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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05784714
Enrollment
32
Registered
2023-03-27
Start date
2023-07-14
Completion date
2024-11-30
Last updated
2024-12-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV, Mental Health, Substance Use

Keywords

Adherence, mHealth, Care engagement

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.

Interventions

BEHAVIORALNOLA 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.

Sponsors

Tulane University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

* Having a reported HIV infection and being on ART.

Exclusion criteria

\-

Design outcomes

Primary

MeasureTime frameDescription
Feasibility of intervention30 day post-assessmentApp usage paradata
Adherence30 day post-assessmentSelf report taking all HIV-related medication and treatment in past 30 days
Viral Load90 days post assessmentSelf report last blood draw was under 50 copies of HIV/mL in past 90 days
Care Engagement90 days post assessmentSelf report % of missed appointments in past 90 days
Acceptability of intervention30 day post-assessmentUser Experience Questionnaire-Short Form

Secondary

MeasureTime frameDescription
PTSD30 day post-assessmentPTSD Checklist for DSM-5; higher scores indicate higher levels of PTSD symptomology
Depression, anxiety30 day post-assessmentHospital Anxiety Depression Scale; 0-21; higher scores indicate higher levels of anxiety and/or depression
Stress30 day post-assessmentStudy generated daily stressors severity checklist
Coping30 day post-assessmentBrief-COPE; higher scores indicate higher levels of emotion focused, problem focused, and avoidant coping styles
Substance use30 day post-assessmentAdapted Addiction Severity Index

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 8, 2026