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Behavioral Intervention

NOLA GEM App for HIV/AIDS

N/A

Recruiting

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

Study 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.Check my eligibility

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.See study design

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 below

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 90 days post assessment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~90 days post assessment

This trial's timeline: 3 weeks for screening, Varies for treatment, and 90 days post assessment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Acceptability of intervention

Adherence

Care Engagement

+2 more

Secondary outcome measures

Coping

Depression, anxiety

PTSD

+2 more

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.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Tulane UniversityLead Sponsor

115 Previous Clinical Trials

226,442 Total Patients Enrolled

Media Library

NOLA GEM (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05784714 — N/A

Mental Health Research Study Groups: Intervention, GEMA

Mental Health Clinical Trial 2023: NOLA GEM Highlights & Side Effects. Trial Name: NCT05784714 — N/A

NOLA GEM (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05784714 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the criteria for this trial disqualify persons under four decades of age?

"This trial requires all participants to be between 18 and 65 years of age, as outlined in the enrollment criteria."

Answered by AI

Who is the optimal candidate for participating in this medical research?

"60 individuals aged 18 to 65 who currently have a mental health issue and are living with HIV/AIDS, while also receiving antiretroviral therapy (ART), will be accepted into this study."

Answered by AI

How many participants have signed up for this research project?

"Affirmative. Clinicaltrials.gov displays that this clinical trial, first posted on July 14th 2023, is currently enrolling patients at 4 sites with the need of 60 participants in total."

Answered by AI

Are there still opportunities for prospective participants to join this research study?

"According to the information hosted on clinicaltrials.gov, this medical trial is currently recruiting patients for participation. The study was first posted on July 14th 2023 and underwent its last update a month later on August 17th 2023."

Answered by AI

What is the underlying goal of this medical research?

"The primary outcome to be evaluated over the 30 days following assessment is Care Engagement. The secondary objectives of this trial include Stress (measured by Perceived Stress Scale 4 with higher scores indicating increased stress), Coping (assessed using adapted Coping Self-Efficacy Scale, wherein high scores denote greater coping self-efficacy) and PTSD (determined through a PTSD Checklist for DSM-5; elevated levels are indicated by heightened symptomology)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "NOLA GEM: Feasibility and Acceptability of an mHealth Intervention for Violence-affected PLWH". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05784714.

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