PositiveLinks for Youth (PL4Y) for Texas
2 other identifiers
interventional
600
1 country
2
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 \[describe the main tasks participants will be asked to do, interventions they'll be given and use bullets if it is more than 2 items\].
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2027
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 31, 2026
CompletedFirst Posted
Study publicly available on registry
September 4, 2026
CompletedStudy Start
First participant enrolled
April 1, 2027
ExpectedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2031
Study Completion
Last participant's last visit for all outcomes
April 1, 2031
September 4, 2026
August 1, 2026
4 years
August 31, 2026
August 31, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Virologic Suppression
HIV-1 Plasma RNA level \<200 copies/ml at 12 months
Baseline to 12 months (+/- 3 months)
Secondary Outcomes (5)
Patient Health Questionnaire-9 (PHQ-9)
Baseline to Study End (approximately 18 months)
HIV Stigma Scale Survey (HIVSS)
Baseline to Study End (approximately 18 months)
National Institute of Drug Abuse (NIDA) - Modified ASSIST
Baseline to study end (approximately 18 months)
System Usability Survey
Month 12 and Month 18
HIV Care Engagement
Baseline through end of study, measured at each study time point (baseline, 6mos, 12 mos, 18 mos)
Study Arms (1)
mHealth Intervention group
EXPERIMENTAL18-29yos with HIV who are in care in one of the participating clinics.
Interventions
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.
Eligibility Criteria
You may qualify if:
- yo 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.
- 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.
- Interviews only- A stakeholder in one of the network clinics
- years or older
- able to participate in the informed consent process
You may not qualify if:
- They cannot provide consent
- Unwilling or unable to complete virtual study visits
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
University of Texas Health Science Center San Antonio
San Antonio, Texas, 78229, United States
University of Texas San Antonio Health Campus
San Antonio, Texas, 78229, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Barbara Taylor, MD, MS
The University of Texas Health Science Center at San Antonio
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
August 31, 2026
First Posted
September 4, 2026
Study Start (Estimated)
April 1, 2027
Primary Completion (Estimated)
March 31, 2031
Study Completion (Estimated)
April 1, 2031
Last Updated
September 4, 2026
Record last verified: 2026-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- After study closure, data analysis and publication of summary results in ClinicalTrials.gov and a peer-review journal.
In an effort to protect your privacy, the study staff will use code numbers instead of participant name, to identify any health information. Numbers will be used on any photocopies of your records, and other study materials containing health information that are sent outside the clinic the participant attends for review or testing. If the results of this study are reported in medical journals or at meetings, participants will not be identified.