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

HIV Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05784714
• Other study ID #: R34AA02896m
• Status: Recruiting
• Phase: N/A
• Start date: July 14, 2023
• Est. completion date: May 31, 2024

Study information

• Verified date: April 2024
• Source: Tulane University
• Contact: Gretchen Clum, PhD
• Phone: 504-988-4536
• Email: gclum[@]tulane.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: May 31, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Having a reported HIV infection and being on ART.

Exclusion Criteria:

-

Related Conditions & MeSH terms

• HIV
• Mental Health
• Substance Use
• Substance-Related Disorders

Intervention

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.

Locations

Country	Name	City	State
United States	Access Health Louisiana	New Orleans	Louisiana
United States	CrescentCare	New Orleans	Louisiana
United States	Institute of Women & Ethnic Studies	New Orleans	Louisiana
United States	Women With A Vision	New Orleans	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
Tulane University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherence	Self report taking all HIV-related medication and treatment in past 30 days	30 day post-assessment
Primary	Viral Load	Self report last blood draw was under 50 copies of HIV/mL in past 90 days	90 days post assessment
Primary	Care Engagement	Self report % of missed appointments in past 90 days	90 days post assessment
Primary	Care Engagement	HIV Treatment Adherence Self-Efficacy Scale; 0-120; higher score means more self-efficacy for care engagement	30 days post assessment
Primary	Acceptability of intervention	User Experience Questionnaire-Short Form	30 day post-assessment
Primary	Acceptability of intervention	Net Promotor Score; 0-10; higher score means more likely to recommend to a friend	30 day post-assessment
Primary	Feasibility of intervention	App usage paradata	30 day post-assessment
Primary	Feasibility of intervention	Participation rates	30 day post-assessment
Secondary	PTSD	PTSD Checklist for DSM-5; higher scores indicate higher levels of PTSD symptomology	30 day post-assessment
Secondary	Depression, anxiety	Hospital Anxiety Depression Scale; 0-21; higher scores indicate higher levels of anxiety and/or depression	30 day post-assessment
Secondary	Stress	Study generated daily stressors severity checklist	30 day post-assessment
Secondary	Stress	Perceived Stress Scale 4; 0-16; higher score is correlated to more stress	30 day post-assessment
Secondary	Coping	Brief-COPE; higher scores indicate higher levels of emotion focused, problem focused, and avoidant coping styles	30 day post-assessment
Secondary	Coping	adapted Coping Self-Efficacy Scale; higher score means more coping self-efficacy	30 day post-assessment
Secondary	Substance use	Adapted Addiction Severity Index	30 day post-assessment
Secondary	Substance use	Alcohol Use Disorders Identification Test-C; 0-12; higher score indicates more problematic drinking	30 day post-assessment