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| ID | Type | Description | Link |
|---|---|---|---|
| R34MH114604 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: Intervention | Experimental | 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mobile Health Application | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility: Rate of Participant Recruitment | Recruit at least 55 participants (i.e. 70% of target N) | 8 Months |
| Feasibility: Frequency of WYZ Access | Mean number of logins/week over the 6 month period of using WYZ | 6 Months |
| Feasibility: Length of Session (Minutes) | Mean minutes/week spent in the app over the 6 month period of using WYZ | 6 Months |
| 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. | 6 Months |
| 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 | 6 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Acceptability: Participant Retention | Percentage of individuals who enrolled and completed the study at 6 months | 6 Months |
| Acceptability: Overall App Experience | Percent of participants who rated their overall experience with the app as excellent to very good |
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Eligibility Criteria:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Parya Saberi, PhamD | UCSF School of Medicine, Division of Prevention Science | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California San Francisco, Mission Bay Campus | San Francisco | California | 94143 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31061063 | Background | 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. | |
| 34463622 | Result | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Feasibility: Rate of Participant Recruitment | Recruit at least 55 participants (i.e. 70% of target N) | Overall Number of Participants Analyzed represents number of participants screened for study interest prior to recruitment/enrollment | Posted | Count of Participants | Participants | 8 Months |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Parya Saberi | UCSF | 415-502-1000 ext. 17171 | parya.saberi@ucsf.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 26, 2019 | May 21, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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|
|
| 6 Months |
| Acceptability: Privacy, Security, and Anonymity | Percent of participants who reported being extremely to somewhat comfortable with the security, privacy, and anonymity of WYZ | 6 Months |
| Acceptability: Continue Using WYZ | Percent of participants who stated that they would be extremely to somewhat likely to continue to use WYZ | 6 Months |
| 33920803 | Result | 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. |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | 1 declined to answer | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Primary | Feasibility: Frequency of WYZ Access | Mean number of logins/week over the 6 month period of using WYZ | Posted | Mean | Standard Deviation | Mean logins/week | 6 Months |
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|
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| Primary | Feasibility: Length of Session (Minutes) | Mean minutes/week spent in the app over the 6 month period of using WYZ | Posted | Mean | Standard Deviation | Mean minutes/week | 6 Months |
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| 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. | Posted | Mean | Full Range | % mean times tracked/week | 6 Months |
|
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| 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 | Posted | Mean | Full Range | Mean postings/person/week | 6 Months |
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| Secondary | Acceptability: Participant Retention | Percentage of individuals who enrolled and completed the study at 6 months | Posted | Count of Participants | Participants | 6 Months |
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| Secondary | Acceptability: Overall App Experience | Percent of participants who rated their overall experience with the app as excellent to very good | Posted | Count of Participants | Participants | 6 Months |
|
|
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| Secondary | Acceptability: Privacy, Security, and Anonymity | Percent of participants who reported being extremely to somewhat comfortable with the security, privacy, and anonymity of WYZ | Posted | Count of Participants | Participants | 6 Months |
|
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| Secondary | Acceptability: Continue Using WYZ | Percent of participants who stated that they would be extremely to somewhat likely to continue to use WYZ | Posted | Count of Participants | Participants | 6 Months |
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|
| 0 |
| 79 |
| 0 |
| 79 |
| 0 |
| 79 |
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| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |