Summary

for people ages 18-29 (full criteria)
study started
estimated completion:
PhamD Parya Saberi

Description

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 pilot randomized trial to assess the feasibility, acceptability, and preliminary clinical impact (i.e., adherence, plasma HIV RNA, and CD4+ cell count) of the use of this app among YLWH and their healthcare providers. 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.

Official Title

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

Details

WYZ is a prescriptive mobile health app created based on formative work with youth living with HIV (YLWH) using a Human-Centered Design (HCD) approach and grounded in the Information-Motivation-Behavioral Skills (IMB) theoretical model to help improve engagement in care and antiretroviral therapy (ART) adherence among this population. The investigators chose IMB as the theoretical model for the app due to the extensive use in adherence research, research with youth, and because the components closely fit the app features. The HCD approach was selected because it allows for iterative development and places the 'beneficiary' at the center and asks them to lead the design and refinement.

The investigators will complete development and field test the initial release (WYZ 1.0) 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.

An innovative two-phase clinical trial design was chosen to allow the investigators to make preliminary impact comparisons between the two arms, assess the acceptability of randomization, iteratively refine the app, and collect longer-term data on participants in the intervention arm. Given the intent of the pilot study, the investigators chose a sample size of 78 to provide adequate variability in qualitative and quantitative data while remaining within a feasible scope for an exploratory study.

In the first phase, the investigators will randomize 78 YLWH to receive the intervention (i.e., WYZ 2.0) versus a wait-list control. The intervention arm will use the app for 6 months. The investigators will asses feasibility, acceptability and preliminary clinical impact of WYZ among the intervention arm.

In the second phase, the investigators will provide access to the mobile app (WYZ 2.0) to the wait-list control for another 6 months. Participants in the intervention arm (i.e., Arm 1) will be able to continue to use the app during months 6-12. The investigators will evaluate the acceptability, feasibility and preliminary clinical impacts among and between both cohorts (intervention and wait-list control).

Based on the data from participants in this pilot study, the investigators will develop WYZ 3.0, which will be used in a future R01 to examine the efficacy of the intervention with a much larger sample.

Keywords

HIV/AIDS Mobile Health Young Adults Health Disparity Mobile Health Application

Eligibility

For people ages 18-29

Eligibility Criteria:

  • Must be between 18 and 29 years of age
  • Must be living with HIV
  • Must reside in San Francisco
  • 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.

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT03587857
Lead Scientist
PhamD Parya Saberi
Study Type
Interventional
Last Updated