NOLA GEM: Feasibility and Acceptability of an mHealth Intervention for Violence-affected PLWH

Study Overview
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Brief Summary
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The objective of the proposed research is to conduct formative work to develop, pilot and refine a smartphone delivered intervention for violence affected people living with HIV utilizing a novel spatial-temporal methodology, geographical ecological momentary assessment (GEMA), to first identify the activity spaces and daily psychosocial experiences (mental health symptoms, substance use, self-efficacy, coping) impacting adherence and viral suppression, and apply them to intervention. Guided by an ecological perspective, the investigators will adapt Living in the Face of Trauma to a mobile platform with GEMA informed intervention targets. The resulting app shall be referred to as NOLA GEM. Our long-term goal is delivering accessible interventions informed by daily experiences that affect health for PLWH. The investigators will test feasibility, acceptability and preliminary efficacy of the GEMA-informed NOLA GEM app against GEMA alone on adherence and care, and secondary outcomes of mental health and substance use.

Official Title
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Development of a Geographical Momentary Assessment Informed Trauma Intervention to Improve ART Adherence and Viral Suppression in Violence-Affected Persons Living With HIV

Conditions
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HIV, Mental Health, Substance Use

Intervention / Treatment
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* Behavioral: NOLA GEM


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Having a reported HIV infection and being on ART. Exclusion Criteria: -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>This arm will include daily diary assessment and GPS phone tracking, access to psychoeducational modules, skills practice, and tools to help with coping and stress reduction. Enhancements include geofencing alerts for risky environments; progress tracking and feedback reports; self-initiated tool engagement (e.g. push button to engage in coping exercise), robust JITAI programming that recommends skills for participants to use in the moment based on daily diary responses, positive mood building exercises, and support. | Behavioral: NOLA GEM<br>* This is a mobile application that has 6 psychoeducational sessions and related skills, local resources, and a way for participants to track their progress. Further information is in the arm descriptions.<br>|
| No Intervention: GEMA<br>This arm will include daily diary and phone tracking. Participants in this arm will also respond to daily diary assessments twice daily but will not receive the psychoeducation interactive components such as tracking and feedback, alerts, or capacity to send alerts that connect them to tools. This arm will have access to resources. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence | Self report taking all HIV-related medication and treatment in past 30 days | 30 day post-assessment | 
| Viral Load | Self report last blood draw was under 50 copies of HIV/mL in past 90 days | 90 days post assessment | 
| Care Engagement | Self report % of missed appointments in past 90 days | 90 days post assessment | 
| Care Engagement | HIV Treatment Adherence Self-Efficacy Scale; 0-120; higher score means more self-efficacy for care engagement | 30 days post assessment | 
| Acceptability of intervention | User Experience Questionnaire-Short Form | 30 day post-assessment | 
| Acceptability of intervention | Net Promotor Score; 0-10; higher score means more likely to recommend to a friend | 30 day post-assessment | 
| Feasibility of intervention | App usage paradata | 30 day post-assessment | 
| Feasibility of intervention | Participation rates | 30 day post-assessment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PTSD | PTSD Checklist for DSM-5; higher scores indicate higher levels of PTSD symptomology | 30 day post-assessment | 
| Depression, anxiety | Hospital Anxiety Depression Scale; 0-21; higher scores indicate higher levels of anxiety and/or depression | 30 day post-assessment | 
| Stress | Study generated daily stressors severity checklist | 30 day post-assessment | 
| Stress | Perceived Stress Scale 4; 0-16; higher score is correlated to more stress | 30 day post-assessment | 
| Coping | Brief-COPE; higher scores indicate higher levels of emotion focused, problem focused, and avoidant coping styles | 30 day post-assessment | 
| Coping | adapted Coping Self-Efficacy Scale; higher score means more coping self-efficacy | 30 day post-assessment | 
| Substance use | Adapted Addiction Severity Index | 30 day post-assessment | 
| Substance use | Alcohol Use Disorders Identification Test-C; 0-12; higher score indicates more problematic drinking | 30 day post-assessment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adherence, mHealth, Care engagement