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| ID | Type | Description | Link |
|---|---|---|---|
| 5R34MH122332-03 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mobile Health App group | Experimental | Mobile 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mobile health app | Behavioral | A mobile app provided to participants to assess effectiveness in managing HIV |
|
| Measure | Description | Time Frame |
|---|---|---|
| Completion of Feasibility Survey | Feasibility survey completion by participants regarding usability of the PL4Y intervention | 12 months |
| 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. | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Barbara Taylor, MD, MS | The University of Texas Health Science Center at San Antonio | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Health Center Downtown | San Antonio | Texas | 78207 | United States |
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.
At study completion and when all data have been analyzed to publish in a peer reviewed journal.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | May 4, 2023 | Feb 29, 2024 | ICF_000.pdf |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 23, 2026 |
| ID | Term |
|---|---|
| D006679 | HIV Seropositivity |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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Participants will be randomized in a 2:1 ratio to intervention (PL4Y use) or standard of care
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| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |