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NCT Number: NCT07804602

PositiveLinks for Youth (PL4Y) for Texas

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].

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Key information

Conditions

Human Immunodeficiency Virus Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases HIV HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year–29 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Texas Health Science Center San Antonio, San Antonio, Texas, United States

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • 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
  • 18 years or older
  • able to participate in the informed consent process

Exclusion criteria

  • They cannot provide consent
  • Unwilling or unable to complete virtual study visits

Treatment and study plan

PositiveLinks for Youth Smartphone App

Behavioral

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

Primary outcomes

  1. Virologic Suppression

    Time frame: Baseline to 12 months (+/- 3 months)

    HIV-1 Plasma RNA level <200 copies/ml at 12 months

Secondary outcomes

  1. 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

  2. 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

  3. 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.

  4. 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.

  5. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Barbara Taylor, MD, MS

CONTACT

[email protected]

210-450-8144

Cyrena Cote

CONTACT

[email protected]

210-450-7277

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center at San Antonio

Other

Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

Registry information

Official study title

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

Important dates

Study start
2027
Primary completion
2031
Study completion
2031
First posted
Sep 4, 2026
Registry last updated
Sep 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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