search
Back to results

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

Primary Purpose

HIV, Mental Health, Substance Use

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
NOLA GEM
Sponsored by
Tulane University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for HIV focused on measuring Adherence, mHealth, Care engagement

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Access Health LouisianaRecruiting
  • Women With A VisionRecruiting
  • CrescentCareRecruiting
  • Institute of Women & Ethnic StudiesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

GEMA

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
February 15, 2023
Last Updated
August 17, 2023
Sponsor
Tulane University
search

1. Study Identification

Unique Protocol Identification Number
NCT05784714
Brief Title
NOLA GEM: Feasibility and Acceptability of an mHealth Intervention for Violence-affected PLWH
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 14, 2023 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
March 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tulane University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV, Mental Health, Substance Use
Keywords
Adherence, mHealth, Care engagement

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
GEMA
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
NOLA GEM
Intervention Description
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.
Primary Outcome Measure Information:
Title
Adherence
Description
Self report taking all HIV-related medication and treatment in past 30 days
Time Frame
30 day post-assessment
Title
Viral Load
Description
Self report last blood draw was under 50 copies of HIV/mL in past 90 days
Time Frame
90 days post assessment
Title
Care Engagement
Description
Self report % of missed appointments in past 90 days
Time Frame
90 days post assessment
Title
Care Engagement
Description
HIV Treatment Adherence Self-Efficacy Scale; 0-120; higher score means more self-efficacy for care engagement
Time Frame
30 days post assessment
Title
Acceptability of intervention
Description
User Experience Questionnaire-Short Form
Time Frame
30 day post-assessment
Title
Acceptability of intervention
Description
Net Promotor Score; 0-10; higher score means more likely to recommend to a friend
Time Frame
30 day post-assessment
Title
Feasibility of intervention
Description
App usage paradata
Time Frame
30 day post-assessment
Title
Feasibility of intervention
Description
Participation rates
Time Frame
30 day post-assessment
Secondary Outcome Measure Information:
Title
PTSD
Description
PTSD Checklist for DSM-5; higher scores indicate higher levels of PTSD symptomology
Time Frame
30 day post-assessment
Title
Depression, anxiety
Description
Hospital Anxiety Depression Scale; 0-21; higher scores indicate higher levels of anxiety and/or depression
Time Frame
30 day post-assessment
Title
Stress
Description
Study generated daily stressors severity checklist
Time Frame
30 day post-assessment
Title
Stress
Description
Perceived Stress Scale 4; 0-16; higher score is correlated to more stress
Time Frame
30 day post-assessment
Title
Coping
Description
Brief-COPE; higher scores indicate higher levels of emotion focused, problem focused, and avoidant coping styles
Time Frame
30 day post-assessment
Title
Coping
Description
adapted Coping Self-Efficacy Scale; higher score means more coping self-efficacy
Time Frame
30 day post-assessment
Title
Substance use
Description
Adapted Addiction Severity Index
Time Frame
30 day post-assessment
Title
Substance use
Description
Alcohol Use Disorders Identification Test-C; 0-12; higher score indicates more problematic drinking
Time Frame
30 day post-assessment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Having a reported HIV infection and being on ART. Exclusion Criteria: -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gretchen Clum, PhD
Phone
504-988-4536
Email
gclum@tulane.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Stephanie Tokarz, MPH
Phone
504-988-8826
Email
stokarz@tulane.edu
Facility Information:
Facility Name
Access Health Louisiana
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jordan Probst
First Name & Middle Initial & Last Name & Degree
MarkAlain Dery
Facility Name
Women With A Vision
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70113
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jenny Holl
First Name & Middle Initial & Last Name & Degree
Charles Haywood
Facility Name
CrescentCare
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70117
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeremy Shroeder
First Name & Middle Initial & Last Name & Degree
Owen Ever
Facility Name
Institute of Women & Ethnic Studies
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70122
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Leticia De los Rios

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs