HIV, Human Immunodeficiency Virus
Conditions
Keywords
Communication with providers, Smartphone App, Anonymous Virtual chat group, Medication reminders
Brief summary
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 \[describe the main tasks participants will be asked to do, interventions they'll be given and use bullets if it is more than 2 items\].
Detailed description
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
Interventions
BEHAVIORALPositiveLinks for Youth Smartphone App
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.
Sponsors
The University of Texas Health Science Center at San Antonio
National Institute of Allergy and Infectious Diseases (NIAID)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Type 1 hybrid study. Staircase design is a particular variation of the incomplete stepped-wedge design.It allows for phased implementation of the intervention across all participating clusters in a staggered fashion, ensuring all clusters receive the intervention. A cluster serves both as its control, as it spends time under both control and intervention conditions.
Eligibility
Sex/Gender
ALL
Age
18 Years to 29 Years
Healthy volunteers
No
Inclusion criteria
1. 18-29yo living with HIV 2. Attending at least one in-person visit in the clinic site of enrollment in the past 12 mos, 3. English speaking 4. Able to participate in the informed consent process. 5. Access to a personal smartphone with a data plan capable of supporting the PL4Y app. The phone must be password protected and not shared with others for confidentiality purposes. 6. Interviews only- A stakeholder in one of the network clinics 1. 18 years or older 2. able to participate in the informed consent process
Exclusion criteria
1. They cannot provide consent 2. Unwilling or unable to complete virtual study visits
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Virologic Suppression | Baseline to 12 months (+/- 3 months) | HIV-1 Plasma RNA level \<200 copies/ml at 12 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Health Questionnaire-9 (PHQ-9) | Baseline to Study End (approximately 18 months) | 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 |
| HIV Stigma Scale Survey (HIVSS) | Baseline to Study End (approximately 18 months) | 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 |
| National Institute of Drug Abuse (NIDA) - Modified ASSIST | Baseline to study end (approximately 18 months) | 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. |
| System Usability Survey | Month 12 and Month 18 | 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. |
| HIV Care Engagement | Baseline through end of study, measured at each study time point (baseline, 6mos, 12 mos, 18 mos) | At least two clinic visits \>60 days apart in the prior 12 months |
Countries
United States
Contacts
CONTACTBarbara Taylor, MD, MS
CONTACTCyrena Cote
PRINCIPAL_INVESTIGATORBarbara Taylor, MD, MS
The University of Texas Health Science Center at San Antonio
Outcome results
None listed