Clinical trial NCT04383223: 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
Overall status: COMPLETED
Phase: NA
Conditions: Human Immunodeficiency Virus
HIV Seropositivity
Keywords: HIV
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2020-05-12
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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).

Primary outcomes:
measure: Linkage to adult care
timeFrame: 18 month post-intervention
Secondary outcomes:
measure: Change in Care retention
timeFrame: Baseline, 6 month post-intervention, 12 month post-intervention, 18-month post-intervention
measure: Change in viral suppression
timeFrame: Baseline, 1-year post-intervention
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Grady Hospital
state: Georgia
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania Health System - HUP and Presby infectious disease clinics
state: Pennsylvania
Study officials:
affiliation: Emory University
name: Sophia Hussen, MD
role: PRINCIPAL_INVESTIGATOR
References: