HIV/AIDSYEHENCT05789875

Youth Ending the HIV Epidemic

A study testing aDOT-CEI in people with HIV/AIDS and Mobile Health, run by University of California, San Francisco at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 29 years
Conditions the study is for: HIV/AIDS, Mobile Health, Young Adults
What is being tested?: aDOT-CEI
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 28 participants
Where: 1 siteUnited States
Study dates: 31 Jan 2023to 8 Sep 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 29 years
All sexes
No healthy volunteers
Adult

Who may be able to join

18 to 29 years of age
Have access to a smartphone
Can speak and read English
Client is at an AHF clinic in California or Florida
Client has an unsuppressed HIV viral load at least 3 months post HIV diagnosis
Client is on once daily oral antiretroviral therapy
Consent to participate in the proposed study

Who cannot join

YLWH who are newly HIV diagnosed in the past 3 months
Smartphone is a Samsung galaxy s21 or iPhone 5SE (app is not supported by these phones)

Trial locations and contacts

1 site in 1 country.

United States1 site

UCSF Center for AIDS Prevention Studies
San Francisco, California, 94158

Other trials in United States

About this study

Official title: Youth Ending the HIV Epidemic - Automated Directly Observed Therapy Pilot: Improving HIV Care Among Youth

Young adults have a disproportionately high rate of HIV infection, high rates of attrition at all stages of the HIV care continuum, an increased risk of antiretroviral therapy (ART) nonadherence and virologic failure, and a high probability of disease progression and transmission. Tracking and monitoring objective measures of ART adherence in real time is critical to strategies to support adherence and improve clinical outcomes. However, adherence monitoring often relies on self-reported and retrospective data or requires extra effort from providers to understand adherence patterns, making it difficult for providers to accurately determine how to support their patients in real time. In the proposed interventional study, the investigators aim to pilot test an automated directly observed therapy intervention paired with conditional economic incentives to improve ART adherence among youth living with HIV (YLWH) (18-29 years-old) who have an unsuppressed HIV viral load.

Aim 1: Conduct a pilot study to assess feasibility and acceptability of the use of automated directly observed therapy with conditional economic incentives (aDOT-CEI) among YLWH (aged 18-29; N= 30) at AIDS Healthcare Foundation (AHF) clinics in California and Florida. Primary outcomes will be feasibility and acceptability, assessed using predefined feasibility metrics and acceptability surveys at three months.

Aim 2: Explore experiences of YLWH and staff/providers with the aDOT-CEI intervention and implementation facilitators and barriers. The investigators will conduct in-depth qualitative interviews with a sample of YLWH from Aim 1 and staff/providers purposively selected from participating AHF clinics to explore intervention experiences, potential influences on ART adherence, individual-level and clinic-level barriers and facilitators to intervention implementation, and suggested refinements for a future efficacy trial.

The investigators hypothesize that the aDOT-CEI intervention to improve ART adherence among YLWH will have high feasibility and acceptability.

Read the detailed description

Automated directly observed therapy (aDOT) is an innovative technology that uses artificial intelligence (AI) with computer vision and deep learning algorithms to track and support adherence through a smartphone. Additionally, aDOT provides a seamless and convenient platform for providing Conditional Economic Incentives (CEIs) because it monitors real-time adherence to automatically determine who can receive incentives. For the design and development of the mobile health app, the investigators have partnered with AiCure to use an existing HIPAA-compliant mobile health app. The investigators will invite YLWH from AIDS Healthcare Foundation (AHF) sites in CA and FL to form the study Youth Advisory Panel (YAP) and seek their input on the AiCure app. The investigators will work with AiCure to implement any required changes to the app that have emerged from formative research. The app will then be piloted with YLWH (aged 18-29; N= 30) who will use the platform for a period of 3 months (Aim 1).

The app will record video of the participant taking their HIV medication in order to monitor the participant's medication adherence. Participants will complete online surveys at baseline and 3 months. The investigators will have monthly check-ins with participants which the investigators will assess app use and help increase study engagement. The investigators will measure feasibility and acceptability through app paradata (i.e., app use information) and self-report in surveys (baseline, 3 months). And the investigators will use adherence-related medical record data from AHF to compare against adherence monitored by the AiCure app.

