Feasibility of Positive Links for Youth Care Engagement Intervention

Not Applicable

Completed

• Conditions: HIV Antibody Positivity
• Interventions: Behavioral: Mobile health app

• Registration Number: NCT05689515
• Lead Sponsor: The University of Texas Health Science Center at San Antonio

Brief Summary

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

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 Timeline

• Study First Submitted: 2023-01-09
• Study First Submitted QC: 2023-01-09
• Study First Posted: 2023-01-19
• Study Start: 2023-02-02
• Primary Completion: 2025-01-30
• Study Completion: 2025-01-30
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-03
• Last Update Posted: 2025-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mobile Health App group	Mobile health app	Mobile health app to increase rates of engagement in care in youths living with HIV

Primary Outcome Measures

Name	Time	Method
Viral plasma load measurement	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.
Completion of Feasibility Survey	12 months	Feasibility survey completion by participants regarding usability of the PL4Y intervention

Trial Locations

Locations (1)

University Health Center Downtown; 🇺🇸 San Antonio, Texas, United States