HIV Antibody PositivityNCT05689515
Feasibility of Positive Links for Youth Care Engagement Intervention
A study testing Mobile health app in people with HIV Antibody Positivity, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
Trial summary
A small pilot study to assess feasibility and acceptability of the PL4Y intervention. Read more about this study
- Who is it for?
- Ages 18 to 29 years
- Conditions the study is for
- HIV Antibody Positivity
- What is being tested?
- Mobile health app
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Feb 2023to 30 Jan 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- 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)
Who cannot join
- Cannot consent
- Unwilling to come to visits
- Unwilling to be in San Antonio for a year
Trial locations and contacts
1 site in 1 country.
United States1 site
University Health Center Downtown
San Antonio, Texas, 78207
About this study
Official title: PL4Y: A Pilot Randomized Control Trial to Study the Feasibility of Positive Links for Youth Care Engagement Intervention
A small pilot study to assess feasibility and acceptability of the PL4Y intervention.
Read the 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.
- Conditions
- HIV Antibody Positivity
- Being tested
- Mobile health app
- Keywords
- Positive Links, Youth, Emerging Adults
- Medical subject headings
- HIV Seropositivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile health appBehavioural
Also called PL4Y
A mobile app provided to participants to assess effectiveness in managing HIV
| Study group | Role | What they receive |
|---|---|---|
| Mobile Health App group | Experimental | Mobile health app to increase rates of engagement in care in youths living with HIV Receives: Behavioral: Mobile health app |
| Control group | No intervention | Standard of care for youths living with HIV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Undetectable Viral Load
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. This outcome is categorized as: Undetectable (VL <200 at 12 months)
Measured: 12 months
Feasibility Survey Completion
Feasibility of the intervention assessed using a participant-completed survey at 6 and 12 months. Measured as number of participants that completed the survey in the arm that received the intervention only.
Measured: 6 and 12 month time points
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2023
- Study start2 Feb 2023
- Primary completion30 Jan 2025
- Study completion30 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HIV Antibody PositivityStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized in a 2:1 ratio to intervention (PL4Y use) or standard of care
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Barbara Taylor, MD, MS, Principal investigator, The University of Texas Health Science Center at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05689515
- Sponsor's protocol ID
- HSC20220752H
- Other IDs
- 5R34MH122332-03
- Status last verified
- Aug 2026
- First submitted
- 9 Jan 2023
- Last updated
- 15 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PL4Y: A Pilot Randomized Control Trial to Study the Feasibility of Positive Links for Youth Care Engagement Intervention
- ClinicalTrials.gov ID
- NCT05689515
- Acronym / sponsor ID
- HSC20220752H
- Conditions
- HIV Antibody Positivity
- Keywords
- Positive Links, Youth, Emerging Adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 2 Feb 2023 (actual)
- Primary completion
- 30 Jan 2025 (actual)
- Study completion
- 30 Jan 2025 (actual)
- First posted
- 19 Jan 2023 (actual)
- Results
- Posted 15 Sep 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomized in a 2:1 ratio to intervention (PL4Y use) or standard of care
| Arm | Type | Receives |
|---|---|---|
| Mobile Health App group | Experimental | Behavioral: Mobile health appMobile health app to increase rates of engagement in care in youths living with HIV |
| Control group | No intervention | –Standard of care for youths living with HIV |
Who may qualify
- Ages
- 18 to 29 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (3 listed)
- Cannot consent
- Unwilling to come to visits
- Unwilling to be in San Antonio for a year
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 |
|---|---|---|
| Mobile health appAlso: PL4YA mobile app provided to participants to assess effectiveness in managing HIV | Behavioural | Mobile Health App group |
Primary outcome
Number of Participants With Undetectable Viral Load
Time frame: 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. This outcome is categorized as: Undetectable (VL <200 at 12 months)
Feasibility Survey Completion
Time frame: 6 and 12 month time points
Feasibility of the intervention assessed using a participant-completed survey at 6 and 12 months. Measured as number of participants that completed the survey in the arm that received the intervention only.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. 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.
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. This study is not recruiting at the moment.
Barbara Taylor, MD, MS principal investigator
The University of Texas Health Science Center at San Antonio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile health app in people with HIV Antibody Positivity, run by The University of Texas Health Science Center at San Antonio at 1 site 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 2 inclusion and 3 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: finished, as of the sponsor's last update on 15 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 1 site 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?
Yes. Results are posted in the registry (first posted 15 Sep 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Undetectable Viral Load (time frame: 12 months). The study lists 2 primary outcomes in all. 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 15 Sep 2026.