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Youth to Text or Telehealth for Engagement in HIV Care (Y2TEC)

Primary Purpose

HIV/AIDS, Mental Health Issue (E.G., Depression, Psychosis, Personality Disorder, Substance Abuse), Depression

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Counselor delivered telehealth intervention
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for HIV/AIDS focused on measuring Young Adults, Telehealth, Health Disparity

Eligibility Criteria

18 Years - 29 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • English-speaking
  • HIV+
  • Youth (18-29 years)
  • Living or receiving health care in the eastern region of the San Francisco Bay Area (i.e.

East Bay)

  • 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

Exclusion Criteria:

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

Sites / Locations

  • University of California San Francisco Mission Hall

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Group A-Intervention

Group B-Wait-list

Arm Description

Participants will receive the study intervention immediately after study enrollment has been completed. The intervention will be delivered in 12, 20-30 minute sessions and text messaging over 4 months (1st session in person, remaining 11 sessions will be remote). The investigators will asses feasibility, acceptability and preliminary clinical outcomes of the Y2TEC intervention at 4 months and 6 months. During the waiting period, participants will receive text messages.

Participants will be placed in a waitlist group for four months after study enrollment. Participants will receive the revised study intervention in 12, 20-30 minute sessions and text messaging over 4 months( all sessions remote). The investigators will asses feasibility, acceptability and preliminary clinical outcomes of the Y2TEC intervention at 4 months and 6 months. During the waiting period, participants will receive text messages.

Outcomes

Primary Outcome Measures

Feasibility: Participant Retention at 4 months
Percentage of participants retained in the study at 4 months
Feasibility: Mean Number of Teleconference Disconnections
Mean of one disconnection per videoconferencing session
Feasibility: Video Quality
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
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 Response Time to Text
Mean number of days between bi-directional text message and participants' response
Acceptability: Measure participant satisfaction of the telehealth intervention as assessed by use of original 30-item satisfaction survey
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.
Acceptability: Measure participant satisfaction of the telehealth sessions from 0 to 8 months via 2-item scale adapted from Session Rating Scale (SRS)
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: Participant Retention at 8 months
Percentage of participants retained in the study at 8 months

Secondary Outcome Measures

Clinical Impact: Self-reported medication adherence
Measure changes in participants' self-reported medication adherence based on 1-item adherence rating (1-Excellent- 6 Poor, lower rating indicates higher adherence) from baseline to 8 months.
Clinical Impact: Frequency of Substance Use
Measure participants' change in substance use from baseline to 8 months using a 10-item questionnaire adapted from the Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) administered through an online survey to measure frequency of participants' substance use. Scoring range is 0-Never to 6 almost daily, lower rating indicates lower substance use.
Severity of Substance Use from 0 to 8 months
Measure participants' changes in substance use from baseline to 8 months using the Drug Abuse Screening Test (DAST), a 10-item questionnaire administered through an online survey to measure severity of participants' substance use. Responses are summed. Scoring (0-10);0-2 Low substance use, 9-10 Severe substance use.
Alcohol Use
Measure participants' alcohol use from baseline to 8 months using the Alcohol Use Disorder Test (AUDIT), a 10-item questionnaire administered through an online survey to measure severity of participants' alcohol use. Responses are summed. Scoring range is 0-20+; 0-7 Low alcohol use, 20+ High dependence.
Clinical Impact: Depression
Measure participants' depression from baseline to 8 months using the Patient Health Questionnaire ( PHQ-9), a 9-item Likert scale score (0 - 3) 0 "not at all", 3 "nearly every day". Responses are summed. Scores will have a range of 0-27. PHQ-9 scores of > 10 are associated with moderate to severe depression.
Clinical Impact: Post Traumatic Stress Disorder (PTSD)
Measure participants' self-reported PTSD from baseline to 8 months using the Psychopathy Checklist-revised (PCL), a 20-item Likert questionnaire administered through an online survey. Scoring: 0 points for "not at all", 1 point for "a little bit", 2 points for "moderately", 3 points for "quite a bit", 4 points for "extremely".Scores will have a range of 0-80. Responses are summed.
Measure participant HIV Knowledge using HIV Treatment Knowledge Scale
Assess participants' knowledge of HIV from baseline to 8 months through the HIV Treatment Knowledge measure, a 15-item self-report questionnaire. Scoring out of 15 (0-11 Inadequate, 12-15 Adequate). Scores will have a range of 0-15.

Full Information

First Posted
July 10, 2018
Last Updated
June 28, 2022
Sponsor
University of California, San Francisco
Collaborators
California HIV/AIDS Research Program, National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT03681145
Brief Title
Youth to Text or Telehealth for Engagement in HIV Care
Acronym
Y2TEC
Official Title
Youth to Text or Telehealth for Engagement in HIV Care
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
August 15, 2018 (Actual)
Primary Completion Date
November 8, 2019 (Actual)
Study Completion Date
November 8, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
California HIV/AIDS Research Program, National Institute on Drug Abuse (NIDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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: 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. 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV/AIDS, Mental Health Issue (E.G., Depression, Psychosis, Personality Disorder, Substance Abuse), Depression, Substance Use
Keywords
Young Adults, Telehealth, Health Disparity

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A-Intervention
Arm Type
Experimental
Arm Description
Participants will receive the study intervention immediately after study enrollment has been completed. The intervention will be delivered in 12, 20-30 minute sessions and text messaging over 4 months (1st session in person, remaining 11 sessions will be remote). The investigators will asses feasibility, acceptability and preliminary clinical outcomes of the Y2TEC intervention at 4 months and 6 months. During the waiting period, participants will receive text messages.
Arm Title
Group B-Wait-list
Arm Type
Experimental
Arm Description
Participants will be placed in a waitlist group for four months after study enrollment. Participants will receive the revised study intervention in 12, 20-30 minute sessions and text messaging over 4 months( all sessions remote). The investigators will asses feasibility, acceptability and preliminary clinical outcomes of the Y2TEC intervention at 4 months and 6 months. During the waiting period, participants will receive text messages.
Intervention Type
Behavioral
Intervention Name(s)
Counselor delivered telehealth intervention
Other Intervention Name(s)
Y2TEC
Intervention Description
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.
Primary Outcome Measure Information:
Title
Feasibility: Participant Retention at 4 months
Description
Percentage of participants retained in the study at 4 months
Time Frame
4 months
Title
Feasibility: Mean Number of Teleconference Disconnections
Description
Mean of one disconnection per videoconferencing session
Time Frame
8 months
Title
Feasibility: Video Quality
Description
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.
Time Frame
4 months
Title
Feasibility: Sound Quality
Description
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.
Time Frame
4 months
Title
Feasibility: Participant Response Time to Text
Description
Mean number of days between bi-directional text message and participants' response
Time Frame
8 months
Title
Acceptability: Measure participant satisfaction of the telehealth intervention as assessed by use of original 30-item satisfaction survey
Description
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.
Time Frame
8 months
Title
Acceptability: Measure participant satisfaction of the telehealth sessions from 0 to 8 months via 2-item scale adapted from Session Rating Scale (SRS)
Description
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.
Time Frame
8 months
Title
Feasibility: Participant Retention at 8 months
Description
Percentage of participants retained in the study at 8 months
Time Frame
8 months
Secondary Outcome Measure Information:
Title
Clinical Impact: Self-reported medication adherence
Description
Measure changes in participants' self-reported medication adherence based on 1-item adherence rating (1-Excellent- 6 Poor, lower rating indicates higher adherence) from baseline to 8 months.
Time Frame
8 months
Title
Clinical Impact: Frequency of Substance Use
Description
Measure participants' change in substance use from baseline to 8 months using a 10-item questionnaire adapted from the Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) administered through an online survey to measure frequency of participants' substance use. Scoring range is 0-Never to 6 almost daily, lower rating indicates lower substance use.
Time Frame
0 to 8 months
Title
Severity of Substance Use from 0 to 8 months
Description
