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

NCT05784714 | Completed

• 1 other identifier: R34AA02896m
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

HIV; Mental Health; Substance Use

Keywords

Adherence; mHealth; Care engagement

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (8)

• PTSD

  30 day post-assessment

• Depression, anxiety

  30 day post-assessment

• Stress

  30 day post-assessment

• Stress

  30 day post-assessment

• Coping

  30 day post-assessment

Study Arms (2)

Intervention

EXPERIMENTAL

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

GEMA

NO INTERVENTION

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.

Interventions

NOLA GEM BEHAVIORAL

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.

Intervention

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Having a reported HIV infection and being on ART.

Sponsors & Collaborators

• Tulane University: lead

Study Sites (4)

Access Health Louisiana

New Orleans, Louisiana, 70112, United States

Location

Women With A Vision

New Orleans, Louisiana, 70113, United States

Location

CrescentCare

New Orleans, Louisiana, 70117, United States

Location

Institute of Women & Ethnic Studies

New Orleans, Louisiana, 70122, United States

Location

Related Publications (2)

• Gasik RE, Skeen SJ, Tokarz S, Theall KP, Clum GA. Outcomes of a Pilot Mobile App Just-in-Time-Adaptive-Intervention Supporting Coping Skills in Trauma Affected People with HIV. AIDS Behav. 2026 Jan 23. doi: 10.1007/s10461-026-05032-6. Online ahead of print.

  PMID: 41575709 DERIVED

• 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 Oct 24;12:e47151. doi: 10.2196/47151.

  PMID: 37874637 DERIVED

MeSH Terms

Conditions

Psychological Well-Being; Substance-Related Disorders

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior; Chemically-Induced Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2023
• First Posted: March 27, 2023
• Study Start: July 14, 2023
• Primary Completion: November 30, 2024
• Study Completion: November 30, 2024
• Last Updated: December 17, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)