Youth to Text or Telehealth for Engagement in HIV Care — Y2TEC  

Depression Clinical Trial

Official title: Youth to Text or Telehealth for Engagement in HIV Care

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• HIV/AIDS
• Mental Health Issue (E.G., Depression, Psychosis, Personality Disorder, Substance Abuse)
• Personality Disorders
• Substance Use
• Substance-Related Disorders

• NCT number: NCT03681145
• Study type: Interventional
• Source: University of California, San Francisco
• Status: Completed
• Phase: N/A
• Start date: August 15, 2018
• Completion date: November 8, 2019