NOLA GEM: Feasibility and Acceptability of an MHealth Intervention for Violence-affected PLWH
- Conditions
- Mental HealthSubstance UseHIV
- Interventions
- Behavioral: NOLA GEM
- Registration Number
- NCT05784714
- Lead Sponsor
- Tulane University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 32
- Having a reported HIV infection and being on ART.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention NOLA GEM 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.
- Primary Outcome Measures
Name Time Method Acceptability of intervention 30 day post-assessment Net Promotor Score; 0-10; higher score means more likely to recommend to a friend
Viral Load 90 days post assessment Self report last blood draw was under 50 copies of HIV/mL in past 90 days
Care Engagement 30 days post assessment HIV Treatment Adherence Self-Efficacy Scale; 0-120; higher score means more self-efficacy for care engagement
Adherence 30 day post-assessment Self report taking all HIV-related medication and treatment in past 30 days
Feasibility of intervention 30 day post-assessment Participation rates
- Secondary Outcome Measures
Name Time Method PTSD 30 day post-assessment PTSD Checklist for DSM-5; higher scores indicate higher levels of PTSD symptomology
Depression, anxiety 30 day post-assessment Hospital Anxiety Depression Scale; 0-21; higher scores indicate higher levels of anxiety and/or depression
Substance use 30 day post-assessment Alcohol Use Disorders Identification Test-C; 0-12; higher score indicates more problematic drinking
Stress 30 day post-assessment Perceived Stress Scale 4; 0-16; higher score is correlated to more stress
Coping 30 day post-assessment adapted Coping Self-Efficacy Scale; higher score means more coping self-efficacy
Trial Locations
- Locations (4)
Access Health Louisiana
🇺🇸New Orleans, Louisiana, United States
Women With A Vision
🇺🇸New Orleans, Louisiana, United States
CrescentCare
🇺🇸New Orleans, Louisiana, United States
Institute of Women & Ethnic Studies
🇺🇸New Orleans, Louisiana, United States