Following completion of the pilot, the investigators will conduct in-depth interviews (IDIs) with YLWH and staff /providers purposively selected from participating AHF clinics (Aim 2). Interviews will explore intervention experiences, potential influences on current and long-term ART adherence, unaddressed adherence barriers and the potential benefit of features (e.g., reminders), individual-level and clinic-level barriers and facilitator to intervention implementation, assess ease of use of aDOT-CEI, likes and dislikes, and suggested modifications for a future efficacy trial.

This interventional pilot study will assess the feasibility and acceptability of aDOT-CEI and will provide preliminary data to inform an R01 to test the efficacy of aDOT-CEI in addressing disproportionately low viral suppression among YLWH.

Conditions: HIV/AIDS, Mobile Health, Young Adults
Being tested: aDOT-CEI
Medical subject headings: Acquired Immunodeficiency Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

aDOT-CEIOther
Also called AiCure
For the design and development of the mobile health app, we have partnered with AiCure to use an existing HIPAA-compliant mobile health app. The app will record video of the participant taking their HIV medication in order to monitor the participant's medication adherence and track incentives for this behavior in real-time.

Study groups in NCT05789875
Study group	Role	What they receive
Intervention	Experimental	All YLWH who choose to enroll in the study will receive access to AiCure, the mobile health application. The participants will be asked to use the app for 3 months, during which the investigators will assess the feasibility and acceptability of AiCure. Receives: Other: aDOT-CEI

What is being measured

The primary outcome is the main question the study is designed to answer.

Feasibility: Rate of Participant Retention
Rate of Participant Retention will be calculated as the percent of those who were retained in the study and completed the final survey.
Measured: 3 Months
Feasibility: Mean Logins Per Week
Mobile app data from the AiCure Application (paradata) will be used to measure the number of participant logins per week and thereby calculate mean logins per participant per week.
Measured: 3 months
Feasibility: Mean Number of Seconds in App Per Day
Mobile app data from the AiCure Application (Paradata) will be used to measure the number of seconds each participant spends in that app each day, thereby calculating the mean number of seconds in app per day per participant.
Measured: 3 months
Feasibility: Mean Percent Doses a Participant May Have "Falsified" Med-taking
The AiCure mobile application platform uses an artificial intelligence or AI platform to recognize dosing patterns recorded by users that do not correspond to what has been defined as 'normal' dosing by the AI. The AI accordingly flags any video recording featuring abnormal dosing for review by the AiCure Video Review team. Upon confirmation of abnormal dosing, the AiCure Video Review team notifies the research coordinator in the form of a "Red Alert". Each of these "Red Alerts" message will be counted as an event of intentional nonadherence, and the mean number of times a participant may have "falsified" medication taking will be calculated and compared against the number of 'normal' doses.
Measured: 3 months
Acceptability: System Usability Scale (SUS) >68, Considered Above Average and Acceptable
The acceptability of the AiCure Mobile application will be through the System Usability Scale (SUS). The intervention was considered acceptable if ≥80% had a SUS score >68, which is considered above average acceptability.
Measured: 3 months
Acceptability: Client Satisfaction Questionnaire (CSQ-8) Score of ≥17, Considered Above Average and Acceptable
Client satisfaction will be measured using a Client Satisfaction Questionnaire (CSQ-8). The CSQ-8 is an 8-item scale with higher values indicating higher satisfaction. Acceptability was set as a cutoff of 80% having a score of ≥17, which is the score cutoff considered above average and acceptable for this measure.
Measured: 3 months
Acceptability: Likelihood of Recommending the Study to a Friend (Extremely, Very)
Recommend study to a friend. 7-point Likert Scale of how likely participants are to recommend the study to a friend. The intervention was considered acceptable if ≥80% reported likely or very likely to recommend.
Measured: 3 months.
Acceptability: Satisfaction With the App+Incentives (Mostly, Very)
Client satisfaction with the app+incentives. 7-point Likert Scale values from 1-7 with lower values corresponding to least satisfaction and higher values corresponding to greater satisfaction.
Measured: 3 months

Secondary outcomes (5)

