Youth to Text or Telehealth for Engagement in HIV Care
Condition: HIV/AIDS; Mental Health Issue (E.G., Depression, Psychosis, Personality Disorder, Substance Abuse); Depression; Substance Use
MeSH terms: Substance-Related Disorders; Depression; Depressive Disorder; Personality Disorders
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.

      The investigators hypothesize that the Y2TEC intervention will be feasible and acceptable for
      YLWH. Our secondary hypotheses: H1: Antiretroviral adherence, engagement in care, and CD4+
      cell count will be higher and HIV RNA levels will be lower in the intervention arm (Group A)
      relative to the wait-list arm (Group B) at 4 months. H2: Among those enrolling in the study
      with a detectable HIV RNA, there will be a minimum of 1log10 reduction in HIV RNA at 4 months
      among the intervention arm and at 8 months among the wait-list arm relative to baseline and 4
      months, respectively. H3: Among those enrolling in the study with an undetectable HIV RNA,
      there will be a maintenance of virologic suppression at 4 months among the intervention arm
      and at 8 months among the wait-list control arm relative to baseline and 4 months,
      respectively.

      The investigators postulate parallel hypotheses for self-reported ART adherence, appointment
      attendance based on medical records, and self-reported composite of engagement in care with
      mean levels of these variables being highest in the Telehealth arm and lowest in the control
      arm. Conversely, the screener for substance use (CRAFFT score) should be highest in the
      control arm and lowest in the Telehealth arm. If this innovative intervention is found to be
      feasible and acceptable, it can be scaled up for a multi-site adaptive randomized trial.
    

Intervention name(s): Counselor delivered telehealth intervention
Intervention type(s): Behavioral
Intervention description(s): This is a technology-based counseling intervention for youth living with HIV (YLWH) focused on engagement in HIV care, mental health, and substance use challenges through text messaging and teleconferencing (telehealth). The intervention is delivered in 12 brief sessions.
Other intervention name(s): Y2TEC
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Young Adults; Telehealth; Health Disparity