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Clinical Trials/NCT04383223
NCT04383223
Completed
Not Applicable

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

Emory University3 sites in 1 country78 target enrollmentAugust 28, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Human Immunodeficiency Virus
Sponsor
Emory University
Enrollment
78
Locations
3
Primary Endpoint
Linkage to Adult Care
Status
Completed
Last Updated
8 months ago

Overview

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 subjects in Atlanta, GA and Philadelphia, PA: around 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 (YLH), 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.

Registry
clinicaltrials.gov
Start Date
August 28, 2020
End Date
June 30, 2024
Last Updated
8 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Sophia Hussen

Assistant Professor

Emory University

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.

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Linkage to Adult Care

Time Frame: 18 month post-intervention

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

Secondary Outcomes

  • 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 Sites (3)

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