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Running head: PROMOTING LINKAGE TO CARE AMONG THE HIV POPULATION: 1
Promoting Linkage to Care among the HIV population: Utilizing the Same- Day Access Clinic
for a Initiating Antiretroviral TherapyTest and Treat Initiative in Hillsborough County
Digy Paul
NGR 7974
University of South Florida
Running head: PROMOTING LINKAGE TO CARE AMONG THE HIV POPULATION 2
Abstract
Promoting Linkage to Care among the HIV population: Utilizing the Same Day Access
Clinic for Initiating Antiretroviral Therapy
Abstract
In an attempt to answer the question “Does implementation of a Same Day Access clinic with
ART initiation improve access to care among newly diagnosed HIV Patients?”, I have
endeavored to prove that tTreatment for Human Immunodeficiency Viral infection (HIV)
through Same Day Access clinics, coupled with Same Day Antiretroviral Therapy (ART) has
dramatically improved the quality of life and life expectancy of people living with HIVthe
disease. Initiation of sameSame D day Antiretroviral Therapy ART is an evidence-based
intervention that facilitates the care for HIV- positive patients. The guidelines published by the
Centers for Disease Control and Prevention (CDC) have issued guidelines that emphasize a on
“tTest and tTreat” initiative for HIV prevention, which . This approach emphasizes on universal
HIV testing, followed by Antiretroviral treatment to improve linkage and retention in care.
Improving patients’ access to care is very crucial in the HIV care continuum. The overriding
concept of the Same D Day Access Clinic concept is that a change in practice that can be
implemented in any HIV clinic for an early initiation of Antiretroviral Therapy (ART). This
quality improvement project proposes that the initiation of same- day ART (Test & Treat
Initiate) through a Same D Day Access Clinic will have a positive impact on accessibility to
care.e.
PROMOTING LINKAGE TO CARE AMONG THE HIV POPULATION 3
Promoting Linkage to Care among the HIV population: Utilizing the Same Day Access
clinic for Initiating Same Day Antiretroviral Therapy
for Initiating Same Day Antiretroviral Therapy.
Early initiation of an Antiretroviral Therapy (ART) reduces the morbidity and mortality
of patients with HIV infection. As per the HIV/AIDS Clinical Care guidelines, the five key
components to eliminate HIV transmission and related deaths are as follows:
1. 1. Implement routine HIV screening in healthcare and non-healthcare settings.
2. 2 Increase access to antiretroviral therapyART
3. 3. Ensure retention in care.
4. 4. Improve access to antiretroviral pre-exposure prophylaxis (PreP)
5. 5. Increase the HIV awareness through community outreach programs (AIDS info,
2017).
In 2010, the San Francisco Department of Public Health offered ART to all patients with
human immunodeficiency virus (HIV) regardless of their CD4 count. In 2013, San Francisco
General Hospital have launched a clinical health system intervention, the entitled Rapid ART
Program Initiative for HIV Diagnoses (Rapid RAPID) ART program for HIV patients, by
initiating same- day antiretroviral therapyART. The results of the program report reveal that
repeated HIV testing, followed by immediate ART, could substantially decrease the incidence
incidents of HIV (“SFGH Rapid RAPID ART program,””, 2013). The HIV Treatment Cascade
recommends that same day ART initiation and early accessibility to care could reduce the
prevalence of HIV infection (CDC, 2017). The primary objective of the Hillsborough County,
FL, Department of Health in of implementing the Same Day Access Clinic in Hillsborough
PROMOTING LINKAGE TO CARE AMONG THE HIV POPULATION 4
County Health Department is to increase the accessibility to of care among newly- diagnosed
HIV patients.
PROMOTING LINKAGE TO CARE AMONG THE HIV POPULATION 5
Description of the Problem (Background & Significance)
According to the Centers for Disease Control and Prevention (CDC), as of 2016, more
than 1.1 million people in the United States are were living with HIVV according to US
government data as of 2016. . The year before that, In 2015, an estimated 38,500 new patients
people were diagnosed with new HIV. infection in this country. While there was an overall eight
percent decline in annual HIV infections in the United States from 2010 to 2015 (from 41,800 to
38,500), in 2016, 39,782 people were diagnosed with HIV (CDC, 2017).
Despite impressive advances in antiretroviral therapy (ART) for HIV-infected
individuals, only around one-third of the 1.1 million individuals who are eligible for treatment
are currently receiving it. As perof the 2011 US Ccensus, it was estimated that only 21% of HIV-
infected individuals in the United States are were aware of their HIV status. The data also shows
that 31% of newly- diagnosed HIV patients delay the linkage to care for about six months or
longer, (“Guide for HIV/AIDS,”, 2011). Missed appointments are often common and are
associated with the delayed initiation of ART. According to the CDC’s (2011) data collection,
480,000 (40%) out of 1.2 million people with HIV in the US infection, 40% (480,000) were
engaged in any form of HIV medical care. Only 92% (444,000) of tthose hose 480,000 were
prescribed ART, and 82% (360,000) were withpresented a suppressed Viral Lload (VL) below
200 copies/ml. (CDC, 2011).
In 2016, Florida was ranked ranked the third in the United States for HIV cases in 2016.
