An Integrated mHealth App for Smoking Cessation in Black Smokers With HIV: Protocol for a Randomized Controlled Trial
Bibliographic record
Abstract
BACKGROUND: Black adults who smoke and have HIV experience immense stressors (eg, racial discrimination and HIV stigma) that impede smoking cessation success and perpetuate smoking-related health disparities. These stressors also place Black adults who smoke and have HIV at an increased risk of elevated interoceptive stress (eg, anxiety and uncomfortable bodily sensations) and smoking to manage symptoms. In turn, this population is more likely to smoke to manage interoceptive stress, which contributes to worse HIV-related outcomes in this group. However, no specialized treatment exists to address smoking cessation, interoceptive stress, and HIV management for Black smokers with HIV. OBJECTIVE: This study aims to test a culturally adapted and novel mobile intervention that targets combustible cigarette smoking, HIV treatment engagement and adherence, and anxiety sensitivity (a proxy for difficulty and responsivity to interoceptive stress) among Black smokers with HIV (ie, Mobile Anxiety Sensitivity Program for Smoking and HIV [MASP+]). Various culturally tailored components of the app are being evaluated for their ability to help users quit smoking, manage physiological stress, and improve health care management. METHODS: This study is a pilot randomized controlled trial in which Black combustible cigarette smokers with HIV (N=72) are being recruited and randomly assigned to use either (1) the National Cancer Institute's QuitGuide app or (2) MASP+. Study procedures include a web-based prescreener; active intervention period for 6 weeks; smartphone-based assessments, including daily app-based ecological momentary assessments for 6 weeks (4 ecological momentary assessments each day); a video-based qualitative interview using Zoom Video Communications software at week 6 for participants in all study conditions; and smartphone-based follow-up assessments at 0, 1, 2 (quit date), 3, 4, 5, 6, and 28 weeks postbaseline (26 weeks postquitting date). RESULTS: Primary outcomes include biochemically verified 7-day point prevalence of abstinence, HIV-related quality of life, use of antiretroviral therapy, and HIV care appointment adherence at 26 weeks postquitting date. Qualitative data are also being collected and assessed to obtain feedback that will guide further tailoring of app content and evaluation of efficacy. CONCLUSIONS: The results of this study will determine whether the MASP+ app serves as a successful aid for combustible cigarette smoking cessation, HIV treatment engagement, and physiological stress outcomes among Black people with HIV infection. If successful, this study will provide evidence for the efficacy of a new means of addressing major mental and physical health difficulties for this high-risk population. If the results are promising, the data from this study will be used to update and tailor the MASP+ app for testing in a fully powered randomized controlled trial that will evaluate its efficacy in real-world behavioral health and social service settings. TRIAL REGISTRATION: ClinicalTrials.gov NCT05709002; https://clinicaltrials.gov/study/NCT05709002. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/52090.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.026 | 0.024 |
| Meta-epidemiology (narrow) | 0.006 | 0.003 |
| Meta-epidemiology (broad) | 0.012 | 0.007 |
| Bibliometrics | 0.003 | 0.003 |
| Science and technology studies | 0.005 | 0.003 |
| Scholarly communication | 0.005 | 0.004 |
| Open science | 0.003 | 0.002 |
| Research integrity | 0.007 | 0.009 |
| Insufficient payload (model declined to judge) | 0.117 | 0.014 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".