iTransition Development

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: HIV Seropositivity; Human Immunodeficiency Virus
• Intervention / Treatment: Behavioral: iTransition

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 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.

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30303
      • Grady Hospital
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Children's Hospital of Philadelphia
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania Health System - HUP and Presby infectious disease clinics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: YLH Historical Control Group; Participants in this group will have the following phases: Screening; Single visit assessment
Experimental: YLH iTransition Intervention Group; Participants in this group will have the following phases: Screening; Baseline Visit; Follow-Up visits at 6, 12 and 18 month; Interview visits for selected YLH around 3 and 9 month	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.
Experimental: Provider Group; Participants in this group will have the following phases: Screening; Baseline Visit; Follow-Up visits at 6, 12 and 18 month; Interview visits for selected YLH around 3, 9 and 15 month	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.
Experimental: Transition Champion Group; Participants in this group will have the following phases: Screening; Baseline Visit and Follow-Up visits at 6, 12 and 18 month; Interview visits for selected YLH around 3, 9 and 15 month	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Linkage to adult care	Defined dichotomously as having one completed adult clinic appointment or not.	18 month post-intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Change in viral suppression	Viral suppression is defined as <200 copies/ml blood at 1 year post-baseline.	Baseline, 1-year post-intervention

Collaborators and Investigators

• Sponsor: Emory University
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Sophia Hussen, MD, Emory University

Study record dates

Study Major Dates

• Study Start (Actual): August 28, 2020
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): June 30, 2024

Study Registration Dates

• First Submitted: May 7, 2020
• First Submitted That Met QC Criteria: May 7, 2020
• First Posted (Actual): May 12, 2020

Study Record Updates

• Last Update Posted (Actual): October 19, 2023
• Last Update Submitted That Met QC Criteria: October 18, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: HIV
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases; Urogenital Diseases; Genital Diseases; HIV Infections; Acquired Immunodeficiency Syndrome; HIV Seropositivity
• Other Study ID Numbers: IRB00114532; R34MH116805-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Survey data will be shared as well as de-identified clinical outcome data Study protocols and statistical analysis plans upon request
• IPD Sharing Time Frame: Data is expected to become available in September 2022 upon completion of the study.
• IPD Sharing Access Criteria: 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No