mHealth App for Engagement in Care Among Youth Living With HIV

HIV/AIDS Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03587857
• Other study ID #: R34MH114604
• Secondary ID: R34MH114604
• Status: Completed
• Phase: N/A
• Start date: July 1, 2019
• Est. completion date: May 1, 2020

Study information

• Verified date: June 2022
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 83
• Est. completion date: May 1, 2020
• Est. primary completion date: May 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 29 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• HIV/AIDS
• Mobile Health
• Young Adults

Intervention

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.

Locations

Country	Name	City	State
United States	University of California San Francisco, Mission Bay Campus	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

References & 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. — View 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). pii: 4170. doi: 10.3390/ijerph18084170. — View 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 R — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	Feasibility: Rate of Participant Recruitment	Recruit at least 55 participants (i.e. 70% of target N)	8 Months
Primary	Feasibility: Frequency of WYZ Access	Percentage of participants who achieve an average of 1 log-in per week	Baseline to 6 Months
Primary	Feasibility: Length of Session (Minutes)	Percentage of participants who achieve an average of 15 minutes in application per week	Baseline To 6 Months
Primary	Feasibility: Rate of Use of Refill Reminders	Percentage of participants that use feature once monthly (if receiving 30-day ART supply)	Baseline To 6 Months
Primary	Feasibility: Rate of Use of ART Adherence Tracking	Percentage of participants that track med adherence at least 3 times per week	Baseline To 6 Months
Primary	Feasibility: Rate of Access of Laboratory Data	Percentage of participants that review laboratory data at least one-time per month	Baseline To 6 Months
Primary	Feasibility: Rate of Communication With Clinical Team Members	Percentage of participants who achieve an average of 1 communication exchange per month with clinical team member	Baseline To 6 Months
Primary	Feasibility: Rate of Communication With Peers	Percentage of participants who achieve an average of one post or response to a post per week	Baseline To 6 Months
Primary	Feasibility: Rate of Access of Health News	Percentage of participants who review health news at least once per week	Baseline To 6 Months
Primary	Feasibility: Rate of Access of Event Calendar	Percentage of participants who review event calendar at least once per week	Baseline To 6 Months
Primary	Feasibility: Time For Participant Onboarding (Minutes)	Average time to onboard new participant (including downloading app and reviewing app features)	Baseline To 6 Months
Primary	Feasibility: Time To Maintain & Support (Minutes)	Average time required for administrative, maintenance, and support per participant per week (excludes 1st visit)	Baseline To 6 Months
Secondary	Acceptability: Participant Retention	Percentage of individuals who enrolled and completed the study at 6 months	Baseline To 6 Months
Secondary	Acceptability: System Usability Score	Ten-items, Likert scale (1-5), 1 is strongly disagree and 5 is strongly agree; To calculate the System Usability Score (SUS), first sum the score contributions from each item. Each item's score contribution will range from 0 to 4. For items 1,3,5,7,and 9 the score contribution is the scale position minus 1. For items 2,4,6,8 and 10, the contribution is 5 minus the scale position. Multiply the sum of the scores by 2.5 to obtain the overall value of System Usability (SU). SUS scores have a range of 0 to 100.	Baseline To 6 Months
Secondary	Acceptability: Satisfaction Acceptability Questionnaire	Measure participant satisfaction with intervention delivered via mobile application at 6-months using a 30-item questionnaire (1 Excellent-6 Unsatisfied) administered through an online survey. An average score greater than or equal to 144 (80%) will be considered acceptable.	Baseline To 6 Months