An interventional study of Mobile health app in HIV Antibody Positivity, sponsored by The University of Texas Health Science Center at San Antonio. Completed at 1 site in United States. Open to participants aged 18 Years to 29 Years. Per ClinicalTrials.gov, last updated 2026-09-15.
Sponsored by The University of Texas Health Science Center at San Antonio · Not applicable, Interventional, and Other
A small pilot study to assess feasibility and acceptability of the PL4Y intervention.
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.
210 studies on the registry are indexed under HIV Seropositivity; 10 are open to participants now.
This study's enrollment of 29 is below the median of 89 across 140 interventional studies indexed under HIV Seropositivity.
Browse HIV Seropositivity studies →The University of Texas Health Science Center at San Antonio is the lead sponsor of 435 studies on the registry; 88 are open to participants now.
Of its 62 completed or terminated interventional studies of FDA-regulated products, 31 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Mobile health app to increase rates of engagement in care in youths living with HIV
Behavioral: Mobile health app
Standard of care for youths living with HIV
A mobile app provided to participants to assess effectiveness in managing HIV
Also known as: PL4Y
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)
Time frame: 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.
Time frame: 6 and 12 month time points
Participants were recruited from San Antonio, Texas based HIV clinics through a combination of provider referrals, electronic health record screening, and study outreach materials (e.g., flyers, phone calls, and/or email). Individuals who met preliminary eligibility criteria were contacted by study staff and provided with information about the study. Interested participants completed a screening process to confirm eligibility prior to enrollment. Recruitment occurred January - December 2023.
| Milestone | Mobile Health App Group | Control Group |
|---|---|---|
| Started | 20 | 9 |
| Completed | 16 | 6 |
| Not completed | 4 | 3 |
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)
| Participants | Mobile Health App Group | Control Group |
|---|---|---|
| Number of Participants With Undetectable Viral Load | 18 | 4 |
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.
| Participants | Mobile Health App Group |
|---|---|
| 6 month assessment | 18 |
| 12 month assessment | 16 |
Collected over From Baseline to study end, approximately 12 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Mobile Health App Group | 0/20 (0%) | 0/20 (0%) | 0/20 (0%) |
| Control Group | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) |
The baseline analysis population included all participants who were randomized and had baseline data available. Baseline characteristics were assessed prior to assignment to study arms.
| Age, Categorical(Participants) | Mobile Health App Group | Control Group | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 20 | 9 | 29 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(Years) | Mobile Health App Group | Control Group | Total |
|---|---|---|---|
| Mean | 25.65 ± 3.4 | 25.96 ± 3.0 | 25.69 ± 3.3 |
| Sex: Female, Male(Participants) | Mobile Health App Group | Control Group | Total |
|---|---|---|---|
| Female | 3 | 2 | 5 |
| Male | 17 | 7 | 24 |
| Race (NIH/OMB)(Participants) | Mobile Health App Group | Control Group | Total |
|---|---|---|---|
| American Indian or Alaska Native | 1 | 0 | 1 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 3 | 1 | 4 |
| White | 12 | 6 | 18 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 4 | 2 | 6 |
| Region of Enrollment(Participants) | Mobile Health App Group | Control Group | Total |
|---|---|---|---|
| United States | 20 | 9 | 29 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: 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.
Supporting information: Study protocol, Sap, Icf
This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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The University of Texas Health Science Center at San Antonio