Assessing the Impact of Providing Pharmacists With Medical Records in a Patient-Centered, Community Pharmacy-Based, HIV Care Model
Phase: NA
Conditions: HIV/AIDS, Diabetes Mellitus, Type 2, Hypertension
Sponsor: University of North Texas Health Science Center

 
 
              
 
 
       
 
 
 
Clinical Study Protocol 
 
 
 
 
 
 
Study Title: 
Impact of Providing Medical Records in a Patient-Centered, 
Community Pharmacy Based, HIV Care Model (HIV-MOI) of the 
Community Pharmacy-Based HIV Care Model study 
 
 
ClinicalTrials.gov 
Identifier: 
NCT03437694 
 
 
Sponsor: 
National Institute on Minority Health and Health Disparities 
 
 
Sponsor Project 
Title: 
Texas Center for Minority Health, Education, Research and 
Outreach 
 
 
FAIN Number: 
U54MD006882 
 
 
IRB Number 
1436643/2018-094 
 
 
Protocol 
Version/Date: 
Original Approval: 5/24/2019 
Most Recent Approval: 10/17/2023 
 
 
 
 

North Texas Regional Institutional Review Board (NTRIRB)
University of North Texas Health Science Center 
PROTOCOL INFORMATION 
Title of Research Activity:  Medical record based versus non-medical record based community 
pharmacy provided medication therapy management
Name of Principal Investigator: Dr. Crystal Hodge, PharmD, BCIDP, BCPS (formerly known as 
Crystal Howell)
Institution: UNTHSC
Sponsoring Agency / Company (if applicable): NIMHD
Sponsor’s Protocol Number (if applicable): ClinicalTrials.gov Identifier: NCT03437694
Specific Aims – 
A. To investigate the change in control of diabetes and/or hypertension in adult African-
Americans  with HIV, who receive medication therapy management (MTM) from their 
community pharmacist when the pharmacist is provided the information from the 
participants’ medical records (intervention) or not provided the information from the 
medical records (control, standard of care is no medical record information is provided). 
Control will primarily be determined using HgbA1c & plasma glucose from medical 
records (diabetes), and systolic blood pressure from medical records (hypertension) and 
these will be compared against nationally accepted standards for each condition. Control 
of HIV will be monitored (no change anticipated) via medical record provided HIV-RNA 
viral loads and CD4 counts.
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Figure 1: Adapted from Ribaudo 2016
B. Background and Significance
Despite  being  only  12%  of  the  United 
States (US) population, African-Americans 
(AA) represent 45% of all persons with HIV. 
Rates  of  new  infections  nationwide  are 
highest in AA (44.3/100,000 persons) with 
the next closest race being less than half 
(16.4/100,000,  Hispanics).  Texas’  2016 
surveillance  epidemiology  mirrors  this 
disparity  in  AA  with  infection  rates  of 
49.8/100,000 compared to 16/100,000 in 
Hispanic (next highest group). Once diagnosed, standard of care is to immediately initiate a 
3-drug combination of antiretrovirals. With the overall effectiveness of current antiretroviral 
therapies (defined as an HIV plasma viral load (HIV-RNA) of less than 20 copies/mL) at or 
This disparity is not fully explained by socio-economic factors or adherence. Controlling for 
many known socioeconomic disparity factors, ACTG A5257 could not explain the low rate of 
virologic suppression in AA. Controlling for adherence rates, antiretroviral agents used, 
years diagnosed and use of antiretroviral therapy in 31,055 persons with HIV, a joint NIMH/
NIAID funded study revealed AA odds ratio to achieve virologic suppression was 0.48 
compared  to  whites  (p<0.01)  –  the  only  race  with  statistical  difference.  Thus,  using 
adherence to explain outcomes is insufficient. Recent evidence demonstrates even within 
HIV populations, AA have significantly (p<0.001) fewer years of productive life among other 
races. Specifically, for every 1 year of productive life lost among non-Hispanic and whites, 
1.52 and 1.75 years were lost by AA women and men, respectively (p<0.001). These deaths 
often result from cardiovascular disease and DM. It has been known for a decade DM and 
HTN rates are higher in persons with HIV. A 2016 analysis of >50,000 adults with HIV, AA 
had higher incidence rates for both DM (RR=1.4-2.0, p<0.01) and HTN (RR=1.5-1.8, p<0.001) 
compared to whites with projections of worsening over the next 20 years. With higher 
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Figure 2: Traditional CMTM (no routine exchange of medical information
rates, AA with HIV also have poorer control of DM and HTN (both p<0.001). A cohort of 
persons with HIV (n=23,974, 53.4% AA) found control to be significantly worse for AA 
compared to whites for DM and HTN (p<0.001, both). Again, adherence differences alone 
fail to explain these disparities. Therefore, innovative approaches must prove improved 
control of more than just HIV. Control of HIV, DM and HTN require medications.
What is MTM? In 2003, MTM 
became a standard of care for 
all  Medicare  Part  D  patients 
(CFR
 
423.153(d), 
www.cms.gov).
 
MTM
 
is 
substantially more than patient 
counseling.
 
In
 
MTM, 
pharmacists  comprehensively 
address  modifiable  barriers. 
Pharmacists
 
provide 
individualized, patient-centered 
services  addressing  known 
domains and levels influencing 
health disparities in AA. Pharmacists, using the patient’s language of choice (due to limited 
English) in the community pharmacy (due to stigma and/or availability of health services) or 
via telephone (due to mobility) educate on diagnoses and medications (due to health 
literacy), assess patient understanding (empowering medical decision making) of medical 
provider’s  treatment  plan  (patient-clinician  relationship)  while  optimizing  medications 
(individual  health  outcome),  adherence  and  provide  medication  acquisition  assistance 
(insurance coverage). The consensus definition of MTM is as follows: 
Medication Therapy Management is a distinct service or group of services that  
optimize  therapeutic  outcomes  for  individual  patients.  Medication  Therapy 
Management services are independent of, but can occur in conjunction with, the 
provision of a medication product. Medication Therapy Management encompasses a  
broad  range  of  professional  activities  and  responsibilities  within  the  licensed  
pharmacist's, or other qualified health care provider's, scope of practice. A guideline  
of services that may be provided at each visit are listed below. The list is not  
prescriptive or all-inclusive. The pharmacist decides what to do according to the  
individual needs of the patient at the time of the visit:

Performing or obtaining necessary assessments of the patient’s health status

Formulating a medication treatment plan

Selecting, initiating, modifying, or administering medication therapy
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
Monitoring and evaluating the patient’s response to therapy, including safety  
and effectiveness

Performing  a  comprehensive  medication  review  to  identify, resolve,  and 
prevent medication-related problems, including adverse drug events

Documenting the care delivered and communicating essential information to 
the patient’s other primary care providers

Providing  verbal  education  and  training  designed  to  enhance  patient  
understanding and appropriate use of his/her medications

Providing information, support services, and resources designed to enhance  
patient adherence with his/her therapeutic regimens

Coordinating  and  integrating  medication  therapy  management  services 
within the broader health care management services being provided to the  
patient
control (p<0.001). (17) A 2nd systematic review involving 14,225 patients showed MTM 
decreased systolic blood pressures in all patient populations. MTM ideally includes all 
elements of the Pharmacist Patient Care Process. This 5-steps of this process are: Collect, 
Assess,  Plan,  Implement  and  Follow-up/Monitor.  While  COLLECT  refers  to  gathering 
information from both patients and medical records, information typically only consists of 
prescriptions transmitted and results of patient interview in the pharmacy. MTM (Figure 2) 
does not requires providers to exchange patient’s medical information with the pharmacist. 
Only in rare or exceptional cases is the community pharmacist ever provided information 
directly  from  a  patient’s  medical  record.  The  CDC  project’s  MTM’s  innovation had 
pharmacists gain access to the patient’s medical information, permitting greater knowledge 
of the medical provider’s comprehensive plan as well as the full scope of conditions present 
and not just those being prescribed therapies. By having access to the medical records, 
pharmacists were able to: (1) more accurately ask questions, (2) independently determine 
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the state of each of the patient’s medical condition, and (3) make more appropriate 
recommendations to optimize patient outcomes. The results of this scientifically rigorous 
study  will  provide  the  level  of  evidence  currently  missing  of  MTM’s  effectiveness  in 
outcomes, make known the domains and levels of influence necessary to address to make it 
acceptable by the patients (and providers), and create the toolkit to deploy it into other 
communities where disparities exist.
INNOVATION
The innovation of medical record shared MTM is illustrated in the logic model (Figure 3): 
the sharing of a patient’s medical information with the community pharmacist. Figure 3 is a 
logic model only and not representative of the actual flow of the study, procedures or study  
requirements. This  proactive  sharing  of  medical  information  prior  to  the  pharmacist 
providing MTM is what is novel. The impact of this study is the likely demonstration that 
MTM improves the health in AA with HIV and discovers influences on MTM acceptability 
and uptake by patients, their community and providers. Knowledge gained can create a 
toolkit  instructive  on  expanding  MTM  into  additional  communities  with  healthcare 
disparities and thereby multiply the impact of this limited measure.
C. Preliminary Studies 
UNTHSC recently completed a 4-year demonstration/pilot project that was designed to 
develop a MTM program for persons with HIV. The demonstration project focus was to 
assess if MTM could be implemented in a community pharmacy. A secondary goal was to 
describe  the  impact  on  retention  in  care,  viral  load  suppression  and  adherence  to 
antiretrovirals. As that project’s data analyses are ongoing, only partial results available.
Retention in care: Historical baseline data was that of the 1.2 million people in the US living 
with HIV, less than half were retained in care (Figure 5). MTM incorporated quarterly visits 
as a means to engage persons with HIV outside their clinic to see if this impacted retention 
in care. MTM visits (as compared to returning to medical clinic) permitted a novel approach 
to maintain engagement with patient. It also provided medical providers routine reports on 
the safety and effectiveness of the agreed upon medical plan. It worked. Of the 796 
participants in the demonstration project, 98% (n=779) were retained in care. However, as a 
demonstration project, investigators were unable prove causality or assess for domains or 
levels of influence on why retention improved. This study is designed to demonstrate 
causality.
Virologic suppression: Preliminary analyses suggest improved outcomes in the 201 AA with 
HIV with data currently available. In AA with HIV (representing 48% of the CDC project 
enrolled participants), 85% achieved either virologic suppression (<20 copies/mL) or in 
those enrolled who already had virologic suppression, these participants CD4 count rose 
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from  below  to  above  200  cells/mcL.  Both  strongly  suggest  clinically  significant 
improvements in control of HIV in AA.
Adherence to medications: these data are not currently available.
Although  our  CDC-funded  demonstration  project  showed  encouraging  and  promising 
results,  it  does  not  establish  causal  relationship  between  intervention  and  clinical 
outcomes. There was neither a control group nor random allocation of treatment. The 
primary critique of demonstration/pilot projects are the lack of scientific rigor to state 
cause:effect. Therefore, without the evidence this proposal will provide, the population that 
stands to see the most benefit from such an intervention, i.e., African-Americans, will not.
D. Investigator Experience
In combining post-graduate training and employment after my terminal degree, I have 
participated in the direct patient care management of a plethora of patient populations with 
infectious diseases (ID), including HIV. As a clinical pharmacist specialist and board certified in 
ID, I have a broad understanding of the multidisciplinary team nature of the delivery of HIV care 
and experience working collaboratively with other health professional disciplines at large 
academic medical centers, community hospitals, and hybrids of the two. The variety of patient 
populations and world-class patient care teams I have worked with and continue to work with 
at the University of Texas Southwestern Medical Center, has provided a solid practice 
foundation in the field of ID, inclusive of HIV. Correspondingly, prior to finishing my terminal 
degree, I worked as a pharmacy technician and intern at Walgreens where I personally 
delivered MTM services. 
As pharmacy faculty in ID with a hospital-based clinical practice, I have developed three main pillars of 
research to stomp out ID focused on outcomes, utilization, and therapy-specific. My primary practice 
and research interests include multi-drug resistance, scholarship of teaching and learning, and infections 
in immunocompromised hosts, which include persons living with HIV (PLH). Due to the lack of an 
immune system, immunocompromised patients are more likely to develop infections not typically seen 
in immunocompetent patients. This often leads to difficulty in ethically conducting quality research due 
to available research designs, having an adequate number of patients, or exorbitant numbers of 
confounding variables. I have particular interests in PLH and am driven to provide more data for both 
the management of as well as prevention of infection in these patients so that I can better optimize their 
care. I have provided significant contributions to the literature for transplant recipients, was a CO-I for 
multiple CDC grants related to latent tuberculosis infection (LTBI), and am a current CO-I of a HRSA 
grant, “TAKE on HIV for Health Professions Programs” intending to include the National HIV Curriculum 
into undergraduate education, various health professions education, as well as post-graduation 
education. I have since joined this project, initially as a CO-I to provide a pharmacist perspective that has 
conducted MTM and as a subject matter expert on HIV. Starting in July of 2022, I became the PI for this 
project which will hopefully lead to decreased health disparities for AA living with HIV. My clinical 
experiences, research skill set, and experience in teaching and education of health professions students 
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make me well suited for my role in this project. 
Dr.  Howell  has participated in the management of a plethora of patient populations with 
infectious  diseases  (ID).  These  experiences  include  but  are  not  limited  to  antimicrobial 
stewardship  for  adults  and  pediatrics,  solid  organ  transplant  recipients,  bone  marrow 
transplant recipients, patients with cancer, persons living with HIV (PLWH), indigent patient 
populations in a county hospital, indigent patients at charity clinics, a cystic fibrosis center, a 
travel medicine clinic, and a leprosy clinic. She has worked for both large academic medical 
centers, private community hospitals, hybrids of the two, and navigated health systems with 
several hospitals. The variety of patient populations and world-class patient care teams have 
provided a solid practice foundation in the field of ID that can be applied to any number of 
research  projects.  As  such,  my  respect  for  the  intricacies  of  the  puzzle  involving  the 
microorganism (bug), the drug, and the patient has only grown over time. 
Dr. Howell received her PharmD from the University of Texas at Austin and completed a PGY-1 
Pharmacy Practice Residency at Emory University Hospital followed with a PGY-2 Infectious 
Diseases Residency at Emory University Hospital Midtown and Emory University Hospital.
E. Experimental Design and Methods
1) Methods and Procedures
Statement of Clinical Trial Conduct:
This trial will be conducted in accordance with the principles and guidance provided by the 
