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| ID | Type | Description | Link |
|---|---|---|---|
| R34MH116805-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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Youth living with HIV are at high risk of falling out of care when they transition from pediatric to adult care. The investigators are proposing to develop a mobile app to help both clinical providers and patients navigate this process.
The transition from pediatric/adolescent to adult-oriented care settings can be disruptive to care engagement for youth living with HIV (YLH).
The objective of this trial is to pilot and evaluate effectiveness of iTransition, an mHealth intervention to improve healthcare transition (HCT) at the patient, provider, and clinic levels.It is a prospective non-randomized intervention pilot trial of subjects in Atlanta, GA and Philadelphia, PA: around 100 YLH (50 intervention and 50 historical controls), 20 providers, and 8 Transition Champions. The study duration is 12 and 18 months for YLH and provider/champions, respectively.
At baseline, YLH ≥18 years planning for care transition within 6 months, and reporting consistent internet access. Providers and Transition Champions must report working with transitioning YLH at pediatric/adolescent and/or adult HIV care centers.
Data measures include iTransition usage, intervention satisfaction and health surveys, interviews (select participants), and medical chart review to measure clinical outcomes. The primary clinical outcome variable, measured at the patient-level (YLH), is linkage to adult care (defined dichotomously as having one completed adult clinic appointment or not). Secondary clinical outcomes are care retention (dichotomously defined as having or not having one visit in each 6-month period) and viral suppression (<200 copies/ml) at 1-year post-baseline visit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| YLH Historical Control Group | No Intervention | Participants in this group will have the following phases:
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| YLH iTransition Intervention Group | Experimental | Participants in this group will have the following phases:
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| Provider Group | Experimental | Participants in this group will have the following phases:
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| Transition Champion Group | Experimental | Participants in this group will have the following phases:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| iTransition | Behavioral | Is a mobile website application (app), and it can be used on a range of devices (computer, tablet, smartphone) and operating systems (iOS, Android, Windows). Features of iTransition will include, but are not limited to: medication reminders, calendar tracking of appointments, direct messaging between youth and providers, and privacy password lock. |
| Measure | Description | Time Frame |
|---|---|---|
| Linkage to Adult Care | Defined dichotomously as having one completed adult clinic appointment or not. | 18 month post-intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Care Retention Per Each 6-month Period | Defined dichotomously as having one completed medical visit in each 6-month period. | Baseline, 6 month post-intervention, 12 month post-intervention, 18-month post-intervention |
| Number of Participants With Viral Suppression |
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Inclusion Criteria:
For YLH Historical Control Group
For YLH iTransition Intervention Group
For Provider Group
For Transition Champion Group
Exclusion Criteria For YLH Historical Control Group
For YLH iTransition Intervention Group
For Provider Group
For Transition Champion Group
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| Name | Affiliation | Role |
|---|---|---|
| Sophia Hussen, MD | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Grady Hospital | Atlanta | Georgia | 30303 | United States | ||
| Children's Hospital of Philadelphia |
Survey data will be shared as well as de-identified clinical outcome data Study protocols and statistical analysis plans upon request
Data is expected to become available in September 2022 upon completion of the study.
Data will not be deposited into a public repository, but will be made available upon request to the principal investigator. The PI will discuss requests with the other study team members, and make a determination about whether data can be shared.
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| ID | Title | Description |
|---|---|---|
| FG000 | YLH Historical Control Group | Participants in this group will have the following phases:
|
| FG001 | YLH iTransition Intervention Group | Participants in this group will have the following phases:
iTransition: Is a mobile website application (app), and it can be used on a range of devices (computer, tablet, smartphone) and operating systems (iOS, Android, Windows). Features of iTransition will include, but are not limited to: medication reminders, calendar tracking of appointments, direct messaging between youth and providers, and privacy password lock. |
| FG002 | Provider Group | Participants in this group will have the following phases:
iTransition: Is a mobile website application (app), and it can be used on a range of devices (computer, tablet, smartphone) and operating systems (iOS, Android, Windows). Features of iTransition will include, but are not limited to: medication reminders, calendar tracking of appointments, direct messaging between youth and providers, and privacy password lock. |
| FG003 | Transition Champion Group | Participants in this group will have the following phases:
iTransition: Is a mobile website application (app), and it can be used on a range of devices (computer, tablet, smartphone) and operating systems (iOS, Android, Windows). Features of iTransition will include, but are not limited to: medication reminders, calendar tracking of appointments, direct messaging between youth and providers, and privacy password lock. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | YLH Historical Control Group | Participants in this group will have the following phases:
|
| BG001 | YLH iTransition Intervention Group | Participants in this group will have the following phases:
iTransition: Is a mobile website application (app), and it can be used on a range of devices (computer, tablet, smartphone) and operating systems (iOS, Android, Windows). Features of iTransition will include, but are not limited to: medication reminders, calendar tracking of appointments, direct messaging between youth and providers, and privacy password lock. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Linkage to Adult Care | Defined dichotomously as having one completed adult clinic appointment or not. | This outcome only applies to the groups with YLH (Youth Living With HIV) participants. | Posted | Count of Participants | Participants | 18 month post-intervention |
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Information on adverse events was collected beginning at the time of the intervention and continuing through the end of the study, at 18 months post-intervention.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | YLH Historical Control Group | Participants in this group will have the following phases:
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Sophia Hussen | Emory University | 404-727-2446 | sophia.ahmed.hussen@emory.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 11, 2019 | Jul 15, 2025 | Prot_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 10, 2019 | Apr 27, 2023 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| D006679 | HIV Seropositivity |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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Viral suppression is defined as <200 copies/ml blood at 1-year post-baseline. |
| Baseline, 1-year post-intervention |
| Philadelphia |
| Pennsylvania |
| 19104 |
| United States |
| University of Pennsylvania Health System - HUP and Presby infectious disease clinics | Philadelphia | Pennsylvania | 19104 | United States |
| BG002 | Provider Group | Participants in this group will have the following phases:
iTransition: Is a mobile website application (app), and it can be used on a range of devices (computer, tablet, smartphone) and operating systems (iOS, Android, Windows). Features of iTransition will include, but are not limited to: medication reminders, calendar tracking of appointments, direct messaging between youth and providers, and privacy password lock. |
| BG003 | Transition Champion Group | Participants in this group will have the following phases:
iTransition: Is a mobile website application (app), and it can be used on a range of devices (computer, tablet, smartphone) and operating systems (iOS, Android, Windows). Features of iTransition will include, but are not limited to: medication reminders, calendar tracking of appointments, direct messaging between youth and providers, and privacy password lock. |
| BG004 | Total | Total of all reporting groups |
| years |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| OG002 | Provider Group | Participants in this group will have the following phases:
iTransition: Is a mobile website application (app), and it can be used on a range of devices (computer, tablet, smartphone) and operating systems (iOS, Android, Windows). Features of iTransition will include, but are not limited to: medication reminders, calendar tracking of appointments, direct messaging between youth and providers, and privacy password lock. |
| OG003 | Transition Champion Group | Participants in this group will have the following phases:
iTransition: Is a mobile website application (app), and it can be used on a range of devices (computer, tablet, smartphone) and operating systems (iOS, Android, Windows). Features of iTransition will include, but are not limited to: medication reminders, calendar tracking of appointments, direct messaging between youth and providers, and privacy password lock. |
|
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| Secondary | Care Retention Per Each 6-month Period | Defined dichotomously as having one completed medical visit in each 6-month period. | This outcome only applies to the groups with YLH (Youth Living With HIV) participants. | Posted | Count of Participants | Participants | Baseline, 6 month post-intervention, 12 month post-intervention, 18-month post-intervention |
|
|
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| Secondary | Number of Participants With Viral Suppression | Viral suppression is defined as <200 copies/ml blood at 1-year post-baseline. | This outcome only applies to the groups with YLH (Youth Living With HIV) participants. | Posted | Count of Participants | Participants | Baseline, 1-year post-intervention |
|
|
|
| 0 |
| 21 |
| 0 |
| 21 |
| 0 |
| 21 |
| EG001 | YLH iTransition Intervention Group | Participants in this group will have the following phases:
iTransition: Is a mobile website application (app), and it can be used on a range of devices (computer, tablet, smartphone) and operating systems (iOS, Android, Windows). Features of iTransition will include, but are not limited to: medication reminders, calendar tracking of appointments, direct messaging between youth and providers, and privacy password lock. | 0 | 33 | 0 | 33 | 0 | 33 |
| EG002 | Provider Group | Participants in this group will have the following phases:
iTransition: Is a mobile website application (app), and it can be used on a range of devices (computer, tablet, smartphone) and operating systems (iOS, Android, Windows). Features of iTransition will include, but are not limited to: medication reminders, calendar tracking of appointments, direct messaging between youth and providers, and privacy password lock. | 0 | 17 | 0 | 17 | 0 | 17 |
| EG003 | Transition Champion Group | Participants in this group will have the following phases:
iTransition: Is a mobile website application (app), and it can be used on a range of devices (computer, tablet, smartphone) and operating systems (iOS, Android, Windows). Features of iTransition will include, but are not limited to: medication reminders, calendar tracking of appointments, direct messaging between youth and providers, and privacy password lock. | 0 | 7 | 0 | 7 | 0 | 7 |
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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 |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| Number of participants with one completed medical visit from 6 to 12 month post-intervention |
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| Number of participants with one completed medical visit from 12 to 18 month post-intervention |
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