As perThe Florida Department of Health reports that there were 4,972 people were diagnosed
with HIV in that year. With 114,772 persons living with HIV in Florida, antiretroviral
Antiretroviral (ARV) drug use is very essential in the treatment of HIV Florida’s population
(114,772 people) living with HIV (CDC, 2016).
PROMOTING LINKAGE TO CARE AMONG THE HIV POPULATION 6
The US Department of Health and Human Service (DHHS) guidelines recommend s
universal ART to all patients with HIV as the early as possible. In 2016, DHHS identified the
strategic directions to achieve this outcome, including are encouraging people to know their
HIV status, accelerating the scale-up of HIV/AIDS treatment, maximizing the health sector’s
contribution to HIV prevention, and investing in obtaining strategic information’s to guide the
patient’s outcome (DHHS, 2016).
One of the issues currently facing being faced today in the Hillsborough County Health
Department’s (HCHD) , Specialty Care Clinic is the lack of accessibility to immediate HIV care
among HIV- positive individuals. Initiating ART at the early stage of HIV diagnosis, as well
asnd connecting patients to care, are necessary to keep the viral load under control. Patients were
seen in this Specialty Care Clinic as an 80/20 mix of scheduled and walk-in patients respectively.
The current practice of initiating ART takes three to four3-4 months, to initiate an Antiretroviral
Therapy, and the system was is currently not capable of accommodating the newly- diagnosed
HIV patients. As a result,This prompted the HCHD to initiate a Same Day Access Clinic
mModel was identified to initiatefor Antiretroviral TherapyART therapy among this newly-
diagnosed HIV population.
PROMOTING LINKAGE TO CARE AMONG THE HIV POPULATION 7
Review of LiteratureReview of Literature
Introduction
The review of literature provides the relevant information for validating the necessity of
initiating ART at the early stages of HIV diagnosis. The HIV/AIDS tTreatment guidelines
support the initiation of same day antiretroviralSame Day ART therapy on a newly diagnosed
HIV patient. I have also reviewed Same Day ART initiation and its impact on linkage to care,
along with and its effect on viral load suppression are reviewed. Furthermore, I have appraised a
synopsis of related themes found in supportive literature. are appraised.
Search Strategy
A systematic literature search was done in theI have utilized the literature database
PubMed, ; the search engine Google Scholar, and Research Gate for my systematic literature
search. The search terms used are “Test and Treat initiative;”’’; “Same -Day Antiretroviral
Therapy;”’’; “Early viral load suppression;””, and “linkage to care among the HIV population.””.
Additionally, the eligibility criteria were set as follows: the publication period from
January 1, 2013, to June 1, 2018;, however interventional, non-interventional; multiple design
studies and randomized control trials were included. The grey literature, editorials, comments,
congress abstracts, and letters were excluded. The search in PubMed revealed seventy suitable
records; ten duplicates were removed, resulting in sixty records for screening. The first hundred
hits for each of the search terms in Google Scholar were considered, resulting in two additional
records after removing duplicates. Each title of the article was read and evaluated. Sixty-two
PROMOTING LINKAGE TO CARE AMONG THE HIV POPULATION 8
non- duplicate citations were screened. Thirty-two articles were excluded after title/abstract
screening, fifteen articles were excluded after full text screening, and ten articles were excluded
during data extraction. After the entire search process were was completed, five were selected.
For a depiction of the search, see the Prisma Diagram in Appendix A.
PRISMA DIAGRAM
Patient Problem, Intervention, Comparison, Outcome and Time (PICOT) and tThe Johns
Hopkins Nursing Evidence-Based Practice (JHNEBP) tools were used to develop the practice
question, evidence and translation. After using PICOT to formulate the practice question, “Does
implementation of a Same Day Access Clinic with ART initiation improve access to care among
PROMOTING LINKAGE TO CARE AMONG THE HIV POPULATION 9
newly diagnosed HIV Patients?”, was determined, a search for an evidence was conducted on
selected articles regarding the impact of same day ART on access to care among HIV population.
As per the Poe & White (2010), I propose afollowing evidences, a practice change of
implementing the Same Day Access Clinic model as a means of achieving virology suppression
in newly-diagnosed patients. is proposed. (Poe &White, 2010).
Literature Appraisal
Research has shown that prioritizing immediate ART initiation can reduce the time
needed to achieve virology suppression in newly- diagnosed patients. Pilcher, et al. (2015)
performed a quantitative study (“Providing Same Day, Observed ART to newly diagnosed
HIV+ out patients are associated with improved virology suppression” and published in the
Journal of Acquired Deficiency Syndrome) in 86 patients, out of which; 39 were eligible. & 37
(94.9%) of those patients out of 39 began ART within 24 hours. VThe virology suppression was
faster (within 1.8 months) in comparison to universal ART treatment in a standard clinic (within
4.3 months). This study agreed that same Same day Day ART shortens the time- to- virology
suppression.
One limitation of the study, however, identified that ART was begun without some
baseline laboratory results, yet n. No safety or ART resistance issues were identified. As a result,
there were intensified demands on clinical providers to consider early regimen modifications on
follow- up visits were intensified. Furthermore, Aa second limitation of this study is that the
RCT was performed with a small sample size; h. However, the data provided was substantial and
evidence-based (Pilcher et al., 2015).
