Pilot RCT of Patient Centered eHealth Intervention for Nonadherent HIV+ Substance Users
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- Feasibility
研究概览
简要总结
This project has developed a patient-centered eHealth intervention; specifically, an Internet intervention, targeting multiple issues and nonadherence in HIV. The intervention, Pos4Health, includes peer role model videos and evidence-based interactions to promote understanding, coping with, and managing risk factors for nonadherence to ART, and to improve nonadherence itself. In this Pilot Trial, investigators will test the eHealth intervention Pos4Health with PLWH who reside outside urban centers. The pilot trial will determine the acceptability and feasibility of Pos4Health and explore data on HIV clinical outcomes.
详细描述
Improving treatment adherence among active substance users requires addressing many health barriers beyond substance use alone.(Dr N. Zaller Ph. D, Gillani, & Rich, 2007; Simoni, Amico, Pearson, & Malow, 2008; Willenbring, 2005) Behaviors like smoking and drug use, and experiences like poverty, poor social support, stigma, fear of HIV disclosure, depression, and anxiety, all reduce antiretroviral (ART) adherence and engagement in care, while accelerating disease progression.(Atkinson & Petrozzino, 2009; Bouhnik et al., 2002; Hendershot, Stoner, Pantalone, & Simoni, 2009; Mugavero et al., 2009; Shuter & Bernstein, 2008; Simoni, Frick, & Huang, 2006; Tucker, Burnam, Sherbourne, Kung, & Gifford, 2003; Villes et al., 2007) Improving multiple health behaviors that are related to nonadherence is a promising approach that will be used in the current project. Emerging evidence supports simultaneously targeting multiple health behaviors.(Prochaska et al., 2008) Unfortunately, few interventions address the range of issues that undermine adherence to HIV care.
Extending a program of research by the investigative team, this project will develop a patient-centered eHealth intervention; specifically, an Internet intervention, targeting multiple issues and nonadherence in HIV.
The specific aims are:
- To develop a prototype of a patient-centered eHealth (Internet) intervention targeting adherence and a set of behaviors and experiences known to undermine adherence among non-urban PLWH.
- To evaluate the prototype for usability, feasibility and acceptability among PLWH and HIV care clinicians, modify it using PLWH and clinician feedback, and finalize it for pilot testing
- To pilot test the finalized intervention to determine whether it warrants a subsequent randomized clinical trial.
The pilot test will:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HIV positive and on ART
- •Reports ART nonadherence in the past 30 days (Subject reports missed taking HIV medication at least 5/90 days on the 90 day TLFB at enrollment)
- •Screens positive for substance use in the past 30 days (Subject reports using illicit drug at least once on the 90 day TLFB at enrollment) OR Screens positive for alcohol abuse in past 30 days (Subject reports binging or exceeding weekly drinking limit (for women 8 drinks/week; for men 15 drinks/week) at least twice on the 90 day TLFB at enrollment)
- •At least 18 years old
- •Speaks and reads English
- •Can provide meaningful informed consent
- •Willing to be followed for 4-5 months
- •Has regular access to a phone, email, and computer connected to the Internet
排除标准
- •• Never missed an ART dose in past 90 days
- •Reports no use of illicit drugs or risky drinking in past 90 days
- •Cognitive disorders including mental retardation and dementia that could impair ability to understand the intervention material or give informed consent, or psychotic disorder due to the same issues
- •A prisoner, hospitalized, or institutionalized
- •Illiterate
- •Does not have email or ability to access the internet
研究组 & 干预措施
Pos4Health
Pos4Health is a 6 Core Internet intervention focusing on improving adherence to ART among nonadherent substance users living with HIV in non urban areas. Pos4Health Cores each present a topic, show videos of HIV+ peers discussing that topic, and how they have coped with it, and use interactions to teach about the topic and to develop knowledge and skills. Each core ends with tips to try that include tips mentioned by peers or from expert material. Content is personalized to the user and users receive tailored feedback. Cores are metered out weekly after each Core is completed.
干预措施: Pos4Health (Behavioral)
Patient Education
Patient Education is a static (unchanging) website that presents accurate information about the same topics in Pos4Health, but without personalization, peer videos, or interactivity.
干预措施: Patient Education (Behavioral)
结局指标
主要结局
Feasibility
时间窗: 6 months
Study Acceptance will be determined by consents obtained divided by patients approached for the study. The trial will be considered feasible if the acceptance rate among eligible patients is equal to or greater than 56%.
Acceptability
时间窗: 6 months
Is the intervention acceptable? Acceptability will be judged by participant ratings, and by actual program usage data. Participants will rate the Intervention at follow-up. The range of items on this scale is from 1 to 7. An item mean of 3.5 would be mid-range. Basic descriptive information will be gathered from the tracking system about whether participants logged in, how many times, and for how long. Time spent in each Core will be tracked and summarized. Pos4Health will be judged acceptable if if the average score on the evaluation was \> 5.6, which is 80% of the highest score (range 1-7), and if 75% of participants completed at least half of the Cores and provide 4 of 7daily diaries of adherence on at least 4 weeks.
Knowledge and Usage of Coping Strategies
时间窗: 6 months
The study will compare the Pos4Health and PtEd groups are knowledge and usage of evidence-based coping strategies for the problems targeted by each Core. Linear models will compare change between groups from baseline to post-treatment follow-up.
次要结局
- Adherence by Pharmacy Refill Rate and Treatment Engagement by Missed Visit Proportion(6 months)
研究者
Karen Ingersoll
PI
University of Virginia