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| ID | Type | Description | Link |
|---|---|---|---|
| K23MH102128 | U.S. NIH Grant/Contract | View source | |
| P30AI045008 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
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This study will help determine feasibility, acceptability, and preliminary efficacy of an app for HIV medication adherence over a 3-month period. Participation is 3 months consisting of two study visits: An initial study visit and a 3 month follow up visit with both visits lasting about 60-90 minutes. The participant must use the study application (app) at least once daily, and at study visits, must complete surveys.
Young men who have sex with men (YMSM) are disproportionately affected by HIV in the US and fewer than half of youth who are prescribed antiretroviral therapy (ART) achieve viral suppression. Yet few interventions have been developed to address adherence in this population with unique developmental/psychosocial needs. Mobile technology, which is constantly consumed by youth, has the potential to deliver interventions that provide support and feedback in real time as youth go about their daily lives.
This pilot study will test a theory-driven, patient-centered, mobile phone-based intervention (mHealth app) targeting medication adherence among HIV+ youth. It is a three-month prospective feasibility trial to test a medication adherence mobile application consisting of two study visits: baseline and 3-month follow up.
Data collection consists of app usage, Computer Assisted Self-Interview (CASI) for participant satisfaction with the app, demographics, and mental health and risk behaviors, as well as medical chart abstraction of disease biomarkers (CD4, viral load) and pharmacy refill data.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HIV medication adherence app | Experimental | Youth in this arm will receive a medication adherence application to help them remember to take their HIV treatment medication (antiretroviral therapy) as a supplement to current HIV standard of care. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HIV medication adherence app | Device | A medication adherence mobile application for HIV+ youth. It is a theory-driven, patient-centered, mobile phone-based intervention targeting medication adherence and engagement in care among HIV+ youth with features including, but not limited to: custom avatar, medication reminders, calendar tracking of medication adherence, and anonymous chat function for social support. |
| Measure | Description | Time Frame |
|---|---|---|
| Suppressed viral load at 3-months | Percentage of participants with suppressed HIV viral load (≤ 200 copies/mL) at the 3-month follow-up study visit. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Self-reported medication adherence rates by participants at 3 months | Measure participants' self-reported rate of adherence at 3-month study visit using the AIDS Clinical Trials Group (ACTG) adherence 4-day recall question administered through computer-assisted self-interview (CASI) survey. | 3 months |
| Medication adherence measure using prescription refill information |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nadia L Dowshen, MD, MSHP | Children's Hospital of Philadelphia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
individual participant data will not be shared with other researchers. If shared, datasets will be deidentified of participant health information.
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| ID | Term |
|---|---|
| D006716 | Homosexuality |
| ID | Term |
|---|---|
| D019529 | Sexuality |
| D012725 | Sexual Behavior |
| D001519 | Behavior |
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Percentage of participants who refilled their ART medication determined from medical chart abstraction at 3-month study visit. |
| 3 months |
| Self-reported medication adherence rates by participants over 3-months within the medication adherence application | Percentage participants self-reported medication adherence over a 3-month period within the mHealth app where participants recorded yes/no on whether they adhered to their ART daily. | 3 months |
| Measure participant satisfaction of the medication adherence application at 3-months | Measure participant satisfaction with the medication adherence application at the 3-month study visit measured by a xx-item questionnaire that includes likert scales and open-ended qualitative questions administered through computer-assisted self-interview (CASI) survey. | 3 months |
| Suppressed viral load at 6-months | a. Percentage of participants with suppressed HIV viral load (≤ 200 copies/mL) at 6-months through medical chart abstraction to determine if participants remained virally suppressed or reached viral suppression since 3-months. No study visit for participant at 6-months, medical abstraction conducted by study team as labs are conducted as part of routine HIV care. | 6 months |