Exploring, Predicting, and Intervening on Long-term Viral Suppression Electronically
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 2
- 主要终点
- Level of Adherence based on HIV appointments
研究概览
简要总结
Despite the widespread availability of effective antiretroviral therapy (ART) in the United States, there remains significant numbers of people living with HIV (PLWH) who fail to achieve and or maintain viral suppression (VS). Disparities persist with the lowest levels of VS among Black individuals, people who use drugs, youth ages 18-24 and people residing in rural areas. Investigators will examine the syndemics underlying these outcomes including substance use, mental health, and barriers to HIV care including racial discrimination, stigma and rural isolation.
详细描述
This study will follow a digital cohort via the REMAIN App. The REMAIN App is adapted from the HealthMPowerment (HMP) platform and tailored to our focus population's unique needs. Digital cohorts, or eCohorts, utilize the flexibility and capacity of the internet to complement traditional approaches to epidemiological research, helping address some of the limitations and challenges associated with conventional cohort studies.
Aim 1 of this study is to recruit and retain a geographically and demographically diverse cohort of PLWH who are sub optimally engaged in care and with a history of, at high risk for, or not currently virally suppressed. Outcomes for this are levels of recruitment and retention to hit the study objectives to enroll 1,000 PLWH at risk for or experiencing VNS and follow them for up to 48 months. Aim 2 is to evaluate longitudinal patterns of care engagement within the cohort by modeling and advanced epidemiologic methods utilizing remote collection of biomarkers of HIV disease (e.g., viral load), online surveys, and brief, frequent app-based "check-ins". Outcomes include both those related to VS and engagement in care as well as engagement in the digital cohort.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
盲法说明
N/A - all participants get the app
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
- •Have access to a personal smartphone device;
- •Over 18 years of age;
- •Speak English or Spanish;
- •Living with HIV
- •Are either 1) not currently virally suppressed, 2) not currently engaged in care, or 3) have one or more factors associated with viral non suppression including a history of missed appointments or viral non suppression;
- •Active substance use or mental health disorder;
- •Willing and able to provide written informed consent to take part in the study.
排除标准
- •Unwilling or unable to provide reliable contact information;
- •Unwilling to provide blood sample for HIV virology testing;
- •Living with HIV and virally suppressed and not at risk of becoming unsuppressed in the near future.
结局指标
主要结局
Level of Adherence based on HIV appointments
时间窗: one year
Adherence defined as not missing more than 1 HIV care appointment in 1 year
Level of Adherence to HIV medication
时间窗: past 6 months
Adherence of at least 80% to ARV medication
Incidence of HIV Viral Suppression
时间窗: past 3 months
Suppression defined as having less than 200 copies of HIV per milliliter of blood.
次要结局
未报告次要终点
研究者
Pamina Mae Gorbach
Principal Investigator
University of California, Los Angeles