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

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

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.

Study Overview

• Status: Completed
• Conditions: HIV; Substance Use; Mental Health
• Intervention / Treatment: Behavioral: NOLA GEM

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Louisiana
    • New Orleans, Louisiana, United States, 70112
      • Access Health Louisiana
    • New Orleans, Louisiana, United States, 70113
      • Women With A Vision
    • New Orleans, Louisiana, United States, 70117
      • CrescentCare
    • New Orleans, Louisiana, United States, 70122
      • Institute of Women & Ethnic Studies

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Having a reported HIV infection and being on ART.

Exclusion Criteria:

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; 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; 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.
No Intervention: GEMA; 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?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability of intervention	User Experience Questionnaire-Short Form	30 day post-assessment
Feasibility of intervention	App usage paradata	30 day post-assessment
Feasibility of intervention	Participation rates	30 day post-assessment
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	Net Promotor Score; 0-10; higher score means more likely to recommend to a friend	30 day post-assessment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stress	Study generated daily stressors severity checklist	30 day post-assessment
Substance use	Adapted Addiction Severity Index	30 day post-assessment
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	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	Alcohol Use Disorders Identification Test-C; 0-12; higher score indicates more problematic drinking	30 day post-assessment

Collaborators and Investigators

• Sponsor: Tulane University

Study record dates

Study Major Dates

• Study Start (Actual): July 14, 2023
• Primary Completion (Actual): November 30, 2024
• Study Completion (Actual): November 30, 2024

Study Registration Dates

• First Submitted: February 15, 2023
• First Submitted That Met QC Criteria: March 13, 2023
• First Posted (Actual): March 27, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 12, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Adherence; mHealth; Care engagement
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders
• Other Study ID Numbers: R34AA02896m

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No