An interventional study of PositiveLinks for Youth Smartphone App in Human Immunodeficiency Virus and HIV, sponsored by The University of Texas Health Science Center at San Antonio. Not yet recruiting at 2 sites in United States. Open to participants aged 18 Years to 29 Years. Per ClinicalTrials.gov, last updated 2026-09-04.
Sponsored by The University of Texas Health Science Center at San Antonio · Not applicable, Interventional, and Supportive care
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The goal of this interventional clinical trial is to test an an app, PL4Y, installed on a mobile smartphone to see if it can help participants aged 18-29 years who have HIV achieve success with their HIV care and feel supported by their clinic community.
The first 6 months will be standard of care, after which participants will continue to meet virtually with their health care providers and will also be provided with and taught how to use the app. The standard of care clinic visits will continue as before and virtual visits using the app will be started and continue for abot 18 months.
Adherence to medications Appointment reminders Provide secure communication with providers
Provide a support group in [describe participant population/primary condition; could include any of the following: sex/gender, age groups, healthy volunteers]. The main question[s] it aims to answer [is/are]:
[primary hypothesis or outcome measure 1]? [primary hypothesis or outcome measure 2]?
If there is a comparison group: Researchers will compare [arm information] to see if [insert effects].
Participants will [describe the main tasks participants will be asked to do, interventions they'll be given and use bullets if it is more than 2 items].
The overall objective of this proposal is to implement and rigorously test an existing mHealth care engagement intervention, PL4Y, in a six clinic network in Texas. The investigators will use the Exploration, Preparation, Implementation, Sustainment (EPIS) framework to inform a type 1 hybrid study, assessing effectiveness of PL4Y alongside measures of acceptability, feasibility, and sustainability. The study has two main components:
3,037 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 307 are open to participants now.
This study's planned enrollment of 600 is above the median of 96 across 2,252 interventional studies indexed under Acquired Immunodeficiency Syndrome.
Browse Acquired Immunodeficiency Syndrome studies →The University of Texas Health Science Center at San Antonio is the lead sponsor of 445 studies on the registry; 89 are open to participants now.
Of its 65 completed or terminated interventional studies of FDA-regulated products, 35 (54%) have results posted.
Compared within Acquired Immunodeficiency Syndrome, the registry's first condition term, which may not be this study's main condition. Counted across the registry records on this site, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Interviews only- A stakeholder in one of the network clinics
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
18-29yos with HIV who are in care in one of the participating clinics.
Behavioral: PositiveLinks for Youth Smartphone App
PL4Y, a smartphone application (app), is a clinic-based multimodal intervention designed by and for youth living with HIV, including daily adherence assessment, appointment reminders, secure messaging with clinic providers, and an asynchronous, anonymized virtual support group.
Also known as: PL4Y
Virologic Suppression
HIV-1 Plasma RNA level \<200 copies/ml at 12 months
Time frame: Baseline to 12 months (+/- 3 months)
Patient Health Questionnaire-9 (PHQ-9)
A 9 item survey with each item scored: 0: Not at all 1: Several days 2: More than half the days 3: Nearly every day Total possible score is between 0-27, with a higher score indicating more symptoms indicative of depression
Time frame: Baseline to Study End (approximately 18 months)
HIV Stigma Scale Survey (HIVSS)
A 40 item scale, with each item scored from 1=Strongly agree, 2=Disagree, 3=Agree, 4=Strongly agree. The total score can range from 10-40 with a higher score indicating more stigma
Time frame: Baseline to Study End (approximately 18 months)
National Institute of Drug Abuse (NIDA) - Modified ASSIST
A quick screen questionnaire that includes only Question 2 of the NIDA-modified ASSIST regarding substance abuse. 10 substances are included and each is scored depending on use: Never=0, Once or Twice=2, Monthly=3, Weekly=4, Daily or Almost daily = 6. Total scores range from 0-60 with a higher score indicating more frequent substance abuse.
Time frame: Baseline to study end (approximately 18 months)
System Usability Survey
This survey is administered at Visits 2 and 3 with 10 structured questions scored from 0=Strongly Disagree, 1=Disagree, 2=Somewhat Disagree, 4=Neither Agree nor Disagree, 5=Somewhat Agree, 6=Agree, 7=Strongly Agree. There are 3 additional free response questions that are not scored. Total scores range from 0-70 with a higher score indicating better system usability.
Time frame: Month 12 and Month 18
HIV Care Engagement
At least two clinic visits \>60 days apart in the prior 12 months
Time frame: Baseline through end of study, measured at each study time point (baseline, 6mos, 12 mos, 18 mos)
Plan to share: Yes — In an effort to protect your privacy, the study staff will use code numbers instead of participant name, to identify any health information. Numbers will be used on any photocopies of your records, and other study materials containing health information that are sent outside the clinic the participant attends for review or testing. If the results of this study are reported in medical journals or at meetings, participants will not be identified.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: After study closure, data analysis and publication of summary results in ClinicalTrials.gov and a peer-review journal.
No publications or documents are linked to this record.
Start is estimated for Apr 2027; primary completion for Mar 2031, 47 months later.
Of 642 non-industry interventional studies with no phase under Acquired Immunodeficiency Syndrome, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 45. This study's planned 47 months is above that.
Counting every sponsor, half of 648 studies reached it within 29 months; a quarter within 17 and three quarters within 45.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Acquired Immunodeficiency Syndrome →
The University of Texas Health Science Center at San Antonio →