Human Immunodeficiency VirusNCT07804602
PositiveLinks for Youth (PL4Y) for Texas
A study testing PositiveLinks for Youth Smartphone App in people with Human Immunodeficiency Virus and HIV, run by The University of Texas Health Science Center at San Antonio at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 29 years
- Conditions the study is for
- Human Immunodeficiency Virus, HIV
- What is being tested?
- PositiveLinks for Youth Smartphone App
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Apr 2027to Apr 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 29 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 18-29yo living with HIV
- Attending at least one in-person visit in the clinic site of enrollment in the past 12 mos,
- English speaking
- Able to participate in the informed consent process.
- Access to a personal smartphone with a data plan capable of supporting the PL4Y app. The phone must be password protected and not shared with others for confidentiality purposes.
- Interviews only- A stakeholder in one of the network clinics
- 18 years or older
- able to participate in the informed consent process
Who cannot join
- They cannot provide consent
- Unwilling or unable to complete virtual study visits
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
University of Texas Health Science Center San Antonio
San Antonio, Texas, 78229
TaylorB4@uthscsa.edu
University of Texas San Antonio Health Campus
San Antonio, Texas, 78229
Barbara Taylor, MD, MS, (210)450-8144, TaylorB4@uthscsa.edu
Cyrena Cote, (210)567-4661, cotec@uthscsa.edu
About this study
Official title: PositiveLinks for Youth (PL4Y) for Texas: Effectiveness, Feasibility, and Acceptability of mHealth to Improve Care Outcomes for Young Adults With HIV
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.
Read more
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].
Read the detailed description
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:
- A cluster randomized longitudinal staircase trial across six clinics in Texas
- Qualitative assessment, using semi-structured interviews and focus groups, of acceptability and feasibility of PL4Y implementation in the clinics
- Conditions
- Human Immunodeficiency Virus, HIV
- Being tested
- PositiveLinks for Youth Smartphone App
- Keywords
- Communication with providers, Smartphone App, Anonymous Virtual chat group, Medication reminders
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PositiveLinks for Youth Smartphone AppBehavioural
Also called PL4Y
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.
| Study group | Role | What they receive |
|---|---|---|
| mHealth Intervention group | Experimental | 18-29yos with HIV who are in care in one of the participating clinics. Receives: Behavioral: PositiveLinks for Youth Smartphone App |
What is being measured
The primary outcome is the main question the study is designed to answer.
Virologic Suppression
HIV-1 Plasma RNA level <200 copies/ml at 12 months
Measured: Baseline to 12 months (+/- 3 months)
Secondary outcomes (5)
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
Measured: 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
Measured: 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.
Measured: 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.
Measured: Month 12 and Month 18
HIV Care Engagement
At least two clinic visits >60 days apart in the prior 12 months
Measured: Baseline through end of study, measured at each study time point (baseline, 6mos, 12 mos, 18 mos)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2026
- Study start1 Apr 2027 (estimated)
- Primary completion31 Mar 2031 (estimated)
- Study completionApr 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Immunodeficiency VirusStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center at San AntonioThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Type 1 hybrid study. Staircase design is a particular variation of the incomplete stepped-wedge design.It allows for phased implementation of the intervention across all participating clusters in a staggered fashion, ensuring all clusters receive the intervention. A cluster serves both as its control, as it spends time under both control and intervention conditions.
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Barbara Taylor, The University of Texas Health Science Center at San Antonio
- Investigators
- Barbara Taylor, MD, MS, Principal investigator, The University of Texas Health Science Center at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07804602
- Sponsor's protocol ID
- STUDY00002531
- Other IDs
- R01AI205724
- Status last verified
- Aug 2026
- First submitted
- 31 Aug 2026
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PositiveLinks for Youth (PL4Y) for Texas: Effectiveness, Feasibility, and Acceptability of mHealth to Improve Care Outcomes for Young Adults With HIV
- ClinicalTrials.gov ID
- NCT07804602
- Acronym / sponsor ID
- STUDY00002531
- Conditions
- Human Immunodeficiency Virus, HIV
- Keywords
- Communication with providers, Smartphone App, Anonymous Virtual chat group, Medication reminders
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- 1 Apr 2027 (estimated)
- Primary completion
- 31 Mar 2031 (estimated)
- Study completion
- Apr 2031 (estimated)
- First posted
- 4 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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].
Detailed description
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:
- A cluster randomized longitudinal staircase trial across six clinics in Texas
- Qualitative assessment, using semi-structured interviews and focus groups, of acceptability and feasibility of PL4Y implementation in the clinics
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Type 1 hybrid study. Staircase design is a particular variation of the incomplete stepped-wedge design.It allows for phased implementation of the intervention across all participating clusters in a staggered fashion, ensuring all clusters receive the intervention. A cluster serves both as its control, as it spends time under both control and intervention conditions.
| Arm | Type | Receives |
|---|---|---|
| mHealth Intervention group | Experimental | Behavioral: PositiveLinks for Youth Smartphone App18-29yos with HIV who are in care in one of the participating clinics. |
Who may qualify
- Ages
- 18 to 29 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 18-29yo living with HIV
- Attending at least one in-person visit in the clinic site of enrollment in the past 12 mos,
- English speaking
- Able to participate in the informed consent process.
- Access to a personal smartphone with a data plan capable of supporting the PL4Y app. The phone must be password protected and not shared with others for confidentiality purposes.
Key exclusion criteria (2 listed)
- They cannot provide consent
- Unwilling or unable to complete virtual study visits
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PositiveLinks for Youth Smartphone AppAlso: PL4YPL4Y, 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. | Behavioural | mHealth Intervention group |
Primary outcome
Virologic Suppression
Time frame: Baseline to 12 months (+/- 3 months)
HIV-1 Plasma RNA level <200 copies/ml at 12 months
5 secondary outcomes
Patient Health Questionnaire-9 (PHQ-9)
Time frame: Baseline to Study End (approximately 18 months)
HIV Stigma Scale Survey (HIVSS)
Time frame: Baseline to Study End (approximately 18 months)
National Institute of Drug Abuse (NIDA) - Modified ASSIST
Time frame: Baseline to study end (approximately 18 months)
System Usability Survey
Time frame: Month 12 and Month 18
HIV Care Engagement
Time frame: Baseline through end of study, measured at each study time point (baseline, 6mos, 12 mos, 18 mos)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Barbara Taylor, MD, MS principal investigator
The University of Texas Health Science Center at San Antonio
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PositiveLinks for Youth Smartphone App in people with Human Immunodeficiency Virus and HIV, run by The University of Texas Health Science Center at San Antonio at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Barbara Taylor, MD, MS (210-450-8144, taylorb4@uthscsa.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Virologic Suppression (time frame: Baseline to 12 months (+/- 3 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.