Youth Ending the HIV Epidemic - Automated Directly Observed Therapy Pilot: Improving HIV Care Among Youth
Phase: NA
Conditions: HIV/AIDS, Mobile Health, Young Adults
Sponsor: University of California, San Francisco

YEHE Study Protocol 
 
Study Title: Youth Ending the HIV Epidemic - Automated Directly Observed Therapy Pilot: 
Improving HIV Care Among Youth 
National Clinical Trial Number: NCT05789875 
IRB Study Number: 22-36721 
Version #2, Date: 8/1/2023 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
YEHE Study Protocol 

 
Contents 
Protocol Title ................................................................................................................................................. 2 
Background ................................................................................................................................................... 2 
Objectives ..................................................................................................................................................... 3 
Preliminary Studies ....................................................................................................................................... 4 
Sample Size and Eligibility ............................................................................................................................. 4 
Recruitment .................................................................................................................................................. 5 
Procedures .................................................................................................................................................... 5 
Consent Process ............................................................................................................................................ 7 
Data Collection and Analysis ......................................................................................................................... 7 
Risks to Subjects ............................................................................................................................................ 9 
Risk to Benefit Ratio .................................................................................................................................... 10 
Data Management ...................................................................................................................................... 11 
References .................................................................................................................................................. 11 
 
 
Protocol Title 
Youth Ending the HIV Epidemic - Automated Directly Observed Therapy Pilot: Improving HIV 
Care Among Youth 
Background 
Health disparities among young adults living with HIV (YLWH). Despite improvements in life 
expectancy among people living with HIV (PLWH) and reductions in HIV transmission with 
increased availability of antiretroviral therapy (ART), a sustained effect of ART depends on high 
levels of adherence. In the US in 2018, for every 100 youth diagnosed with HIV, 79 received 
some HIV care, 58 were retained in care, and 60 were virally suppressed.1 These figures are 
dramatically lower than those for older adults.2-5 In addition to increased onward HIV 
transmission, poor adherence can increase drug resistance, leading to less effective treatment 
options and worse clinical outcomes.6 Consequently, YLWH represent a priority population to 
address with efforts to increase re-engagement in care and improved ART adherence. The 
overarching goal of this Ending the HIV Epidemic (EHE) Supplement application is to pilot test 
an innovative intervention, Youth Ending the HIV Epidemic (YEHE), to improve ART adherence 
and HIV virologic suppression in 18–29-year-old YLWH.  
 

Use of an innovative intervention to improve HIV health outcomes among YLWH. There is 
growing interest in the use of novel technologies to provide objective measures to efficiently 
monitor and support medication adherence with reduced cost and burden to patients and 
providers. These tools are well suited for young people who are proportionately high users of 
mobile technologies.7-9 Digital directly observed therapy (DOT) has been shown to be 
acceptable, feasible, and effective at increasing medication adherence in different populations 
and for a range of health outcomes, including adherence to HIV pre-exposure prophylaxis 
(PrEP).10-14 Automated DOT (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.10,15-17 However, to our knowledge, aDOT has not been used to help enhance ART 
adherence among YLWH who may need adherence support. 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. CEIs 
use operant conditioning to reinforce behavior through financial incentives or prizes18 that have 
been shown to be sustainable in some settings.19 CEI has been used successfully to increase ART 
adherence and promote behavior change, and studies using in-person DOT for tuberculosis 
have found that the benefits of DOT were even further increased with the addition of financial 
incentives.20-25 Consequently, a combined aDOT-CEI platform where medication-taking is 
monitored and incentivized in real time is a promising approach to increase ART adherence in 
YLWH. We aim to pilot test an aDOT-CEI intervention, YEHE, to improve ART adherence among 
YLWH (18–29 years-old) in California and Florida who have an unsuppressed HIV viral load. 
 
