Trial Outcomes & Findings for mHealth App for Engagement in Care Among Youth Living With HIV (NCT NCT03587857)

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

79 participants

Primary outcome timeframe

8 Months

Results posted on

2025-07-01

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	79
Overall Study COMPLETED	69
Overall Study NOT COMPLETED	10

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

1 declined to answer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm 1: Intervention n=79 Participants 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.
Age, Categorical <=18 years	0 Participants n=79 Participants
Age, Categorical Between 18 and 65 years	79 Participants n=79 Participants
Age, Categorical >=65 years	0 Participants n=79 Participants
Age, Continuous	26.9 years STANDARD_DEVIATION 2.9 • n=79 Participants
Sex: Female, Male Female	9 Participants n=78 Participants • 1 declined to answer
Sex: Female, Male Male	69 Participants n=78 Participants • 1 declined to answer
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=79 Participants
Race (NIH/OMB) Asian	3 Participants n=79 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	3 Participants n=79 Participants
Race (NIH/OMB) Black or African American	20 Participants n=79 Participants
Race (NIH/OMB) White	18 Participants n=79 Participants
Race (NIH/OMB) More than one race	21 Participants n=79 Participants
Race (NIH/OMB) Unknown or Not Reported	12 Participants n=79 Participants
Region of Enrollment United States	79 participants n=79 Participants

PRIMARY outcome

Timeframe: 8 Months

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

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

Outcome measures

Outcome measures
Measure	Arm 1: Intervention n=92 Participants 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.
Feasibility: Rate of Participant Recruitment	79 Participants

PRIMARY outcome

Timeframe: 6 Months

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

Outcome measures

Outcome measures
Measure	Arm 1: Intervention n=79 Participants 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.
Feasibility: Frequency of WYZ Access	5.3 Mean logins/week Standard Deviation 5.6

PRIMARY outcome

Timeframe: 6 Months

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

Outcome measures

Outcome measures
Measure	Arm 1: Intervention n=79 Participants 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.
Feasibility: Length of Session (Minutes)	8.7 Mean minutes/week Standard Deviation 5

PRIMARY outcome

Timeframe: 6 Months

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.

Outcome measures

Outcome measures
Measure	Arm 1: Intervention n=79 Participants 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.
Feasibility: Rate of Use of ART Adherence Tracking	58 % mean times tracked/week Interval 0.0 to 100.0

PRIMARY outcome

Timeframe: 6 Months

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

Outcome measures

Outcome measures
Measure	Arm 1: Intervention n=79 Participants 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.
Feasibility: Rate of Communication With Peers	4.8 Mean postings/person/week Interval 1.0 to 42.0

SECONDARY outcome

Timeframe: 6 Months

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

Outcome measures

Outcome measures
Measure	Arm 1: Intervention n=79 Participants 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.
Acceptability: Participant Retention	69 Participants

SECONDARY outcome

Timeframe: 6 Months

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

Outcome measures

Outcome measures
Measure	Arm 1: Intervention n=69 Participants 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.
Acceptability: Overall App Experience	53 Participants

SECONDARY outcome

Timeframe: 6 Months

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

Outcome measures

Outcome measures
Measure	Arm 1: Intervention n=69 Participants 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.
Acceptability: Privacy, Security, and Anonymity	69 Participants

SECONDARY outcome

Timeframe: 6 Months

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

Outcome measures

Outcome measures
Measure	Arm 1: Intervention n=69 Participants 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.
Acceptability: Continue Using WYZ	57 Participants

Adverse Events

Arm 1: Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Parya Saberi

UCSF

Phone: 415-502-1000 ext. 17171

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place