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临床试验/NCT03681145
NCT03681145已完成不适用

Youth to Text or Telehealth for Engagement in HIV Care

University of California, San Francisco2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2018年8月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
2
主要终点
Feasibility: Participant Response Time to Text

研究概览

简要总结

Youth To Text or Telehealth for Engagement in HIV Care (Y2TEC) is a randomized control pilot to assess the feasibility and acceptability of delivering a targeted problem-solving intervention to youth ages 18-29 living with HIV (YLWH) for improving HIV care engagement, mental health, and decreasing substance use. The intervention will be delivered to participants in two condition groups in remote telehealth sessions delivered via video-conference over 4 months. Participation in the study will last about 8 months.

The investigators hypothesize that the Y2TEC intervention will be feasible and acceptable for YLWH, and will result in improved HIV clinical outcomes. If feasible and acceptable, it can be scaled up for a multi-site randomized clinical trial and ultimately offered in the clinical care of YLWH.

详细描述

Due to a 50% increase in HIV-related deaths in youth from 2005 to 2012, there is a critical need for research to address health disparities in youth ages 18 to 29 years old living with HIV (YLWH) and for the tailoring of healthcare delivery to their unique and complex health needs. YLWH experience worse clinical outcomes than adults including high rates of mental health and substance use challenges that impact their medical care and adherence. Many YLWH have sub-optimal engagement in HIV care, including missed HIV provider visits and routine lab work. The consequence of suboptimal adherence in YLWH is increased risk of HIV transmission and a future generation of immunodeficient adults with drug-resistant virus. In response to this critical public health dilemma, the researchers propose to develop a telehealth intervention for YLWH focused on addressing engagement in HIV care, mental health, and substance use challenges. Telehealth holds promise in overcoming barriers to clinic attendance or research participation, such as transportation difficulties or HIV-related stigma concerns. Text messaging has also been used successfully for Antiretroviral therapy (ART) adherence and virologic suppression in African settings and has been examined in youth. The investigators have chosen these technology-based methods due to the presence of data supporting their efficacy, feasibility and acceptability, promise for future dissemination, limited research in YLWH, and ability to tailor based on patients' unique health needs. While these technologies can act on specific barriers to engagement in HIV care, they are inversely related in cost, burden to patient and provider, and intensity. Existing interventions for YLWH have been adapted to create the Youth to Text or Telehealth for Engagement in HIV Care Intervention (Y2TEC) through text messaging and teleconferencing (telehealth).

The Y2TEC telehealth intervention uses problem-solving therapy, a strengths-based orientation, and motivational interviewing to help participants identify and resolve potential barriers to engagement in HIV care and other barriers to overall wellness. Consisting of twelve 20-30 minute sessions with a trained social worker using a menu of structured sessions. Each session will focus on a specific topic as it relates to healthcare engagement and wellness, such as substance use, family support, or social support. The curriculum is designed increase engagement in HIV care and reduce viral loads. To achieve these outcomes, the behaviors most commonly targeted through the problem-solving activities will be related to medication adherence, attending clinic visits, and completing labs.

At the end of the study, the investigators will explore feasibility and acceptability using quantitative and qualitative methods. Participants will complete quantitative surveys at baseline, 4 months, 8 months, and study completion, as well as qualitative exit interviews conducted over the phone. Participants will consent to the study in person and will be randomized into one of two condition groups to receive the following: Group A: participants will immediately receive 1 brief counseling intervention in-person and 11 subsequent weekly sessions delivered remotely via video-conference and weekly text messaging. Then cross over to a waiting period receiving text messages for 12 weeks. Group B: Participants in the wait-list after consent and receive text messaging only for a period of 12 weeks then will receive a revised version of the intervention for 12 weeks with all sessions completed remotely via video-conference and text message.

The aims of this study are:

  1. Employ: (1) mixed methods research to assess engagement in HIV care, technology use, substance use, and challenges with current systems of care among YLWH (18-29 years), (2) qualitative research to examine the perceptions of clinicians/managers of clinics and organizations serving YLWH on available referral services, system-wide barriers to care or referrals to substance use treatment, and age-specific challenges to patient care.
  2. Develop a technology-based intervention for improving mental health and reducing substance for delivery in YLWH based on prior data and information learned in Aim 1.
  3. Examine feasibility, acceptability, and preliminary clinical outcomes of the technology-based intervention among YLWH on improved engagement in HIV care and mental health, and reduced substance use.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Health Services Research
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

入选标准

  • English-speaking
  • Youth (18-29 years)
  • Living or receiving health care in the eastern region of the San Francisco Bay Area (i.e.
  • Willing and able to provide informed consent
  • Access to a mobile phone with text messaging capability
  • Access to the internet through a mobile phone, computer or tablet

排除标准

  • The Investigators will exclude those with evidence of severe cognitive impairment or active psychosis that may impede the ability to provide informed consent.

结局指标

主要结局

Feasibility: Participant Response Time to Text

时间窗: 8 months

Mean number of days between bi-directional text message and participants' response

Acceptability: Measure participant satisfaction of the telehealth sessions from 0 to 8 months via 2-item scale adapted from Session Rating Scale (SRS)

时间窗: 8 months

Measure participant satisfaction of each telehealth session via 2-item scale adapted from Session Rating Scale (SRS) (1-Strongly Agree to 4 Strongly Disagree, lower rating indicates higher satisfaction) administered by text-messaging. Average participant satisfaction over 12 telehealth sessions from baseline to 8 months.

Feasibility: Video Quality

时间窗: 4 months

1 item, Likert scale (0-10) (0= poor quality; 10= excellent quality) To calculate feasibility by video quality, the investigators will report the average score among all users.

Feasibility: Sound Quality

时间窗: 4 months

1 item, Likert scale (0-10) (0= poor quality; 10= excellent quality) To calculate feasibility by sound quality, the investigators will report the average score among all users.

Feasibility: Participant Retention at 4 months

时间窗: 4 months

Percentage of participants retained in the study at 4 months

Feasibility: Mean Number of Teleconference Disconnections

时间窗: 8 months

Mean of one disconnection per videoconferencing session

Acceptability: Measure participant satisfaction of the telehealth intervention as assessed by use of original 30-item satisfaction survey

时间窗: 8 months

Measure participant satisfaction with the telehealth intervention at 8-months using a 30-item questionnaire (1 Excellent-6 Unsatisfied) administered through an online survey. An average score greater than or equal to 144 (80%) will be considered acceptable.

Feasibility: Participant Retention at 8 months

时间窗: 8 months

Percentage of participants retained in the study at 8 months

次要结局

  • Clinical Impact: Self-reported medication adherence(8 months)
  • Severity of Substance Use from 0 to 8 months(0 to 8 months)
  • Clinical Impact: Frequency of Substance Use(0 to 8 months)
  • Measure participant HIV Knowledge using HIV Treatment Knowledge Scale(0 to 8 months)
  • Alcohol Use(0 to 8 months)
  • Clinical Impact: Depression(0 to 8 months)
  • Clinical Impact: Post Traumatic Stress Disorder (PTSD)(0 to 8 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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