Our study is significant because it has the potential to be cost-effective while improving ART 
adherence and virologic suppression among a key population experiencing health disparities. 
This research builds on our prior work using technology-based interventions to improve HIV 
clinical outcomes among YLWH.26-29 Our intervention is innovative because we will use a novel 
aDOT-CEI intervention among YLWH who are not virologically suppressed. This EHE application 
will document 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. 
 
Objectives 
 
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,30 making it difficult for providers to accurately 
determine how to support their patients in real time. In the proposed study, we will monitor 

medication-taking using a real-time objective measure of adherence that does not rely on 
healthcare providers for assessment.  
 
Prior research shows high feasibility and acceptability of technology-based directly observed 
therapy (DOT) to improve medication adherence with reduced provider and patient burden 
versus in-person DOT.10-14 Additionally, financial barriers, side effects, and struggles with 
waning motivation to continue ART are commonly cited barriers to adherence among young 
adults living with HIV (YLWH).31,32 Conditional Economic Incentives (CEIs) have been used 
successfully to promote a range of positive behaviors and have specifically been coupled with 
in-person DOT to improve ART adherence.18,20,21 In the current proposal, we build on the 
existing evidence and interventions and address underlying gaps in research by aiming to pilot 
test the Youth Ending the HIV Epidemic (YEHE) intervention to improve ART adherence in 18–
29-year-old YLWH in California and Florida. 
 
In Aim 1, we will enroll YLWH aged 18 to 29 to participate in a 3-month pilot study to assess the 
feasibility and acceptability of a novel automated directly observed therapy-conditional 
economic incentive (aDOT-CEI) intervention. In Aim 2, some of the pilot participants and 
staff/providers from participating AIDS Healthcare Foundation (AHF) clinics will participate in 
individual in-depth qualitative interviews to explore intervention and implementation 
facilitators and barriers. These Aims will provide quantitative and qualitative evidence on 
feasibly and acceptability to determine whether a future trial is merited based on set criteria. 
 
Preliminary Studies 
 
Prior research shows high feasibility and acceptability of technology-based DOT to improve 
medication adherence with reduced provider and patient burden versus in-person DOT.10-14 
Additionally, financial barriers, side effects, and struggles with waning motivation to continue 
ART are commonly cited barriers to adherence among YLWH.31,32 CEIs have been used 
successfully to promote a range of positive behaviors and have specifically been coupled with 
in-person DOT to improve ART adherence.18,20,21 In the current proposal, we build on the 
existing evidence and interventions and address underlying gaps in research by aiming to pilot 
test a novel mHealth app that combines aDOT with CEI to improve ART adherence in 18–29-
year-old YLWH. 
Sample Size and Eligibility 
 
Total Enrollment – 30 participants and 5 providers/staff from the AHF clinics 
- 
Aim 1: 30 YLWH  
- 
Aim 2: 15 YLWH from Aim 1 + 5 providers/staff from the AHF clinics 
 
Inclusion Criteria – Participants will be included if they meet the following 
criteria: 

- 
18 to 29 years of age 
- 
Have access to a smartphone 
- 
Can speak and read English or Spanish 
- 
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 
 
Exclusion Criteria - Participants will be excluded if they meet the following 
criteria: 
- 
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) 
Recruitment 
 
We will recruit YLWH from AHF clinics in CA (San Francisco, Oakland, Los Angeles, and San 
Diego) and FL. AHF will generate a list of clients from their database of YLWH aged 18–29 who 
have an unsuppressed viral load. From this list, clients will be randomly selected and contacted 
by AHF for interest in the study (refer to attached recruitment script). To recruit YLWH who are 
out of care, clients will be contacted by AHF providers or staff through the Back in Care 
program. Clients out of care are called regularly and will be offered the intervention to assess 
interest and eligibility. Interested clients will be encouraged to contact the study team for 
further information, screening, and enrollment; or they may be asked for permission to share 
their contact information with the study team to reach out to them (refer to attached screening 
script).  
 