A randomized control trial, performed by Rosen et al. (2016), shows There is an evidence
that that offering single-visit -ART initiation to adult patients in South Africa increased the
PROMOTING LINKAGE TO CARE AMONG THE HIV POPULATION 10
uptake of ART by 36% and viral suppression by 26 %. The trial A randomized control trial
performed by Rosen et al. (2016) measured the outcome of viral suppression (<400 copies/ml) in
377 patients. In the rapid RAPID group, 119 out of /187patients (64%) initiated same daySame
Day ART treatment and were virally suppressed at 10 months compared to 96/190 (51%) in the
standard group. This study demonstrated a strong relationship between sameSame dDay ART
initiation and early linkage to care. However, the long-term effect of reducing the number of
clinic visits prior to ART initiation remains unclear. The results could not be generalized as the
trialit was conducted only in two clinics (Rosen et al., 2016).
A randomized control trial performed by Michael, et al (2012), concluded that higher
rates of early retention in HIV care are associated with same same-dday ay initiation of ART, as
well as helping . It also helps to attain early viral load suppression. The study identified that,
aAmong 676 HIV patients that were included in the trial, the study identified that 63% achieved
VL<50 copies/ml within three hundred and eight308 days. These findings validated the
importance of same- day ART initiation on a newly diagnosed HIV patient (Michael et al.,
2012).
Same- –day HIV testing, and ART initiation is feasible, beneficial, and improves
retention in care with virology suppression among patients with early clinical HIV disease. As
per Serena et al. (2017), a randomized control trial in Haiti enrolled 762 patients, out of which ; a
356 standard group initiated ART (standard group) in 3 weeks after HIV testing vs 347 in the
same- day ART group. In the standard group, the 156 (44 %) participants who were retained in
care with 12-month HIV RNA <50 copies/ml; 184 (52%), had <1000 copies/ ml. In the Same
DSame Day ART group, 184 (53%) participants were retained with HIV RNA below 50
copies/ml, and 212 (61%) had <1,000 copies/ml (Serena et al., 2017).
PROMOTING LINKAGE TO CARE AMONG THE HIV POPULATION 11
CASCADE trial, an RCT by Labhardt, et al. (2016), concluded that the same- day home-
based ART initiation after a positive HIV test is a feasible approach to improve linkage to care,
retention in care, and e & viral load suppression. The study points out that there was a
significant increase in linkage to care at three months and viral suppression at twelve months
(Labhardt et al., 2016). Among these evidences, five level- one high- quality quantitative control
trials were appraised. All of these studies concluded that Same Day ARTnti-Retroviral Treatment
improves access to care, retention in care, and faster viral load suppression among HIV-positive+
patients.
Literature Synthesis
Throughout the review of multiple literature,The multiple sources I
have reviewed agree that Same day Day HIV testing and combined with ART
initiation has been shown to improve the virology suppression among
patients with an HIV. Pilcher, et.al., and disease (Pilcher et al.2015). Serena, et. al,
agree that Same day Day ART will shorten the time to virology suppression
and support the fact that . Hhigher rates of early retention in HIV care are
associated with achieving VL suppression and lower VL burden (Serena et al.
2017). Labhardt, et. al., agree that Same day Day Anti-Retroviral Treatment
improves access to care, ; retention in care, and faster HIV viral suppression
among newly diagnosed HIV patients (Labhardt et al. 2016). Overall, the
literature supported thatsupporting Same daySame Day ART initiation is
rigorous, feasible, and beneficial.
Patient, Implementation, Outcome, Time (PICOT)
PROMOTING LINKAGE TO CARE AMONG THE HIV POPULATION 12
PICOT (Patient Problem, Intervention, Comparison, Outcome and Time) was utilized to
develop a proper quality improvement question. The “P” addressed in thine PICOT represents
the number of Adult HIV patients of all ethnicities and genders that could benefit from linkage to
care in the Same Day Access Clinic. The “I,” for Intervention recommended, includes same- day
ART initiation as per “Test & Treat” guidelines. The “C” “represents comparison of access to
care through a Same Day Clinic versus a Standard Clinic. Outcome is measured by the number
of days it took to initiate ART through au Same Day Clinic, while . “T” represents time, which
includesand represents a four- a four-month retrospective chart review. Utilizing the PICOT
development tool, a formal PICOT question was established: “Does implementation of a Same
Day Access clinic with ART initiation improve access to care among newly diagnosed HIV
Patients?” (Poe & W white, 2010).
Goals/ & Objectives
The primary objective of this quality improvement project is to increase the accessibility
of care among the HIV population through a “Same Day Access Clinic” that minimizes the time
to initiate an Anti-Retroviral Therapy on a newly diagnosed HIV+ patient.
Theoretical or conceptual Conceptual models Models that guide Guide the project Project
designDesign
The HIV Treatment Cascade (Appendix B) is a powerful model that
represents a quantitative depiction of discrete steps in the HIV Care
Continuumcontinuum. This model is consistent with the National HIV/AIDS
Strategy and its specific national goals for testing, linkage, retention, and
viral suppression (CDC, 2017). By applying this Eevidence-based Based
practice Practice (EBP) model, a Same Day Access Clinic concept was
PROMOTING LINKAGE TO CARE AMONG THE HIV POPULATION 13
introduced to initiate ART on newlyto newly- diagnosed HIV patients in order
to promote early linkage to care. This concept was created specifically by
using the latest research findings as well as incorporating the best practices
in patient care.
HIV Treatment Cascade
{Retrieved from Clinical Infectious Diseases., 57(8), 2013.}
Early initiation of ART will benefit individuals from in their pathophysiological
progression to AIDS. In broad sense, ART initiation has various types of impact such as: It
reducesimpacts, such as reducing the opportunity of secondary transmission by suppressing
the viral load to an undetectable level. It impacts an individual’s life expectancy by
PROMOTING LINKAGE TO CARE AMONG THE HIV POPULATION 14
reducing the risk of AIDs and AIDS- related death. The ultimate aim for an HIV treatment
program is for people living with HIV to be virally suppressed. For this to happen, people
living with HIV need to be diagnosed promptly, quickly receive antiretroviral treatment
(ART), continuously engage with medical services, and adhere to medication. Their c, and
the care also needs to be managed appropriately. If any of these steps are missed, the
benefits of treatment for the individual and their sexual partners can be lost. (Mugavero,
etal. 2017). The Joint United Nations program on HIV/AIDS (UNAIDS) has introduced the
concept of an HIV Treatment Cascade to fill the gaps in the continuum of services for
testing, care and effective treatment (UNAID, 2018).
Implementation Plan
Setting
The study will be conducted at Specialty Care Clinic, in Hillsborough County,; Florida.
This clinic is operated by the Hillsborough County Health Department (HCHD) in , Tampa and.
This clinic provides services to the local population of patients with HIV/AIDS population. An
estimated of 2000 HIV patients were as established with this clinic, and & 2300 unduplicated
services were provided in the year 2017. Six nurse practitioners and two physicians are
provideing various services, including to this population. This clinic provides medical, ; dental, ;
laboratory,; pharmaceutical, and ART assistance programs for all patients with HIV/AIDS.
Target Population
All newly- diagnosed HIV patients are included, irrespective of age, gender, or ethnicity.
Patients who will be excluded from this project are:
1. Patients with HIV+ diagnosis for more than two years,
PROMOTING LINKAGE TO CARE AMONG THE HIV POPULATION 15
2. Patients who would not be safe to start therapy on the same day,
3. Patients transferring HIV care from other clinics or already on ART at the time of
initial visit to Same Day Access Clinic.
Procedure or Intervention
The HIV Treatment Cascade model will guide administrators who wish to facilitate a
practice change at Specialty Care Clinic. The review of evidence-based literature supports that
early initiation of ART on newly diagnosed HIV patients helps not only the accessibility to care
but also helps to attain early viral load suppression. Same Day ART on newly diagnosed HIV
patients will improve the linkage to care and will reduce the time span from diagnosis to the
initiation of treatment.
To achieve this outcome, the Same Day Access Clinic will be utilized to implement the
Test & Treat Initiative. The Same Day Access clinic will see all newly diagnosed HIV patients
who walk in any day (Monday to Friday) from 7 am to 3 pm. The purpose of this clinic is to
offer same- day healthcare evaluation and treatment to three types of HIV infected patients on a
walk-in basis. They include newly diagnosed HIV patients, previous patients that are being
readmitted to the clinic who are fallen out of care for more than a year, and established patients
who are sick and need to be seen before their next scheduled appointment. At the initial visit,
prescribing provider offers mental health screening, risk assessment, discuss sexual health,
education regarding HIV infection, and benefits of initiating antiretroviral therapyART. Options
will be given to patients for declining the treatment or initiation of ART on the same day. To
those who are willing to start the ART, all baseline laboratory tests (CD4 count, HIV RNA level,
renal and liver function tests, hepatitis serology, HLA B 5701 testing and HIV resistance
PROMOTING LINKAGE TO CARE AMONG THE HIV POPULATION 16
genotyping) will be obtained. Pre-approved ART regimen (Tivicay & Descovy or Prezista &
Descovy or Genvoya) will be initiated and the patient will be given a 30-day supply of ART with
a 2 two-weeks follow up appointment in a regular clinic. Also, Drug assistance Assistance
program Program(ADAP) / Ryan White funding appointments for unfunded patients will be
arranged on the same day so that these patients will be eligible to get free medication through
these funding. The Same Day Access Clinic will increase the number of patients added to the
practice and thereby access to care for newly diagnosed HIV patients as well as those who want
to get re-established with the services.
Measurement & Evaluation Plan
Measures
After the implementation of Same Day Access Clinic, the quantitative data will be collected
related to patient metrics and no show rates. Also, the qualitative data pertaining to the referral
process and clinic flow will be evaluated using a quality assessment questionnaire developed
from the Agency for Healthcare Research and Quality (AHRQ, 2017).