Measure participants' changes in substance use from baseline to 8 months using the Drug Abuse Screening Test (DAST), a 10-item questionnaire administered through an online survey to measure severity of participants' substance use. Responses are summed. Scoring (0-10);0-2 Low substance use, 9-10 Severe substance use.
Time Frame
0 to 8 months
Title
Alcohol Use
Description
Measure participants' alcohol use from baseline to 8 months using the Alcohol Use Disorder Test (AUDIT), a 10-item questionnaire administered through an online survey to measure severity of participants' alcohol use. Responses are summed. Scoring range is 0-20+; 0-7 Low alcohol use, 20+ High dependence.
Time Frame
0 to 8 months
Title
Clinical Impact: Depression
Description
Measure participants' depression from baseline to 8 months using the Patient Health Questionnaire ( PHQ-9), a 9-item Likert scale score (0 - 3) 0 "not at all", 3 "nearly every day". Responses are summed. Scores will have a range of 0-27. PHQ-9 scores of > 10 are associated with moderate to severe depression.
Time Frame
0 to 8 months
Title
Clinical Impact: Post Traumatic Stress Disorder (PTSD)
Description
Measure participants' self-reported PTSD from baseline to 8 months using the Psychopathy Checklist-revised (PCL), a 20-item Likert questionnaire administered through an online survey. Scoring: 0 points for "not at all", 1 point for "a little bit", 2 points for "moderately", 3 points for "quite a bit", 4 points for "extremely".Scores will have a range of 0-80. Responses are summed.
Time Frame
0 to 8 months
Title
Measure participant HIV Knowledge using HIV Treatment Knowledge Scale
Description
Assess participants' knowledge of HIV from baseline to 8 months through the HIV Treatment Knowledge measure, a 15-item self-report questionnaire. Scoring out of 15 (0-11 Inadequate, 12-15 Adequate). Scores will have a range of 0-15.
Time Frame
0 to 8 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
29 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: English-speaking HIV+ Youth (18-29 years) Living or receiving health care in the eastern region of the San Francisco Bay Area (i.e. East Bay) 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 Exclusion Criteria: The Investigators will exclude those with evidence of severe cognitive impairment or active psychosis that may impede the ability to provide informed consent.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Parya Saberi, PharmD
Organizational Affiliation
UCSF School of Medicine, Division of Prevention Science
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California San Francisco Mission Hall
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31315868
Citation
Wootton AR, Legnitto DA, Gruber VA, Dawson-Rose C, Neilands TB, Johnson MO, Saberi P. Telehealth and texting intervention to improve HIV care engagement, mental health and substance use outcomes in youth living with HIV: a pilot feasibility and acceptability study protocol. BMJ Open. 2019 Jul 16;9(7):e028522. doi: 10.1136/bmjopen-2018-028522.
Results Reference
background
PubMed Identifier
29731672
Citation
Saberi P, Ming K, Dawson-Rose C. What does it mean to be youth-friendly? Results from qualitative interviews with health care providers and clinic staff serving youth and young adults living with HIV. Adolesc Health Med Ther. 2018 Apr 24;9:65-75. doi: 10.2147/AHMT.S158759. eCollection 2018.
Results Reference
result
PubMed Identifier
31132864
Citation
Saberi P, Dawson Rose C, Wootton AR, Ming K, Legnitto D, Jeske M, Pollack LM, Johnson MO, Gruber VA, Neilands TB. Use of technology for delivery of mental health and substance use services to youth living with HIV: a mixed-methods perspective. AIDS Care. 2020 Aug;32(8):931-939. doi: 10.1080/09540121.2019.1622637. Epub 2019 May 28.
Results Reference
result
PubMed Identifier
33575683
Citation
Saberi P, McCuistian C, Agnew E, Wootton AR, Legnitto Packard DA, Dawson-Rose C, Johnson MO, Gruber VA, Neilands TB. Video-Counseling Intervention to Address HIV Care Engagement, Mental Health, and Substance Use Challenges: A Pilot Randomized Clinical Trial for Youth and Young Adults Living with HIV. Telemed Rep. 2021 Jan 7;2(1):14-25. doi: 10.1089/tmr.2020.0014. eCollection 2021.
Results Reference
result
PubMed Identifier
31800368
Citation
Wootton AR, McCuistian C, Legnitto Packard DA, Gruber VA, Saberi P. Overcoming Technological Challenges: Lessons Learned from a Telehealth Counseling Study. Telemed J E Health. 2020 Oct;26(10):1278-1283. doi: 10.1089/tmj.2019.0191. Epub 2019 Dec 3.
Results Reference
result

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Youth to Text or Telehealth for Engagement in HIV Care

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