Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

mHealth App for Engagement in Care Among Youth Living With HIV

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03587857
Recruitment Status : Not yet recruiting
First Posted : July 16, 2018
Last Update Posted : April 3, 2019
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

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 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.


Condition or disease Intervention/treatment Phase
HIV/AIDS Mobile Health Young Adults Other: Mobile Health Application Not Applicable

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 private online community of YLWH.

The investigators will complete development of WYZ (1.0), field test the initial release with a sample 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 receive care in the San Francisco Bay Area. The objectives of this forthcoming phase are to refine the design and development and pilot test WYZ.

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 monthly check-ins to examine satisfaction with application use, the system usability scale (SUS), a study-developed acceptability 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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 76 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Mobile Health Application for Engagement in Care Among Youth Living With HIV
Estimated Study Start Date : May 1, 2019
Estimated Primary Completion Date : June 1, 2020
Estimated Study Completion Date : August 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

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 Name: WYZ




Primary Outcome Measures :
  1. Feasibility: Rate of Participant Recruitment [ Time Frame: 8 Months ]
    Recruit at least 55 participants (i.e. 70% of target N)

  2. Feasibility: Frequency of WYZ Access [ Time Frame: Baseline to 6 Months ]
    Percentage of participants who achieve an average of 1 log-in per week

  3. Feasibility: Length of Session (Minutes) [ Time Frame: Baseline To 6 Months ]
    Percentage of participants who achieve an average of 15 minutes in application per week

  4. Feasibility: Rate of Use of Refill Reminders [ Time Frame: Baseline To 6 Months ]
    Percentage of participants that use feature once monthly (if receiving 30-day ART supply)

  5. Feasibility: Rate of Use of ART Adherence Tracking [ Time Frame: Baseline To 6 Months ]
    Percentage of participants that track med adherence at least 3 times per week

  6. Feasibility: Rate of Access of Laboratory Data [ Time Frame: Baseline To 6 Months ]
    Percentage of participants that review laboratory data at least one-time per month

  7. Feasibility: Rate of Communication With Clinical Team Members [ Time Frame: Baseline To 6 Months ]
    Percentage of participants who achieve an average of 1 communication exchange per month with clinical team member

  8. Feasibility: Rate of Communication With Peers [ Time Frame: Baseline To 6 Months ]
    Percentage of participants who achieve an average of one post or response to a post per week

  9. Feasibility: Rate of Access of Health News [ Time Frame: Baseline To 6 Months ]
    Percentage of participants who review health news at least once per week

  10. Feasibility: Rate of Access of Event Calendar [ Time Frame: Baseline To 6 Months ]
    Percentage of participants who review event calendar at least once per week

  11. Feasibility: Time For Participant Onboarding (Minutes) [ Time Frame: Baseline To 6 Months ]
    Average time to onboard new participant (including downloading app and reviewing app features)

  12. Feasibility: Time To Maintain & Support (Minutes) [ Time Frame: Baseline To 6 Months ]
    Average time required for administrative, maintenance, and support per participant per week (excludes 1st visit)


Secondary Outcome Measures :
  1. Acceptability: Participant Retention [ Time Frame: Baseline To 6 Months ]
    Percentage of individuals who enrolled and completed the study at 6 months

  2. Acceptability: System Usability Score [ Time Frame: Baseline To 6 Months ]

    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.


  3. Acceptability: Satisfaction Acceptability Questionnaire [ Time Frame: Baseline To 6 Months ]
    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.


Other Outcome Measures:
  1. Mobile Application Engagement Index (EI) [ Time Frame: Baseline To 6 Months ]

    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.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 29 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 or iOS 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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03587857


Contacts
Layout table for location contacts
Contact: Parya Saberi, PhamD 415-502-1000 ext 17171 Parya.Saberi@ucsf.edu
Contact: Xavier A Erguera Xavier.Erguera@ucsf.edu

Sponsors and Collaborators
University of California, San Francisco
Investigators
Layout table for investigator information
Principal Investigator: Parya Saberi, PhamD UCSF School of Medicine, Division of Prevention Science

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT03587857     History of Changes
Other Study ID Numbers: R34MH114604 ( U.S. NIH Grant/Contract )
First Posted: July 16, 2018    Key Record Dates
Last Update Posted: April 3, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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

Keywords provided by University of California, San Francisco:
Health Disparity