mHealth App for Engagement in Care Among Youth Living With HIV

A Mobile Health Application 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.

Study Overview

• Status: Completed
• Conditions: HIV/AIDS; Mobile Health; Young Adults
• Intervention / Treatment: Other: Mobile Health Application

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.

• Study Type: Interventional
• Enrollment (Actual): 79
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94143
      • University of California San Francisco, Mission Bay Campus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 29 years (Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1: Intervention; All YLWH who choose to enroll in the study will receive access to WYZ, the mobile health application. The participants will be asked to use the app for 6 months, during which the investigators will assess the feasibility and acceptability of WYZ. Based on this initial data, the investigators will refine and release a new version of the app (WYZ 3.0).	Other: Mobile Health Application; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility: Rate of Participant Recruitment	Recruit at least 55 participants (i.e. 70% of target N)	8 Months
Feasibility: Frequency of WYZ Access	Mean number of logins/week over the 6 month period of using WYZ	6 Months
Feasibility: Length of Session (Minutes)	Mean minutes/week spent in the app over the 6 month period of using WYZ	6 Months
Feasibility: Rate of Use of ART Adherence Tracking	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.	6 Months
Feasibility: Rate of Communication With Peers	Mean number of postings of chat topics on the My Community chat per person per week, over 6 months of using WYZ	6 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability: Participant Retention	Percentage of individuals who enrolled and completed the study at 6 months	6 Months
Acceptability: Overall App Experience	Percent of participants who rated their overall experience with the app as excellent to very good	6 Months
Acceptability: Privacy, Security, and Anonymity	Percent of participants who reported being extremely to somewhat comfortable with the security, privacy, and anonymity of WYZ	6 Months
Acceptability: Continue Using WYZ	Percent of participants who stated that they would be extremely to somewhat likely to continue to use WYZ	6 Months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mobile Application Engagement Index (EI)	The engagement index (EI) measures overall engagement with the app. The score is calculated by adding scores for 5 sub-indices: (1) click depth (number of pages viewed per session), (2) loyalty (frequency of application access), (3) recency (time between each session), (4) interaction (number of notifications opened), (5) feedback (participant's satisfaction with the application). The final score incorporated click depth, loyalty, recency, interaction, and feedback sub-indices. Equal weight was assigned for each of the sub-index. Four of the sub-indices were calculated using app data. The feedback index was informed using responses to the 6-month satisfaction survey. The EI was then converted to a value between 0 and 100. Cut-off points were developed based on the distribution of the total samples' EI scores using quartiles. Participants were then categorized as either poorly, moderately, or highly engaged.	Baseline To 6 Months

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Parya Saberi, PhamD, UCSF School of Medicine, Division of Prevention Science

Publications and helpful links

General Publications

• Erguera XA, Johnson MO, Neilands TB, Ruel T, Berrean B, Thomas S, Saberi P. WYZ: a pilot study protocol for designing and developing a mobile health application for engagement in HIV care and medication adherence in youth and young adults living with HIV. BMJ Open. 2019 May 5;9(5):e030473. doi: 10.1136/bmjopen-2019-030473.
• Saberi P, Lisha NE, Erguera XA, Hudes ES, Johnson MO, Ruel T, Neilands TB. A Mobile Health App (WYZ) for Engagement in Care and Antiretroviral Therapy Adherence Among Youth and Young Adults Living With HIV: Single-Arm Pilot Intervention Study. JMIR Form Res. 2021 Aug 31;5(8):e26861. doi: 10.2196/26861.
• Lisha NE, Neilands TB, Erguera XA, Saberi P. Development of the Mobile Technology Vulnerability Scale among Youth and Young Adults Living with HIV. Int J Environ Res Public Health. 2021 Apr 15;18(8):4170. doi: 10.3390/ijerph18084170.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2019
• Primary Completion (Actual): May 1, 2020
• Study Completion (Actual): May 1, 2020

Study Registration Dates

• First Submitted: April 29, 2018
• First Submitted That Met QC Criteria: July 3, 2018
• First Posted (Actual): July 16, 2018

Study Record Updates

• Last Update Posted (Estimated): July 1, 2025
• Last Update Submitted That Met QC Criteria: June 11, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Health Disparity
• Additional Relevant MeSH Terms: Blood-Borne Infections; Urogenital Diseases; Genital Diseases; Immune System Diseases; Infections; RNA Virus Infections; Virus Diseases; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Slow Virus Diseases; HIV Infections; Acquired Immunodeficiency Syndrome
• Other Study ID Numbers: R34MH114604 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No