Mean Percent Adherence Over the Study Period (Excluding Those Lost to Follow up)
Adherence data will be abstracted from the automated directly observed therapy platform within the AiCure mobile health application. Percent adherence will be calculated as the percentage of days over the study period that participants recorded taking their medication within the app.
Measured: 3 months
Median Self-Reported Adherence Score at Study Exit
The preliminary effect on ART adherence will be measured through self-report using a 3-item scale that has been previously validated. Questions ask about frequency of missed medications in the last 30 days, adherence frequency in the last 30 days, and adherence rating in the last 30 days. Reponses to the 3 questions were transformed to a 0-100 scale, with higher scores indicating better adherence. A summary score was calculated as the mean of the 3 individual items.
Measured: 3 months
Monitoring of Behavior: Number of Seconds in App
Number of seconds in app collected using mobile app data (paradata) from AiCure platform.
Measured: 3 months
Monitoring of Behavior: Ease of Use
How easy/difficult was it to use your personal phone; use adherence monitoring; receive incentives? Measured using a 7-point Likert Scale ranging from easy to difficult. Higher values correspond to greater ease of use, lower values correspond to greater difficulty.
Measured: 3 months
Monitoring of Behavior: Frequency of App Related Issues
Did you ever have trouble accessing app, using adherence monitoring, receiving reminders, receiving incentives, or finding a private place? 7-point Likert of frequency ranging from often to never with high value corresponding to app related issues occurring with greater frequency and lower value corresponding to app related issues issues occurring with lesser frequency.
Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

31 Jan 20238 Sep 2023

First posted29 Mar 2023
Study start31 Jan 2023
Primary completion24 Aug 2023
Study completion8 Sep 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for HIV/AIDSStudies of the same condition, open and under way.
More trials run by University of California, San FranciscoThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 28 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05789875
Sponsor's protocol ID: 22-36721
Other IDs: 3P30MH062246-22S3
Acronym: YEHE
Status last verified: Aug 2024
First submitted: 16 Mar 2023
Last updated: 26 Aug 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Stoner MCD, Ming K, Wagner D, Smith L, Patani H, Sukhija-Cohen A, Johnson MO, Napierala S, Neilands TB, Saberi P. Youth Ending the HIV Epidemic (YEHE): Protocol for a pilot of an automated directly observed therapy intervention with conditional economic incentives among young adults with HIV. PLoS One. 2023 Dec 22;18(12):e0289919. doi: 10.1371/journal.pone.0289919. eCollection 2023.
PubMed 38134037

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 26 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Youth Ending the HIV Epidemic - Automated Directly Observed Therapy Pilot: Improving HIV Care Among Youth
ClinicalTrials.gov ID: NCT05789875
Acronym / sponsor ID: YEHE / 22-36721
Conditions: HIV/AIDS, Mobile Health, Young Adults
Study type: Interventional
Recruitment status: Completed
Enrolment: 28 participants (actual)
Lead sponsor: University of California, San FranciscoUniversity, hospital or other
Collaborators: AiCure, RTI International, National Institute of Mental Health (NIMH)
Study start: 31 Jan 2023 (actual)
Primary completion: 24 Aug 2023 (actual)
Study completion: 8 Sep 2023 (actual)
First posted: 29 Mar 2023 (actual)
Results: Posted 26 Aug 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The investigators hypothesize that the aDOT-CEI intervention to improve ART adherence among YLWH will have high feasibility and acceptability.

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Intervention	Experimental	Other: aDOT-CEIAll YLWH who choose to enroll in the study will receive access to AiCure, the mobile health application. The participants will be asked to use the app for 3 months, during which the investigators will assess the feasibility and acceptability of AiCure.

Who may qualify

Ages: 18 to 29 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (7 listed)

18 to 29 years of age
Have access to a smartphone
Can speak and read English
Client is at an AHF clinic in California or Florida
Client has an unsuppressed HIV viral load at least 3 months post HIV diagnosis

Key exclusion criteria (2 listed)

YLWH who are newly HIV diagnosed in the past 3 months
Smartphone is a Samsung galaxy s21 or iPhone 5SE (app is not supported by these phones)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
aDOT-CEIAlso: AiCureFor the design and development of the mobile health app, we have partnered with AiCure to use an existing HIPAA-compliant mobile health app. The app will record video of the participant taking their HIV medication in order to monitor the participant's medication adherence and track incentives for this behavior in real-time.	Other	Intervention

