mHealth App for Engagement in Care Among Youth Living With HIV
Condition: HIV/AIDS; Mobile Health; Young Adults
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Study type: Interventional

Summary: 
      In the US, fewer than 6% of all youth living with HIV (YLWH) achieve HIV viral suppression.
      However, health disparities among youth extend across the entire HIV care continuum in that
      there is a strong association between younger age and later HIV diagnosis, lower engagement
      in care, lower levels of antiretroviral therapy (ART) adherence, and worse HIV clinical
      outcomes. In response to this critical public health dilemma, the investigators propose to
      develop a novel mobile health application ("app") to improve engagement in health care and
      ART adherence and to pilot test this mobile health app in 18-29-year-old YLWH residing in San
      Francisco.

      The aims of this study are to:

      Aim 1: Build on a theory-guided model and formative work to complete the development of a
      novel personalized mobile health app for improved HIV clinical outcomes among YLWH (includes
      field test of initial release to ensure adequate usability and engagement).

      Aim 2: Conduct a six-month single arm pilot study to examine WYZ feasibility and
      acceptability among YLWH ( N = 76) living in the San Francisco Bay Area. Finally, the
      investigators will conduct in-depth qualitative interviews with a subset of participants (N =
      20) and clinical team members (N = 10) whose patients participated in the pilot study.

      The investigators hypothesize that this mobile health app will be feasible and acceptable and
      will result in improved HIV clinical outcomes. Upon completion, the investigators will be
      ready to test the efficacy of this app in a subsequent large-scale randomized control trial
      among a population that is disproportionately impacted by HIV and at elevated risk for poor
      clinical outcomes.
    

Detailed description: 
      WYZ is a modular, adaptive, and personalized intervention delivered via a mobile phone. It is
      grounded in the Information-Motivation-Behavioral Skills (IMB) model which has been valuable
      for understanding and guiding the development of interventions for complex health behaviors.
      WYZ was created in collaboration with 18-29 year-old YLWH using a Human-Centered Design (HCD)
      approach that emphasizes understanding the perspective of the users of the technology. WYZ is
      intended to improve engagement in HIV care by 1) enhancing medication adherence
      self-efficacy, 2) increasing awareness and use of community resources, 3) reducing barriers
      to communication between youth and their healthcare team, and 4) providing a secure platform
      for the formation of a supportive closed online community of YLWH.

      The investigators will complete development of WYZ (1.0), field test the initial release with
      a cohort of 10 potential users over a period of three months to identify and address
      technical challenges, and develop a fully functioning version (WYZ 2.0) that can be used in a
      pilot investigation. The investigators will then conduct a six-month single-arm pilot study
      to examine WYZ feasibility and acceptability among (N = 76) YLWH (18-29 years old) who live
      and/or receive care in the San Francisco Bay Area. The objectives of this forthcoming phase
      are to refine the design so as to improve satisfaction and engagement with the intervention
      among YLWH and their healthcare providers.

      The main outcomes of the pilot trial include feasibility and acceptability as indicated by
      meeting or exceeding proposed benchmarks. Feasibility will be assessed via user metrics by
      examining the participant's interactions with WYZ via a mobile analytics service called
      Flurry and backend (Salesforce) reporting tools. Acceptability will be examined during
      regular phone check-ins, a system usability scale (SUS), a satisfaction survey, and an exit
      qualitative interview.

      In addition to feasibility measures, the investigators will calculate an engagement index
      (EI) for each participant. The EI has been detailed and used successfully in other mHealth
      interventions. The EI includes the following sub-indices: (1) click depth (number of pages a
      user views per session), (2) loyalty (measures how frequently users access the application
      during the study period), (3) recency (the time difference between each session the user
      accessed the application), (4) interaction (number of push notifications opened from those
      sent through the application), and (5) feedback (subjective measure of participants'
      satisfaction with the application).

      Based on the data from participants in this pilot study, the investigators will develop a
      refined version of WYZ (3.0), which will be used in a future investigation to examine the
      efficacy of the intervention with a much larger sample.
    

Intervention name(s): Mobile Health Application
Intervention type(s): Other
Intervention description(s): This mobile health app is a modular, adaptive, and personalized intervention delivered via a mobile phone. It is grounded in the Information Motivation Behavioral Skills (IMB) model. It was created in collaboration with YLWH (18-29 years-old) using a Human-Centered Design approach to help improve engagement in HIV care among this age group.
Other intervention name(s): WYZ
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Health Disparity