mHealth App for Engagement in Care Among Youth Living With HIV

NCT03587857 | Completed Results

• 1 other identifier: R34MH114604
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

HIV/AIDS; Mobile Health; Young Adults

Keywords

Health Disparity

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (4)

• Acceptability: Participant Retention

  6 Months

• Acceptability: Overall App Experience

  6 Months

• Acceptability: Privacy, Security, and Anonymity

  6 Months

• Acceptability: Continue Using WYZ

  6 Months

Study Arms (1)

Arm 1: Intervention

EXPERIMENTAL

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

Interventions

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.

Also known as: WYZ

Arm 1: Intervention

Eligibility Criteria

• Age: 18 Years - 29 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

University of California San Francisco, Mission Bay Campus

San Francisco, California, 94143, United States

Location

Related Publications (3)

• 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.

  PMID: 31061063 BACKGROUND

• 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.

  PMID: 34463622 RESULT

• 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.

  PMID: 33920803 RESULT

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Results Point of Contact

• Title: Dr. Parya Saberi
• Organization: UCSF

parya.saberi@ucsf.edu

415-502-1000 ext. 17171

Study Officials

• Parya Saberi, PhamD

  UCSF School of Medicine, Division of Prevention Science

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2018
• First Posted: July 16, 2018
• Study Start: July 1, 2019
• Primary Completion: May 1, 2020
• Study Completion: May 1, 2020
• Last Updated: July 1, 2025
• Results First Posted: July 1, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)