Leveraging mHealth and Peers to Engage African-Americans and Latinxs in HIV Care (LEAN)
Phase: NA
Conditions: HIV/AIDS
Sponsor: Johns Hopkins University

 
 
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Leveraging mHealth and Peers to Engage African-Americans and Latinxs in HIV Care (LEAN) 
 
Protocol Date: 2 November 2023 
 
NCT: NCT03934437 
 
 
 

 
 
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Date: 2 November 2023 
Principal Investigator: ___Kathleen Page______________ 
Application Number: __ IRB00195120 
 
 
 
JHM IRB - eForm A – Protocol 
 
Leveraging mHealth and peers to Engage African- Americans and Latinxs in HIV care (LEAN) 
 
 
 
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1. 
Abstract 
 
Baltimore’s HIV prevalence rate (586/100,000) is among the top 5 in metropolitan areas in the US, and 
disparities are profound.i African Americans have an HIV prevalence that is 5 times higher than among 
whites, and they account for 78% of all HIV cases. Latinxs also have a higher prevalence of HIV than 
whites and are at the highest risk for late HIV diagnosis among all racial/ethnic groups.ii  In addition, HIV 
viral load suppression, which is the best predictor of long-term survival among HIV-infected patients, is 
substantially lower among minority populations in Baltimore. 
 
The hypothesis of this study is that an mHealth-enhanced Linkage to Care and Retention (mLTCR) 
intervention can improve HIV outcomes among HIV-infected African Americans and Latinxs compared to 
standard linkage and care support protocols. The mLTCR intervention consists of two smartphone 
applications (app), one for patients and one for support staff such as linkage officers or patient navigators, 
to help facilitate communication. Communication will focus on issues related to HIV care (e.g. 
appointment scheduling, need for laboratory tests), as well as patient-directed requests. Using HIV 
surveillance data (e.g. dated HIV viral load), support staff will be automatically alerted if a patient has a 
high viral load or has not had labs done in > 4 months and prompted to contact the patient. In addition to 
appointment and laboratory reminders, patients will receive positive reinforcement behavioral text 
messages.  
 
This is a pragmatic randomized controlled study comparing existing linkage and care support (LTC) 
services to an mHealth-enhanced linkage to care and retention (mLTCR) protocol.   
 
According to modelling studies, improvement in linkage and retention in care indicators is the single most 
important component to achieve the 2020 National HIV/AIDS Strategy targets and substantially reduce the 
burden of HIV in the United States.iii The results of this randomized study will contribute to the evidence 
on the effectiveness of mHealth-enhanced LTCR initiatives implemented by the local health department 
and clinics. Evidence supporting the feasibility and effectiveness of this intervention will be important for 
HIV clinics, the BCHD and other health departments as they allocate limited resources to address the HIV 
epidemic in their jurisdictions. The information will also be relevant to Ryan White officials responsible for 
allocating federal dollars to support clinical and ancillary services to improve HIV outcomes, particularly 
among patients who are uninsured or underinsured. 
 
 
2. 
Objectives  
 
Aim 1: To compare virologic suppression and retention in care between HIV-infected individuals 
who are randomized to receive standard of care linkage and care support services versus mHealth-
enhanced LTCR (mLTCR) services. The primary outcome measure will be virologic suppression 

 
 
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at 12 months of study enrollment, and secondary outcomes will include retention in care at 12 
months.  
 
Aim 2: To examine the implementation of mLTCR services using a mixed-methods approach to 
determine the intervention’s feasibility, acceptability, coverage, fidelity, sustainability, and patient 
satisfaction. 
 
3. 
Background  
 
HIV Disparities among African Americans and Latinos.  African Americans represent 12% of the 
population but account for 43% of people living with HIV in the US and are less likely to receive ART or 
achieve virologic suppression compared to whites.iv HIV rates among Latinos are 3 times higher than 
among whites, and Latinos are at high risk for delays in diagnosis and linkage to care.v,vi  Delayed 
initiation of ART is associated with increased morbidity and mortality.vii  In addition, high viral load is the 
most important predictor of HIV transmission and drives the risk of HIV infection among sexual 
networks.viii, ix,x In Baltimore City, efforts to curve the HIV epidemic have led to a reduction in new HIV 
diagnoses but disparities persist. In 2016, 78% of new HIV diagnoses were among African Americans, 
whose rate of HIV infection is 5 times higher than among whites. In addition, linkage to care is lower for 
African Americans and only a third of HIV-infected African Americans from Baltimore have suppressed 
HIV viral loads (VL), dramatically short of the 80% goal outlined by the National HIV/AIDS Strategy 
(NHAS).i, xi  
 
Health Department Response and Linkage to Care Initiatives. To address the HIV epidemic, health 
departments across the US have operationalized the Center for Disease Control and Prevention’s (CDC) 
Data–to-Care initiative to optimize the HIV care cascade.xiiUsing routine HIV surveillance data, health 
departments, including the BCHD, systematically identify HIV-infected people who are newly diagnosed 
or out of care, and reach out to them to facilitate linkage to care.xiii In 2017, BCHD linkage officers 
engaged 1942 HIV-infected patients who needed linkage services. However, loss to follow up after initial 
engagement in care is a persistent problem. Under current BCHD Linkage protocols, linkage officers do not 
follow up patients after linking them to a clinic.  Patients may be identified as out of care at a later point if 
they do not follow up with appointments. However, re-engaging patients in care is challenging because 
linkage officers do not have ongoing relationships with patients and contact information obtained from 
surveillance databases is often out of date, especially for those living in poverty and in unstable housing 
conditions.  
 
Clinic-Based Retention in Care Initiatives. Health departments have traditionally focused on linkage to 
care, while clinics have mostly been responsible for retention of patients in their practice. Many HIV 
clinics have retention protocols, but these vary widely, ranging from simple automatic reminder calls to 
systematic review of patients to identify those who have fallen out of care.xiv  Evidence suggests that 
increased contact with the clinic can improve retention in care but may not be enough.  A randomized 
controlled trial conducted in six HIV clinics in the US showed that among patients who were newly 
diagnosed or had missed at least one appointment in the past year, enhanced contact with a clinic worker 
improved retention in care. In this study, patients who met with a clinic worker at study enrollment and 
maintained contact throughout the year by phone (personalized reminder calls and follow up for missed 
appointments) were more likely to keep appointments than those receiving automated appointment 
reminder calls (56% vs. 46%).xiv The intervention, however, was less effective among patients with at least 
one unmet need or active substance use disorder.   
 
Unmet Needs and Linkage and Retention in Care.  The Data-to-Care experience has shown that a 
significant proportion of individuals out of care are homeless, transitionally housed, transient, and without 
working phone numbers.xv Interviews with patients out of care contacted by the San Francisco Health 

 
 
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Department identified several personal and structural barriers to care. The top unmet needs included 
difficulty with transportation to the clinic and lack of practical support in navigating the system.xvi 
Participants expressed willingness in engaging with health department staff to receive assistance with 
ancillary services and HIV engagement in care. In Los Angeles, HIV-infected patients reported that the 
main reasons for not accessing HIV services were lack of information (do not know where to go or who to 
call), agency barrier (system too confusing, wait list too long), or financial/practical barriers (too expensive, 
transportation problem).  In this study, African American were 3 times more likely to report unmet needs 
compared to whites.xvii 
 
Integrating Retention Services into Health Department Linkage Protocols. Implementing homogenous 
retention to care services in all HIV clinics is neither feasible nor advisable, as clinics should be able to 
tailor their approach based on their resources and their clients’ needs.  This is where health departments can 
leverage routine HIV surveillance data and provide an additional layer of support to patients and clinics 
independent of clinic-based services. In most linkage protocols, contact with linkage officers is limited to 
one or two interactions, as linkage officers primarily assist with facilitating the initial appointment for 
engagement or reengagement in care. This model may be efficient for patients who are linked to care 
without additional support. However, for many patients, engagement in care occurs within a spectrum of 
frequent engagement and disengagement cycles due to complex personal and structural barriers. An 
evaluation of the San Francisco Health Department LTC model found that rather than being truly out of 
care or never in care, many patients were in intermittent HIV care, and were willing to accept health 
department assistance to help them stay in care. xvi 
 
An alternative to one-time linkage services is to provide ongoing support to maintain continuity of care, 
particularly among minority populations that face multiple contextual challenges, such as poverty, 
substance use disorder, or housing instability. Providing linkage and longitudinal retention (LTCR) services 
from the health department that complements existing clinic-based retention efforts has not been 
systematically evaluated. This model assumes that a significant proportion of individuals will require not 
only linkage services but also retention support during their HIV care trajectory, and that providing 
longitudinal support may enhance timely linkage to care and facilitate future re-engagement attempts, if 
needed.  
 
Enhancing Efficiency through Tailored mHealth Interventions. A health department or clinic-based 
LTCR approach could be enhanced with the use of evidence-based mobile health (mHealth) strategies that 
leverage mobile phones to improve health outcomes. Systematic reviews have found that mHealth 
interventions can promote engagement in care, adherence to ART, and virologic suppression.xviii, xix, xx 
These platforms can be programmed to send tailored messages, reminders, and alerts to patients and 
providers (such as linkage officers) using algorithms that leverage existing data (e.g. surveillance data) and 
patient input (e.g. response to prompts). A distinct advantage of mHealth platforms is the ability to 
facilitate patient-centered approaches to LTCR efficiently and without overburdening providers (alert for 
action to providers can be designed to focus on areas that truly require provider input).    
 
Our team has previously partnered with emocha Mobile Health (https://www.emocha.com) to develop 
evidence-based HIPAA compliant mHealth applications to facilitate engagement in care.
xxiii
xxi,xxii, 
  The 
miLINC platform, for example, facilitates direct communication and linkage between outreach workers, 
patients, and providers and has been used to link patients to tuberculosis services and improve coordination 
of care and timely treatment for patients with multi-drug-resistant tuberculosis in South Africa. A video 
directly observed therapy application (miDOT) has been evaluated and adopted by public health 
departments in the US for tuberculosis, hepatitis C, and opioid use disorder treatment.  These emocha 
platforms have shown acceptability and feasibility of implementation in Baltimore City, including African 
American men who have sex with men, people who inject drugs, and foreign-born Latinos, and in diverse 
settings.xxiv,xxv 

 
 
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4. 
Study Procedures 
a. Study design, including the sequence and timing of study procedures. 
 
This is a pragmatic randomized controlled trial comparing Standard BCHD and HIV clinic-based linkage 
and care support services to mHealth-enhanced LTCR services described below. 
 
Description of usual care and comparator arm: 
 
Standard BCHD Linkage Services. The 2007 Maryland HIV/AIDS Reporting Act requires that HIV cases 
be reported by name.  Laboratories are required to report HIV positive tests within 48 hours to the BCHD 
through PRISM, a morbidity and case management software. Data from PRISM is used to identify new 
HIV diagnoses and refer cases to a BCDH Disease Intervention Specialist for contact investigations and 
referral to linkage services. In addition, the Maryland Department of Health (MDH) HIV Surveillance 
Branch receives laboratory-based reports with results indicating HIV infection (including HIV diagnostic 
tests, CD4, HIV viral loads, and HIV genotype and phenotype tests) through the enhanced HIV/AIDS 
Reporting System (eHARS). Using this data, MDH generates weekly “Never in Care” and “Out of Care” 
lists for BCHD. Guided by these data, the BCDH linkage team contacts patients by phone or in person to 
connect them to care. Providers can also request assistance from the BCHD LTC program to link patients 
newly diagnosed or re-engage those lost to HIV care by contacting the LTC team. Therefore, the BCHD 
linkage officers attempt to contact and provide linkage services to all Baltimore residents newly diagnosed 
with HIV or who are presumed to be Out of Care or Never in Care, as identified through surveillance data 
or by referral from providers. Patients who agree to be linked to care by linkage officers are provided a 
same-day appointment and warm handoff to clinical care (the outreach worker drives the patient to the 
clinic of his or her choice). After the patient is seen by a provider, the linkage officer can assist with 
retention to the second appointment, but after the two initial appointments, the LTC officer is no longer 
involved in the case unless the patients appears again in the MDH Out of Care report at a later time or is 
referred by a provider.   Linkage officers record patient encounters, and linkage attempts and outcomes in 
PRISM. 
 
Clinic-based Linkage and Retention Services.  In response to the “End the HIV Epidemic” strategy, many 
HIV clinics have strengthened their HIV Linkage and Retention Services.  The Johns Hopkins Bartlett 
Clinic, for example, has implemented a Rapid ART initiation (RART) protocol where patients who are 
newly diagnosed with HIV in the Emergency Department and linked to the clinic within 1 business day 
with same-day ART initiation at the time of visit.  In addition, the clinic uses “Data-to-Care” to identify 
patients who are out of care (no visits for > 8 months) or whose viral load is not suppressed, and provides 
them patient navigation services, appointment reminders, and pharmacy/adherence support. 
 
mHealth-enhanced LTCR (mLTCR). This approach leverages the existing BCHD and clinic-based LTC 
and support protocols to identify newly diagnosed patients, those out of care, and those in need of retention 
services to provide ongoing linkage and retention to care services for 12 months.  The intervention has an 
mHealth LTCR application based on an existing evidence-based HIPAA-compliant mHealth application 
facilitates direct communication and linkage between support staff such as outreach workers or patient 
navigators and patients, allowing for two-way communication to improve coordination of care and timely 
treatment. The app allows support staff and patients to communicate over time.  In contrast to standard 
BCHD Linkage services, where linkage officers provide two-time support to link patients to care, the 
mLTCR approach will promote ongoing engagement between support staff and a patient over a period of 
12 months. This allows for repeated doses of support (patient and algorithm-driven) and provides more 
opportunities for patients to develop a trusting relationship with support staff. The communication between 
patients and support staff will be driven by the patient’s needs. Patients will be assigned a specific support 
staff member to allow for relationship-building, with backup as needed for support staff absences, 

 
 
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vacations, and sick leave. The BCHD linkage officers and clinic-based patient navigators are representative 
of the community served (primarily African American or bilingual Latino) and have long-standing 
experience working with the community. 
 
mHealth Application for mLTCR arm. The mHealth application is designed to facilitate communication 
between the patient and support staff, and to automate certain tasks/alerts/reminders, so that support staff 
can focus their efforts on patients at high risk of falling out of care (such as calling a patient with a high 
viral load), rather than on time-consuming tasks not specifically targeted to high risk patients (like general 
appointment reminders). The patient application will be available in English and Spanish. Spanish-speaking 
limited English proficiency patients will be assigned a bilingual support staff person who will communicate 
with them in their preferred language. The study team has experience with cultural and linguistic adaptation 
of interventions and will elicit feedback from the Steering Committee (see below) to ensure messages are 
tailored to the health literacy and language proficiency of the target population. Tasks, alerts, and action 
prompts are outlined in Table 1 for the patient application and in Table 2 for the mHealth application. 
 
Table 1. emocha mHealth-enhanced Participant Application 
 
Task 
Description 
 Support Staff Action 
Laboratory Alerts 
Participant in the intervention arm contacted by Support staff if he/she has not 
had a viral load in > 4 months or if the viral load is detectable (> 200 copies/ml) 
Support staff contacts 
participant if alerted (see 
Table 2) 
Appointment Data 
Tab to record date/time/place of upcoming HIV appointment (entered by 
participant) 
 
Appointment 
Reminder 
Participant automatically receives reminders about upcoming appointments (3 
and 1 day prior). Day after scheduled appointment, participant receives prompt 
“Did you go to your appointment yesterday?” (Yes/No) If “Yes” receives message 
saying “Great job keeping your appointment” If “No” receives message “Do you 
need help rescheduling your appointment?” 
Support staff contacts 
participant if alerted (see 
Table 2) 
Ability to Directly 
Message Linkage 
Officer 
Participant can click on prompts (eg “I need help with making appointments” or 
can free text message to Support staff) 
Support staff contacts 
participant if alerted (see 
Table 2) 
Control Over Messages 
Participant has the option to type STOP if he/she prefers not to receive messages 
 
Note: To protect participant confidentiality no alerts will specify HIV. 
 
 
Table 2. emocha mHealth-enhanced Support Staff Application 
Task 
Description 
 Support Staff Action 
Laboratory Data 
HIV surveillance data (Viral load and date) is provided by the BCHD and uploaded 
to emocha platform 
 
Laboratory Alerts 
Support staff is alerted if participant in the intervention arm has not had a viral 
load in > 4 months or if the viral load is detectable (> 200 copies/ml) 
Support staff contacts 
participant if alerted  
Appointment Alerts 
Support staff alerted if no upcoming appointment is documented in the emocha 
app or the patient responds “No” or does not respond to the question “Did you 
go to your appointment yesterday” or patient requests help rescheduling 
appointment 
Support staff contacts 
participant if alerted  
Patient initiated 
messages 
Support staff alerted when participant sends message 
Support staff contacts 
participant if alerted  
 
 
 
 
Study Design. 
This study is a pragmatic individual randomized trial comparing standard BCHD linkage services or clinic-
based linkage and retention and care support services to mLTCR services. The study will not be masked to 
participants or support staff due to practical considerations, but all data analysis related to Aim 1 will be 
conducted in a blinded fashion.  Figure 2 describes the study design.  
 

 
 
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The BCHD identifies newly diagnosed patients with HIV or those who are out of care based on laboratory-
based HIV surveillance report. In addition, clinics and providers can identify patients in need of retention 
services and refer patients to their clinic’s patient navigators or the BCHD linkage to care program. HIV 
Clinics can also get assistance from study team members in identifying patients by sharing the “Data-to-
Care” report.  Using the report, study team members will identify patients in need of retention services and 
alert their providers.  Providers can then refer the patients to their support staff, clinic’s patient navigators 
or the BCHD linkage to care program. Support staff reach out to the patient identified through surveillance 
or referred by providers to offer linkage and retention and care support services.  When support staff meet 
or talk with the patient, he/she will tell them that they may be eligible for a study and ask them for 
permission to be contacted by a study research assistant (RA). All patients, regardless of their interest in the 
study, will be linked to care by warm handoff per BCHD protocol or receive standard linkage and retention 
and care support services provided at the clinic.  Support staff will call the study RA to let him or her know 
that there is a potential participant. The RA will meet or call the potential participant to go over the study. 
After obtaining and documenting written informed consent (for in person enrollment) or oral consent (for 
over-the-phone enrollment) of participants who wish to enroll in the study, the participant will complete a 
baseline questionnaire and the RA will use a randomization program that will electronically assign the 
patient to the control or intervention arm. Patients randomized to the control arm will have no further 
interaction with the study team other than receiving a satisfaction survey and potentially being invited to an 
in-depth interview (which they can decline).  Participants randomized to the intervention arm will be 
instructed to download the app to their personal phones (or study phone if participant does not own a 
compatible phone) and practice using the app by messaging the support staff, ideally in the presence of the 
RA (this can be done by phone or videoconference), who can trouble shoot any issues and show the patient 
how to use the various features of the app. Participants in the intervention arm will continue to be in touch 
with support staff for 12 months using the app, and by phone or in person, depending on the participants 
needs and Covid-19 situation (as identified through the app algorithms and patient-generated messages). 
 
HIV Surveillance Data Flow.   HIV laboratory data (dated viral load) will be used to drive emocha app 
alerts and for evaluation of primary outcomes.  A list of the individuals who have consented to the study 
(including those recruited in the clinics) will be provided to the BCDH on a weekly basis.  The BCHD will 
send this information to the Maryland Department of Health HIV Surveillance Branch. MDH will generate 
a weekly report of HIV viral load test results and dates and send this information to the BCHD. The BCHD 
will share this information with emocha so that it can be uploaded to the emocha platform. Alerts to 
participants will not include HIV-specific information.  HIV surveillance data will be uploaded to the 
Patient Agrees to Participate 
BCHD 
laboratory-based 
Clinic-based 
Referrals 
List of new HIV diagnosis of 
out-of-care patients generated 
using surveillance data 
(eHARS) 
Patients in need of  HIV 
linkage and retention services 
identified by clinicians and/or 
using Data-to-Care data 
Support staff follows standard 
BCHD or clinic linkage and 
retention protocol. Support 
staff also offers information 
about the study, clarifying 
that linkage and retention 
services are not contingent on 
participation 
Patient Declines Participation 
 Usual BCHD and/or clinic-based 
linkage and retention services  
CONTROL 
Usual protocol  
INTERVENTION 
Usual support staff protocol 
and ongoing support 
facilitated by mHealth 
li
i
 

 
 
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emocha platform for all participants (intervention and control) and used for data analysis. However, this 
data will be integrated into the emocha algorithms and alerts only for participants in the intervention arm.   
Data on all participants will be exported from emocha to JHU secure servers for data analysis. 
 
A backup system will be implemented in the event the MDH or BCHD is unable to generate and/or share 
the weekly HIV viral load test results. Study team members will access viral load data through health 
provider records and upload data directly from JHU secure servers to the emocha platform.   
 
Laboratory Assessments. There will be no study-associated laboratory assessments.  All laboratory 
assessments will be conducted as part of clinical care and reported to BCHD HIV surveillance databases 
(eHARS and PRISM).  We will consider those with a suppressed viral load (HIV RNA <200 c/mL) to be 
fully engaged in HIV care. While some individuals are able to maintain immune control of HIV in the 
absence of ART, this occurs in <1% of infected persons. 
 
Randomization plan. The study Statistician will generate a randomization schedule to assign 250 
participants to each of the study arms with an arbitrary labelling of the arms. All but the data manager will 
be blinded to the arm assignment to the arbitrary labels initially. When a linkage officer makes the initial 
contact with an eligible participant /patient, they will introduce the study and if consent to participate is 
obtained, the officer will telephone the data center to obtain an arm assignment and proceed to enroll the 
participant. All data analysis will be conducted in a blinded fashion, but the linkage officers and 
participants cannot be masked from the intervention. 
 
Mortality Assessment. Participants will be cross referenced with the Center for Disease Control and 
Prevention’s National Death Index, a database for all deaths in the United States, to determine if there is a 
known date of death and cause of death. 
 
Implementation Assessment 
RE-AIM Framework. Using a hybrid study design, we will also incorporate implementation science 
evaluations to assess important implementation questions while also assessing effectiveness. Hybrid 
designs are efficient approaches to obtaining information that can help understand research findings in 
terms of internal validity and external generalizability, and provide data to facilitate translating research 
into real world policy and programs. We propose using the well-established RE-AIM Framework for 
implementation science research to provide methodological specificity for Aim 2. This framework was 
created to encourage consideration of program elements that can improve the sustainable adoption and 
implementation of effective, generalizable, and evidence-based interventions.  
 
A summary of how the 5 components will be assessed in this proposal is shown below.  
  
Summary of mHealth-enhanced LTCR implementation evaluation using the RE-AIM approach 
Component 
Research Question 
Assessment Method(s) 
Outcome(s) of Interest 
Reach 
Who received the intervention? 
Program Data 
Proportion of out of care or newly diagnosed 
HIV-infected patients contacted by linkage 
officers. 
Effectiveness 
What impact did the intervention 
have on outcomes? 
End-of-study viral load 
See Aim 1.  
Adoption 
Did the community and providers 
adopt the intervention? 
Program data, In-depth 
interviews 
Frequency of contacts between support staff 
and patients. Services provided/received. 
Implementation 
Was the intervention delivered as 
intended?  
Program data, In-depth 
interviews 
Roll-out program fidelity. 
Maintenance 
Was the intervention sustained over 
time? 
Program data, In-depth 
interviews 
Consistent implementation and effectiveness 
over time. Retention. 
 

