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In the United States, adolescents and young adults are disproportionately affected by HIV and have poorer HIV-related health outcomes than adults. Health care transition (HCT) from pediatric or adolescent to adult-oriented HIV care is associated with disruptions to youths’ care retention, medication adherence, and viral suppression. However, no evidence-based interventions exist to improve HCT outcomes for youth living with HIV.
There are 2 phases of this project. Phase 1 involves the iterative development and usability testing of a Social Cognitive Theory–based mobile health (mHealth) HIV HCT intervention (
The iterative phase 1 development process will involve in-person and virtual meetings and a design team comprising youth living with HIV and health care providers. The design team will both inform the content and provide feedback on the look, feel, and process of the
Phase 1 (development) of
The development and pilot implementation trial of the
DERR1-10.2196/24565
Adolescents and young adults are disproportionately affected by HIV in the United States compared with their adult counterparts [
Mobile health (mHealth) interventions are used to improve medication adherence, care retention, and viral suppression among youth living with HIV [
Theory-informed mHealth interventions can improve health outcomes for youth living with HIV, and Social Cognitive Theory [
The Institutional Review Board (IRB) at the Children’s Hospital of Philadelphia (CHOP) is the IRB of record for all the participating institutions (CHOP, Emory University, and the University of Carolina Greensboro). The CHOP IRB has reviewed and approved all the procedures outlined in this protocol. The study is registered with ClinicalTrials.gov (NCT04383223).
This protocol is being implemented at high-volume HIV care centers that frequently transition youth living with HIV from pediatric or adolescent to adult-oriented care. The Grady Infectious Disease Program in Atlanta, Georgia, is affiliated with a large public safety net health system and is among the largest HIV care centers in the United States, serving approximately 6000 patients per year, 10% of whom are youth living with HIV under 25 years of age. It contains pediatric or adolescent and adult-oriented clinic spaces in the same building but has no formal HCT protocol. CHOP, located in Philadelphia, Pennsylvania, contains 2 academic hospital-based HIV clinics that transition youth living with HIV to multiple adult clinics, including infectious disease clinics at the Hospital of the University of Pennsylvania and the Penn Presbyterian Medical Center. CHOP has a formal HCT protocol that includes guided pre-HCT visits to adult clinics with a pediatric or adolescent social worker. Piloting
In addition, we draw on supportive accountability theory [
Domains of health care transition success, Social Cognitive Theory constructs, and intervention strategies.
Domains of HCTa success | Measurable social cognitive theory constructs | |
Preparation of YLHb for autonomous disease management |
Self-management skills Self-efficacy |
Youth-friendly educational modules and readiness assessments (youth) HCT educations modules (providers) Interactive case scenarios (youth and providers) |
Enhancing YLH’s connectedness to adult clinics |
Self-management skills Self-efficacy |
Motivational messages (youth) TCc interactions (providers) Online support forum (youth) |
Effective between clinic provider communication |
Self-efficacy Behavior |
Reminders and updates about patients going through HCT process (providers) Communication between adult and pediatric or adolescent providers (providers) |
Implementation of formalized HCT protocols in pediatric or adolescent and adult clinics |
Behavior Cues to action |
Clinic-level implementation (youth) TC intervention (providers) |
aHCT: health care transition.
bYLH: youth living with HIV.
cTC: Transition Champion.
Phase 1 of this study,
To develop
iTransition development. HCT: health care transition.
In phase 2, we will conduct a pilot implementation trial of
Phase 2 activities by participant type.
For phase 1, we will recruit approximately 10 youth and 8 providers for our design team. Phase 2 will include a total of 128 participants: 100 transition-eligible youth (50 for the intervention group and 50 for the historical control group), 20 providers (approximately 10 from each city site) who work with transitioning youth living with HIV, and the 8 design team providers (recruited in phase 1) who will function as Transition Champions provider participants. Historical control youth will participate for 1 day, intervention group youth will participate for 12 months, and all providers (including Transition Champions) will participate for 18 months.
Inclusion criteria include (1) living with HIV, (2) age 18+ years, (3) expected to undergo HCT within the next 6 months, and (4) enrolled in care at participating clinics in Atlanta and Philadelphia. Potentially eligible youth will be identified through chart review in collaboration with clinic staff and approached by a research assistant during or after regular HIV care visits at the pediatric or adolescent clinic (face-to-face or during telehealth visits). Those who express interest will be consented (including signing a consent form for the release of medical information) and screened to determine eligibility. Those who enroll will complete a single cross-sectional survey before HCT, and they will receive US $25 for their time.
Following the recruitment and participation of the historical control group, we will recruit youth living with HIV for the intervention group. Inclusion criteria for the intervention group will be identical to the historical control group with the additional criteria that they must own a smartphone or tablet and report consistent internet access (defined as no lapse >24 hours in the last 6 months). Youth without a device are not eligible for this pilot trial; larger future trials will provide access to devices as needed. Similar to the historical control group, a research assistant will invite potentially eligible youth to participate during or after regular HIV care visits at the pediatric or adolescent clinic (face-to-face or during telehealth visits). Those who express interest will provide consent (including the release of medical information) and be screened to determine eligibility. Enrolled participants will complete the same baseline survey as the historical control group at the first study visit, during which time they will also be oriented to the
Inclusion criteria for the provider intervention group include (1) staff members at participating clinics, (2) work with transitioning youth, and (3) access to the internet via any device (eg, a smartphone, tablet, or computer). Research assistants will directly invite providers at each of the participating pediatric or adolescent and adult clinics. Enrolled participants will complete a baseline survey and be oriented to
Inclusion criteria for the Transition Champion group include the same criteria as provider participants and nomination by a clinic staff member in their clinic to be an
The goals of this study are to estimate effect sizes so that we can fully power a future randomized control trial and to evaluate
Data collection for surveys and electronic medical record abstraction will occur in Research Electronic Data Capture [
Youth participants will complete a baseline survey with questions related to demographics, general health status, health behaviors (eg, substance use and medication adherence), Social Cognitive Theory–related factors, and other psychosocial covariates affecting HCT (eg, stigma, discrimination, social support, self-efficacy, skills, and readiness). The majority of measures have been validated and used in previous research (
Intervention youth will also complete subsequent surveys at 6 and 12 months, including all the same baseline measures (except demographics). A subset of intervention youth will be invited to complete interviews related to
We will review the electronic medical charts of youth in both study groups for a 3-year period: 12 months before baseline through 24 months after baseline. The use of medical chart data helps address potential attrition over time by allowing the assessment of outcomes (eg, medial appointment attendance and viral suppression). Chart reviews will be completed at 3 time points: baseline, 12 months after baseline, and 24 months after baseline. Each abstraction will capture data from the previous 12 months (ie, initial abstraction includes the 12 months before baseline, 12-month abstraction covers baseline to 12 months, and 24-month abstraction includes data between 12 months and 24 months). Information abstracted will include HIV history (eg, date of diagnosis, antiretroviral therapy information, and other sexually transmitted infection [STI] diagnoses), viral load, CD4+ count and percentage, diagnoses of STIs, and appointment information at pediatric or adolescent and adult clinics.
The primary clinical outcome variable for youth, measured at the patient level, is linkage to adult care (defined dichotomously as having 1 completed adult clinic appointment or not). Secondary clinical outcomes are care retention (dichotomously defined as having or not having 1 visit in each 6-month period) and viral suppression (<200 copies/mL) at 1 year after baseline. We will explore whether individual characteristics (eg, gender, race or ethnicity, and sexual orientation), Social Cognitive Theory–related covariates (eg, self-efficacy), and intervention dosage (as quantified by paradata metrics) are associated with outcomes or whether there is any preliminary evidence that it moderates intervention effects.
Data collection for the provider intervention and Transition Champion groups includes baseline and follow-up (at 6, 12, and 18 months) surveys (
To estimate intervention efficacy, we will use a logistic regression model with a term for intervention status to compare the likelihood of being linked to adult care between the intervention and historical control groups. We will conduct univariable and multivariable logistic regression analyses to test the intervention effects on our secondary outcomes of care retention and viral suppression after 12 months. Retention for patients who never achieve HCT or who undergo HCT too late in the 12-month follow-up period to calculate the retention outcome will be treated as missing. Other outcomes will include acceptability and feasibility of the app, app use metrics, and Social Cognitive Theory–related measures, such as self-efficacy for managing HCT.
We will conduct descriptive statistics to assess the feasibility, acceptability, and use of
Our interview data will help describe participants’ experiences with
Phase 1 (development) of
Although every youth in pediatric or adolescent HIV care will need to transition to adult-oriented care, there are no evidence-based HCT interventions [
Screenshots of iTransition.
Primary and other outcome measures: operationalization and schedule.
Children’s Hospital of Philadelphia
health care transition
Institutional Review Board
mobile health
sexually transmitted infection
This work was supported by the National Institutes of Mental Health (R34MH116805; principal investigators Hussen and Tanner). The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. The authors acknowledge the contribution of the research team in Atlanta and Philadelphia, including Kayla Knowles’ role in the development of the manuscript.
None declared.