Development of a Geographical Momentary Assessment Informed Trauma Intervention to Improve ART Adherence and Viral Suppression in Violence-Affected Persons Living with HIV
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 4
- 主要终点
- Acceptability of intervention
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Having a reported HIV infection and being on ART.
排除标准
- 未提供
研究组 & 干预措施
Intervention
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.
干预措施: NOLA GEM (Behavioral)
GEMA
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.
结局指标
主要结局
Acceptability of intervention
时间窗: 30 day post-assessment
User Experience Questionnaire-Short Form
Feasibility of intervention
时间窗: 30 day post-assessment
App usage paradata
Viral Load
时间窗: 90 days post assessment
Self report last blood draw was under 50 copies of HIV/mL in past 90 days
Care Engagement
时间窗: 30 days post assessment
HIV Treatment Adherence Self-Efficacy Scale; 0-120; higher score means more self-efficacy for care engagement
Adherence
时间窗: 30 day post-assessment
Self report taking all HIV-related medication and treatment in past 30 days
Care Engagement
时间窗: 90 days post assessment
Self report % of missed appointments in past 90 days
次要结局
- Substance use(30 day post-assessment)
- Stress(30 day post-assessment)
- Coping(30 day post-assessment)
- PTSD(30 day post-assessment)
- Depression, anxiety(30 day post-assessment)