NCT03587857

mHealth App for Engagement in Care Among Youth Living With HIV

Completed NA Results posted Last updated 1 July 2025

What this trial tests

NA trial testing Mobile Health Application in HIV/AIDS in 79 participants. Completed in 1 May 2020.

Timeline

1 July 2019

Primary endpoint
1 May 2020

1 May 2020

Quick facts

Lead sponsor	University of California, San Francisco
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	supportive care
Enrollment	79
Start date	1 July 2019
Primary completion	1 May 2020
Estimated completion	1 May 2020
Sites	1 location across United States

Drugs / interventions tested

• Mobile Health Application

Conditions studied

• HIV/AIDS — all drugs for HIV/AIDS →
• Mobile Health — all drugs for Mobile Health →
• Young Adults — all drugs for Young Adults →

Sponsor

University of California, San Francisco

Who can join

Adults 18 to 29, any sex, with HIV/AIDS or Mobile Health. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Feasibility: Rate of Participant Recruitment Primary · 8 Months

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

Group	Value	95% CI
Arm 1: Intervention	79

Feasibility: Frequency of WYZ Access Primary · 6 Months

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

Group	Value	95% CI
Arm 1: Intervention	5.3	± 5.6

Feasibility: Length of Session (Minutes) Primary · 6 Months

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

Group	Value	95% CI
Arm 1: Intervention	8.7	± 5

Feasibility: Rate of Use of ART Adherence Tracking Primary · 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.

Group	Value	95% CI
Arm 1: Intervention	58	0 – 100

Feasibility: Rate of Communication With Peers Primary · 6 Months

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

Group	Value	95% CI
Arm 1: Intervention	4.8	1 – 42

Acceptability: Participant Retention Secondary · 6 Months

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

Group	Value	95% CI
Arm 1: Intervention	69

Acceptability: Overall App Experience Secondary · 6 Months

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

Group	Value	95% CI
Arm 1: Intervention	53

Acceptability: Privacy, Security, and Anonymity Secondary · 6 Months

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

Group	Value	95% CI
Arm 1: Intervention	69

Acceptability: Continue Using WYZ Secondary · 6 Months

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

Group	Value	95% CI
Arm 1: Intervention	57

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. 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.
   Erguera XA, Johnson MO, Neilands TB, Ruel T, et al · · 2019 · cited 22× · PMID 31061063 · DOI 10.1136/bmjopen-2019-030473
2. 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.
   Saberi P, Lisha NE, Erguera XA, Hudes ES, et al · · 2021 · cited 16× · PMID 34463622 · DOI 10.2196/26861