HIV Seropositivity, Human Immunodeficiency Virus
Conditions
Keywords
HIV
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.
Interventions
BEHAVIORALiTransition
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.
Sponsors
National Institute of Mental Health (NIMH)
Emory University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Linkage to Adult Care | 18 month post-intervention | Defined dichotomously as having one completed adult clinic appointment or not. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Care Retention Per Each 6-month Period | 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. |
| Number of Participants With Viral Suppression | Baseline, 1-year post-intervention | Viral suppression is defined as \<200 copies/ml blood at 1-year post-baseline. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| YLH Historical Control Group Participants in this group will have the following phases:
* Screening
* Single visit assessment | 21 |
| 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
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. | 33 |
| 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
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. | 17 |
| 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
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. | 7 |
| Total | 78 |
Baseline characteristics
| Characteristic | Provider Group | Transition Champion Group | Total | YLH Historical Control Group | YLH iTransition Intervention Group |
|---|---|---|---|---|---|
| Age, Continuous | 41.47 years STANDARD_DEVIATION 7.71 | 39.00 years STANDARD_DEVIATION 6 | 29.62 years STANDARD_DEVIATION 0.97 | 24.73 years STANDARD_DEVIATION 0.94 | 24.64 years STANDARD_DEVIATION 1.03 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 0 Participants | 3 Participants | 1 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 15 Participants | 7 Participants | 75 Participants | 20 Participants | 33 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 1 Participants | 3 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 2 Participants | 54 Participants | 16 Participants | 31 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 4 Participants | 4 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 0 Participants | 2 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 8 Participants | 4 Participants | 14 Participants | 1 Participants | 1 Participants |
| Region of Enrollment United States | 17 participants | 7 participants | 78 participants | 21 participants | 33 participants |
| Sex/Gender, Customized Female | 12 Participants | 4 Participants | 26 Participants | 7 Participants | 3 Participants |
| Sex/Gender, Customized Male | 5 Participants | 3 Participants | 49 Participants | 13 Participants | 28 Participants |
| Sex/Gender, Customized Non-binary | 0 Participants | 0 Participants | 3 Participants | 1 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 21 | 0 / 33 | 0 / 17 | 0 / 7 |
| other Total, other adverse events | 0 / 21 | 0 / 33 | 0 / 17 | 0 / 7 |
| serious Total, serious adverse events | 0 / 21 | 0 / 33 | 0 / 17 | 0 / 7 |
Outcome results
Primary
Linkage to Adult Care
Defined dichotomously as having one completed adult clinic appointment or not.
Time frame: 18 month post-intervention
Population: This outcome only applies to the groups with YLH (Youth Living With HIV) participants.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| YLH Historical Control Group | Linkage to Adult Care | 16 Participants |
| YLH iTransition Intervention Group | Linkage to Adult Care | 22 Participants |
| Provider Group | Linkage to Adult Care | 0 Participants |
| Transition Champion Group | Linkage to Adult Care | 0 Participants |
Secondary
Care Retention Per Each 6-month Period
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
Population: This outcome only applies to the groups with YLH (Youth Living With HIV) participants.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| YLH Historical Control Group | Care Retention Per Each 6-month Period | Number of participants with one completed medical visit from Baseline to 6 month post-intervention | 17 Participants |
| YLH Historical Control Group | Care Retention Per Each 6-month Period | Number of participants with one completed medical visit from 12 to 18 month post-intervention | 16 Participants |
| YLH Historical Control Group | Care Retention Per Each 6-month Period | Number of participants with one completed medical visit from 6 to 12 month post-intervention | 14 Participants |
| YLH iTransition Intervention Group | Care Retention Per Each 6-month Period | Number of participants with one completed medical visit from Baseline to 6 month post-intervention | 27 Participants |
| YLH iTransition Intervention Group | Care Retention Per Each 6-month Period | Number of participants with one completed medical visit from 12 to 18 month post-intervention | 22 Participants |
| YLH iTransition Intervention Group | Care Retention Per Each 6-month Period | Number of participants with one completed medical visit from 6 to 12 month post-intervention | 31 Participants |
| Provider Group | Care Retention Per Each 6-month Period | Number of participants with one completed medical visit from 6 to 12 month post-intervention | 0 Participants |
| Provider Group | Care Retention Per Each 6-month Period | Number of participants with one completed medical visit from Baseline to 6 month post-intervention | 0 Participants |
| Provider Group | Care Retention Per Each 6-month Period | Number of participants with one completed medical visit from 12 to 18 month post-intervention | 0 Participants |
| Transition Champion Group | Care Retention Per Each 6-month Period | Number of participants with one completed medical visit from Baseline to 6 month post-intervention | 0 Participants |
| Transition Champion Group | Care Retention Per Each 6-month Period | Number of participants with one completed medical visit from 12 to 18 month post-intervention | 0 Participants |
| Transition Champion Group | Care Retention Per Each 6-month Period | Number of participants with one completed medical visit from 6 to 12 month post-intervention | 0 Participants |
Secondary
Number of Participants With Viral Suppression
Viral suppression is defined as \<200 copies/ml blood at 1-year post-baseline.
Time frame: Baseline, 1-year post-intervention
Population: This outcome only applies to the groups with YLH (Youth Living With HIV) participants.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| YLH Historical Control Group | Number of Participants With Viral Suppression | 10 Participants |
| YLH iTransition Intervention Group | Number of Participants With Viral Suppression | 26 Participants |
| Provider Group | Number of Participants With Viral Suppression | 0 Participants |
| Transition Champion Group | Number of Participants With Viral Suppression | 0 Participants |