Clients may also reach out to the study team directly if they see a flyer in the clinic. 
 
For Aim 2, a sample of the YLWH participants and staff/providers from participating AHF clinics 
will be purposively selected and invited to participate in an interview. Research staff will reach 
out by phone/text/email to assess for interest and schedule a time for the interview. 
 
Procedures 
 
In Aim 1, we will enroll YLWH aged 18 to 29 to participate in a 3-month pilot study to assess the 
feasibility and acceptability of a novel automated directly observed therapy-conditional 
economic incentive (aDOT-CEI) intervention. In Aim 2, some of the pilot participants and 
staff/providers from participating AIDS Healthcare Foundation (AHF) clinics will participate in 
individual in-depth qualitative interviews to explore intervention and implementation 

facilitators and barriers. These Aims will provide quantitative and qualitative evidence on 
feasibly and acceptability to determine whether a future trial is merited based on set criteria. 
In the first year of the study, we will hire and train study staff. We will invite YLWH from AHF 
sites in CA to form the study Youth Advisory Panel (YAP) and seek their input throughout the 
study on the AiCure app used for the intervention, financial incentive structure, recruitment 
and retention strategies, and dissemination of the study findings. The YAP will provide feedback 
on (1) the schedule used to deliver incentives, (2) the size of the incentive, and (3) the type of 
incentive. YAP members also will provide input on the information that should be provided 
through the app and other study materials (e.g., communication about how to use the app to 
receive incentives, and reminder messages). YAP members will review study materials (surveys, 
instructions, videos) before study launch and will provide input on recruitment, engagement, 
and retention strategies, next steps, and contextualization and dissemination of the findings. 
We 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 who will use the platform for 
a period of 3 months (Aim 1).  
For the pilot, we will recruit YLWH from AHF clinics in CA and FL. During enrollment, 
participants will be informed about the study. Following consent, participants will be given 
instructions to download the app to their mobile phone, and study staff will demonstrate how 
to use the app via a remote conferencing platform. They will complete a tutorial and 
demonstrate taking ART using the app. 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. We will have monthly check-ins with 
participants which we will assess app use and help increase study engagement. We will 
measure feasibility and acceptability through app paradata (i.e., app use information) and self-
report in surveys (baseline, 3 months). At consent, we will also have the participants sign a 
HIPAA form so that we may request adherence related medical record data from their AHF 
clinic. We will use this data to compare against adherence monitored by the AiCure app. 
Following completion of the pilot, we will conduct in-depth interviews (IDIs) with YLWH and 
staff/providers purposively selected from participating AHF clinics. 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. Interviews will be conducted remotely using a HIPAA-compliant, licensed Zoom account 
and audio-recorded. The interviews will be semi-structured to explore key questions, with 
allowance for iteration and probing on emergent themes raised by participants. We will explore 
the benefit of individual (aDOT, CEI) and combined components (aDOT+CEI). 
During the study, we will continue to meet with the YAP to discuss challenges and potential 
solutions. After completion of the study, we will discuss the study findings with the YAP and 
other groups, such as the Center for AIDS Prevention Studies (CAPS), the CAPS Community 
Advisory Board (CAPS CAB), Departments of Public Health in major cities of California, California 
State Office of AIDS, Medi-Cal managed care plans, private insurers (such as Kaiser 

Permanente), Ryan White planning councils, and other groups with a strong working knowledge 
of HIV service delivery and funding in California. The purpose of these meetings will be to 
determine next steps and developing sustainable models for implementation of this service 
should it be found to be effective. For example, if the study is efficacious, we will explore 
mechanisms for its implementation. 
Consent Process 
 
Aim 1: Interested clients will be encouraged to contact the study team, or will be asked for 
permission to share their contact information with the study team. The study team will screen 
them to determine eligibility, and if eligible, will offer to enroll them in the study. Consent and 
enrollment will occur online through Qualtrics by a study team member. Interested individuals 
will be given adequate time to read the consent form and the study team member will be 
available to answer any questions via phone. The consent form will include information about 
potential risks and benefits, that participation is completely voluntary and will not affect the 
care that participants receive, and that they may withdraw from the study at any time. The 
individual must read and sign the informed consent before participating. As part of the consent 
form, participants will be notified that we will collect extensive contact information to facilitate 
tracking, including (1) names and information of 1 to 3 contacts who may know the 
participant’s whereabouts; (2) collection of additional information, including addresses of sites 
that the participant frequents, such as free food distribution centers, shelters, bars, 
probation/parole offices, etc.; and (3) attaining at least 3 methods of contact (e.g., mobile 
telephone number, email address, mailing address, or social media username). 
 
Aim 2: Study staff will obtain verbal informed consent either by phone or Zoom, and consent 
documents will be emailed to participants. Any and all participant questions and concerns will 
be addressed prior to beginning the interview. 
 
Data Collection and Analysis 
 
In Aim 1, we will conduct a pilot study to assess feasibility and acceptability of the use of aDOT-
CEI among 30 YLWH and collect survey data at baseline and after 3 months of app use (Table 1). 
We will measure feasibility and acceptability through app paradata (i.e., app use information) 
and self-report in surveys (baseline, 3 months).  
 
 
Table 1. Outcome and Descriptive Variables. 
Variables 
Source  
Threshold 
Process outcomes (Primary feasibility outcomes) 
Retention by 3 
months 
Retention data; measured at 3-month survey 
≥ 80% retention (i.e., 24 YLWH 
retained) 

Mean logins/week 
App use data for time on task or time using app 
≥ of 5 logins/week (i.e., ≥70% 
use/week) 
Mean number of 
minutes in app  
App use data for time on task or duration of time in app 
(min/day) 
≥ of 1 minute in app/day 
Intentional 
nonadherence 
AI flagging the video to be confirmed by human review 
Mean number of times 
participant may have 
“falsified” medication-taking 
(<20%) 
Client-level outcomes from exit survey (Primary acceptability outcomes) 
Acceptability at 3 
months  
System Usability Scale (SUS; range 0–100)101  
≥ 80% will have a score >68, 
considered above average and 
acceptable 
Acceptability at 3 
months 
Client Satisfaction Questionnaire (CSQ-8)102  
8 items; higher values indicate 
higher satisfaction / 80% have 
a score of ≥17103  
Recommend study 
to a friend 
How likely are you to recommend the study to a 
friend?29,31  
7-point Likert Scale / ≥80% 
likely or very likely to 
recommend  
Acceptability of 
intervention 
components 
How satisfied were you with adherence monitoring, CEI, 
reminders, security and privacy, support?29,31  
7-point Likert Scale / ≥80% 
satisfied or very satisfied 
Clinical-level outcomes (Exploratory) 
ART adherence  
Adherence data from AiCure platform  
Adherent: ≥80% of doses taken 
Non-adherent: <80% of doses 
taken 
Self-reported ART 
adherence 
Survey data. How much did participation in this study help 
you improve adherence to your medications?29  
3-item self-reported measure of ART adherence104 
Adherent: no missed doses 
Non-adherent: any missed 
doses 
Mechanisms of action from app paradata and exit survey 
Monitoring of 
behavior 
Number of minutes in app; How easy/difficult was it to 
use your personal phone; use adherence monitoring; 
receive incentives?29,31 Did you ever have trouble 
accessing app, using adherence monitoring, receiving 
reminders, receiving incentives, or finding a private 
place?29,31 
7-point Likert Scale / 80% say 
it’s easy or very easy to use. 
Target behavior 
Number of confirmed doses 
- 
 
In Aim 2, we will explore intervention and implementation facilitators/barriers by conducting 
in-depth qualitative interviews with 15 YLWH and 5 staff/providers from participating AHF 
clinics. We will examine their intervention experiences, potential influences on current and 
long-term ART adherence, unaddressed adherence barriers and potential benefit of features 
(e.g., reminders), individual-level and clinic-level barriers and facilitators to intervention 
implementation, assess ease of use of aDOT-CEI, and suggested modifications for a future 
efficacy trial. 
 
The proposed project aims to assess the feasibility and acceptability of a novel aDOT-CEI 
intervention and is not designed or powered to determine the overall intervention effect nor 
the effects of individual components.33-37 It will provide quantitative and qualitative evidence 

on feasibly and acceptability to determine whether a future trial is merited based on set 
criteria.  
 
Quantitative analysis. The primary outcomes are feasibility and acceptability of the aDOT-CEI 
intervention. To assess these outcomes, we will describe feasibility and acceptability measures 
at each time point within the intervention arm. One-way frequency tables will be generated for 
all feasibility and acceptability measures and measures of central tendency and variability will 
be computed for continuous measures. To examine feasibility of intervention procedures, we 
will examine demographic characteristics of those who participated in the study as compared 
with those who did not, and who were retained as compared with those who were not, using 
two-way tables. Demographic characteristics will include age, sex/gender, race/ethnicity, sexual 
identity, education, income, work, school, living situation, city of residence, and ever homeless 
or incarcerated. To determine if there is evidence to support a future trial, we will describe the 
percentage who meet each threshold for feasibility and acceptability at the end of the study 
period. We selected these thresholds based on our prior pilot studies among YLWH.27,29 
Mechanisms of action will be assessed in formative research and through qualitative and 
quantitative data to inform any needed modifications to implementation for a future trial. 
 
Qualitative analysis. The research coordinator will transcribe and de-identify all interviews by 
removing names and identifying details, and assist with analysis using Dedoose qualitative 
analysis software. Dedoose software allows for excerpts of transcribed interviews to be coded 
to be identified and associated with different themes from the interviews. This will allow the 
analysis to organize content into higher-order themes while also allowing easy access to 
personal narratives of the respondents. We will develop a codebook and organize themes on 
the basis of the interview excerpts and discuss and utilize analytic memos.38 During analysis, we 
will draw on our knowledge of the intervention and the Key Principles in Contingency 
Management Implementation23 to determine how participant feedback may shape future 
iterations of the aDOT-CEI. 
Risks to Subjects 
Protection against loss of privacy:  
Loss of confidentiality is the main potential risk associated with participation in this study. We 
will take appropriate precautions to minimize loss of confidentiality. Identifying information will 
be stored separately from health and behavioral information. Health and behavioral data will 
be identified only with a participant ID. Individuals will not be identified in any reports or 
publications of the research. All participant identifying data maintained for the study will be 
accessible only to the project staff via the aDOT mobile health app or Qualtrics, which are 
HIPAA-compliant, and via a HIPAA-compliant server that is only accessible to selected project 
staff. 
Security and privacy are our top priority. Consequently, for the design and development of the 
mobile health app, we have partnered with AiCure to use an existing HIPAA-compliant mobile 
health app that maximizes security. Participants are automatically logged off each time they 

