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Accepted for/Published in: JMIR Research Protocols

Date Submitted: Mar 14, 2023
Date Accepted: Sep 12, 2023

The final, peer-reviewed published version of this preprint can be found here:

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

Skeen SJ, Tokarz S, Gasik RE, Solano CM, Smith EA, Sagoe MB, Hudson LV, Steele K, Theall KP, Clum GA

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

JMIR Res Protoc 2023;12:e47151

DOI: 10.2196/47151

PMID: 37874637

PMCID: 10630874

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

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

ABSTRACT

Background:

In 2020, greater New Orleans was home to 7,048 people living with HIV (PLWH): 1,083 per 100,000 residents, 2.85 times the U.S. national rate. With Louisiana routinely ranked last in indices of health equity, violent crime rates in Orleans Parish quintuple national averages, and in-care New Orleans PLWH surviving twice the U.S. average of adverse childhood experiences, accessible, trauma-focused, evidence-based interventions (EBIs) for PLWH are needed urgently.

Objective:

To meet this need, we adapted LIFT: Living in the Face of Trauma, a well-established EBI tailored for PLWH, into NOLA GEM, a just-in-time adaptive mHealth intervention. The present study aims to assess the NOLA GEM app’s acceptability, feasibility, and preliminary efficacy on care engagement, medication adherence, viral suppression, and mental wellbeing, among in-care PLWH in greater New Orleans.

Methods:

Development of NOLA GEM entailed: Aim I: identification of real-time tailoring variables via a 14-day geographic ecological momentary assessment (GEMA) study (n = 49); Aim II: place-based and user-centered tailoring, responsive to the unique cultural contexts of HIV survivorship in New Orleans, via formative interviews (n = 12). 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 LIFT session content. GPS tracking in the app also allows participants to be prompted when they enter a pre-identified stressful location. Aim III: the pilot trial will enroll a target N = 100 New Orleans PLWH, individual randomized to parallel NOLA GEM (intervention) versus 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 usage via paradata metrics, and pre-validated usability measures. At post-assessment, care engagement and viral suppression will be assessed via past missed appointments and self-reported viral load, respectively, at past 30 and 90 days, and by well-demonstrated adherence self-efficacy measures. Medication adherence will be tapped via visual analogue, and mental wellbeing via a range of well-validated domain-specific symptom severity scales.

Results:

The NOLA GEM app is presently undergoing Beta testing. Aims I and II are fulfilled, and all Aim III methods recounted here reviewed and approved by the Institutional Review Board of [MASKED]. Outpatient clinic–based recruitment will launch in April 2023, with a target date for follow-up assessment completion of December 2023.

Conclusions:

By leveraging user-centered development practices and embracing principles that elevate the lived expertise of New Orleans PLWH, mHealth-adapted EBIs can reflect community wisdom on the drivers of post-traumatic 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 PLWH survivorship and wellbeing.


 Citation

Please cite as:

Skeen SJ, Tokarz S, Gasik RE, Solano CM, Smith EA, Sagoe MB, Hudson LV, Steele K, Theall KP, Clum GA

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

JMIR Res Protoc 2023;12:e47151

DOI: 10.2196/47151

PMID: 37874637

PMCID: 10630874

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