iTransition Development

Sponsor

Emory University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04383223

Collaborator

National Institute of Mental Health (NIMH) (NIH)

128

Enrollment

Locations

Arms

23.1

Anticipated Duration (Months)

42.7

Patients Per Site

1.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Human Immunodeficiency Virus HIV Seropositivity	Behavioral: iTransition	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

128 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Aug 28, 2020

Anticipated Primary Completion Date :

Aug 1, 2022

Anticipated Study Completion Date :

Aug 1, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

Linkage to adult care [18 month post-intervention]
Defined dichotomously as having one completed adult clinic appointment or not.

Secondary Outcome Measures

Change in Care retention [Baseline, 6 month post-intervention, 12 month post-intervention, 18-month post-intervention]
Defined dichotomously as having one completed medical visit in each 6-month period.
Change in viral suppression [Baseline, 1-year post-intervention]
Viral suppression is defined as <200 copies/ml blood at 1 year post-baseline.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
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

Sponsors and Collaborators

Emory University
National Institute of Mental Health (NIMH)

Investigators

Principal Investigator: Sophia Hussen, MD, Emory University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Sophia Hussen, Assistant Professor, Emory University

ClinicalTrials.gov Identifier:

NCT04383223

Other Study ID Numbers:

IRB00114532
R34MH116805-01A1

First Posted:

May 12, 2020

Last Update Posted:

Mar 11, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Sophia Hussen, Assistant Professor, Emory University

HIV

Additional relevant MeSH terms:

Acquired Immunodeficiency Syndrome

HIV Infections

HIV Seropositivity

Study Results

No Results Posted as of Mar 11, 2022