Sustaining Healthy Choices: Optimizing a State-wide Scalable Intervention to Improve Alcohol and HIV Self-management in Adolescents and Emerging Adults
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 150
- 试验地点
- 8
- 主要终点
- ART Adherence
研究概览
简要总结
The goal of PROJECT SUSTAIN is to optimize Healthy Choices to advance an adaptive and scalable intervention designed to improve self-management of alcohol and HIV in Young People with HIV (YPWH) while understanding the context for state-wide implementation and sustainment in a Hybrid Experimental Design (HED). SUSTAIN utilizes mHealth and telehealth intervention delivery of Healthy Choices (HC), combined with text messaging between sessions, to increase the likelihood of daily medication adherence (primary outcome), and increase the likelihood of achieving viral suppression and meeting criteria for no risky alcohol use at month 3 (secondary outcome).
详细描述
Primary aim: To test whether, on average, delivering (vs. not delivering) a text messaged prompt focused on medication adherence or stress increases the likelihood of medication adherence by the end of the current day.
Secondary aim: To test whether offering (vs. not offering) a Healthy Choices telehealth coaching session at the end of week 2 (day 14) increases the likelihood of achieving viral suppression and meeting criteria for no risky alcohol use at month 3.
Implementation Aim: Assess barriers and facilitators to the implementation and sustainment of intervention sequences for state-wide scale up using mixed methods (EPIS qualitative interviews, youth satisfaction and dose received, fidelity for telehealth, paradata for mHealth, and cost-effectiveness analysis).
Cross-project Moderator Aim: Explore age, biological sex and gender, ethnicity, other substance use, and mental health as moderators of intervention effects.
Primary hypothesis to be tested: Delivering (vs. not delivering) a text messaged prompt will lead to greater likelihood of medication adherence by the end of the current day.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 29 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Be 18 years and 0 months to 29 years and 11 months.
- •Currently reside in Florida
- •History of alcohol use
- •Are not pregnant nor trying to conceive within the study's timeline
- •Are able to read and understand English
- •Have internet access via smartphone, tablet or computer
- •Are willing to provide informed consent.
排除标准
- •Adults unable to consent
- •Prisoners
- •Those using long-acting injectables as HIV medication regimen
研究组 & 干预措施
Within-participant micro-randomization - Prompt
Participants will be randomized daily to receive a text messaged prompt focused on medication adherence or stress.
干预措施: Text Message Prompts (Behavioral)
Within-participant micro-randomization - No Prompt
Participants will be randomized daily to not receive a text messaged prompt focused on medication adherence or stress.
Between-participant randomization - CIAS + Week 2 Coaching Session
Participants will be randomized at the end of week 2 (day 14) to receive the Healthy Choices telehealth intervention with trained interventionist at week 2.
All enrolled participants will receive an initial Healthy Choices mHealth intervention which involves a MI based coaching session via Computerized Intervention Authoring Software (CIAS).
干预措施: Healthy Choices (Behavioral)
Between-participant randomization - CIAS + No Week 2 Coaching Session
Participants will be randomized at the end of week 2 (day 14) to NOT receive the Healthy Choices telehealth intervention with trained interventionist at week 2.
All enrolled participants will receive an initial Healthy Choices mHealth intervention which involves a MI based coaching session via Computerized Intervention Authoring Software (CIAS).
结局指标
主要结局
ART Adherence
时间窗: Daily for 56 Days
Antiretroviral (ART) adherence will be assessed daily using an Ecological Momentary Assessment (EMA) survey delivered via SMS. Individuals will be asked whether they took some or all of their medication.
次要结局
- Alcohol Use(Baseline, 3 month, and 6 month)
- HIV Viral Load(Baseline, 3 month, and 6 month)
研究者
Sylvie Naar
Principal Investigator
Florida State University