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Completed

NCT Number: NCT03587857

mHealth App for Engagement in Care Among Youth Living With HIV

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Eligibility Criteria:

  • Must be between 18 and 29 years of age
  • Must be living with HIV
  • Must reside and/or get care in San Francisco Bay Area
  • Must be able to provide informed consent to be a research participant
  • Must be able to speak and understand English
  • Must have access to an Android (5.0 or higher) or iOS (10.0 or higher) mobile phone

Exclusion criteria

Evidence of cognitive impairment or psychotic disorder that prevents one from understanding the purpose of the study and/or participating fully in study activities. This determination will be made by trained study staff in consultation with the principal investigator.

Treatment and study plan

Mobile health application

Other

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 names: WYZ

Primary outcomes

  1. Feasibility: Rate of Participant Recruitment

    Time frame: 8 Months

    Recruit at least 55 participants (i.e. 70% of target N)

  2. Feasibility: Frequency of WYZ Access

    Time frame: 6 Months

    Mean number of logins/week over the 6 month period of using WYZ

  3. Feasibility: Length of Session (Minutes)

    Time frame: 6 Months

    Mean minutes/week spent in the app over the 6 month period of using WYZ

  4. Feasibility: Rate of Use of ART Adherence Tracking

    Time frame: 6 Months

    Mean percentage of times/week that participants tracked ART adherence in the app over 6 months of using WYZ. E.g. 3 mean times/week = 43% mean/week.

  5. Feasibility: Rate of Communication With Peers

    Time frame: 6 Months

    Mean number of postings of chat topics on the My Community chat per person per week, over 6 months of using WYZ

Secondary outcomes

  1. Acceptability: Participant Retention

    Time frame: 6 Months

    Percentage of individuals who enrolled and completed the study at 6 months

  2. Acceptability: Overall App Experience

    Time frame: 6 Months

    Percent of participants who rated their overall experience with the app as excellent to very good

  3. Acceptability: Privacy, Security, and Anonymity

    Time frame: 6 Months

    Percent of participants who reported being extremely to somewhat comfortable with the security, privacy, and anonymity of WYZ

  4. Acceptability: Continue Using WYZ

    Time frame: 6 Months

    Percent of participants who stated that they would be extremely to somewhat likely to continue to use WYZ

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

A Mobile Health Application for Engagement in Care Among Youth Living With HIV

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jul 16, 2018
Registry last updated
Jul 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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