Data collection Procedure
Upon IRB approval, the data will be collected for a period of four months after
implementation of the project. Indicators are as follows :1. The percentage of newly diagnosed
HIV patients who initiated ART through the Same Day Access Clinic for a period of four months
2. The time frame from the date of diagnosis to ART initiation in each individual cases. 3.
Percentage of no-show rates will be assessed for a period of four months status post
implementation of the project. To measure the no show rate, the total number of referrals will be
collected from various referral units such as HIV screening, Disease Intervention Specialists
(DIS) and the Health Department Business Center. Data will be compared with the number of
PROMOTING LINKAGE TO CARE AMONG THE HIV POPULATION 17
patients who are not showing up for their initiation of ART. The student researcher will create a
form and will answer six series of open-ended questions after analyzing the data and will record
the results in narrative text format. The researcher will be using a series of tables and graphs to
summarize the information gathered. To have an easy understanding of the process a flow chart
will be developed that will guide other Health Department Clinics who would like to implement
Test & Treat initiative in their practice settings. A minimum of thirty newly diagnosed HIV
patients will be included for the study. However, sample size may vary according to the
availability of new cases, plan is to include all the newly diagnosed HIV patients for a period of
four months post implementation of the project.
Data Management
Data analysis will be done on an Excel spreadsheet. A flow chart will be created to show
the comparative analysis of patients who initiated ART on the same day versus those not
initiated same day antiretroviral therapy. The researcher will collect the data by reviewing the
patient chart from Electronic Health Record (EHR) for a period of four months upon IRB
approval. The data will be stored in health department computer with a protected password. Once
the project is completed, the hardcopy of files will be destroyed by shredding, and the researcher
will delete the computer files permanently.
Data Analysis Plan
The author will evaluate both quantitative and qualitative data from Same Day Access
clinic to see if the goals and objectives of the project have been met and intervention is
beneficial. It is assumed that initiation of an ART on the same day of HIV diagnosis will not
only increase the access to care but also improves the patient metrics of the facility. The
Researcher also will evaluate whether this Same Day Access Clinic process will reduce time
PROMOTING LINKAGE TO CARE AMONG THE HIV POPULATION 18
frame to initiate ART on a newly diagnosed patient. In addition, it will serve as a practice model
for other county health departments to increase the accessibility of care for their HIV population.
The process of referrals and barriers will be analyzed. Based on the results, the recommendations
for a process improvement will be given.
Measurement & Evaluation Plan
Measures
After the implementation of the Test & Treat Initiative through the Same Day Access
Clinic, this researcher will evaluate the process of outcome by looking into four steps in the
process (see Appendix C)
1. S creening for HIV
2. L inkage to care
3. I nitiating Same Day ART
4. T ransition to care.
Data collection Procedure
Upon IRB approval, the qualitative outcome pertaining to the Test and Treat initiative
will be assessed by using a checklist, and the data will be collected every month for a period of
four months after implementation of the project. The outcome will be evaluated are as follows:
1. Percentage of patients who had screening and tested positive for HIV
2. Linkage to care as measured by the percentage of patients who were registered at the
Same Day Access Clinic, are seen by the provider on same day, and who were issued a
prescription for Same Day ART
3. Percentage of patients who initiated Same Day ART and those who got their first dose of
medication in the clinic
PROMOTING LINKAGE TO CARE AMONG THE HIV POPULATION 19
4. Transition to care as measured by the percentage of patients who had shown up for
follow-up appointments in two weeks.
This researcher will utilize a series of tables and graphs to summarize the information
gathered. To facilitate easy understanding of the process, a flow chart will be developed that
will also serve as a guide for other Health Department Clinics that would like to implement the
Test and Treat initiative in their practice settings. A minimum of thirty newly-diagnosed HIV
patients will be included in the study; however, sample size may vary according to the
availability of new cases.
Data Management
A checklist will be created in questionnaire format, and adherence to each step of the
Test and Treat Initiative will be marked by answering “Yes” or “No.” The data will be collected
each month, and the results of the analysis will be marked on an Excel™ spreadsheet. There will
also be a monthly comparative analysis of patients who initiated ART on the same day versus
those who did not. This researcher will collect the data by a retrospective review of the patient
chart from Electronic Health Record (EHR) for a period of four months upon IRB approval. The
data will be stored in health department computer with a protected password. Once the project is
completed, any hard copies of files will be destroyed by shredding, and this researcher will
delete the computer files permanently.
Data Analysis Plan
The author will evaluate quantitative as well as qualitative data from the Same Day
Access Clinic to see if the goals and objectives of the project have been met and intervention is
beneficial. It is assumed that the Test and Treat initiative through the Same Day Access clinic
will increase the access to care, an early initiation of ART and the transition to care. A flow chart
PROMOTING LINKAGE TO CARE AMONG THE HIV POPULATION 20
will be created to show the Same Day Access Clinic process of implementing the Test and Treat
Initiative. In addition, it will serve as a practice model for other county health departments that
wish to increase the accessibility of care for their HIV+ population, where the process and
barriers can be analyzed and recommendations for process improvement can be made based on
those results.
Protection of Human Subjects
As Because this study focuses on practice improvement, it will have pose a low risk for
human subjects. There are no known or anticipated risks associated with participation in this
study. Volunteers who agreed to participate in the practice improvement project will be provided
an with all information pertaining to informed consent prior to the implementation of the project.
. There is no compensation; cost or conflict of interest because of participation. Records
and data will remain private and confidential. Outcomes from this study may be published,; in
which case no information that would allow for patient identification will be includedpatient
identification will be impossible. No names or patient identifiers will be included in the data
collection process. A pPatient’s health information will remain private and their human rights
will be protected.
