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

Tulane University logo

Tulane University

Status

Completed

Conditions

Substance Use
HIV
Mental Health

Treatments

Behavioral: NOLA GEM

Study type

Interventional

Funder types

Other

Identifiers

NCT05784714
R34AA02896m

Details and patient eligibility

About

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.

Enrollment

32 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Having a reported HIV infection and being on ART.

Exclusion criteria

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

32 participants in 2 patient groups

Intervention
Experimental group
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.
Treatment:
Behavioral: NOLA GEM
GEMA
No Intervention group
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.

Trial contacts and locations

4

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Central trial contact

Gretchen Clum, PhD; Stephanie Tokarz, MPH

Data sourced from clinicaltrials.gov

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