 
 
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Support staff and patient navigators in-depth interviews. In an effort to measure the intervention’s 
feasibility and degree of fidelity, we will conduct in-depth interviews (IDIs) with support staff (N=5) 
before and 12 months after the implementation of the mLTCR intervention to allow for sufficient time for 
staff to acclimatize to service delivery and to give ample time to adapt services based on feedback. 
Interviews with support staff will examine: the nature of service delivery; client interactions and how this 
differs from standard linkage and retention activities; barriers and facilitators of engaging out-of-care 
patients; challenges and solutions to the mLTCR service delivery; and recommendations for service 
delivery improvements and expansion of reach.  Additional interviews with patient support staff may be 
requested beyond 12 months if and when additional feedback would be useful to further adapt services. 
 
In-depth interviews with participants randomized to the intervention arm and the control arm. In 
order to examine feasibility and acceptability, IDIs will be conducted (in person or by phone due to Covid-
19) with study participants randomized to standard linkage and retention and care support services (n=20) 
and to mLTCR services (n=20) to assess program fit and appropriateness of mLTCR services. Participants 
will be asked what they liked/disliked about the linkage/retention/care and mLTCR services they received 
as well as recommendations for additional services. Participants randomized to the intervention arm will be 
asked if the text message topics and materials in the patient portal were important to them, their motivation 
for engaging the support staff-delivered text messages, and their suggestions for other ways the mobile 
phone may facilitate HIV retention in care and adherence to medications. We will also assess facilitators 
and barriers to program participation. IDIs will take place in a private location and will last 45-60 minutes 
and participants will be paid $50 for their time (remuneration may be revised by the Steering Committee 
during planning phase). 
 
Client satisfaction survey. All participants (control and intervention, n= 500) will be asked to complete a 
brief client satisfaction survey using a validated Client Satisfaction Questionnaire (CSQ-8). Participants in 
the intervention arm will be asked to complete the validated System Usability Scale (SUS) to assess 
acceptability and ease of use of the mHealth application. 
 
Intervention fidelity We will monitor support staff-participant contacts weekly using phone records. This 
will allow an assessment of the level of intensity of support staff-participant contact that may be associated 
with clinical outcomes (retention in care, virologic suppression), as well as inform the appropriate caseload 
for support staff. Fidelity and quality assurance feedback will be provided during monthly meetings or 
more frequently if necessary.   
 
Key-informant interviews with BCHD and clinic officials. In order to examine the mLTCR acceptability 
and sustainability, study investigators will conduct key-informant interviews with program managers and 
executives at the city health department and Bartlett Clinic. Interviews with BCHD and clinical staff will 
explore how the mLTCR intervention has affected the flow and efficiency of surveillance work at the 
BCHD and Bartlett clinic, any observed changes in the number of patients linked to care and time to 
engagement in care, and recommendations for service delivery improvements. These interviews will 
provide insights about policy, acceptability, political buy-in for the intervention, and potential for adoption 
in other settings going forward. 
 
b. Study duration and number of study visits required of research participants. 
Study Duration: 4 years  
Number of visits:   
Participants in the RTC: One baseline visit (can be done by phone). This is a pragmatic 
implementation trial with outcomes (such as retention in care) that could be influenced by frequent 
study-related interactions, so we will minimize study contact to a baseline visit. During the baseline 
visit, support staff or patient navigator will obtain basic demographic and contact information as is 
routinely done for LTC and patient navigator operations. 

 
 
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Participants in qualitative in depth interviews: One visit (can be done by phone) for study 
participants and BCHD stakeholders, two visits for support staff (12 months apart) 
 
c. Blinding, including justification for blinding or not blinding the trial, if applicable. 
This is a non-blinded pragmatic randomized trial. Blinding is not feasible with this design. 
 
d. Justification of why participants will not receive routine care or will have current therapy 
stopped. 
Not applicable 
 
e. Justification for inclusion of a placebo or non-treatment group. 
The control group will receive usual linkage and retention to care services provided by the BCHD 
or the participant’s clinic.  The objective of the trial is to determine the benefit of delivering 
mHealth enhanced, longitudinal linkage to care and retention services.  
 
f. Definition of treatment failure or participant removal criteria. 
Not applicable 
 
g. Description of what happens to participants receiving therapy when study ends or if a 
participant’s participation in the study ends prematurely. 
Participants randomized to the intervention arm will receive mHealth-enhanced LTCR services for 
a year.  Following the 12 month follow up, patients will receive usual BCHD LTC services or 
clinic-based retention and care services. The BCHD or clinics may decide to continue to provide 
mHealth-enhanced LTCR services beyond the patient’s 12 month enrollment in the study based on 
the studies interim analysis of effectiveness, patient satisfaction and cost. 
 
5. 
Inclusion/Exclusion Criteria 
 
Enrollment criteria for RTC: 
Eligibility criteria include: 
1. ≥ 18 years of age 
2. Ability to provide consent 
3. Identified by BCHD Linkage protocol to be a new HIV diagnosis or HIV-infected and “out of 
care” or referred by HIV clinic-based patient navigator, nurse, or provider. 
Exclusion criteria include: 
1. Excluded due to insufficient facility using a smartphone based upon participant and/or study 
staff assessment during enrollment process.   
 
