Clinical trial NCT05784714: NOLA GEM: Feasibility and Acceptability of an MHealth Intervention for Violence-affected PLWH
Official title: Development of a Geographical Momentary Assessment Informed Trauma Intervention to Improve ART Adherence and Viral Suppression in Violence-Affected Persons Living with HIV
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Mental Health
Substance Use
Keywords: Adherence
mHealth
Care engagement
Lead sponsor: Tulane University
Sponsor class: OTHER
First posted: 2023-03-27
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: Inclusion Criteria:

* Having a reported HIV infection and being on ART.

Exclusion Criteria:

-

Primary outcomes:
measure: Adherence
timeFrame: 30 day post-assessment
measure: Viral Load
timeFrame: 90 days post assessment
measure: Care Engagement
timeFrame: 90 days post assessment
measure: Care Engagement
timeFrame: 30 days post assessment
measure: Acceptability of intervention
timeFrame: 30 day post-assessment
measure: Acceptability of intervention
timeFrame: 30 day post-assessment
measure: Feasibility of intervention
timeFrame: 30 day post-assessment
measure: Feasibility of intervention
timeFrame: 30 day post-assessment
Secondary outcomes:
measure: PTSD
timeFrame: 30 day post-assessment
measure: Depression, anxiety
timeFrame: 30 day post-assessment
measure: Stress
timeFrame: 30 day post-assessment
measure: Stress
timeFrame: 30 day post-assessment
measure: Coping
timeFrame: 30 day post-assessment
measure: Coping
timeFrame: 30 day post-assessment
measure: Substance use
timeFrame: 30 day post-assessment
measure: Substance use
timeFrame: 30 day post-assessment
Other outcomes:
Locations:
city: New Orleans
country: United States
facility: Access Health Louisiana
state: Louisiana
city: New Orleans
country: United States
facility: Women With A Vision
state: Louisiana
city: New Orleans
country: United States
facility: CrescentCare
state: Louisiana
city: New Orleans
country: United States
facility: Institute of Women & Ethnic Studies
state: Louisiana
Study officials:
References: