PositiveLinks for Youth (PL4Y) for Texas

August 31, 2026 updated by: Barbara Taylor, The University of Texas Health Science Center at San Antonio

PositiveLinks for Youth (PL4Y) for Texas: Effectiveness, Feasibility, and Acceptability of mHealth to Improve Care Outcomes for Young Adults With HIV

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].

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Estimated)

600

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Texas
      • San Antonio, Texas, United States, 78229
      • San Antonio, Texas, United States, 78229
        • University of Texas San Antonio Health Campus
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: mHealth Intervention group
18-29yos with HIV who are in care in one of the participating clinics.
Behavioral: PositiveLinks 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.
Other Names:
  • PL4Y

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Virologic Suppression
Time Frame: Baseline to 12 months (+/- 3 months)
HIV-1 Plasma RNA level <200 copies/ml at 12 months
Baseline to 12 months (+/- 3 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Health Questionnaire-9 (PHQ-9)
Time Frame: 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
Baseline to Study End (approximately 18 months)
HIV Stigma Scale Survey (HIVSS)
Time Frame: 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
Baseline to Study End (approximately 18 months)
National Institute of Drug Abuse (NIDA) - Modified ASSIST
Time Frame: 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.
Baseline to study end (approximately 18 months)
System Usability Survey
Time Frame: 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.
Month 12 and Month 18
HIV Care Engagement
Time Frame: 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
Baseline through end of study, measured at each study time point (baseline, 6mos, 12 mos, 18 mos)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas Health Science Center at San Antonio

Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

  • Principal Investigator: Barbara Taylor, MD, MS, The University of Texas Health Science Center at San Antonio

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2027

Primary Completion (Estimated)

March 31, 2031

Study Completion (Estimated)

April 1, 2031

Study Registration Dates

First Submitted

August 31, 2026

First Submitted That Met QC Criteria

August 31, 2026

First Posted (Actual)

September 4, 2026

Study Record Updates

Last Update Posted (Actual)

September 4, 2026

Last Update Submitted That Met QC Criteria

August 31, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00002531
  • R01AI205724 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

After study closure, data analysis and publication of summary results in ClinicalTrials.gov and a peer-review journal.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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