HIV Clinical Trial
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
NCT number | NCT05784714 |
Other study ID # | R34AA02896m |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | July 14, 2023 |
Est. completion date | May 31, 2024 |
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.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | May 31, 2024 |
Est. primary completion date | May 31, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - Having a reported HIV infection and being on ART. Exclusion Criteria: - |
Country | Name | City | State |
---|---|---|---|
United States | Access Health Louisiana | New Orleans | Louisiana |
United States | CrescentCare | New Orleans | Louisiana |
United States | Institute of Women & Ethnic Studies | New Orleans | Louisiana |
United States | Women With A Vision | New Orleans | Louisiana |
Lead Sponsor | Collaborator |
---|---|
Tulane University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Adherence | Self report taking all HIV-related medication and treatment in past 30 days | 30 day post-assessment | |
Primary | Viral Load | Self report last blood draw was under 50 copies of HIV/mL in past 90 days | 90 days post assessment | |
Primary | Care Engagement | Self report % of missed appointments in past 90 days | 90 days post assessment | |
Primary | Care Engagement | HIV Treatment Adherence Self-Efficacy Scale; 0-120; higher score means more self-efficacy for care engagement | 30 days post assessment | |
Primary | Acceptability of intervention | User Experience Questionnaire-Short Form | 30 day post-assessment | |
Primary | Acceptability of intervention | Net Promotor Score; 0-10; higher score means more likely to recommend to a friend | 30 day post-assessment | |
Primary | Feasibility of intervention | App usage paradata | 30 day post-assessment | |
Primary | Feasibility of intervention | Participation rates | 30 day post-assessment | |
Secondary | PTSD | PTSD Checklist for DSM-5; higher scores indicate higher levels of PTSD symptomology | 30 day post-assessment | |
Secondary | Depression, anxiety | Hospital Anxiety Depression Scale; 0-21; higher scores indicate higher levels of anxiety and/or depression | 30 day post-assessment | |
Secondary | Stress | Study generated daily stressors severity checklist | 30 day post-assessment | |
Secondary | Stress | Perceived Stress Scale 4; 0-16; higher score is correlated to more stress | 30 day post-assessment | |
Secondary | Coping | Brief-COPE; higher scores indicate higher levels of emotion focused, problem focused, and avoidant coping styles | 30 day post-assessment | |
Secondary | Coping | adapted Coping Self-Efficacy Scale; higher score means more coping self-efficacy | 30 day post-assessment | |
Secondary | Substance use | Adapted Addiction Severity Index | 30 day post-assessment | |
Secondary | Substance use | Alcohol Use Disorders Identification Test-C; 0-12; higher score indicates more problematic drinking | 30 day post-assessment |
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