Human Immunodeficiency VirusNCT04383223
iTransition Development
A study testing iTransition in people with Human Immunodeficiency Virus and HIV Seropositivity, run by Emory University at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Human Immunodeficiency Virus, HIV Seropositivity
- What is being tested?
- iTransition
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 3 sitesUnited States
- Study dates
- 28 Aug 2020to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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).
Who cannot join
- 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
Show all 20Show fewer
- 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).
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Grady Hospital
Atlanta, Georgia, 30303
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
University of Pennsylvania Health System - HUP and Presby infectious disease clinics
Philadelphia, Pennsylvania, 19104
About this study
Official title: iTransition: Pilot Testing a Multilevel Technology Based Intervention to Support Youth Living With HIV From Adolescent to Adult Care
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.
Read the 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.
- Conditions
- Human Immunodeficiency Virus, HIV Seropositivity
- Being tested
- iTransition
- Keywords
- HIV
- Medical subject headings
- Acquired Immunodeficiency Syndrome, HIV Seropositivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iTransitionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: Behavioral: iTransition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Linkage to Adult Care
Defined dichotomously as having one completed adult clinic appointment or not.
Measured: 18 month post-intervention
Secondary outcomes (2)
Care Retention Per Each 6-month Period
Defined dichotomously as having one completed medical visit in each 6-month period.
Measured: Baseline, 6 month post-intervention, 12 month post-intervention, 18-month post-intervention
Number of Participants With Viral Suppression
Viral suppression is defined as <200 copies/ml blood at 1-year post-baseline.
Measured: Baseline, 1-year post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2020
- Study start28 Aug 2020
- Primary completion30 Jun 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Human Immunodeficiency VirusStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Sophia Hussen, Emory University
- Investigators
- Sophia Hussen, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04383223
- Sponsor's protocol ID
- IRB00114532
- Other IDs
- R34MH116805-01A1
- Status last verified
- Aug 2025
- First submitted
- 7 May 2020
- Last updated
- 13 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Survey data will be shared as well as de-identified clinical outcome data Study protocols and statistical analysis plans upon request
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- iTransition: Pilot Testing a Multilevel Technology Based Intervention to Support Youth Living With HIV From Adolescent to Adult Care
- ClinicalTrials.gov ID
- NCT04383223
- Acronym / sponsor ID
- IRB00114532
- Conditions
- Human Immunodeficiency Virus, HIV Seropositivity
- Keywords
- HIV
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 28 Aug 2020 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 12 May 2020 (actual)
- Results
- Posted 13 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| YLH Historical Control Group | No intervention | –Participants in this group will have the following phases: * Screening * Single visit assessment |
| YLH iTransition Intervention Group | Experimental | Behavioral: iTransitionParticipants 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 |
| Provider Group | Experimental | Behavioral: iTransitionParticipants 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 |
| Transition Champion Group | Experimental | Behavioral: iTransitionParticipants 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- 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
Key exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| iTransitionIs 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. | Behavioural | Provider Group, Transition Champion Group, YLH iTransition Intervention Group |
Primary outcome
Linkage to Adult Care
Time frame: 18 month post-intervention
Defined dichotomously as having one completed adult clinic appointment or not.
2 secondary outcomes
Care Retention Per Each 6-month Period
Time frame: Baseline, 6 month post-intervention, 12 month post-intervention, 18-month post-intervention
Number of Participants With Viral Suppression
Time frame: Baseline, 1-year post-intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Survey data will be shared as well as de-identified clinical outcome data Study protocols and statistical analysis plans upon request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sophia Hussen, MD principal investigator
Emory University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iTransition in people with Human Immunodeficiency Virus and HIV Seropositivity, run by Emory University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Linkage to Adult Care (time frame: 18 month post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2025.