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

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ClinicalTrials.gov Identifier: NCT03681145
Recruitment Status : Recruiting
First Posted : September 21, 2018
Last Update Posted : March 4, 2019
Sponsor:
Collaborator:
California HIV/AIDS Research Program
Information provided by (Responsible Party):
University of California, San Francisco

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.


Condition or disease Intervention/treatment Phase
HIV/AIDS Mental Health Issue (E.G., Depression, Psychosis, Personality Disorder, Substance Abuse) Depression Substance Use Behavioral: Counselor delivered telehealth intervention Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Youth to Text or Telehealth for Engagement in HIV Care
Actual Study Start Date : August 15, 2018
Estimated Primary Completion Date : September 30, 2019
Estimated Study Completion Date : December 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: Group A-Intervention
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
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 Name: Y2TEC

Experimental: Group B-Wait-list
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
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 Name: Y2TEC




Primary Outcome Measures :
  1. Feasibility: Participant Retention at 4 months [ Time Frame: 4 months ]
    Percentage of participants retained in the study at 4 months

  2. Feasibility: Mean Number of Teleconference Disconnections [ Time Frame: 8 months ]
    Mean of one disconnection per videoconferencing session

  3. Feasibility: Video Quality [ Time Frame: 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.

  4. Feasibility: Sound Quality [ Time Frame: 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.

  5. Feasibility: Participant Response Time to Text [ Time Frame: 8 months ]
    Mean number of days between bi-directional text message and participants' response

  6. Acceptability: Measure participant satisfaction of the telehealth intervention as assessed by use of original 30-item satisfaction survey [ Time Frame: 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.

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

  8. Feasibility: Participant Retention at 8 months [ Time Frame: 8 months ]
    Percentage of participants retained in the study at 8 months


Secondary Outcome Measures :
  1. Clinical Impact: Self-reported medication adherence [ Time Frame: 8 months ]
    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.

  2. Clinical Impact: Frequency of Substance Use [ Time Frame: 0 to 8 months ]
    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.

  3. Severity of Substance Use from 0 to 8 months [ Time Frame: 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.

  4. Alcohol Use [ Time Frame: 0 to 8 months ]
    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.

  5. Clinical Impact: Depression [ Time Frame: 0 to 8 months ]
    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.

  6. Clinical Impact: Post Traumatic Stress Disorder (PTSD) [ Time Frame: 0 to 8 months ]
    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.

  7. Measure participant HIV Knowledge using HIV Treatment Knowledge Scale [ Time Frame: 0 to 8 months ]
    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.



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Ages Eligible for Study:   18 Years to 29 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03681145


Contacts
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Contact: Parya Saberi, PharmD 415-502-1000 ext 17171 Parya.Saberi@ucsf.edu
Contact: Dominique A Legnitto 415-502-1000 ext 14613 Dominique.Legnitto@ucsf.edu

Locations
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United States, California
University of California San Francisco Mission Hall Recruiting
San Francisco, California, United States, 94143
Contact: Dominique Legnitto    415-502-1000 ext 14613    dominique.legnitto@ucsf.edu   
Sponsors and Collaborators
University of California, San Francisco
California HIV/AIDS Research Program
Investigators
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Principal Investigator: Parya Saberi, PharmD UCSF School of Medicine, Division of Prevention Science

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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT03681145     History of Changes
Other Study ID Numbers: HD51-SF-060
First Posted: September 21, 2018    Key Record Dates
Last Update Posted: March 4, 2019
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of California, San Francisco:
Young Adults
Telehealth
Health Disparity

Additional relevant MeSH terms:
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Depression
Depressive Disorder
Substance-Related Disorders
Personality Disorders
Behavioral Symptoms
Mood Disorders
Mental Disorders
Chemically-Induced Disorders