Feasibility of Positive Links for Youth Care Engagement Intervention

February 3, 2025 updated by: The University of Texas Health Science Center at San Antonio

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

30

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 Locations

  • United States
    • Texas
      • San Antonio, Texas, United States, 78207
        • University Health Center Downtown

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

18 years to 29 years (Adult)

Accepts Healthy Volunteers

No

Description

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

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: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mobile Health App group
Mobile health app to increase rates of engagement in care in youths living with HIV
Behavioral: Mobile health app
A mobile app provided to participants to assess effectiveness in managing HIV
Other Names:
  • PL4Y
No Intervention: Control group
Standard of care for youths living with HIV

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Completion of Feasibility Survey
Time Frame: 12 months
Feasibility survey completion by participants regarding usability of the PL4Y intervention
12 months
Viral plasma load measurement
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.
12 months

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 Mental Health (NIMH)

Investigators

  • Principal Investigator: Barbara Taylor, MD, MS, University of Texas Health Science Center 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 (Actual)

February 2, 2023

Primary Completion (Actual)

January 30, 2025

Study Completion (Actual)

January 30, 2025

Study Registration Dates

First Submitted

January 9, 2023

First Submitted That Met QC Criteria

January 9, 2023

First Posted (Actual)

January 19, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 3, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSC20220752H
  • 5R34MH122332-03 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The research team will compose a manuscript including data on preliminary efficacy of the PL4Y program in YLWH with regards to virologic suppression, retention in care, stigma, self-efficacy, and social support. The study team will also have a detailed guide to operating procedures, including successful recruitment and retention techniques and study processes such as teching tarticipants how to use PL4Y and monitoring the community message board. All data regarding participants will be shared as de-identified data.

IPD Sharing Time Frame

At study completion and when all data have been analyzed to publish in a peer reviewed 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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