Project Approval approval was obtained from Mr. Carlos Mercado, the Director of
Hillsborough County Health Department, Mr. Carlos Mercado. (See Appendix D.)
The Same Day Access Clinic model will be submitted to the IRB for review and
approval.
Dissemination Plan
PROMOTING LINKAGE TO CARE AMONG THE HIV POPULATION 21
Meetings will be held weeklyto keep to inform the Same Day Access Clinic staff
(Registered registered Nursesnurses; Nursing nursing supervisors & Medical medical assistants)
up to date on the process who are working in the Same Day Access Clinic will be held
weeklyabout the process.
D. The daily data regarding the number of newly diagnosed HIV patients who initiated
ART through Same Day Access Clinic will be reported to the data analyzer. After
implementation, the all data will be collected, analyzed, and compared by the researcher. The
dissemination Dissemination Pplan involves the internal stakeholders, manuscript, poster,
conferences and meetings. The final report will be submitted to the Program Manager of the
Specialty Care Clinic Health Department, and the results will be shared with Dr. Catherine Ling,
USF faculty supervisor. AThere will be a poster presentation will be made accessible to staff and
students at the University of South Florida, while t. The data will also be shared with internal
stakeholders, providers, nurse practitioners, and nurses who work in the Health Department. A
manuscript will be submitted for publication to the peer- reviewed -journal of the Association of
Nurses in AIDS Care.
Conclusion
The United States Centers for Disease Control and Prevention (CDC) estimates that HIV
has not been diagnosed in about 13% of the people living with this virus (CDC 2017). Review of
the literature shows that only 57% of patients are retained in care since the diagnosis of HIV.
Among this group only 55% are virally suppressed because of poor linkage to care and retention
in care (CDC, 2015). Implementation of Same Day Access Clinic is an evidenced-based
intervention that aims to facilitate linkage to care. Previous quality improvement projects suggest
PROMOTING LINKAGE TO CARE AMONG THE HIV POPULATION 22
that initiation of same daySame Day ART on newly diagnosed HIV patients improves early viral
load suppression as well as keeps them in care. Implementing the proposed changes not only
minimizes the days from HIV diagnosis to initiation of antiretroviral therapyART but is also
proven to suppress the viral load at the earliest. This proposed project investigates the promoting
factors and gaps in the literature, and uses that combined information to implement the Same
Day Access Clinic in the Specialty Care Clinic setting at Hillsborough County Health
Department. This will ultimately promote quality priorities of the FLDH, and improve healthcare
outcomes for its HIV population.
PROMOTING LINKAGE TO CARE AMONG THE HIV POPULATION 23
Appendix A.
PRISMA Diagram
PROMOTING LINKAGE TO CARE AMONG THE HIV POPULATION 24
Appendix B
HIV Treatment Cascade
Retrieved from Clinical Infectious Diseases., 57(8), 2013.
PROMOTING LINKAGE TO CARE AMONG THE HIV POPULATION 25
Appendix CLetter from Mr. Mercado
PROMOTING LINKAGE TO CARE AMONG THE HIV POPULATION 26
Appendix D
Same Day Access Clinic Process in Initiating Same Day ART on
Newly-diagnosed HIV+ Patients
PROMOTING LINKAGE TO CARE AMONG THE HIV POPULATION 27
References
Dearholt, S.L., & Dang, D. (2012). Johns Hopkins nursing evidence-based practice: Model and
Guidelines (2nd ed.). Indianapolis, IN: Sigma Theta Tau International.
FDOH HIV/ AIDS section Test and Treat Protocol. (Sep 2016) retrieved from
hhttp://www.flheath.gov.
1.Screening Test
Positive
Screening Test Positive for HIV
New HIV + Patients
2.Linkage to Care new HIV+
Patients.
Register to same day Acess clinicSeen By Providers
Medical/ Psychosocial EvaluationMedical history/ Physical Exam
Education/ counselling on HIV & its treatment
Prescribe ART
3.Start Same Day ART
Clinician /nurse VisitObtain Baseline labs.
Counselling on risks & benefits of ART
ART dispensed as per provider recomendations.
Educational Hand outs givenEligibility AssessmentCounselling by Ryanwhite/ ADAP funding staff
4.Transition to Care
Monitor/ assure compliance by RN within 7 days
Follow up labs and appointments in 2 weeks
Transition to long term Primary HIV care.
PROMOTING LINKAGE TO CARE AMONG THE HIV POPULATION 28
Melnyk, B.M., & Fineout-Overholt, E. (2015). Evidence-based practice in nursing
& healthcare: A guide to best practice (3rd ed.). Philadelphia, PA: Wolters Kluwer Health.
Mugavero, M.J., Amico, K.R. Westfall, A.O., Crane, H.M., Zincky, A. Willing, J.H.,
Dombrowski, J.C., Norton, W.E., Rapper, J.L, Kitahata, M.M.& Saag, M.S. (2012) Early
retention in HIV care & Viral load suppression: Implications for a Test and Treat approach to
HIV Prevention. Journal of Acquired Deficiency Syndrome,59(1), 86-93. Retrieved from
doi:10.1097/qAI.0b013e318236f7d2.
