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iTransition Development

Primary Purpose

Human Immunodeficiency Virus, HIV Seropositivity

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
iTransition
Sponsored by
Emory University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Human Immunodeficiency Virus focused on measuring HIV

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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).

Sites / Locations

  • Grady Hospital
  • Children's Hospital of Philadelphia
  • University of Pennsylvania Health System - HUP and Presby infectious disease clinics

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Experimental

Experimental

Experimental

Arm Label

YLH Historical Control Group

YLH iTransition Intervention Group

Provider Group

Transition Champion Group

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
May 7, 2020
Last Updated
October 18, 2023
Sponsor
Emory University
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT04383223
Brief Title
iTransition Development
Official Title
iTransition: Pilot Testing a Multilevel Technology Based Intervention to Support Youth Living With HIV From Adolescent to Adult Care
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 28, 2020 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Human Immunodeficiency Virus, HIV Seropositivity
Keywords
HIV

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
YLH Historical Control Group
Arm Type
No Intervention
Arm Description
Participants in this group will have the following phases: Screening Single visit assessment
Arm Title
YLH iTransition Intervention Group
Arm Type
Experimental
Arm Description
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
Arm Title
Provider Group
Arm Type
Experimental
Arm Description
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
Arm Title
Transition Champion Group
Arm Type
Experimental
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
iTransition
Intervention Description
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.
Primary Outcome Measure Information:
Title
Linkage to adult care
Description
Defined dichotomously as having one completed adult clinic appointment or not.
Time Frame
18 month post-intervention
Secondary Outcome Measure Information:
Title
Change in Care retention
Description
Defined dichotomously as having one completed medical visit in each 6-month period.
Time Frame
Baseline, 6 month post-intervention, 12 month post-intervention, 18-month post-intervention
Title
Change in viral suppression
Description
Viral suppression is defined as <200 copies/ml blood at 1 year post-baseline.
Time Frame
Baseline, 1-year post-intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sophia Hussen, MD
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Grady Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30303
Country
United States
Facility Name
Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
University of Pennsylvania Health System - HUP and Presby infectious disease clinics
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

Learn more about this trial

iTransition Development

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