PositiveLinks for Youth (PL4Y) for Texas
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-29
SponsorThe University of Texas Health Science Center at San Antonio
About this trial
The goal of this interventional clinical trial is to test an an app, PL4Y, installed on a mobile smartphone to see if it can help participants aged 18-29 years who have HIV achieve success with their HIV care and feel supported by their clinic community.
The first 6 months will be standard of care, after which participants will continue to meet virtually with their health care providers and will also be provided with and taught how to use the app. The standard of care clinic visits will continue as before and virtual visits using the app will be started and continue for abot 18 months.
Adherence to medications Appointment reminders Provide secure communication with providers
Provide a support group in \[describe participant population/primary condition; could include any of the following: sex/gender, age groups, healthy volunteers\]. The main question\[s\] it aims to answer \[is/are\]:
\[primary hypothesis or outcome measure 1\]? \[primary hypothesis or outcome measure 2\]?
If there is a comparison group: Researchers will compare \[arm information\] to see if \[insert effects\].
Participants will \[describe the main tasks participants will be asked to do, interventions they'll be given and use bullets if it is more than 2 items\].
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
18-29yo living with HIV
Attending at least one in-person visit in the clinic site of enrollment in the past 12 mos,
English speaking
Able to participate in the informed consent process.
Disqualifiers
They cannot provide consent
Unwilling or unable to complete virtual study visits
Trial design
Design model
Single group
Treatments tested in this trial
PositiveLinks for Youth Smartphone App
BehavioralPL4Y, a smartphone application (app), is a clinic-based multimodal intervention designed by and for youth living with HIV, including daily adherence assessment, appointment reminders, secure messaging with clinic providers, and an asynchronous, anonymized virtual support group.
Treatment groups
600 Participants
are divided into 1 treatment groupGroup A: mHealth Intervention groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Virologic Suppression
HIV-1 Plasma RNA level \<200 copies/ml at 12 months
Time frame
Baseline to 12 months (+/- 3 months)Secondary outcomes
1
Patient Health Questionnaire-9 (PHQ-9)
A 9 item survey with each item scored: 0: Not at all 1: Several days 2: More than half the days 3: Nearly every day Total possible score is between 0-27, with a higher score indicating more symptoms indicative of depression
Time frame
Baseline to Study End (approximately 18 months)2
HIV Stigma Scale Survey (HIVSS)
A 40 item scale, with each item scored from 1=Strongly agree, 2=Disagree, 3=Agree, 4=Strongly agree. The total score can range from 10-40 with a higher score indicating more stigma
Time frame
Baseline to Study End (approximately 18 months)3
National Institute of Drug Abuse (NIDA) - Modified ASSIST
A quick screen questionnaire that includes only Question 2 of the NIDA-modified ASSIST regarding substance abuse. 10 substances are included and each is scored depending on use: Never=0, Once or Twice=2, Monthly=3, Weekly=4, Daily or Almost daily = 6. Total scores range from 0-60 with a higher score indicating more frequent substance abuse.
Time frame
Baseline to study end (approximately 18 months)4
System Usability Survey
This survey is administered at Visits 2 and 3 with 10 structured questions scored from 0=Strongly Disagree, 1=Disagree, 2=Somewhat Disagree, 4=Neither Agree nor Disagree, 5=Somewhat Agree, 6=Agree, 7=Strongly Agree. There are 3 additional free response questions that are not scored. Total scores range from 0-70 with a higher score indicating better system usability.
Time frame
Month 12 and Month 18Sponsors and contacts
Click on the lead sponsor to view all of their trials.
The University of Texas Health Science Center at San Antonio
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: