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 (Preprint)

• DOI: 10.2196/preprints.47151
• Publication Date: 2023-03-17T17:42:27Z
• Authors: Simone J Skeen; Stephanie Tokarz; Rayna E Gasik; Chelsea McGettiga...; Ethan A Smith; Momi Binaifer Sagoe; Lauryn V Hudson; Kara Steele; Katherine P Theall; Gretchen A Clum
• Keywords: mHealth

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