Skip to main content
OpenTrials
Completed

NCT Number: NCT05784714

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

HIV Behavior Chemically-Induced Disorders Mental Disorders Mental Health Personal Satisfaction Psychological Well-Being Substance Use Substance-Related Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Access Health Louisiana, New Orleans, Louisiana, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Having a reported HIV infection and being on ART.

Exclusion criteria

-

Treatment and study plan

NOLA GEM

Behavioral

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 outcomes

  1. Adherence

    Time frame: 30 day post-assessment

    Self report taking all HIV-related medication and treatment in past 30 days

  2. Viral Load

    Time frame: 90 days post assessment

    Self report last blood draw was under 50 copies of HIV/mL in past 90 days

  3. Care Engagement

    Time frame: 90 days post assessment

    Self report % of missed appointments in past 90 days

  4. Care Engagement

    Time frame: 30 days post assessment

    HIV Treatment Adherence Self-Efficacy Scale; 0-120; higher score means more self-efficacy for care engagement

  5. Acceptability of intervention

    Time frame: 30 day post-assessment

    User Experience Questionnaire-Short Form

  6. Acceptability of intervention

    Time frame: 30 day post-assessment

    Net Promotor Score; 0-10; higher score means more likely to recommend to a friend

  7. Feasibility of intervention

    Time frame: 30 day post-assessment

    App usage paradata

  8. Feasibility of intervention

    Time frame: 30 day post-assessment

    Participation rates

Secondary outcomes

  1. PTSD

    Time frame: 30 day post-assessment

    PTSD Checklist for DSM-5; higher scores indicate higher levels of PTSD symptomology

  2. Depression, anxiety

    Time frame: 30 day post-assessment

    Hospital Anxiety Depression Scale; 0-21; higher scores indicate higher levels of anxiety and/or depression

  3. Stress

    Time frame: 30 day post-assessment

    Study generated daily stressors severity checklist

  4. Stress

    Time frame: 30 day post-assessment

    Perceived Stress Scale 4; 0-16; higher score is correlated to more stress

  5. Coping

    Time frame: 30 day post-assessment

    Brief-COPE; higher scores indicate higher levels of emotion focused, problem focused, and avoidant coping styles

  6. Coping

    Time frame: 30 day post-assessment

    adapted Coping Self-Efficacy Scale; higher score means more coping self-efficacy

  7. Substance use

    Time frame: 30 day post-assessment

    Adapted Addiction Severity Index

  8. Substance use

    Time frame: 30 day post-assessment

    Alcohol Use Disorders Identification Test-C; 0-12; higher score indicates more problematic drinking

Sponsors and collaborators

Lead sponsor

Tulane University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Mar 27, 2023
Registry last updated
Dec 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.