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 \[describe the main tasks participants will be asked to do, interventions they'll be given and use bullets if it is more than 2 items\].
The overall objective of this proposal is to implement and rigorously test an existing mHealth care engagement intervention, PL4Y, in a six clinic network in Texas. The investigators will use the Exploration, Preparation, Implementation, Sustainment (EPIS) framework to inform a type 1 hybrid study, assessing effectiveness of PL4Y alongside measures of acceptability, feasibility, and sustainability. The study has two main components: * A cluster randomized longitudinal staircase trial across six clinics in Texas * Qualitative assessment, using semi-structured interviews and focus groups, of acceptability and feasibility of PL4Y implementation in the clinics
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
600
PL4Y, 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.
University of Texas Health Science Center San Antonio
San Antonio, Texas, United States
University of Texas San Antonio Health Campus
San Antonio, Texas, United States
Virologic Suppression
HIV-1 Plasma RNA level \<200 copies/ml at 12 months
Time frame: Baseline to 12 months (+/- 3 months)
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)
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)
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)
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 18
HIV Care Engagement
At least two clinic visits \>60 days apart in the prior 12 months
Time frame: Baseline through end of study, measured at each study time point (baseline, 6mos, 12 mos, 18 mos)
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