Peers Plus Mobile App for Treatment in HIV (PATH)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 309
- 试验地点
- 2
- 主要终点
- Viral suppression
研究概览
简要总结
This study called "Peers plus mobile App for Treatment in HIV (PATH)" is a two-arm randomized controlled trial (RCT) evaluating the efficacy of an intervention that combines peer navigation and mobile health (mHealth) technology to support HIV care outcomes among Hispanic and Black Persons Living with HIV (HBPLH).
详细描述
PATH is a community-academic collaboration with a federally qualified health center serving patients in South San Diego under the Ryan White model of care.
The scientific premise of this RCT is that combining two interventions developed by this team (peer navigation + mHealth) into a single mHealth peer navigation intervention (PATH) will eliminate the need for in-person support from peer navigators, promote high impact on HIV care continuum outcomes, as well as extend broader reach to underserved communities.
The RCT will test the efficacy of PATH with 375 HBPLH (among whom >33% will report stimulant and/or opioid use in the past 6 months).
Aim 1. Improve the primary outcomes - sustained viral suppression (i.e., suppressed viral load at both 6- and 12-month follow-up), and secondary outcomes (e.g., retention in care) compared to usual care.
Sub-aim 1: Explore subgroup differences in efficacy based on factors like race/ethnicity 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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •≥18 years old
- •Can read and speak English or Spanish
- •Self-reported diagnosis of HIV by a physician or healthcare provider
- •Currently prescribed HIV medication
- •Having access to an internet browser on a home computer, tablet, or smart phone
- •Does not plan to move out of the San Diego area in the next 12 months
- •Meets one or more of the following medical chart verified or self-reported criteria
- •One or more detectable viral load test result (>200 copies m/L) in the past 12-months while on antiretroviral therapy for at least 3 months
- •Having missed 1 or more scheduled HIV care appointments in the last 12 months
- •Last HIV care visit was more than 6 months ago
- •Self-reporting less than 90% antiretroviral therapy adherence in the last 4 weeks using the Wilson-3 scale
- •Report stimulant or opioid use (non-prescription) in the past 6 months
排除标准
- •<18 years old
- •Currently enrolled in any program, intervention, or research study designed to improve antiretroviral therapy adherence or engagement in HIV care (e.g., LinkPositively)
- •Members of one of the community advisory boards providing advisement on the study.
结局指标
主要结局
Viral suppression
时间窗: 12 months
Having an undetectable HIV viral load; \<200 copies/mL
次要结局
- Antiretroviral therapy adherence(12 months)
- Retention in HIV care(12 months)
- Gap in HIV medical visits(12 months)