Enrollment criteria for in-depth interviews 
Participant meets one of the following criteria:  
1. Participant in the RTC, OR 
2. Linkage to care officer, OR 
3. Patient navigator, OR 
4. Other support staff members, e.g. nurses 
5. Stakeholders at the Baltimore City Health Department (BCHD) who has administrative or 
programmatic input on HIV services 
 
6. 
Drugs/ Substances/ Devices 
a. The rationale for choosing the drug and dose or for choosing the device to be used. 
Not applicable 

 
 
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b. Justification and safety information if FDA approved drugs will be administered for non-FDA 
approved indications or if doses or routes of administration or participant populations are 
changed. 
Not applicable 
 
c. Justification and safety information if non-FDA approved drugs without an IND will be 
administered.  
Not applicable 
 
 
7. 
Study Statistics 
a. Primary outcome variable. Virologic suppression: Viral load < 200 copies/cc within a 6-month 
window of 12 month follow up period (i.e. 3 months before or after 12 month follow-up).  
 
b. Secondary outcome variables.  
1. Retention in care: Viral load or CD4 count reported in eHARS within a 6 month window 
of 12 month follow up period (i.e. 3 months before or after 12 month follow up) 
2. Mortality: Death occurring within a 6 month window of 12 month follow up period (i.e. 
3 months before or after 12 month follow up) 
3. Implementation outcomes will include: 
a. Proportion of out of care or newly diagnosed HIV-infected patients contacted by 
support staff. 
b. Frequency of contacts between support staff and patients.  
c. Qualitative assessments from in-depth interviews with support staff, 
BCHD/clinic officials, and study participants 
d. Client satisfaction surveys   
 
c. Statistical plan including sample size justification and interim data analysis. 
 
Statistical Analysis. For the study’s main outcome, we will conduct a test for the equality of 
proportions of virologically suppressed/not suppressed or missing VL individuals at 12 months 
between the two study arms, in line with the randomized design of the study. Secondary to this, 
and to adjust for any residual confounding, we will conduct a logistic regression using 
individual outcomes (yes/no suppressed) with study arm as a main predictor and adjusting for 
patient demographic characteristics, socio-economic status at baseline, and other factors. A 
subgroup analysis will be conducted to assess the effects of the intervention among African-
Americana and people of Hispanic/Latino descent.   
 
Secondary outcomes analysis. An evaluation of the differences in retention in care and 
participant mortality will follow the same analytical approach as for the main outcome. That is, 
we will test for the difference in proportions between the 2 arms and a logistic regression will be 
conducted adjusting for study arm and patient characteristics.   
 
Qualitative data analysis. Qualitative data analysis involves the search for patterns in data and 
for ideas that help to explain the presence of those patterns. Transcripts from in-depth interviews 
and key informant interviews will be entered and managed in Atlas.ti. Separate coding schemes 
will be developed for HIV-infected patients (control and intervention arm) and the other groups 
of BCHD staff (Linkage officers and BCHD officials). An iterative coding process in Atlas.ti 
will be used to conceptually name the data and reduce it to manageable units of information that 
cover broad and general categories. Codes will be informed by the questions in the qualitative 

 
 
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guides, and new themes that emerge from the data will be analyzed through a grounded theory 
approach, allowing for themes to emerge and ensuring that the knowledge assembled from the 
observational data is not subjected to the themes solely established through the interview guide. 
Two coders will conduct open-coding on three transcripts to develop initial coding schemes. 
After discussion and development of a combined draft scheme, two more interviews will be 
coded, and these will be further discussed and inform a final coding scheme under the guidance 
of Dr. Grieb. Through weekly meetings, a team approach to data analysis will be employed, 
whereby different analysts provide feedback on emerging interpretations and check emerging 
categories against the raw data. In this way, an “audit trail” will be used to help ensure 
trustworthiness of findings, gather input from multiple perspectives, and enhance reliability. 
 
Power Calculations. The reported virologic suppression or lack of a VL measurement rate under 
standard of care among HIV-infected African Americans and Latinos in Baltimore City is 
33%.xxvi In order to detect an improvement of 13%, such that 46% of the mHealth enhanced 
LTCR group have a VL and achieve virologic suppression, with 80% power at an alpha=5% 
level of significance, we require a total sample size of 442 (221 per arm).  We plan to enroll 500 
participants to the study to account for withdrawals. 
 
d. Early stopping rules. 
Not applicable 
 
 

 
 
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Date: ____________________    
Principal Investigator: _________________ 
Application Number: ___________ 
 
4. Risks 
a. Medical risks, listing all procedures, their major and minor risks and expected frequency. 
There are no direct medical risks associated with the intervention arm. There is a risk to 
confidentiality in the use of the mHealth application. 
 
b. Steps taken to minimize the risks. 
After obtaining consent, all participant data (such as basic demographics and contact 
information) is entered into the emocha platform.  In addition, HIV surveillance data is imported 
into the emocha platform from the BCDH (see above). Risks to confidentiality will be 
minimized by storing all data in encrypted format on an emocha web-server that is password 
protected. Data collected by the LTCR emocha app will be sent in real-time to a secure server, 
where LTCR activities and data can be accessed through a simple web interface. Only 
authorized study personnel will have access to this data. A triple level of data encryption will be 
used to ensure confidentiality of data and HIPAA-compliance. LTCR phones, and access to the 
LTCR and participant emocha apps will be password protected. To further protect participants’ 
confidentiality, messages to the participant will include non-specific terms without mention of 
HIV or other personal health information. Electronic research data will be exported from 
emocha to central storage (JHU) via secure, encrypted transmission. The National Center for 
Health Statistics is required by law to maintain the confidentiality of identifying information it 
collects including information on individuals supplied by research groups to the National Death 
Index for the purpose of matching study participants to death records. 
 
c. Plan for reporting unanticipated problems or study deviations. 
The research staff and support staff will report problems or study deviations to the study 
supervisor (Jane McKenzie-White). Ms. McKenzie-White with discuss problems and event with 
the study PIs (Drs. Page and Chang) at weekly study meetings (or sooner) depending on the 
severity of the event. The PIs will report unanticipated problems or study deviations that involve 
risks to participants or others promptly to the JHM IRB in accordance with Organization Policy. 
Minor problems and protocol deviations (which pose no risk to subjects or others) will be 
reported in annual protocol continuing review.  
 
d. Legal risks such as the risks that would be associated with breach of confidentiality. 
There are risks that confidential information could be revealed to people not involved in the 
research such as a friend, relative, or an outside organization. This could be embarrassing to the 
participant if the participant wanted to keep participation in the study secret. The legal risks are 
limited because we are not collecting any additional data than is collected during routine BCHD 
activities. Thus, the risks associated with participating in this study are no greater than the risks 
associated with routine psychological examinations or tests. 
 
e. Financial risks to the participants. 
This study entails no financial risks to participants.   
 
 
5. Benefits 
a. 
Description of the probable benefits for the participant and for society. 
The study has the potential to benefit society if the tested intervention (nHealth LTCR) is 
found be effective in improving virologic suppression by reducing HIV transmission risk in 
the community. 

 
 
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6. Payment and Remuneration 
a. 
Detail compensation for participants including possible total compensation, proposed bonus, 
and any proposed reductions or penalties for not completing the protocol. 
Participants will receive $50 for completing the baseline enrollment and $20 for completing client 
satisfaction surveys.  Participants randomized to the intervention arm who do not own a phone will 
be provided a study phone with a pre-paid data plan.  
 
Participants in the in depth interviews will be compensated $50 for their time. 
 
7. Costs 
a. 
Detail costs of study procedure(s) or drug (s) or substance(s) to participants and identify 
who will pay for them. 
There will be no costs to participants for any services or treatment provided in this study. 
The study procedures will be financed by a PCORI grant. 
 
References 
 
 
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https://phpa.health.maryland.gov/OIDEOR/CHSE/SiteAssets/Pages/statistics/Baltimore-City-HIV-Annual-
Epidemiological-Profile-2016.pdf 
ii Flynn C. Maryland Annual HIV Epidemiologic Profile. Available at 
https://phpa.health.maryland.gov/OIDEOR/CHSE/SiteAssets/Pages/statistics/Maryland-HIV-Annual-
Epidemiological-Profile-2015.pdf. 
iii Shah M, Perry A, Risher K, et al. Effect of the US National HIV/AIDS Strategy targets for improved HIV care 
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iv Crepaz N, Dong X, Wang X, Hernandez AL, Hall HI. Racial and Ethnic Disparities in Sustained Viral Suppression and 
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v Chen NE, Gallant JE, Page KR. A systematic review of HIV/AIDS survival and delayed diagnosis among Hispanics in 
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vii Kitahata MM, Gange SJ, Abraham AG, et al. Effect of early versus deferred antiretroviral therapy for HIV on 
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x Rodger AJ, Cambiano V, Bruun T, et al. Sexual Activity Without Condoms and Risk of HIV Transmission in 
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xi National HIV/AIDS Strategy for the United States. Available at https://www.hiv.gov/federal-response/national-
hiv-aids-strategy/nhas-update. Last accessed 2-18.  
xii CDC. Data to Care: Improving Health and Prevention. Available at 
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xiii Tanner AE, Muvva R, Miazad R, et al. Integration of HIV testing and linkage to care by the Baltimore City Health 
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Project in San Francisco. PLoS One 2015; 10(3): e0118923. 

 
 
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