NIMHD Terms of Award. The Principal Investigator will seek to assure no deviations from, or 
changes to the protocol will  take place without prior agreement from the sponsor and 
documented approval from the Institutional Review Board (NTRIRB),  except where 
necessary to eliminate an immediate hazard(s) to the  trial participants. All personnel 
involved in the  conduct of this  study have completed NTRIRB required CITI or UNTHSC 
mandated trainings prior to being permitted to engage in the study. The PI agrees to ensure 
that all staff members involved in the conduct of  this study are informed about their 
obligations in meeting the above commitments.
This study is a prospective, randomized (1:1 medical record based MTM, the intervention to 
non-medical records based MTM, the control or standard of care), clinical trial, comparing 
disease-specific clinical and humanistic outcomes in 200 adult African-Americans with HIV 
(1:1  men:women) and  either DM and/or  HTN.  Data will be  collected from  individual 
participants for a 2-year period. Potential participants will be identified and recruited as 
detailed in the recruitment section. A study screen visit will be arranged. 
Screening visit (Visit 1)
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The screen visit is when the participant will be consented. The screen visit may take place 
over the phone or in-person. Either the PI or SC will conduct the screening visit. For 
screening procedures done over the phone, the necessary documents will be sent to the 
participant’s email through Docusign in an encrypted link. The PI or SC will schedule a 
meeting through zoom to consent the participant and guide them on the pages that 
requires their signatures. For participants who do not have access to internet the consent 
form will be mailed out to them. Later the PI or SC will schedule a meeting over the phone 
to obtain the consenting process and guide the participant on the pages that required their 
signature. A  SCREENING CHECKLIST  has been developed and is attached to facilitate the 
NTRIRB  review  of the  steps being taken by the research team  when conducting the 
screening visit (Visit 1). This (and all) checklists are for use only by research team personnel. 
Participants will not have to complete the survey at screening visit. Participants are not 
compensated for completing the screening visit.
Once properly consented, PI/SC will interview participant to learn of any and all healthcare 
entities who have provided care to the participant. For each of those identified that are, in 
the opinion of the PI/SC, likely to have meaningful information, a UNTHSC Medical Records 
Release  Form  will  be  completed.  Medical  records  from  these  identified  healthcare 
provider(s) for the 12 months prior to the most recent visit to that healthcare provider will 
be requested. These records will be requested to be sent to UNTHSC via (primarily) a secure 
FTP link using the software program, ACCELLION. This is a HIPAA compliant platform for 
data sharing/transfer. The record release form instructs the recipient to send an email to 
the PI to obtain a link. A link is then sent for the records to be securely transferred. The 
secondary method for transfer will be via certified mail and addressed to PI at UNTHSC. 
Medical record focus will primarily be those of the participant’s primary care and/or HIV 
care provider. Healthcare facilities will be instructed (on the medical records release form) 
to contact a research team member to make arrangements to retrieve the medical records 
if neither of these mechanisms work for that institution. Documents will be transported in 
locked, secure containers to substantially reduce the likelihood that accidental spillage 
would occur should the UNTHSC research team personnel be involved in a motor vehicle 
accident on route between the pharmacy, physical assessment sites (if different) and 
UNTHSC. If the participant provides the names for non-primary care/HIV providers but 
whom the participant feels provides or has provided significant care in the past year, these 
will be sought as well. The 12-month is not an absolute limit and this may be extended back 
if the participant feels it is appropriate and gives permission. These requests may include 
ERs (for instance in those participants who use an ER as primary care) or psychiatrists. If it 
includes prisons, these records will not be sought. The focus of initial and repeated medical 
record acquisition for the study will be the participant’s primary care provider.
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Participants  will  then  be  asked  to  provide  the  information  complete  a  PARTICIPANT 
CONTACT INFORMATION FORM. This document, maintained in paper form and updated 
throughout the study, will be securely stored alongside the  Case Report Form and the 
UNTHSC TEAM ASSESSMENT document. 
Medical records will be requested using the UNTHSC Medical Records Release Form. See 
above for details. Billing instructions for costs to provide medical records is provided on the 
UNTHSC Medical Records Release Form. Instructions to participants regarding any bills 
received  for  medical  records  is  provided  in  the  consent  form  and  elsewhere  in  this 
document.
This same process to request, attain and securely maintain medical records will be repeated 
throughout the study every time additional medical records are sought for participants. The 
participant’s responses to questions regarding healthcare provision at each visit will guide 
need  to  attain  additional  records.  It  is  anticipated  this  would  occur  every  90  days, 
maximally. Minimally, we will request medical records every 12 months after enrollment 
(anticipate to be Visits 4 & 9).
All medical record requests are historical. No medical records will be obtained for dates 
after a participant has been discontinued or withdrawn. This does not preclude that medical 
records will be received after a participant has been discontinued. In those instances, where 
medical records are received after a participant has been discontinued or withdrawn, these 
records  will  still  be  reviewed  and  information  used  in  the  database  only.  Medical 
information from this post-discontinuation received medical records will not be provided to 
the study pharmacist via an updated Case Report Form (CRF) (if the participant was in the 
intervention group).
If healthcare facility replies that an additional/alternative form(s) is required, PI/SC will 
contact participants to complete any required elements via the participants preferred and 
authorized (per contact sheet completed at screening) method. An ADDITIONAL MEDICAL 
RECORD RELEASE FORM SIGNATURE NEEDED SCRIPT has been developed and is provided 
for this anticipated need.
Participants will not have to complete the survey at this ‘repeat medical record form release 
signing’ visit.
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The medical records will be reviewed by the study coordinator and confirmed by a second 
UNTHSC research team member using the  ELIGIBLITY CHECKLIST. Once this is completed 
and  eligibility  is  confirmed,  participant  will  be  contacted  (ELIGIBILITY  CONFIRMATION 
CONTACT AND VISIT 1 SCHEDULE SCRIPT) to confirm continued desire to participate and 
schedule  Visit  2.  Both  will  be  completed  prior  to  providing  a  UNIQUE  (participant) 
IDENTIFICATION number (UID) for group assignment. 
Medical records for both groups are necessary. As the study is designed to randomize 
sequentially after medical records are received, medical records will be sought for all those 
consented. This is a study validity requirement. As the information to determine disease 
improvement  or  worsening  is  only  officially  determined  via  medical  records  of  the 
participant’s healthcare provider, medical records must be obtained for both groups to 
compare groups. This is also why medical records will be sought throughout the study. The 
information extracted from the medical records and entered into the database will be 
primarily used to assess for differences between the groups. See the Data Safety Monitoring 
Plan (provided) for more details.
The layman’s description of what specific information will be extracted and used from the 
medical records is provided in the consent form, following the header, “What information is 
being used from your medical records?” A more technical description is found in the 
database section that follows.
Walgreens study pharmacists will not be provided the actual medical records. For those 
participants randomized to intervention group, the medical records will be used to populate 
the CASE REPORT FORMS for Pharmacist Use or CRF-Pharmacist. Only the PI, SC (and Dr. 
Bedimo  who  is  providing  physician  oversight  to  ensure  accuracy,  integrity  and 
meaningfulness of extracted data being provided to the study pharmacist) will see the 
medical records. Only PI and SC will extract clinical data from the medical records for entry 
onto intervention group’s participant’s CRF-Pharmacist. This will occur every time medical 
records are received for participants randomized to the intervention group. Only the CRF-
Pharmacist (not the actual medical records) will be provided to the Walgreens study 
pharmacist. The CRF-Pharmacist will be provided to the study pharmacist in advance of the 
MTM visit. CRF-Pharmacist will be hand carried in a secure container and provided to the 