Pilcher, C.D., Ospina-Norvell, C., Dasgupta A., Jones, D., Hatrogenesis, W., Torres,
S., Calderon, F., Demico, E., Geng, E., Gandhi, M., Havir, D.V., & Hatano, H (2015) Providing
Same Day, Observed ART to newly diagnosed HIV+ out patients are associated with improved
virology suppression. Journal of Acquired Deficiency Syndrome,59(1), 86-
93.doi:10.1097/QAI.0000000000001134
Poe, S. S., & White, K. M. (2010). Johns Hopkins nursing evidence-based practice:
Implementation and Transition. Indianapolis, IN: Sigma Theta Tau International.
Koeing, S. P., Dorvil, N. De Vieaux, J. G., Hedtgautheir, BL, Riviera. C., & Faustin; M. (2017)
same day HIV testing with initiation of antiretroviral therapy versus standard care for persons
living with HIV. PLoSMed,14(7).doi.org/10.1371/journal.pmed.10002357.
Rosen, S., Maskew, M., Fox, M.P., Nyonic, C., Mallet, G., Sannel, L., Bokaba, D., Saul, C., &
Long, L. (2016). Initiating Antiretroviral Therapy for HIV at a Patients First Clinical Visit: The
Rapid IT Randomized Control Trial. PLoS Med. 13(5), e1002015.doi:10.1371.
National Institutes of Health, U.S. Department of Health and Human Services. (2017). Retrieved
July 2, 2018, from http://aidsinfo.nih.gov/guidelines/html/1/adult-and-adolescent-arv/30/
adherenc.
PROMOTING LINKAGE TO CARE AMONG THE HIV POPULATION 29
Pathways of resistance in subjects failing dolutegravir monotherapy (2017).CROI Conference,
Retrieved from http://www.croiconference.org/sessions/initiating-art-patient%C2%92s-first-
clinic-visit-rapit-randomized-trial.
World Health Organization. “Towards Universal Access: Scaling up Priority HIV/AIDS
Interventions in the Health Sector. Progress Report (2008).” Retrieved June 30, 2018 from
http://www.who.int/hiv/pub/towards universal access report 2008.pdf.
Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents,
AIDS info, (2017). Department of Health and Human Services. Retrieved July 2, 2018 from
https://aidsinfo.nih.gov/guidelines.
Appendix E
Evaluation Questionnaires Developed as per Agency for Healthcare Research and
Quality’s (AHRQ), 2017 Tool
Does the Same Day Access Clinic help to reduce the number of days to ART initiation on a newly diagnosed Patients?
Once Implemented the process of Same Day Access Clinic Model, are we able to get zero percent no show rate.
Does the process flow for referrals are executed smoothly and patients get to the provider within recommended time frame.?
What are the benefits of implementing the project?
What are the barriers for implementation of the process?
PROMOTING LINKAGE TO CARE AMONG THE HIV POPULATION 30
Does Same Day Access Clinic will be a model for other health department clinics to follow in providing efficient care for HIV population?
Center for Disease Control and Prevention, Guidelines for Using Antiretroviral Agents Among
HIV-Infected Adults and Adolescents, (2014). Atlanta, GA:US Department of Health and
Human Services, CDC, (2014). Retrieved from https://stacks.cdc.gov/view/cdc/2603.
Mugavero ,M.J., Amico, K. R., K., Horn, T., & Thompson, M.A. (2013).The State of
Engagement in HIV Care in the United States: From Cascade to Continuum to Control. Clinical
Infectious Diseases, 53(8),1164-1171.Retrieved from
https://doi.org/10.1093/cid/cit420.
San Francisco Program for Rapid ART Initiation and Linkage to Care,
Standard Operating Procedures (2016). Retrieved June 28, 2018, from
https://www.gettingtozerosf.org/wp-content/uploads/2016/09/20160822 citywide rapid
protocolv2.pdf.
Guide for HIV/AIDS Clinical Care. (2011). Retrieved June 30, 2018, from
https://www.scribd.com/document/68035987/AIDS-Clinical-Guide-Jan2011.
Labhardt, N.D., Ringera, I., ThaboI.Lejone, T.I., Klimkait, T., Muhairwe, J.,
Amstutz, A., & Glass, T.A. (2018). Effect of offering Same-Day ART VS Usual
Health Facility Referral During Home Based HIV testing on Linkage to Care
and Viral Suppression among Adults with HIV, The CASCADE Randomized
Clinical Trial. JAMA,319(11),1103-1112. doi:10.1001/jama.2018.1818.
PROMOTING LINKAGE TO CARE AMONG THE HIV POPULATION 31
Appendix A
Mission:
To protect, promote & improve the health of all people in Florida through integrated state, county & community efforts.
Vision: To be the Healthiest State in the Nation
June 6, 2018
Rick Scott
Governor
Celeste Philip, MD,
MPH
State Surgeon General and Secret
Digy Paul, MSN, ARNP-c
Florida Department of Health in Hillsborough County 1105 E. Kennedy Boulevard
Tampa, FL 33602-3511
Dear Ms. Paul:
The purpose of this letter is to confirm administrative support and approval for implementation of the proposed quality improvement project, under protocol title "HIV Same Day Access Clinic Model Initiative & Implications on a Practice" at the Florida Department of Health in Hillsborough County in the Specialty Care Center facility. The goals of this quality improvement project are consistent with the Department's commitment to a culture of continuous quality improvement and of our agency's strategic goal to increase healthy life expectancy, including the reduction of health disparities by reducing the number of new HIV infections and fulfill our mission to promote, protect and improve the health of all people in Florida through integrated state, county & community efforts. We welcome this opportunity to support this endeavor and to further achieve our mutual goals and objectives.
