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Behavioral Intervention
NOLA GEM App for HIV/AIDS
N/A
Waitlist Available
Research Sponsored by Tulane University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
* Having a reported HIV infection and being on ART.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 90 days post assessment
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to create a smartphone app to help people living with HIV who have experienced violence, manage their health through understanding their daily experiences.
Who is the study for?
This trial is for people living with HIV who are currently on antiretroviral therapy (ART). It aims to help those affected by violence and dealing with substance use or mental health issues. Participants will need to be comfortable using a smartphone app as part of the study.
What is being tested?
The NOLA GEM trial is testing a new mobile app designed to support individuals with HIV. The app uses geographical ecological momentary assessment (GEMA) to track daily activities and psychosocial experiences, aiming to improve adherence to treatment and overall health outcomes.
What are the potential side effects?
Since this intervention involves the use of a smartphone app rather than medication, traditional side effects are not expected. However, participants may experience stress or emotional discomfort when reflecting on their daily experiences related to violence, substance use, or mental health.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 90 days post assessment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~90 days post assessment
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Acceptability of intervention
Adherence
Care Engagement
+2 moreSecondary study objectives
Coping
Depression, anxiety
PTSD
+2 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: InterventionExperimental Treatment1 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.
Group II: GEMAActive Control1 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.
Find a Location
Who is running the clinical trial?
Tulane UniversityLead Sponsor
121 Previous Clinical Trials
239,040 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am HIV positive and currently on antiretroviral therapy.
Research Study Groups:
This trial has the following groups:- Group 1: Intervention
- Group 2: GEMA
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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