study pharmacist. For those participants randomized to the control group, a case report 
form only containing the participant study UID number and other pertinent document 
header information will be provided to the study pharmacist.
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Information from the medical records for all participants will also be used to enter diseases, 
medications, laboratory results, and vital signs into the study database. More details are 
contained in the database section below.  SCREENSHOTS OF DATABASE entry fields are 
provided to detail what information from the medical records and CRF is to be entered into 
the  database.  To  clarify,  only the  PI/SC will enter  data  into this database.  No  study 
pharmacist or participants will ever engage with this database.
In summary, intervention group participants’ initial and all subsequent CRF-Pharmacist 
given to the study pharmacist will have information extracted from the medical records. 
During the study, if additional medical records are received and contain information not 
previously included on the CRF-Pharmacist or update previously included information on 
the CRF-Pharmacist, this may result in more medical information being added to the CRF-
Pharmacist. Control group participants CRF-Pharmacist will never have any information 
extracted from the medical records included. Recall the standard of care for MTM services 
is that the pharmacists do not have access to medical records directly from the patient’s 
healthcare providers. 
All originals of the CRF-Pharmacist and all medical records will remain at UNTHSC in a 
secured location (PI/SC offices) between study visits. A copy of the case report form will 
remain on site at the pharmacy in a secure location accessible only to study authorized 
Walgreens  study  pharmacists.  Once  randomized,  the  participant  will  be  contacted  to 
arrange  an enrollment visit. The participant will be informed which group they were 
randomized to when contacted to arrange the enrollment visit. A script entitled, “Follow up 
after consenting, medical records received and eligibility confirmed, to set up an enrollment 
visit at Walgreens pharmacy” has been developed for this and is attached. If the participant 
expresses a desire to withdraw upon learning to which group s/he has been randomized, 
the participant will be reminded of the HIPAA release form and procedures to follow should 
they wish to no longer participate at that time. Participants will not be compensated for 
screening visits.
Within the main consent form, the participant will be asked to denote if the participant 
wishes for their HIV / primary care / specialist medical provider to be notified of their 
participation in this study.
Visit 2 
PI/SC will serve as the visit date and time coordinator between the study pharmacist and 
participant. At every MTM ‘visit’, PI/SC will be present. The study pharmacist conducts the 
MTM based on the information on the case report form as well as that obtained via 
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participant interview. Upon completion of the interview with the participant, the study 
pharmacist will develop a prioritized medication problem list and create an action plan. 
Using sound clinical judgement and following any applicable legal and ethical practice 
standards,  the  study pharmacist will  discuss/collaborate  with the  participant  and  any 
relevant  or  applicable  medical  provider/healthcare  team  member  regarding  the  plan. 
Engagement (communication) with a patient’s medical provider is part of the standard of 
care of MTM when deemed appropriate by the pharmacist performing MTM. The study 
pharmacist will use clinical judgement in deciding when to contact medical providers in the 
course of providing MTM to the participants. Included in this plan is the recommended next 
time point when the study pharmacist and the participant should engage for follow up. The 
preferred interval should not exceed 90 days (this is a data analysis plan and not a 
participant  safety  influenced  interval).  If  at  this  visit  (or  any  future  visit),  the  study 
pharmacist  determines  additional  medical  records  are  potentially  available, the  study 
pharmacist will ensure the PI/SC seeks to attain these. Medical records will be sought for 
both groups by the PI/SC. If the study pharmacist feels compelled to obtain complete 
medical records for those randomized to the control group, this is allowed. The study 
pharmacist would be acting outside of the role of the study pharmacist in this regard and 
would have to obtain a separate release of medical records using Walgreen’s standards to 
obtain this. Costs associated with this would fall to the study pharmacist or participant. The 
study pharmacist would be required to communicate this information to the participant. 
This would impact how that participant’s data is managed thereafter but does not require 
discontinuation from the study. This is detailed later in the protocol, section F.1. This is also 
provided in the consent in Alternative Treatment section.
PI/SC are present to serve as scribes for the study pharmacist to aid in data acquisition 
accuracy and completeness. This is communicated in the consent form for telephonic MTM 
visits. PI/SC  will  be in compliance  with all safety and confidentiality requirements as 
applicable.
Visit 3 – 9 
All visits 3-9 will only take place via telephone or in-person per participant preference. 
At the next MTM visit (arranged by the SC and agreed upon by both the participant and the 
study  pharmacist),  the  study  pharmacist  will  interview  the  participant  to  determine 
progress towards plan desired goals or targets. Upon completion of that interview, the 
study pharmacist will collaborate / discuss with participant and any or all medical providers 
as relevant or applicable to the plan and make changes to (update) the plan accordingly. 
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Once this is completed, the study pharmacist will discuss with the participant when the 
following MTM visit should take place. PI/SC will be present for each MTM visit they will 
serve as scribe (note taking on the paper CRF-Pharmacist updated from previous visit) for 
these follow-up visits and confirm accuracy of information recorded with study pharmacist 
as soon as possible following completion of the visit. CRF-Pharmacist will not be made 
available or visible to participant.
This sequence of events will be repeated approximately every 90 days (quarterly) for 2 
years after enrollment. At the final visit, participants will be provided information on how to 
receive MTM visits outside of the study. As MTM is a service that is typically charged to a 
patient or their insurance company, the study is compensating Walgreens to provide MTM 
as part of the study. The amount of personal expense to a patient for MTM varies based on 
how the service is to be billed (cash vs. co-pay). This can also vary based on who provides 
the service (Walgreens vs. another pharmacy). The study pharmacist will explain anticipated 
personal cost to the participant at the final visit if MTM is continued at Walgreens only. This 
is  communicated in the  consent form  in Visit 9. There  is additional  language  in the 
Alternative to Participation section of the consent form.
UNTHSC team assessments: 
A single, qualitative survey assessing barriers to care, health literacy, adherence and other 
domains will be administered verbally by the UNTHSC research team member at Visit 2-9.  A 
single tool was decided upon after receiving feedback from key stakeholders.
At each visit 2-9, consent to attain the records may be sought from the participant for any 
medical care received since the previous visit. This will be done for both groups. This 
process  will  follow  that  described  in  Screening  Visit  section.  Participants  will  not  be 
discontinued if records are not received. As a reminder as to why medical records are being 
sought for both groups, if this is not done for both groups, there is a risk that differences in 
health between the two groups could not be determined. This would not align with data 
safety monitoring plan.
If a participant withdraws consent to continue at any visit, permission to obtain medical 
records up until the date of withdrawal or discontinuation will be sought. This represents 
when information that would be used in the data would be received after discontinuation 
occurred as the information would have been recorded in the medical records prior to the 
discontinuation date.
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Case report form compilation: CRF-Pharmacist will serve as the cumulative list of clinically 
meaningful  (see  further  description  in  Screening  Visit  section)  medical  information 
extracted from the medical records (intervention group) as well as the findings of the study 
pharmacist performing the MTM (control group and intervention group). 
CRF-Pharmacist and CRF-Staff are maintained electronically on the secure LabArchives 
platform. These are only accessible to UNTHSC research team personnel. Printed versions 
will be used during the MTM portion of each study visit. The study pharmacist will review 
and  approve  PI/SC  hand  notations  made  during the  MTM  portion  of  the  visit.  Once 
approved, PI/SC will update the forms electronically (using Word).
