Feasibility of Positive Links for Youth Care Engagement Intervention
PL4Y: A Pilot Randomized Control Trial to Study the Feasibility of Positive Links for Youth Care Engagement Intervention
2 other identifiers
interventional
30
1 country
1
Brief Summary
A small pilot study to assess feasibility and acceptability of the PL4Y intervention.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2023
Typical duration for not_applicable
1 active site
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
January 9, 2023
CompletedFirst Posted
Study publicly available on registry
January 19, 2023
CompletedStudy Start
First participant enrolled
February 2, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
January 30, 2025
CompletedFebruary 4, 2025
February 1, 2025
2 years
January 9, 2023
February 3, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Completion of Feasibility Survey
Feasibility survey completion by participants regarding usability of the PL4Y intervention
12 months
Viral plasma load measurement
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
Study Arms (2)
Mobile Health App group
EXPERIMENTALMobile health app to increase rates of engagement in care in youths living with HIV
Control group
NO INTERVENTIONStandard of care for youths living with HIV
Interventions
A mobile app provided to participants to assess effectiveness in managing HIV
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- Cannot consent
- Unwilling to come to visits
- Unwilling to be in San Antonio for a year
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Health Center Downtown
San Antonio, Texas, 78207, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Barbara Taylor, MD, MS
University of Texas Health Science Center San Antonio
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 9, 2023
First Posted
January 19, 2023
Study Start
February 2, 2023
Primary Completion
January 30, 2025
Study Completion
January 30, 2025
Last Updated
February 4, 2025
Record last verified: 2025-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- At study completion and when all data have been analyzed to publish in a peer reviewed journal.
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.