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A Trauma-Informed, Geospatially Aware, Just-in-Time Adaptive mHealth Intervention to Support Effective Coping Skills Among People Living With HIV in New Orleans: Development and Protocol for a Pilot Randomized Controlled Trial.

作者信息

Skeen Simone J, Tokarz Stephanie, Gasik Rayna E, Solano Chelsea McGettigan, Smith Ethan A, Sagoe Momi Binaifer, Hudson Lauryn V, Steele Kara, Theall Katherine P, Clum Gretchen A

机构信息

Department of Social, Behavioral, and Population Sciences, School of Public Health and Tropical Medicine, Tulane University, New Orleans, LA, United States.

Center for Community-Engaged Artificial Intelligence, Tulane University, New Orleans, LA, United States.

出版信息

JMIR Res Protoc. 2023 Oct 24;12:e47151. doi: 10.2196/47151.


DOI:10.2196/47151
PMID:37874637
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10630874/
Abstract

BACKGROUND: In 2020, Greater New Orleans, Louisiana, was home to 7048 people living with HIV-1083 per 100,000 residents, 2.85 times the US national rate. With Louisiana routinely ranked last in indexes of health equity, violent crime rates in Orleans Parish quintupling national averages, and in-care New Orleans people living with HIV surviving twice the US average of adverse childhood experiences, accessible, trauma-focused, evidence-based interventions (EBIs) for violence-affected people living with HIV are urgently needed. OBJECTIVE: To meet this need, we adapted Living in the Face of Trauma, a well-established EBI tailored for people living with HIV, into NOLA GEM, a just-in-time adaptive mobile health (mHealth) intervention. This study aimed to culturally tailor and refine the NOLA GEM app and assess its acceptability; feasibility; and preliminary efficacy on care engagement, medication adherence, viral suppression, and mental well-being among in-care people living with HIV in Greater New Orleans. METHODS: The development of NOLA GEM entailed identifying real-time tailoring variables via a geographic ecological momentary assessment (GEMA) study (n=49; aim 1) and place-based and user-centered tailoring, responsive to the unique cultural contexts of HIV survivorship in New Orleans, via formative interviews (n=12; aim 2). The iOS- and Android-enabled NOLA GEM app leverages twice-daily GEMA prompts to offer just-in-time, in-app recommendations for effective coping skills practice and app-delivered Living in the Face of Trauma session content. For aim 3, the pilot trial will enroll an analytic sample of 60 New Orleans people living with HIV individually randomized to parallel NOLA GEM (intervention) or GEMA-alone (control) arms at a 1:1 allocation for a 21-day period. Acceptability and feasibility will be assessed via enrollment, attrition, active daily use through paradata metrics, and prevalidated usability measures. At the postassessment time point, primary end points will be assessed via a range of well-validated, domain-specific scales. Care engagement and viral suppression will be assessed via past missed appointments and self-reported viral load at 30 and 90 days, respectively, and through well-demonstrated adherence self-efficacy measures. RESULTS: Aims 1 and 2 have been achieved, NOLA GEM is in Beta, and all aim-3 methods have been reviewed and approved by the institutional review board of Tulane University. Recruitment was launched in July 2023, with a target date for follow-up assessment completion in December 2023. CONCLUSIONS: By leveraging user-centered development and embracing principles that elevate the lived expertise of New Orleans people living with HIV, mHealth-adapted EBIs can reflect community wisdom on posttraumatic resilience. Sustainable adoption of the NOLA GEM app and a promising early efficacy profile will support the feasibility of a future fully powered clinical trial and potential translation to new underserved settings in service of holistic survivorship and well-being of people living with HIV. TRIAL REGISTRATION: ClinicalTrials.gov NCT05784714; https://clinicaltrials.gov/ct2/show/NCT05784714. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/47151.

摘要
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f3ab/10630874/c1a6a9a93cfb/resprot_v12i1e47151_fig3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f3ab/10630874/88eedadf07c3/resprot_v12i1e47151_fig1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f3ab/10630874/6d655c433400/resprot_v12i1e47151_fig2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f3ab/10630874/c1a6a9a93cfb/resprot_v12i1e47151_fig3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f3ab/10630874/88eedadf07c3/resprot_v12i1e47151_fig1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f3ab/10630874/6d655c433400/resprot_v12i1e47151_fig2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f3ab/10630874/c1a6a9a93cfb/resprot_v12i1e47151_fig3.jpg

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引用本文的文献

[1]
Using Geographic Momentary Assessment to Explore Spatial Environment Influences on Wellbeing in People With HIV.

AIDS Behav. 2025-1

本文引用的文献

[1]
The Implementation of a GPS-Based Location-Tracking Smartphone App in South Africa to Improve Engagement in HIV Care: Randomized Controlled Trial.

JMIR Mhealth Uhealth. 2023-5-19

[2]
Feasibility, Acceptability, and Preliminary HIV Care and Psychological Health Effects of iTHRIVE 365 for Black Same Gender Loving Men.

J Acquir Immune Defic Syndr. 2023-5-1

[3]
Use of a Mobile Health Intervention by Older Versus Younger People with HIV: Analysis of Usage, Social Support, and Network Interactions.

Telemed Rep. 2022-12-20

[4]
Advancing digital health equity: Directions for behavioral and social science research.

Transl Behav Med. 2023-4-3

[5]
The updated Consolidated Framework for Implementation Research based on user feedback.

Implement Sci. 2022-10-29

[6]
Pilot evaluation of PrEP EmERGE - A novel digital health innovation designed to support sexual health clinics and HIV-PrEP users.

HIV Med. 2023-4

[7]
Beyond Viral Suppression-The Impact of Cumulative Violence on Health-Related Quality of Life Among a Cohort of Virally Suppressed Patients.

J Acquir Immune Defic Syndr. 2023-1-1

[8]
Integrating Natural Language Processing and Interpretive Thematic Analyses to Gain Human-Centered Design Insights on HIV Mobile Health: Proof-of-Concept Analysis.

JMIR Hum Factors. 2022-7-21

[9]
Geographic ecological momentary assessment methods to examine spatio-temporal exposures associated with marijuana use among young adults: A pilot study.

Spat Spatiotemporal Epidemiol. 2022-6

[10]
Adapting digital health interventions for the evolving HIV landscape: examples to support prevention and treatment research.

Curr Opin HIV AIDS. 2022-3-1

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