Intervention group Case Report Form updates: Prior to each scheduled MTM visit, PI/SC will 
update the CRF-Pharmacist and CRF-Staff with information extracted from the medical 
record (as applicable). The most up-to-date form will be hand carried to the pharmacy for 
the MTM visit via a secure carrying case by either the PI/SC. The form will be updated 
during the MTM visit with the information attained of that visit. At the conclusion of the 
visit, the CRF-Pharmacist will be copied. The copy is stored at the pharmacy in a secure 
location accessible only to study personnel. The original is (securely) hand carried back to 
UNTHSC by PI/SC. The information of the visit is used to update the CRF form electronically, 
then the information is entered into the database and then stored in a secure location. Prior 
to all future scheduled visits (up to 9), PI/SC will review any newly received medical records 
(if applicable), update the most recently completed case report form with this information, 
print the document, then transport it to the pharmacy for the study pharmacist to use at 
the next scheduled MTM visit.
Control  group  Case  Report  Form  updates: At  the  conclusion  of  each  MTM  visit  for 
participants in the control group, all CRFs will be updated based on the study pharmacist-
participant session. The form will be copied and then the copy stored at the pharmacy in a 
secure location accessible only to study personnel. Maintaining the historical information 
will permit the study pharmacist to look back over the course of the study when providing 
currently providing a MTM intervention. The originals will be hand carried back to UNTHSC 
by  UNTHSC  research  team  member,  the  form  updated  electronically  (using  only  the 
information from the MTM visit), then entered into the database and then stored in a 
secure location. Only the notes from the previous visit will be used to update the CRF-
Pharmacist for control group participants. The updated CRF-Pharmacist will be brought to 
the pharmacy in advance of the next scheduled MTM visit. This process is repeated after 
every visit except the final visit where no new updated forms are brought back to the 
pharmacy.
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UNTHSC team assessments: The UNTHSC team assessments will be entered onto the CRF-
Staff. This document is not ever shown to the study pharmacist for either group or the 
participant. The document is also used to update the database.
2) Data Analysis and Data Monitoring – Describe plans for statistical analysis of data when 
appropriate. If a data safety monitoring committee is appropriate to protect the safety 
and/or welfare of subjects, describe its operation (e.g., membership, stopping rules and 
frequency of review).
The diseases being used to validate HIV-CMTM effectiveness are HIV, DM and HTN. For 
HIV, disease control is defined as plasma HIV-RNA of < 20 copies/mL. Standard of care 
recommends follow-up based on viral load. (19) For DM, self-monitoring of blood glucose 
is less reliable than quarterly A1c levels (goal of < 7%) which is monitored every 3 months.
In HTN, goals vary based on comorbid conditions as follow-up varies with medications. As 
AA have 2-3 higher incidental rates of stroke compared to whites. (Howard). As a 10 mmHg 
difference in systolic blood pressure is shown to reduce stroke rate by 24% in AA, a 
decrease in systolic blood pressure reductions of 10 mmHG [or attainment of blood 
pressure goal] was selected as the primary measure for effectiveness on HTN. Medical 
record blood pressure will be the primary source for analyses as ultimately, it is the 
information collected by the diagnostician that is used for decisions. 
Two sample t-test for continuous outcomes (viral loads) and chi-square for categorical 
outcomes (blood pressure under control or not) would be used to assess significance at the 
0.05 level.
DATA AND SAFETY MONITORING PLAN
There are no medical procedures or prescription changes that can occur as part of this 
study that are not first authorized by the patient’s medical provider. A data safety 
monitoring plan has been presented and approved by the NIMHD Program and Science 
Officer that reflects the low safety risk to participants, from a medical perspective. The 
DATA SAFETY PLAN is attached. The risks to participants due to protection of information 
and how information is safely maintained is addressed elsewhere in the protocol.
3) Data Storage and Confidentiality
Data Security, Collection, Entry, Management, and Quality Control: Only authorized study 
personnel will have access to the data. All HIPAA research safeguards and protocols for 
protected health information will be observed. All randomized participants will be assigned 
a unique identification (UID) number for use throughout the project. This number will be 
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assigned at screening. The UIDs by themselves are randomly generated numbers. These are 
not linked to any other database’s PHI (patient identifiers).
The UID is the first column of the  MASTER PATIENT LIST. As the study participants are 
followed up over time, the main purpose of the master list is for data entry by the study 
coordinator. All data will be entered based on the UID for each participant as the key. As 
such, only information necessary to match a participant uniquely to the UID will recorded 
on the master list. As is on the provided blank MASTER PATIENT LIST, information recorded 
are: last name, first name, middle initial, gender, date of birth, last 4 digits of the social 
security number, study arm (intervention/control), and enrollment status (enrolled in the 
study vs. declined to participate). The enrollment status is necessary because the UID is 
assigned when the participant is screened. Not everyone assigned a UID will be enrolled in 
the study. The complete social security numbers are collected for the sole purpose of 
providing compensations to the participants (a requirement of the UNT BSC). The complete 
sequence will be contained only on the PARTICIPANT CONTACT INFORMATION FORM. The 
PARTICIPANT CONTACT INFORMATION FORM will remain in the participant binder that is 
stored in PI/SC offices. The MASTER PATIENT LIST will be stored in a locked cabinet in the 
office of the PI or SC. A copy of the MASTER PATIENT LIST will be provided to the study 
pharmacist for placement in the secure locked cabinet in the study pharmacy that is only 
accessible by authorized study personnel of Walgreens.
During enrollment period, the master list will be updated and printed after each enrollment, 
then stored physically in a secured location (as described previously in a secured cabinet 
only accessible to authorized study personnel at Walgreens or in PI/SC offices). When 
enrollment ends, a final master list will be stored in the pharmacy accessible only by 
authorized study personnel. Password encrypted flash drives containing the cumulative 
patient  list  will  be  securely  stored  at  UNTHSC,  accessible  only  by  authorized  study 
personnel. As participants are being compensated, their identifying information that is 
necessary to satisfy UNT BSC requirements for compensation will be provided to finance. 
Great care has been taken by the PI to remove the word “HIV” from study title and all 
materials that are required to be handled by non-study related personnel at UNTHSC 
(finance personnel). Only non-diagnostic PHI will be provided to finance to satisfy policies 
for study participant compensation.
Medical records will be solicited in accordance with the requirement of the providers or 
institutions of the potential research participants. The frequency of the solicitation will be 
contingent on receipt of medical services as disclosed by the participants during the study. If 
in the course of reviewing medical records, it is discovered there are other providers not 
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previously disclosed by the study participants (or potential participants during screening), 
Dr. Bedimo will be consulted on the need to solicit the additional records. In any event, if 
the records are deemed clinically important by Dr. Bedimo, the participant will be contacted 
and permission sought to obtain those records. To clarify, if it is discovered medical records 
exist that represent period of incarceration, these records will not be solicited.
Delivery of medical records is anticipated to be primarily via ACCELLION (encrypted email), 
certified mail, or fax and if so, addressed to Dr. Howell or the study coordinator.  Mail 
received will be placed in a secure environment (locked cabinet inside a locked office) only 
accessible to authorized study personnel (PI/SC offices). The study has a dedicated fax 
machine located inside a locked office and only accessible to study personnel. The fax 
machine is used to send medical record requests and receive medical records.  Healthcare 
facilities will be instructed (on the medical records release form) to contact Dr. Howell to 
make arrangements to retrieve the medical records if neither of these mechanisms work for 
that institution. Documents will be transported in locked, secure containers to substantially 
reduce the likelihood that accidental spillage would occur should the UNTHSC research 
team personnel be involved in a motor vehicle accident on route between the pharmacy, 
