iTransition Development

Human Immunodeficiency Virus Clinical Trial

Official title:

iTransition: Pilot Testing a Multilevel Technology Based Intervention to Support Youth Living With HIV From Adolescent to Adult Care

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04383223
• Other study ID #: IRB00114532
• Secondary ID: R34MH116805-01A1
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 28, 2020
• Est. completion date: June 30, 2024

Study information

• Verified date: October 2023
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 and patients navigate this process.

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 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 128 subjects in Atlanta, GA and Philadelphia, PA: 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, 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 52
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• HIV Seropositivity
• Human Immunodeficiency Virus

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Grady Hospital	Atlanta	Georgia
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania
United States	University of Pennsylvania Health System - HUP and Presby infectious disease clinics	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Emory University	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Linkage to adult care	Defined dichotomously as having one completed adult clinic appointment or not.	18 month post-intervention
Secondary	Change in Care retention	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
Secondary	Change in viral suppression	Viral suppression is defined as <200 copies/ml blood at 1 year post-baseline.	Baseline, 1-year post-intervention