Status:
COMPLETED
iTransition Development
Lead Sponsor:
Emory University
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
Human Immunodeficiency Virus
HIV Seropositivity
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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...
Detailed Description
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 eff...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- For YLH Historical Control Group
- YLH (regardless of gender/assigned sex at birth) age ≥ 18 years;
- Has plan for HCT within next 6 months;
- Enrolled in care at Grady IDP pediatric/adolescent clinic or CHOP AI/SI clinics.
- For YLH iTransition Intervention Group
- YLH (regardless of gender/assigned sex at birth) age ≥ 18 years;
- Has plan for HCT within next 6 months;
- Enrolled in care at Grady IDP pediatric/adolescent clinic or CHOP AI/SI clinics;
- Owns a smartphone and/or tablet
- Reports consistent internet access (defined as no lapse \>24 hours in last 6 months) via their smartphone or tablet.
- For Provider Group
- Staff member at Grady IDP (pediatric/adolescent clinic, adult women's clinic, and/or adult men's clinic), CHOP AI/SI clinics, UPHS: HUP or Presby infectious disease clinics;
- Works with transitioning YLH;
- Access to internet via any device (e.g., smartphone, tablet, computer);
- Endorse participation in the HCT process.
- For Transition Champion Group
- Staff member at Grady IDP (pediatric/adolescent clinic, adult women's clinic, and/or adult men's clinic), CHOP AI/SI clinics, UPHS: HUP or Presby infectious disease clinics;
- Works with transitioning YLH;
- Endorse participation in the HCT process;
- Access to internet via any device (e.g., smartphone, tablet, computer);
- Nominated by clinic staff where employed to be iTransition intervention point person (champion).
- Exclusion Criteria For YLH Historical Control Group
- Youth who are \<18 years old;
- Youth who are not living with HIV;
- Transition is not expected (from pediatric/adolescent to adult care) within the next 6 months;
- Presence of serious psychiatric symptoms (e.g., active hallucinations, thought disorder) that would impair the individual's ability to provide true informed consent or participate in the study activities;
- Visibly distraught (e.g., suicidal, homicidal, exhibiting violent behavior) at the time of consent.
- For YLH iTransition Intervention Group
- Youth who are \<18 years old;
- Youth who are not living with HIV;
- Transition is not expected (from pediatric to adult care) within the next 6 months;
- Does not own smartphone/tablet and has inconsistent internet access (i.e. has had one or more lapse \>24 hrs in the last three months);
- Presence of serious psychiatric symptoms (e.g., active hallucinations, thought disorder) that would impair the individual's ability to provide true informed consent or participate in the study activities;
- Visibly distraught (e.g., suicidal, homicidal, exhibiting violent behavior) at the time of consent.
- For Provider Group
- Not a staff member at Grady IDP, CHOP SI/AI, UPHS: HUP or Presby infectious disease clinics;
- Does not work with transitioning YLH;
- Does not have access to internet via any device (e.g., smartphone, tablet, computer).
- For Transition Champion Group
- Not a staff member at Grady IDP, CHOP SI/AI, UPHS: HUP or Presby infectious disease clinics;
- Does not work with transitioning YLH;
- Does not have access to internet via any device (e.g., smartphone, tablet, computer).
Exclusion
Key Trial Info
Start Date :
August 28 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2024
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT04383223
Start Date
August 28 2020
End Date
June 30 2024
Last Update
August 13 2025
Active Locations (3)
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1
Grady Hospital
Atlanta, Georgia, United States, 30303
2
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
3
University of Pennsylvania Health System - HUP and Presby infectious disease clinics
Philadelphia, Pennsylvania, United States, 19104