physical assessment sites (if different) and UNTHSC. No medical records will be transported 
outside of the PI/SC offices. Medical records will be scanned and stored into LabArchives 
and paper copies destroyed (if applicable) after this is completed (maximally 1 year after 
last study visit is completed for all participants).
Research team has attained ACCELLION secure data transfer capability. This system permits 
a team member to email a secure link to the institution/individual that has been authorized 
to release the medical records. ACCELLION uses AES-256 encryption, FIPS 140-2 certified 
and FedRAMP Authorized, bring your own encryption keys (BYOK) for secure, encrypted 
transfer of large files as well as a secure email message body whereas only authenticated 
users can read the message along with a unique digital fingerprint verifies email attachment 
integrity. 
Data on the case report forms are entered into the study database. UNTHSC research team 
members will enter this data into the study database. The database is created and managed 
by a project biostatistician. Database only identifies participant UID. 
The CRF is a word document. Extracted information will be typed onto the document. This 
will take place in PI/SC offices (PI & SC offices at UNTHSC). The electronic versions of the 
CRFs will be stored securely on LabArchives, a password protected, backed-up 12 times 
daily, HIPAA compliant platform.
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UNTHSC research team personnel will be trained extensively on data entry, integrity, 
rationale, and methods prior to commencement of data entry. Routinely the statistician will 
meet with PI/SC to provide quality assurance feedback (and if necessary, retraining) during 
the data collection period. Once data collection begins, the quality and usability of the data 
will be closely monitored in various ways. For the first two weeks, every single entry (each 
datum)  will be manually verified and validated to ensure correct data entry. Weekly 
thereafter, descriptive and summary statistics will be computed for data entered during the 
corresponding week to identify any error trends or anomalies. Beginning in month two (2) 
of data collection per site, a random sample of patient data (5%, split evenly between male 
and female participants) will be selected from the prior month’s data and also reviewed 
manually for integrity and quality. Data quality issues will be addressed immediately. All 
changes to entered data will be logged using a memorandum of odd data and errata 
(MODE) form (contains UID, data in question, date issue found, issue description, issue 
remedy, and date completed). MODE forms will be retained securely by biostatistician. All 
CRF collected data will be stored and backed-up using a platform called LabArchives™. 
Content placed in LabArchives™ is password-protected, encrypted in transit and at rest, as 
well as backed up 12 times a day. LabArchives is HIPAA as well as 21 CFR Part 11 compliant. 
Content owners and administrators can specify who can access or edit each file stored. As 
the data are collected, the aggregate database will be updated and will be structured to 
ensure  that  the  study  data  can be  readily retrieved for  report generation, statistical 
analyses, and data transfer. As the data are collected, the aggregate database will be 
updated and will be structured to ensure that the study data can be readily retrieved for 
report generation, statistical analyses, and data transfer.
After the final participant final visit is completed, the Master Patient List, Participant 
Contact Information Form, all remaining medical records and all printed CRF forms will be 
scanned and uploaded to LabArchives. Once this is completed, all paper copies will be 
destroyed in accordance with UNTHSC policies for medical record destruction. At the end of 
the study the master patient list linking specific participants to their UIDs will be destroyed. 
The study pharmacy will maintain its copies of its documents per its Walgreens policies. See 
attached  Walgreens Authorization for Release of Information to a Third Party for their 
document retention policy and requirements. The information from this document has 
been included in the consent form in the section, Terms of Authorization. The form will be 
provided to potential participants during the consenting process and prior to soliciting any 
other medical release forms. This will be the first release form provided for the potential 
participant to sign. If the participant refuses to sign the Walgreens Authorization for Release 
of Information to a Third Party, then the participant will be a screen failure.
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No  information  generated  from  this  study  will  be  uploaded,  stored  or  retained  by 
Walgreens electronically. The information from this study does not go into Walgreens’ MTM 
system. All MTM information for this study will be on paper until PI/SC enters it into 
LabArchives (not a Walgreens database). Walgreens personnel will not have access to 
LabArchives.  All  elements  of  this  study  will  be  represented  in  paper  form  only  and 
stored/housed/secured as described in the protocol. Walgreens retains the materials for 
legal purposes only.
All data for this study will be maintained for 6 years following the conclusion of the study. 
At this point, all remaining electronic and paper documents will be handled in accordance 
with whatever the current UNTHSC policies and procedures for medical record destruction 
is in effect. The MASTER PATIENT LIST will also be destroyed after 6 years. This will remove 
all ability of researchers to connect an individual participant’s data. Walgreens will store the 
master patient list, copies of CRF and Walgreens release until 2031.
4) Setting
All study visits will take place over the phone or in-person. Participants who request in-
person visits will meet with the research coordinator and/or study pharmacist in a room 
properly suited to accommodate the required distancing per the Center for Disease Control 
and Prevention’s (CDC) recommended COVID-19 safety protocols for the 
immunocompromised populations. Social distancing will be observed, and the participants 
will be required to wear a facemask. After the in-person meetings for the consenting 
process and/or study visits are completed, hand sanitizers will be made available for 
disinfecting their hands.
5) Estimated Period of Time to Complete the Study
 MTM sessions typically last up to 90 minutes for the first session then 30-45 minutes for 
each session thereafter. The UNTHSC assessments and survey are estimated to take 10 
minutes or less per visit. Visits are encouraged to not exceed 90-day intervals. There are 8 
planned quarterly visits, totaling 9 visits when including the consenting visit.
Due to funding limitations, the last day of study visits will occur on December 15, 2023. A 
formal memo to be sent via United States Postal Services (or similar university services) and 
text message verbiage will communicate the study termination to study participants. 
Participants who have been lost to follow-up, i.e. have not had a study visit in more than six 
months despite reminder communication, will not receive the physical memo or text 
message alert. Reimbursement for study visits will only occur for study visits that are 
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completed by the December 15th deadline.
F. Human Subjects - Describe the characteristics of the research population: 
1) Sample Size:
Patient  Identification,  Recruitment  (enrollment  rate  included  in  Power  Calculation 
description below), Randomization, and Interim Analysis: 
Two hundred adult AA with HIV and either/both DM or HTN will be recruited using NTRIRB 
approved recruitment materials. Once consented, patient gender and comorbidity stratified 
randomization (i.e., separate randomization by men/women and by DM/HTN) will be used 
to randomize them into the intervention group or control. Randomization assignment will 
be controlled by the biostatistician. This will create eight groups: men with DM receiving 
intervention  (1.a.),  men  with  DM  receiving  control  (2.a.),  women  with  DM  receiving 
intervention (1.b.), etc. (Figure 4). Patients with dual diagnosis of DM and HTN will be 
randomized into either the intervention or control group. Their data will be used in both 
DM and HTN analyses (after conducting a sensitivity analysis to determine that the dual 
diagnosis does not confound or bias the results). A random number generator (range 1 to 
10,000)  will  be  used  for  group  assignment.  UNTHSC  biostatistician  will  be  the  only 
unblinded member of the research team to which number corresponds to the intervention 
or control groups when presenting data during investigator team safety reviews and data 
safety monitoring plan described.
The primary endpoint for this study will be the health indicators collected at the final 
follow-up  visit  comparing  the  corresponding  intervention  and  control  groups  (e.g., 
intervention vs. control for men with diabetes). We computed the power and sample size 
based on the effect sizes estimated from our previous CDC-funded demonstration project 
where observations from 201 African American HIV patients at baseline whose viral loads 
were  either  detectable  (>20  copies/mL)  or  their  CD4  counts were  <200  cells/mcL  at 
