a result of less than 5 ppm in carbon monoxide breath testing. If the participant does not meet both criteria, or if they do not provide data at the time-point they are not considered abstinent. | 3 months |
| Overall Adherence to Nicotine Replacement Therapy | Reported as percent of participants who used the patch at least 80% of the days of the required 8 weeks. Adherence determined by timeline follow back interview. | baseline to 3 months |
| Number of Participants With at Least One Adverse Event Determined to be Related to the Study Interventions | Adverse events reported here will only include those that are determined to be related to the study interventions. | 3 months |
| BG001 | QuitGuide | A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS Clinical Practice Guidelines. This app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches, along with technical smartphone coaching for the first 4 weeks of the study. QuitGuide: A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS Clinical Practice Guidelines. Nicotine patch: All participants will receive an 8-week course of nicotine patches. They will start off with 4 weeks of 21mg/24 hours patches, then move to 2 weeks of 14mg/24 hours patches, and finally end with 2 weeks of 7mg/24 hours patches. Smartphone coaching: All participants will partake in over-the-phone smartphone coaching lead by the PI or a research assistant. This will be a time for participants to bring up any technical issues they are experiencing with the study smartphone or app. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | QuitGuide | A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS Clinical Practice Guidelines. This app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches, along with technical smartphone coaching for the first 4 weeks of the study. QuitGuide: A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS Clinical Practice Guidelines. Nicotine patch: All participants will receive an 8-week course of nicotine patches. They will start off with 4 weeks of 21mg/24 hours patches, then move to 2 weeks of 14mg/24 hours patches, and finally end with 2 weeks of 7mg/24 hours patches. Smartphone coaching: All participants will partake in over-the-phone smartphone coaching lead by the PI or a research assistant. This will be a time for participants to bring up any technical issues they are experiencing with the study smartphone or app. |
|
|
|
| Primary | Frequency of App Use as Measured by Interactions Per Day | Average frequency of app use per arm over participants' 3 months of study participation. | 7 participants from LTQ arm were excluded from the dataset due to technical/mechanical failure to provide Firebase data. 2 participants were removed from the NCI Quit guide arm due to PI withdrawal. | Posted | Mean | Standard Deviation | interactions per day | 3 months |
|
|
|
|
| Primary | Participant Attrition at One Month | Number of participants lost to follow-up at one month. | Two participants were withdrawn from QuitGuide after randomization. | Posted | Count of Participants | Participants | 1 month |
|
|
|
| Primary | Participant Attrition at Two Months | Number of participants lost-to-follow-up at two months. | Two participants were withdrawn from QuitGuide after randomization. | Posted | Count of Participants | Participants | 2 months |
|
|
|
| Primary | Participant Attrition at Three Months | Number of participants lost-to-follow-up at three months. | Two participants were withdrawn from QuitGuide after randomization. | Posted | Count of Participants | Participants | 3 month |
|
|
|
| Primary | Recruitment as Measured by the Proportion of Goal Participants Consented | Number of participants consented divided by goal of consenting 60 participants. | Target sample size represents the numerator which allows us to calculate the proportion of enrolled participants (n=51) relative to the target goal (N=60). Enrolled participants are those who were consented, however not all consented participants progressed to the next step of study procedure where they would be randomized. | Posted | Number | proportion of goal participants | 1 year |
|
|
|
| Primary | App Usability as Measured by the Systems Usability Scale | Average app usability scores as measured by the Systems Usability Scale. The scale has a score range of 0 to 100 with higher scores representing better outcomes. | Two participants from the LTQ arm did not complete the week 4 visit, thus this measure was not obtained. Two participants were withdrawn from Quit Guide after randomization. Three participants from the NCI Quit Guide arm did not complete the week 4 visit, thus this measure was not obtained. | Posted | Mean | Standard Deviation | score on a scale | 1 month or next available time point if participant completed the measure at 3 months. |
|
|
|
|
| Secondary | Reduction in Cigarettes Smoked Per Day | Change in cigarettes smoked per day from baseline to the 12-week follow up. Cigarettes smoked per day are measured with a self-report item at baseline and at the 3-month follow up. This outcome is calculated as the difference between cigarettes smoked per day at baseline and the cigarettes smoked per day at the 3 month timepoint. A positive and large values in this outcome indicate larger reductions in cigarettes smoked per day per group, indicating a more positive outcome. A negative and large value indicate an increase in cigarettes smoked per day per group, indicating a clinically negative outcome. | Two participants were withdrawn from QuitGuide after randomization. From the LTQ arm, one participant did not complete the measure. From the NCI QuitGuide arm, two participants did not complete the measure and one participant's responses were unusable. | Posted | Mean | Standard Deviation | reduction in cigarettes per day | 3 months |
|
|
|
|
| Secondary | Number of Quit Attempts | Quit attempts defined as self-reported no smoking at all for 24 hours; assessed via a Timeline Followback procedure. | Participants who completed a Timeline Followback were included in the analysis. | Posted | Mean | Standard Deviation | quit attempts | 1 month |
|
|
|
|
| Secondary | Number of Quit Attempts | Quit attempts defined as self-reported no smoking at all for 24 hours; assessed via a Timeline Followback procedure. | Participants who completed a Timeline Followback were included in the analysis. | Posted | Mean | Standard Deviation | quit attempts | 3 months |
|
|
|
|
| Secondary | 7-day Point Prevalence Abstinence | Percent of subjects in each group reporting 7-day point prevalence abstinence. Abstinence is determined by a self-report of not smoking any tobacco product at all during the corresponding time frame period, AND by a result of less than 5 ppm in carbon monoxide breath testing. If the participant does not meet both criteria, or if they do not provide data at the time-point they are not considered abstinent. | Data not collected. | Posted | 1 month |
|
|
| Secondary | 7-day Point Prevalence Abstinence | Percent of subjects in each group reporting 7-day point prevalence abstinence. Abstinence is determined by a self-report of not smoking any tobacco product at all during the corresponding time frame period, AND by a result of less than 5 ppm in carbon monoxide breath testing. If the participant does not meet both criteria, or if they do not provide data at the time-point they are not considered abstinent. | The Intention to Treat sample was utilized for this outcome. Two participants were withdrawn from QuitGuide after randomization. Lost to follow up participants were assumed to have maintained their smoking status. | Posted | Mean | Standard Deviation | percentage of participants | 3 months |
|
|
|
|
| Secondary | Overall Adherence to Nicotine Replacement Therapy | Reported as percent of participants who used the patch at least 80% of the days of the required 8 weeks. Adherence determined by timeline follow back interview. | Two participants from LTQ arm did not complete the measure. Two participants were withdrawn from QuitGuide after randomization. Four participants from QuitGuide arm did not complete the measure. | Posted | Number | percentage of participants | baseline to 3 months |
|
|
|
|
| Secondary | Number of Participants With at Least One Adverse Event Determined to be Related to the Study Interventions | Adverse events reported here will only include those that are determined to be related to the study interventions. | Two participants were withdrawn from QuitGuide after randomization. All participants who were randomized were included in the analysis as total population that could have reported adverse events related to the study during their enrollment. | Posted | Count of Participants | Participants | 3 months |
|
|
|
| 0 |
| 22 |
| 0 |
| 22 |
| 6 |
| 22 |
| EG001 | QuitGuide | A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS Clinical Practice Guidelines. This app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches, along with technical smartphone coaching for the first 4 weeks of the study. QuitGuide: A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS Clinical Practice Guidelines. Nicotine patch: All participants will receive an 8-week course of nicotine patches. They will start off with 4 weeks of 21mg/24 hours patches, then move to 2 weeks of 14mg/24 hours patches, and finally end with 2 weeks of 7mg/24 hours patches. Smartphone coaching: All participants will partake in over-the-phone smartphone coaching lead by the PI or a research assistant. This will be a time for participants to bring up any technical issues they are experiencing with the study smartphone or app. | 0 | 21 | 0 | 21 | 5 | 21 |
| Wheezing | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| COVID | Infections and infestations | Systematic Assessment |
|
| Diabetes Diagnosis | Endocrine disorders | Systematic Assessment |
|
| Infection (dermis) | Infections and infestations | Systematic Assessment |
|
| Muscle Ache | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Skin Irritation | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Depression | Psychiatric disorders | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | Systematic Assessment |
|
| Sweating | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| COPD Diagnosis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Headache | General disorders | Systematic Assessment |
|
| Muscle Pain | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Nasal congestion | Infections and infestations | Systematic Assessment |
|
| Numbness/Tingling | Nervous system disorders | Systematic Assessment |
|
| Procedure | Surgical and medical procedures | Systematic Assessment |
|
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| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D015438 | Health Behavior |
| D001519 | Behavior |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |