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OpenTrials
Completed

NCT Number: NCT05689515

Feasibility of Positive Links for Youth Care Engagement Intervention

A small pilot study to assess feasibility and acceptability of the PL4Y intervention.

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Key information

Conditions

HIV Antibody Positivity Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections HIV Seropositivity Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year–29 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Health Center Downtown

San Antonio, Texas, 78207, United States

About this study

After completing enrollment and informed consent, participants will be randomly assigned to PL4Y in a 2:1 fashion (intervention:control) with a target enrollment of 40 receiving the intervention and 20 in the control arm for a total of 60 participants. There is no blinding in this study protocol.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Confirmed HIV infection
  • Recent diagnosis of HIV (within the past 6 months) OR be virologically unsuppressed (>1000 copies/ml) OR disengaged from HIV care (< 2 visits/last 12 months > 90 days apart)

Exclusion criteria

  • Cannot consent
  • Unwilling to come to visits
  • Unwilling to be in San Antonio for a year

Treatment and study plan

mobile health app

Behavioral

A mobile app provided to participants to assess effectiveness in managing HIV

Other names: PL4Y

Primary outcomes

  1. Number of Participants With Undetectable Viral Load

    Time frame: 12 months

    Virologic suppression is the primary goal of HIV treatment. Virologic failure is defined as a measurement over 200 copies per mL by the Department of Health and Human Services, and is the primary determinant of successful HIV control. This outcome is categorized as: Undetectable (VL <200 at 12 months)

  2. Feasibility Survey Completion

    Time frame: 6 and 12 month time points

    Feasibility of the intervention assessed using a participant-completed survey at 6 and 12 months. Measured as number of participants that completed the survey in the arm that received the intervention only.

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center at San Antonio

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

PL4Y: A Pilot Randomized Control Trial to Study the Feasibility of Positive Links for Youth Care Engagement Intervention

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jan 19, 2023
Registry last updated
Sep 15, 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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