baseline. Of these, 171 (85%) showed improvement (viral loads became undetectable or 
CD4 counts became >200 cell/mcL) at follow-up after receiving quarterly HIV-CMTM. Based 
on these results and even assuming a very conservative effect of 45% improvement for the 
control group receiving standard of care projects that a comparison between intervention 
and control will require 22 subjects per group. This enrollment volume enables attaining a 
power of at least 80% at the 0.05 level of significance for each of the comparisons. As some 
attrition is expected, we will recruit 25 patients per group for a total of 200 patients. We 
also note that the sample sizes are very likely larger as the subjects with a dual diagnosis of 
diabetes and hypertension will be included in the analyses, but are not included in the 
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sample size computations shown above. We also conducted additional power analyses 
based on this sample size to verify that the analyses will be sufficiently powered when the 
outcome measures are treated as continuous (testing means) rather than dichotomous. 
Control Group Medical Record Viewing by Study Pharmacist
Pharmacists  are not prohibited from  requesting the  complete medical  record from  a 
medical provider pursuant to normal counseling and care provided, this is just rarely (if 
ever) done. Pharmacists routinely contact medical providers to recommend changes to 
medications. If the study pharmacist, in the course of providing MTM to participants in the 
control group, contacts a medical provider, this will not change the status of the control 
group participants. If, however, the study pharmacist feels compelled to obtain the entire 
medical record for a participant in the control group, s/he will notify the participant and PI/
SC. Should the study pharmacist inadvertently gain access to a control participant’s medical 
records (participant brings medical records themselves to the MTM session and the study 
pharmacist uses the complete medical record for the purposes of MTM), the participant will 
not be discontinued. In either case, the participant will not be discontinued. The time point 
at which the study pharmacist gained access to the medical record for participants in the 
control group will be noted and this will become a controlled variable in the analyses.
2) Describe both Inclusion AND Exclusion Criteria.
Inclusion criteria:
>/= 18 years old or older at time of screening
Male or female
Self identifies as African-American or black
Able to read and speak English sufficiently well enough to be interviewed by study 
pharmacist (as determined at screening visit by PI/SC)
Confirmed diagnosis of HIV (medical record)
Confirmed diagnosis of diabetes, hypertension, or both (medical record)
Stated agreement to comply with study requirements during screening visit
Able and willing to provide written informed consent
Willing to notify study pharmacist if becomes pregnant during study
Expresses a willingness to participate in all study-related assessments and 
adhere to study requirements
Willing to notify research team if planning to relocate
Willing to notify research team if incarcerated at any point during study
Exclusion criteria: (whether discovered at time of consent or after review of medical 
records)
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Inability to self-administer medications (either due to mental or physical state)
Hospice services currently being used or anticipated within the next year
Systemic chemotherapy (topical chemotherapy allowed)
Currently a prisoner or have received all healthcare to date as a prisoner
Early / Administrative withdrawal criteria:
Participants may be withdrawn from the study. Participants will be withdrawn from the 
study if they (i) voluntarily withdraw, (ii) demand to be switched to the other group after 
becoming aware of assignment, (iii) are lost-to-follow-up (moved), (iv) incarcerated, or (v) 
participant’s care provider requests withdrawal. The PI will notify any participant 
terminated for any reason of the reason for termination from the study via phone call (voice 
mail left if no answer) using the following statement, “You are no longer able to participate 
in the study. The Walgreens study pharmacist has been notified. You may continue to use 
Walgreens for your pharmacy services if you choose to do so. Please contact Dr. Howell 
with questions about the study.”
3) Describe intended gender, age range, intended racial and ethnic distribution.
The intended purpose of this study is to limit enrollment only to black/African-American 
adults (> 18) with a goal to enroll 50% women.
4) Identify the source(s) from which you will obtain your study population. 
Study participants will be obtained from multiple sources. There is no requirement to be a 
Walgreens patient to participate in this study. Walgreens pharmacists are able to provide 
MTM to individuals who are not their patients.
5) Describe plans for recruitment of subjects. All materials (e.g., flyers, ads, emails, letters, 
postings, handouts, etc.) to be used for recruiting subjects must be submitted to the 
NTRIRB for review. 
As of October 31, 2022, recruitment and enrollment of subjects are completed for the study. There 
are no current plans for further recruitment. Previous recruitment measures are provided below. 
John Peter Smith (JPS) Clinics: Within the JPS clinics, a site coordinator would review patient 
profiles with the SCREENING CHECKLIST to identify potential study participants. If the patient 
met inclusion criteria according to the checklist, the coordinator would either call or meet with 
the patient, depending on availability, for consent. The coordinator would review the consent 
form, including the risks and benefits, with the potential participant. If the participant agreed, 
they would sign the consent form. Conversations conducted over the phone would require 
follow up with the site coordinator for the potential participant to sign the consent form 
physically. The site coordinator would contact the PI/SC when patients had consented so that 
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the participant could be enrolled in the study. 
Walgreens recruitment: There is no requirement to be a Walgreens patient prior to or 
during the study.Walgreens pharmacy will be used to recruit participants. Only 
Walgreens pharmacists will contact Walgreens’ patients to make their patients aware of 
the study. This is being done to reduce ‘cold call’ aspect. Walgreens’ pharmacists will 
review their patient profile system and attempt to identify potential study participants. 
Walgreens data systems does not contain racial information. Thus, only the patients the 
pharmacist personally believes to be African-American or black will be contacted.
A general report description is provided. The specific query mechanism used by Walgreens 
is proprietary. Pharmacists will perform review of prescription records to identify potential 
study participants by seeking current (within past 12 months) patients who have received 
HIV treatment (not PrEP) medications and either medicines likely to be used for diabetes or 
hypertension. Once this list is created, the pharmacist will review for appropriateness to 
consider initiating contact and making patient aware of study opportunity.
Walgreens study pharmacist will inform current patients of study opportunity either using 
NTRIRB approved materials or a Walgreens pharmacist may verbally engage during regular 
encounters (potential participant picking up routine medications from the pharmacy). The 
specific level of engagement will be left to the discretion of the pharmacist who knows the 
potential participant best. Individuals who are identified as potential research participants 
will be notified how to contact the PI or study coordinator. It is being left to the discretion of 
the study pharmacist how to provide the information regarding the study to their patient. 
No patient information will be shared with the UNTHSC research team for the purposes of 
recruitment. Walgreens personnel not approved to work on the study who are working in 
the study’s pharmacy will direct questions and inquiries regarding the study to the 
Walgreens personnel approved to work on the study. NTRIRB approved materials will be 
provided to regional Walgreens pharmacies for distribution. The approved materials may be 
shared during regional Walgreens pharmacy meetings.
Community-wide (non-Walgreens based) recruitment:
There is no requirement to be a Walgreens patient to participate in this study. Recruitment 
will occur at other healthcare sites around the region. UNTHSC team personnel will conduct 
study awareness sessions with healthcare professionals in the region. This will include non-
Walgreens pharmacies. PI & SC will set up meetings to inform regional healthcare providers 
of the study opportunity. NTRIRB approved materials will be provided for distribution per 
the policies of these individual institutions / entities. PI/SC may coordinate and provide 
meals as part of these meetings, paid for by the funding source.
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NorTex Registry – Personnel who are approved to work on this protocol and with the 
NorTex registery will contact potential participants as per the NorTex approved procedures. 
If individuals are interested and qualify to participate (initial telephone screen script 