Primary outcome

Feasibility: Rate of Participant Retention
Time frame: 3 Months
Rate of Participant Retention will be calculated as the percent of those who were retained in the study and completed the final survey.
Feasibility: Mean Logins Per Week
Time frame: 3 months
Mobile app data from the AiCure Application (paradata) will be used to measure the number of participant logins per week and thereby calculate mean logins per participant per week.
Feasibility: Mean Number of Seconds in App Per Day
Time frame: 3 months
Mobile app data from the AiCure Application (Paradata) will be used to measure the number of seconds each participant spends in that app each day, thereby calculating the mean number of seconds in app per day per participant.
Feasibility: Mean Percent Doses a Participant May Have "Falsified" Med-taking
Time frame: 3 months
The AiCure mobile application platform uses an artificial intelligence or AI platform to recognize dosing patterns recorded by users that do not correspond to what has been defined as 'normal' dosing by the AI. The AI accordingly flags any video recording featuring abnormal dosing for review by the AiCure Video Review team. Upon confirmation of abnormal dosing, the AiCure Video Review team notifies the research coordinator in the form of a "Red Alert". Each of these "Red Alerts" message will be counted as an event of intentional nonadherence, and the mean number of times a participant may have "falsified" medication taking will be calculated and compared against the number of 'normal' doses.
Acceptability: System Usability Scale (SUS) >68, Considered Above Average and Acceptable
Time frame: 3 months
The acceptability of the AiCure Mobile application will be through the System Usability Scale (SUS). The intervention was considered acceptable if ≥80% had a SUS score >68, which is considered above average acceptability.
Acceptability: Client Satisfaction Questionnaire (CSQ-8) Score of ≥17, Considered Above Average and Acceptable
Time frame: 3 months
Client satisfaction will be measured using a Client Satisfaction Questionnaire (CSQ-8). The CSQ-8 is an 8-item scale with higher values indicating higher satisfaction. Acceptability was set as a cutoff of 80% having a score of ≥17, which is the score cutoff considered above average and acceptable for this measure.
Acceptability: Likelihood of Recommending the Study to a Friend (Extremely, Very)
Time frame: 3 months.
Recommend study to a friend. 7-point Likert Scale of how likely participants are to recommend the study to a friend. The intervention was considered acceptable if ≥80% reported likely or very likely to recommend.
Acceptability: Satisfaction With the App+Incentives (Mostly, Very)
Time frame: 3 months
Client satisfaction with the app+incentives. 7-point Likert Scale values from 1-7 with lower values corresponding to least satisfaction and higher values corresponding to greater satisfaction.

5 secondary outcomes

Mean Percent Adherence Over the Study Period (Excluding Those Lost to Follow up)
Time frame: 3 months
Median Self-Reported Adherence Score at Study Exit
Time frame: 3 months
Monitoring of Behavior: Number of Seconds in App
Time frame: 3 months
Monitoring of Behavior: Ease of Use
Time frame: 3 months
Monitoring of Behavior: Frequency of App Related Issues
Time frame: 3 months

Results and safety

Results posted to the registry on 26 Aug 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Intervention	28	22

Primary outcome: Feasibility: Rate of Participant Retention

Time frame: 3 Months. Count of participants. Unit: Participants

Measure	Intervention n = 28
Value	22

Primary outcome: Feasibility: Mean Logins Per Week

Time frame: 3 months

The sponsor has not posted figures for this outcome.

Primary outcome: Feasibility: Mean Number of Seconds in App Per Day

Time frame: 3 months. Mean (Full Range). Unit: seconds/day

Measure	Intervention n = 28
Value	28 (0 to 308)

Primary outcome: Feasibility: Mean Percent Doses a Participant May Have "Falsified" Med-taking

Time frame: 3 months. Mean (Full Range). Unit: % of doses

Measure	Intervention n = 28
Value	2 (0 to 23.8)

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: duration of the study (3 months). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Intervention	0 of 28 (0%)	0 of 28 (0%)	0 of 28

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 38134037Stoner MCD, Ming K, Wagner D, Smith L, Patani H, Sukhija-Cohen A, Johnson MO, Napierala S, Neilands TB, Saberi P. Youth Ending the HIV Epidemic (YEHE): Protocol for a pilot of an automated directly observed therapy intervention with conditional economic incentives among young adults with HIV. PLoS One. 2023 Dec 22;18(12):e0289919. doi: 10.1371/journal.pone.0289919. eCollection 2023.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Parya Saberi, PharmD principal investigator

UCSF School of Medicine, Division of Prevention Science

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing aDOT-CEI in people with HIV/AIDS and Mobile Health, run by University of California, San Francisco at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility: Rate of Participant Retention (time frame: 3 Months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05789875, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2024.