Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of Oklahoma | OTHER |
Not provided
Not provided
Not provided
Not provided
The present study aims to investigate the efficacy of an mHealth smoking cessation and HIV disease management intervention among a nationally representative sample of African America/Black (hereafter refer to as Black) persons with HIV/AIDS (PWH) who smoke cigarettes. Participants will be randomized into one of three conditions: (1) the intervention, ESCAPE (Enhancing Smoking Cessation for African American People Everywhere) + Nicotine Replacement Medications (NRT), (2) the National Cancer Institute's (NCI) quitSTART app, the standard mobile smoking cessation treatment + NRT, and (3) an assessment-only control group + NRT.
This nationwide trial aims to evaluate the efficacy of a smartphone-based smoking cessation and HIV care management intervention culturally tailored for Black PWH who smoke cigarettes with treated and untreated HIV.A RCT will be conducted with 300 Black PWH who smoke cigarettes to evaluate the efficacy of the intervention. Participants will be randomly assigned to the smartphone-based ESCAPE intervention + NRT, the National Cancer Institute's smartphone-based quitSTART intervention + NRT, or assessment-only control + NRT. Participants will complete a self-screener, baseline appointment, 8 weeks of ecological momentary assessments (EMAs), 8 weekly follow-up assessments, 10 monthly check-in surveys, a 28-week follow-up, and a final 54-week follow-up. A subset of participants will also be selected to complete a qualitative interview at the end of their 6th week in the study.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ESCAPE intervention + NRT | Experimental | ESCAPE is a mobile intervention that targets anxiety sensitivity among Black adults who smoke cigarettes and have HIV. This intervention is framed within the cultural context of interoceptive stress among Black adults who smoke, which is supported by theory, empirical evidence, and characteristics of this group. The intervention employs a variety of features to educate users on how to deal with stress, anxiety, and nicotine withdrawal symptoms. The app contains a series of on-demand features, including a coping toolkit, stress management trainings, and a series of educational videos. ESCAPE also utilizes Ecological Momentary Assessments (EMAs) to gather information and provide personalized messages to users in real time. All participants will receive free nicotine replacement therapy (NRT). |
|
| quitSTART intervention + NRT | Active Comparator | quitSTART is a smartphone-based National Cancer Institute (NCI) intervention for standard mobile smoking cessation treatment. The intervention contains features that allow its' users to better understand their smoking patterns, and build skills needed to become and stay smoke free. The app allows users to track cravings and delivers motivational messages to users for each craving they track. All participants will receive free nicotine replacement therapy (NRT). |
|
| Control (CTRL) + NRT | Sham Comparator | The CTRL group will complete the same baseline survey, follow-up surveys, and ecological momentary assessments schedule as the ESCAPE app + NRT and the quitSTART app + NRT group. All participants will receive free nicotine replacement therapy (NRT). They will not receive additional intervention content. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ESCAPE app + NRT | Behavioral | ESCAPE is a mobile intervention that targets anxiety sensitivity among Black adults who smoke cigarettes and have HIV. This intervention is framed within the cultural context of interoceptive stress among Black adults who smoke, which is supported by theory, empirical evidence, and characteristics of this group. The intervention employs a variety of features to educate users on how to deal with stress, anxiety, and nicotine withdrawal symptoms. The app contains a series of on-demand features, including a coping toolkit, stress management trainings, and a series of educational videos. ESCAPE also utilizes Ecological Momentary Assessments (EMAs) to gather information and provide personalized messages to users in real time. All participants will receive free nicotine replacement therapy (NRT). |
| Measure | Description | Time Frame |
|---|---|---|
| 7-day Biochemically Verified Point Prevalence Abstinence (PPA) | PPA will be defined as no cigarette smoking within the past 7 days, and will be biochemically verified via assessment of expired carbon monoxide (< 6 ppm). | Baseline appointment through the 54-week follow-up, inclusive of follow-up assessments (Weeks 1-6, 28, and 54-week). |
| Anxiety | Anxiety will be evaluated via Overall Anxiety Severity Index Scale (OASIS). | Baseline appointment through the 54-week follow-up, inclusive of follow-up assessments (Weeks 1-6, 28, and 54-week) |
| Depression | Depression will be evaluated via the Overall Depression Severity Index Scale (ODSIS). | Baseline appointment through the 54-week follow-up, inclusive of follow-up assessments (Weeks 1-6, 28, and 54-week). |
| HIV (and general) Quality of Life | HIV (and general) quality of life will be evaluated using the the World Health Organization HIV Quality of Life Brief Scale and the EuroQol 5-Dimension 5-Level (EQ-5D-5L). | Baseline appointment through the 54-week follow-up, inclusive of every assessment containing these survey items (weeks 1-6, 28, and 54-week follow-ups) |
| HIV Care Adherence/Engagement | HIV-related outcomes will be evaluated using the dichotomous variables (e.g., ART medication non-adherence and missed treatment appointments). | Baseline appointment through the 54-week follow-up, inclusive of every assessment containing these survey items (weeks 1-6, 28, and 54-week follow-ups) |
| Measure | Description | Time Frame |
|---|---|---|
| Anxiety Sensitivity Reduction | Anxiety sensitivity will be evaluated using the Short Scale Anxiety Sensitivity Index (SSASI). | Baseline appointment through the 54-week follow-up, inclusive of follow-up assessments (Weeks 1-6, 28, and 54-week) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lorra Garey, Ph.D. | Contact | 713-743-8056 | llgarey@central.uh.edu | |
| Jessica Thai, B.S. | Contact | 713-743-8865 | jmthai@cougarnet.uh.edu |
| Name | Affiliation | Role |
|---|---|---|
| Michael S. Businelle, Ph.D. | University of Oklahoma Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73104 | United States |
Deidentified participant data will be uploaded to the Inter-university Consortium for Political and Social Research.
Not provided
1 year from completion of aims of the project (i.e., publication of the main outcome paper)
The data can be accessed by researchers who request access to the data and complete a Data use Certification (DUC), certifying that have a research need related to the data.
Not provided
Not provided
| ID | Term |
|---|---|
| D012907 | Smoking |
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D015438 | Health Behavior |
Not provided
Not provided
| ID | Term |
|---|---|
| D000095488 | Nicotine Replacement Therapy |
| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| quiSTART app + NRT | Behavioral | quitSTART is a smartphone-based National Cancer Institute (NCI) intervention for standard mobile smoking cessation treatment. The intervention contains features that allow its' users to better understand their smoking patterns, and build skills needed to become and stay smoke free. The app allows users to track cravings and delivers motivational messages to users for each craving they track. All participants will receive free nicotine replacement therapy (NRT). |
|
| Control (CTRL) | Behavioral | The CTRL group will complete the same baseline survey, follow-up surveys, and ecological momentary assessments schedule as the ESCAPE app + NRT and the quitSTART app + NRT group. All participants will receive free nicotine replacement therapy (NRT). They will not receive additional intervention content. |
|