approved for 2018-094 will be used), a formal screening visit will be coordinated.
PI/SC will also meet with leaders of local AIDS service organizations and support groups. If 
invited to do so, PI/SC will return to speak to members of these organizations/groups. 
During these meetings, only the materials approved by the NTRIRB will be presented, 
shared or left for distribution. It will be left to the individual/organization to determine 
what, if any, additional levels of approval are needed for participants to be recruited from 
these potential sites. For instance, if these sites require modification to the study flyer, 
revised study flyers will first undergo NTRIRB review and approval before distribution.
For groups where meetings with leaders are not achieved, copies of the consent form and 
other NTRIRB approved materials will be sent to publicly listed addresses for these groups. 
It will be left to the discretion these leaders how to proceed with distribution of the 
materials. 
Media outlets (i.e., buses, billboards, online newsletters, websites) may be used to 
distribute marketing materials. Health fairs and community events may also serve as a 
recruitment site. Only NTRIRB approved materials (regardless if static – like flyers and ads – 
or dynamic – such as website materials, audio or video recordings to include first approval 
or the script then a secondary approval of the actual media) will be distributed at these 
events or submitted to media outlets for distribution.
Study flyers will have a QR code that will redirect possible participants to the study website 
(www.unthsc.edu/addup). 
No referral fees will be paid to any entity facilitating participants to contact UNTHSC 
research team to arrange screening visits. This applies to both healthcare and non-
healthcare personnel.
G. Risk/Benefit Assessment 
1) Describe the level of risk, and if more than minimal, describe how this research holds the 
prospect of a direct benefit for the subjects. If there is NO direct benefit to subjects, state 
such in protocol and in the consent documents. 
Based on nature of the intervention and UNTHSC experience with both the nationwide CDC 
and local Tarrant County Health Department-funded demonstration projects, adverse 
events are not anticipated. The research team assesses this to be a ‘low risk’ study from any 
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medical perspective. We anticipate that most, if not all, adverse events will be due to the 
participants’ medical conditions, lifestyle, or accidents.  Given the nature of the study 
(longitudinal study, data analyses of medical record and questionnaires, and subject 
population), hospitalization and death caused by natural consequences of age and disease 
(i.e. HIV patients), and unrelated to this study, are anticipated. Such death and 
hospitalization will not be immediately reported, but reported at annual review. With 
respect to benefits, other than potentially improving the overall health of participants, 
there is no anticipated benefit.
2) Describe how the anticipated benefit justifies the risk. 
As there is minimal physical risk, the benefit to the participant appears acceptable. The 
RISKS AND DISCOMFORTS section of the consent form provide the usual and customary 
potential risks.
3) Describe how the anticipated benefit of this research is at least as favorable to the 
subjects as that to be received by available alternative approaches for the subjects. 
The anticipated benefit of improvement of control of diabetes or hypertension is potentially 
equivalent to if the participant sought this care from their current pharmacist. It is possible 
to obtain this service from another pharmacist. Obtaining MTM outside the study may 
require payment from the participant. Some health insurance or third-party payers do not 
cover MTM visits (except an annual MTM visit by Medicare).
4) Describe any potential RISKS OR DISCOMFORTS in detail.
The potential risks that is of greatest concern is the accidental disclosure of HIV status. As 
such, great efforts are being taken to ensure medical records arriving at UNTHSC are 
delivered to PI/SC office upon arrival. Further, all documents that are being hand carried to 
the pharmacy will only contain limited identifiers (UID, Initials and gender). The documents 
will have diagnoses and other PHI. Documents will be transported in locked, secure 
containers to substantially reduce the likelihood that accidental spillage would occur should 
the UNTHSC research team personnel be involved in a motor vehicle accident on route 
between the pharmacy, physical assessment sites (if different) and UNTHSC. As PI/SC will be 
on site at Walgreens for each MTM visit, no original documents will be left in the pharmacy 
for storage. Only copies of CRFs (updated manually by PI/SC) [recall that no medical records 
are transported to the pharmacy] will remain in the pharmacy in a locked storage 
cabinet/file accessible only to study authorized personnel. This same cabinet/file will also 
house a copy of the master participant list.
Discomfort can occur by having to answer questions about health in front of the study 
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pharmacist and the PI/SC. This is being reduced by providing several points of 
contact/communication. Because there are multiple visits, participants have ample opportunity 
for concerns and questions to be addressed by the research team.
H. Payment/Compensation - Describe any financial payments for participant participation 
(e.g., compensation for time and travel). Indicate any partial payment schedule for less 
than complete study participation. Recall that payments cannot be perceived as coercive 
(overpayment for time and effort). Remember: payments are NOT benefits. 
During the period of time of the COVID-19 pandemic, enrolled participants who have 
difficulty with any aspect of the compensation process described below will have the 
situation addressed by approved study personnel in accordance with approved 
processes (provide participant a new Greenphire card or gift card) but in keeping with 
minimizing physical contact with enrolled participants.
Participant  compensation:  The  participant  will  receive 
compensation ($50) at the conclusion of the assessment 
collection at visit 2-9 (TOTAL $400).
Primary plan:
The initial payment will be provided via a preloaded debit 
card  (Greenphire™ system).  An  image  of  the  card  is 
provided. The cards do not contain the participant’s name. It will actually display, “Valued 
Cardholder”.
The first debit card is provided to the participant at no cost. At all visits, including the 
enrollment visit, the participant who declines to have any assessments performed or agree 
to sign any additional medical release forms will still be compensated for completing the 
MTM visit ($50). As the compensation is provided remotely (via Greenphire™ debit cards), 
there is no incentive to physically meet with the UNTHSC team at any point during the study 
after Visit 2 just to be paid. If the participant has lost their Greenphire™ debit card (after 
Visit 2), a new one can be mailed to them (minus the cost of card replacement plus postage 
or roughly $3) at the address provided on the most recently updated version of the 
PARTICIPANT CONTACT INFORMATION FORM.
Backup plan: If there is an issue with the debit card system and an alternate means of 
payment is needed, participants will be provided a $50 gift card instead at the conclusion of 
each study visit that is applicable. This is included in the main consent form.
I.
Subject Costs - Describe any anticipated costs to research participant. If none, state 
such.
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After enrollment, participants will be asked if travel or child care represent barriers to 
making MTM visit appointments (at the pharmacy). If participants express a concern 
regarding the cost to travel to visits to the study pharmacy, UNTHSC research team will 
discuss the possibility to reimburse the participants for travel costs with both Office of 
Sponsored Programs and NIMHD. If participants express a concern with retention due to 
obtaining child care to free them up to come to their research visits, UNTHSC research team 
will work with the Office of Sponsored Programs and NIMHD to ensure this reimbursement 
is allowable. If either reimbursements are allowed, UNTHSC research team will develop a 
reimbursement procedure, estimated average amount, then work with and then submit a 
revised consent to the NTRIRB for approval prior to initiating reimbursement for 
participants, if NTRIRB deems this necessary.
Language has been inserted into the consent form (COSTS) to address if participants 
inadvertently receive bills for medical records. PI/SC will, upon notice from participant, 
immediately initiate actions to resolve the incorrect bill so as to avoid any collection notices 
or even late payment notices. The PI/SC will follow up with the participant weekly until such 
time as the issue is resolved. In the event a participant inadvertently pays for medical 
records that were part of the study and the PI/S learns of this, a reimbursement process will 
be developed and obtain approvals as necessary (NTRIRB, NIMHD, UNTHSC OSP, etc.) to 
ensure the participant is repaid.
J. List of KEY PERSONNEL. See Key Personnel Delegation Log  
K. Literature Cited
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