Back to resultsFeasibility of Positive Links for Youth Care Engagement Intervention
Primary Purpose
HIV Antibody Positivity
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mobile health app
Sponsored by
About this trial
This is an interventional other trial for HIV Antibody Positivity focused on measuring Positive Links, Youth, Emerging Adults
Eligibility Criteria
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
Sites / Locations
- University Health Center DowntownRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Mobile Health App group
Control group
Arm Description
Mobile health app to increase rates of engagement in care in youths living with HIV
Standard of care for youths living with HIV
Outcomes
Primary Outcome Measures
Completion of Feasibility Survey
Feasibility survey completion by participants regarding usability of the PL4Y intervention
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05689515
First Posted
January 9, 2023
Last Updated
February 8, 2023
Sponsor
The University of Texas Health Science Center at San Antonio
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT05689515
Brief Title
Feasibility of Positive Links for Youth Care Engagement Intervention
Official Title
PL4Y: A Pilot Randomized Control Trial to Study the Feasibility of Positive Links for Youth Care Engagement Intervention
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 2, 2023 (Actual)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
July 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Texas Health Science Center at San Antonio
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Antibody Positivity
Keywords
Positive Links, Youth, Emerging Adults
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be randomized in a 2:1 ratio to intervention (PL4Y use) or standard of care
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Mobile Health App group
Arm Type
Experimental
Arm Description
Mobile health app to increase rates of engagement in care in youths living with HIV
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Standard of care for youths living with HIV
Intervention Type
Behavioral
Intervention Name(s)
Mobile health app
Other Intervention Name(s)
PL4Y
Intervention Description
A mobile app provided to participants to assess effectiveness in managing HIV
Primary Outcome Measure Information:
Title
Completion of Feasibility Survey
Description
Feasibility survey completion by participants regarding usability of the PL4Y intervention
Time Frame
12 months
Title
Viral plasma load measurement
Description
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.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
29 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Barbara Taylor, MD, MS
Phone
(210) 567-4661
Email
taylorb4@uthscsa.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Ruby Viera Corral
Phone
(210) 567-4709
Email
vieracorral@uthscsa.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barbara Taylor, MD, MS
Organizational Affiliation
University of Texas Health Science Center San Antonio
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Health Center Downtown
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78207
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Barbara Taylor, MD
Phone
210-450-8114
Email
taylorb4@uthscsa.edu
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Learn more about this trial
Feasibility of Positive Links for Youth Care Engagement Intervention
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