Feasibility of Positive Links for Youth Care Engagement Intervention

NCT ID: NCT05689515

Last Updated: 2025-02-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-02

Study Completion Date

2025-01-30

Brief Summary

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

Detailed Description

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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.

Conditions

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HIV Antibody Positivity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants will be randomized in a 2:1 ratio to intervention (PL4Y use) or standard of care
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Mobile Health App group

Mobile health app to increase rates of engagement in care in youths living with HIV

Group Type EXPERIMENTAL

Mobile health app

Intervention Type BEHAVIORAL

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

Control group

Standard of care for youths living with HIV

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Mobile health app

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

Intervention Type BEHAVIORAL

Other Intervention Names

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PL4Y

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

29 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

The University of Texas Health Science Center at San Antonio

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Barbara Taylor, MD, MS

Role: PRINCIPAL_INVESTIGATOR

University of Texas Health Science Center San Antonio

Locations

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University Health Center Downtown

San Antonio, Texas, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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5R34MH122332-03

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HSC20220752H

Identifier Type: -

Identifier Source: org_study_id

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