iTransition Development

NCT04383223 | Completed Results DMC

• 2 other identifiers: IRB00114532R34MH116805-01A1
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 3

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 and patients navigate this process.

Conditions

Human Immunodeficiency Virus; HIV Seropositivity

Keywords

HIV

Outcome Measures

Primary Outcomes (1)

• Linkage to Adult Care

  Defined dichotomously as having one completed adult clinic appointment or not.

  18 month post-intervention

Secondary Outcomes (2)

• Care Retention Per Each 6-month Period

  Baseline, 6 month post-intervention, 12 month post-intervention, 18-month post-intervention

• Number of Participants With Viral Suppression

  Baseline, 1-year post-intervention

Study Arms (4)

YLH Historical Control Group

NO INTERVENTION

Participants in this group will have the following phases: * Screening * Single visit assessment

YLH iTransition Intervention Group

EXPERIMENTAL

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

Provider Group

EXPERIMENTAL

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

Transition Champion Group

EXPERIMENTAL

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

Interventions

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.

Provider Group; Transition Champion Group; YLH iTransition Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Emory University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (3)

Grady Hospital

Atlanta, Georgia, 30303, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

University of Pennsylvania Health System - HUP and Presby infectious disease clinics

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; HIV Seropositivity

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Results Point of Contact

• Title: Dr. Sophia Hussen
• Organization: Emory University

sophia.ahmed.hussen@emory.edu

404-727-2446

Study Officials

• Sophia Hussen, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 7, 2020
• First Posted: May 12, 2020
• Study Start: August 28, 2020
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: August 13, 2025
• Results First Posted: August 13, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data is expected to become available in September 2022 upon completion of the study.
• 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.

Locations

US (3)