exit the app. The patient portal seen by the Research Coordinator is secure and de-identified. 
The app icon is study and treatment agnostic and does not contain any symbol or name that 
would identify someone as being HIV-positive or as a member of the study, so that anyone who 
may inadvertently see the icon on a participant’s mobile phone cannot trace it to this study. 
Founded in 2010 and funded by the National Institutes of Health (NIH) and leading institutional 
investors, AiCure has more than 65 issued patents and works with global clients in over 40 
countries. The AiCure aDOT mobile health app has been used in numerous populations to 
improve adherence to medication and validated with individuals of different races/ethnicities. 
AiCure will continue to update and improve the app within the known best practices for HIPAA-
compliant apps and will maintain the highest level of security. 
Any participant who does not feel comfortable answering any survey questions at baseline and 
3 months will be reminded that study participation is voluntary and that they may withdraw at 
any time. Participants will be reminded that they may withdraw from the study at any point and 
not have their clinical information transferred from AHF and incorporated in the study 
database. 
In Aim 2, to protect against loss of privacy and confidentiality, prior to initiating the audio 
recording of the qualitative interviews, participants will be asked to not use any names and all 
names stated inadvertently will be replaced with aliases in transcripts. All these interviews will 
be conducted and audio-recorded via a HIPAA-compliant web conference platform (e.g., Zoom) 
and audio-recordings will be stored on a HIPAA-compliant server with access available only to 
select study staff who are not employed at AHF (to protect employee participant anonymity). 
All audio recorded files will be deleted on completion of the study. All data will be collected for 
the purpose of this proposed research only and will be password protected. 
Dr. Saberi will consult with Drs. Stoner and Sukhija-Cohen on a weekly basis for specific 
problems and questions as they may arise. Drs. Saberi, Stoner, Neilands, and Sukhija-Cohen 
have been involved in prior large-scale intervention and assessment trials that included 
vulnerable participants and confidential personal information. Dr. Saberi will consult with the 
UCSF Institutional Review Board (IRB) for guidance throughout the course of the study.. 
Risk to Benefit Ratio 
 
Participants may potentially benefit through an improved ability to engage in HIV care 
(including increased retention, enhanced ART adherence, and achievement of viral 
suppression), CEIs, and study-participation incentives. Improving engagement in care could lead 
to improved quality of life and reduced HIV transmission to others. If the study finds that the 
intervention is feasible and acceptable, the intervention could be expanded further to a large 
multisite randomized clinical trial to improve engagement in HIV care among YLWH, other age 
groups living with HIV, and other conditions where medication adherence is critical (e.g., 
hepatitis C treatment). 
 

The proposed study will provide important information about the feasibility and acceptability of 
an aDOT-CEI intervention to increase viral suppression among YLWH. This information is 
important for research among YLWH who may have greater difficulty adhering to their 
medications and experience health disparities at a higher rate than older individuals living with 
HIV. The information gained could influence and improve care for other YLWH. Consequently, 
the minor potential risks to participants are reasonable in relation to the importance of the 
knowledge to be gained. 
Data Management 
 
All data collected during the study will be used for research purposes only. The sources of data 
will be mainly paradata from the AiCure app, self-report from participants on online surveys, 
qualitative interviews, and clinical data provided by AHF. No blood specimens or other body 
fluid will be obtained for this study, and no hazardous conditions are imposed in the conduct of 
this study. The sources of research materials for this proposed study are data from the 
following: 
 
- 
The AiCure platform and app usage data (paradata). We have received approval to use 
this app from the IT security assessment team. 
- 
Online survey data from youth participating in our research (collected at baseline and 3 
months), which include demographic data, healthcare accessibility, technology use, 
perceived engagement in HIV care, engagement with provider, and subsistence needs. 
- 
AHF clinical data (collected as part of health care), including HIV viral load, appointment 
attendance and antiretroviral therapy adherence. 
- 
Qualitative interviews where YLWH and staff/providers from participating AHF clinics 
discuss their experience with and their perspectives on their HIV care and on 
participating in this study. Qualitative interviews will include questions around 
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 aDOTCEI, likes and dislikes, and suggested modifications for a 
future efficacy trial. 
 
The research team will have access to participant identities. Data will be collected solely for this 
study. An electronic database system (stored on a Health Insurance Portability and 
Accountability Act of 1996 [HIPAA]-compliant server) will be used to track participants, and 
participants also will be tracked via the aDOT mobile health app, which is also HIPAA-compliant. 
All files will be password restricted and user ID protected so that only certain identified 
research staff will have access to the files. All data will be electronically collected and stored on 
HIPAA-compliant servers and will be limited to study staff only. 
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