Youth to Text or Telehealth for Engagement in HIV Care

NCT03681145 | Completed

• 2 other identifiers: HD51-SF-060T32DA007250
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Young Adults; Telehealth; Health Disparity

Outcome Measures

Primary Outcomes (8)

• Feasibility: Participant Retention at 4 months

  Percentage of participants retained in the study at 4 months

  4 months

• Feasibility: Mean Number of Teleconference Disconnections

  Mean of one disconnection per videoconferencing session

  8 months

• 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.

  4 months

• 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.

  4 months

• Feasibility: Participant Response Time to Text

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

  8 months

• 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.

  8 months

• 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.

  8 months

• Feasibility: Participant Retention at 8 months

  Percentage of participants retained in the study at 8 months

  8 months

Secondary Outcomes (7)

• Clinical Impact: Self-reported medication adherence

  8 months

• Clinical Impact: Frequency of Substance Use

  0 to 8 months

• Severity of Substance Use from 0 to 8 months

  0 to 8 months

• Alcohol Use

  0 to 8 months

• Clinical Impact: Depression

  0 to 8 months

Study Arms (2)

Group A-Intervention

EXPERIMENTAL

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.

Behavioral: Counselor delivered telehealth intervention

Group B-Wait-list

EXPERIMENTAL

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.

Behavioral: Counselor delivered telehealth intervention

Interventions

Counselor delivered telehealth intervention BEHAVIORAL

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.

Also known as: Y2TEC

Group A-Intervention; Group B-Wait-list

Eligibility Criteria

• Age: 18 Years - 29 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of California, San Francisco: lead
• California HIV/AIDS Research Program: collaborator
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

University of California San Francisco Mission Hall

San Francisco, California, 94143, United States

Location

Related Publications (5)

• 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.

  PMID: 31315868 BACKGROUND

• 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.

  PMID: 29731672 RESULT

• 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.

  PMID: 31132864 RESULT

• 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.

  PMID: 33575683 RESULT

• 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.

  PMID: 31800368 RESULT

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Depression; Psychotic Disorders; Personality Disorders; Substance-Related Disorders

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Behavioral Symptoms; Behavior; Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Chemically-Induced Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2018
• First Posted: September 21, 2018
• Study Start: August 15, 2018
• Primary Completion: November 8, 2019
• Study Completion: November 8, 2019
• Last Updated: September 8, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)