Clinical trial NCT03587857: mHealth App for Engagement in Care Among Youth Living With HIV
Official title: A Mobile Health Application for Engagement in Care Among Youth Living With HIV
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV/AIDS
Mobile Health
Young Adults
Keywords: Health Disparity
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2018-07-16
Enrollment: 83
Sex: ALL
Minimum age (years): 18
Maximum age (years): 29
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Feasibility: Rate of Participant Recruitment
timeFrame: 8 Months
measure: Feasibility: Frequency of WYZ Access
timeFrame: Baseline to 6 Months
measure: Feasibility: Length of Session (Minutes)
timeFrame: Baseline To 6 Months
measure: Feasibility: Rate of Use of Refill Reminders
timeFrame: Baseline To 6 Months
measure: Feasibility: Rate of Use of ART Adherence Tracking
timeFrame: Baseline To 6 Months
measure: Feasibility: Rate of Access of Laboratory Data
timeFrame: Baseline To 6 Months
measure: Feasibility: Rate of Communication With Clinical Team Members
timeFrame: Baseline To 6 Months
measure: Feasibility: Rate of Communication With Peers
timeFrame: Baseline To 6 Months
measure: Feasibility: Rate of Access of Health News
timeFrame: Baseline To 6 Months
measure: Feasibility: Rate of Access of Event Calendar
timeFrame: Baseline To 6 Months
measure: Feasibility: Time For Participant Onboarding (Minutes)
timeFrame: Baseline To 6 Months
measure: Feasibility: Time To Maintain & Support (Minutes)
timeFrame: Baseline To 6 Months
Secondary outcomes:
measure: Acceptability: Participant Retention
timeFrame: Baseline To 6 Months
measure: Acceptability: System Usability Score
timeFrame: Baseline To 6 Months
measure: Acceptability: Satisfaction Acceptability Questionnaire
timeFrame: Baseline To 6 Months
Other outcomes:
measure: Mobile Application Engagement Index (EI)
timeFrame: Baseline To 6 Months
Locations:
city: San Francisco
country: United States
facility: University of California San Francisco, Mission Bay Campus
state: California
Study officials:
affiliation: UCSF School of Medicine, Division of Prevention Science
name: Parya Saberi, PhamD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.