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

Not Applicable

Completed

• Conditions: Mental Health; Substance Use; HIV

• Registration Number: NCT05784714
• Lead Sponsor: Tulane University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-02-15
• Study First Submitted QC: 2023-03-13
• Study First Posted: 2023-03-27
• Study Start: 2023-07-14
• Status Verified: 2024-08
• Primary Completion: 2024-11-30
• Study Completion: 2024-11-30
• Last Update Submitted: 2024-12-12
• Last Update Posted: 2024-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

• Having a reported HIV infection and being on ART.

Exclusion Criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Acceptability of intervention	30 day post-assessment	Net Promotor Score; 0-10; higher score means more likely to recommend to a friend
Viral Load	90 days post assessment	Self report last blood draw was under 50 copies of HIV/mL in past 90 days
Care Engagement	30 days post assessment	HIV Treatment Adherence Self-Efficacy Scale; 0-120; higher score means more self-efficacy for care engagement
Adherence	30 day post-assessment	Self report taking all HIV-related medication and treatment in past 30 days
Feasibility of intervention	30 day post-assessment	Participation rates

Secondary Outcome Measures

Name	Time	Method
PTSD	30 day post-assessment	PTSD Checklist for DSM-5; higher scores indicate higher levels of PTSD symptomology
Depression, anxiety	30 day post-assessment	Hospital Anxiety Depression Scale; 0-21; higher scores indicate higher levels of anxiety and/or depression
Substance use	30 day post-assessment	Alcohol Use Disorders Identification Test-C; 0-12; higher score indicates more problematic drinking
Stress	30 day post-assessment	Perceived Stress Scale 4; 0-16; higher score is correlated to more stress
Coping	30 day post-assessment	adapted Coping Self-Efficacy Scale; higher score means more coping self-efficacy

Trial Locations

Locations (4)

Access Health Louisiana; 🇺🇸 New Orleans, Louisiana, United States

Women With A Vision; 🇺🇸 New Orleans, Louisiana, United States

CrescentCare; 🇺🇸 New Orleans, Louisiana, United States

Institute of Women & Ethnic Studies; 🇺🇸 New Orleans, Louisiana, United States