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mHealth App for Engagement in Care Among Youth Living With HIV

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03587857
Enrollment
79
Registered
2018-07-16
Start date
2019-07-01
Completion date
2020-05-01
Last updated
2025-07-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV/AIDS, Mobile Health, Young Adults

Keywords

Health Disparity

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.

Interventions

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.

Sponsors

National Institute of Mental Health (NIMH)
CollaboratorNIH
University of California, San Francisco
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 29 Years
Healthy volunteers
No

Inclusion 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.

Design outcomes

Primary

MeasureTime frameDescription
Feasibility: Rate of Communication With Peers6 MonthsMean number of postings of chat topics on the My Community chat per person per week, over 6 months of using WYZ
Feasibility: Rate of Participant Recruitment8 MonthsRecruit at least 55 participants (i.e. 70% of target N)
Feasibility: Frequency of WYZ Access6 MonthsMean number of logins/week over the 6 month period of using WYZ
Feasibility: Length of Session (Minutes)6 MonthsMean minutes/week spent in the app over the 6 month period of using WYZ
Feasibility: Rate of Use of ART Adherence Tracking6 MonthsMean 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.

Secondary

MeasureTime frameDescription
Acceptability: Overall App Experience6 MonthsPercent of participants who rated their overall experience with the app as excellent to very good
Acceptability: Privacy, Security, and Anonymity6 MonthsPercent of participants who reported being extremely to somewhat comfortable with the security, privacy, and anonymity of WYZ
Acceptability: Continue Using WYZ6 MonthsPercent of participants who stated that they would be extremely to somewhat likely to continue to use WYZ
Acceptability: Participant Retention6 MonthsPercentage of individuals who enrolled and completed the study at 6 months

Countries

United States

Participant flow

Participants by arm

ArmCount
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). 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.
79
Total79

Baseline characteristics

CharacteristicArm 1: Intervention
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
0 Participants
Age, Categorical
Between 18 and 65 years
79 Participants
Age, Continuous26.9 years
STANDARD_DEVIATION 2.9
Race (NIH/OMB)
American Indian or Alaska Native
2 Participants
Race (NIH/OMB)
Asian
3 Participants
Race (NIH/OMB)
Black or African American
20 Participants
Race (NIH/OMB)
More than one race
21 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
3 Participants
Race (NIH/OMB)
Unknown or Not Reported
12 Participants
Race (NIH/OMB)
White
18 Participants
Region of Enrollment
United States
79 participants
Sex: Female, Male
Female
9 Participants
Sex: Female, Male
Male
69 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 79
other
Total, other adverse events
0 / 79
serious
Total, serious adverse events
0 / 79

Outcome results

Primary

Feasibility: Frequency of WYZ Access

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

Time frame: 6 Months

ArmMeasureValue (MEAN)Dispersion
Arm 1: InterventionFeasibility: Frequency of WYZ Access5.3 Mean logins/weekStandard Deviation 5.6
Primary

Feasibility: Length of Session (Minutes)

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

Time frame: 6 Months

ArmMeasureValue (MEAN)Dispersion
Arm 1: InterventionFeasibility: Length of Session (Minutes)8.7 Mean minutes/weekStandard Deviation 5
Primary

Feasibility: Rate of Communication With Peers

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

Time frame: 6 Months

ArmMeasureValue (MEAN)
Arm 1: InterventionFeasibility: Rate of Communication With Peers4.8 Mean postings/person/week
Primary

Feasibility: Rate of Participant Recruitment

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

Time frame: 8 Months

Population: Overall Number of Participants Analyzed represents number of participants screened for study interest prior to recruitment/enrollment

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Arm 1: InterventionFeasibility: Rate of Participant Recruitment79 Participants
Primary

Feasibility: Rate of Use of ART Adherence Tracking

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.

Time frame: 6 Months

ArmMeasureValue (MEAN)
Arm 1: InterventionFeasibility: Rate of Use of ART Adherence Tracking58 % mean times tracked/week
Secondary

Acceptability: Continue Using WYZ

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

Time frame: 6 Months

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Arm 1: InterventionAcceptability: Continue Using WYZ57 Participants
Secondary

Acceptability: Overall App Experience

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

Time frame: 6 Months

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Arm 1: InterventionAcceptability: Overall App Experience53 Participants
Secondary

Acceptability: Participant Retention

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

Time frame: 6 Months

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Arm 1: InterventionAcceptability: Participant Retention69 Participants
Secondary

Acceptability: Privacy, Security, and Anonymity

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

Time frame: 6 Months

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Arm 1: InterventionAcceptability: Privacy, Security, and Anonymity69 Participants

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026