,
Director, Disease Control Division
Florida Department of Health - Hillsborough County
cc:
HEALTH
PROMOTING LINKAGE TO CARE AMONG THE HIV POPULATION 32
Charurut Samboonvit, MD, Senior Medical Director, Florida Department of Health in Hillsborough County
Michael Wagner, Health Center Administrator, Special Care Center, Florida Department of Health in Hillsborough County
Nadine Connor, DNP, MSN, ARNP-c, Administrative Director for HIV Services, Specialty Care Center, Florida Department of Health in Hillsborough County
Maritza Acosta, Office Manager, Specialty Care Center, Florida Department of Health in Hillsborough County.
Florida Department of Health - Hillsborough County
Division of Disease Control; P. O Box 5135. Tampa, FL 33675-5135. Phone (813) 307-8008. Fax:813-272-6984.
PROMOTING LINKAGE TO CARE AMONG HIV POPULATION: 33
Appendix B
Same Day Access Clinic Process in Initiating Same Day ART on Newly Diagnosed HIV+ Patients.
1.Screening Test
Positive
Screening Test Positive for HIV
New HIV + Patients
2.Linkage to Care new
HIV+ Patients.
Register to same day Acess clinicSeen By Providers
Medical/ Psychosocial valuationMedical history/ Physical Exam
Education/ counselling on HIV & its treatment
Prescribe ART
3.Start Same Day ART
Clinician /nurse VisitObtain Baseline labs.
Counselling on risks & benefits of ART
ART dispensed as per provider recomendations.
Educational Hand outs givenEligibility AssessmentCounselling by Ryanwhite/ ADAP funding staff
4.Transition to Care
Monitor/ assure compliance by RN within 7 days
Follow up labs and appointments in 2 weeks
Transition to long term Primary HIV care.
PROMOTING LINKAGE TO CARE AMONG HIV POPULATION: 34
Appendix C
Evaluation Questionnaires Developed as per Agency for Healthcare Research and
Quality’s (AHRQ), 2017 Tool
Does the Same Day Access Clinic help to reduce the number of days to ART initiation on a
newly diagnosed Patients?
Once Implemented the process of Same Day Access Clinic Model, are we able to get zero
percent no show rate.
Does the process flow for referrals are executed smoothly and patients get to the provider
within recommended time frame.?
What are the benefits of implementing the project?
What are the barriers for implementation of the process?
Does Same Day Access Clinic will be a model for other health department clinics to follow in providing efficient care for HIV population?
PROMOTING LINKAGE TO CARE AMONG HIV POPULATION: 35
References
PROMOTING LINKAGE TO CARE AMONG HIV POPULATION: 36
Center for Disease Control and Prevention, Guidelines for Using Antiretroviral Agents Among
HIV-Infected Adults and Adolescents, (2014). Atlanta, GA:US Department of Health and
Human Services, CDC, (2014). Retrieved from https://stacks.cdc.gov/view/cdc/2603.
Clinical Infectious Diseases (2013). Volume 57, Issue 8, 15 October 2013.
https://doi.org/10.1093/cid/cit420
Dearholt, S.L., & Dang, D. (2012). Johns Hopkins nursing evidence-based practice: Model and
Guidelines (2nd ed.). Indianapolis, IN: Sigma Theta Tau International.
FDOH HIV/ AIDS section Test and Treat Protocol. (Sep 2016) retrieved from
hhttp://www.flheath.gov.
Guide for HIV/AIDS Clinical Care. (2011). Retrieved June 30, 2018, from
https://www.scribd.com/document/68035987/AIDS-Clinical-Guide-Jan2011.
Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents,
AIDS info, (2017). Department of Health and Human Services. Retrieved July 2, 2018
from https://aidsinfo.nih.gov/guidelines.
Koeing, S. P., Dorvil, N. De Vieaux, J. G., Hedtgautheir, BL, Riviera. C., & Faustin; M. (2017)
same day HIV testing with initiation of antiretroviral therapy versus standard care for
persons living with HIV. PLoSMed,14(7).doi.org/10.1371/journal.pmed.10002357.
Labhardt, N.D., Ringera, I., ThaboI.Lejone, T.I., Klimkait, T., Muhairwe, J., Amstutz, A., &
Glass, T.A. (2018). Effect of offering Same-Day ART VS Usual Health Facility Referral
During Home Based HIV testing on Linkage to Care and Viral Suppression among Adults
with HIV, The CASCADE Randomized Clinical Trial. JAMA,319(11),1103-1112.
doi:10.1001/jama.2018.1818.
PROMOTING LINKAGE TO CARE AMONG HIV POPULATION: 37
Mugavero ,M.J., Amico, K. R., K., Horn, T., & Thompson, M.A. (2013).The State of
Engagement in HIV Care in the United States: From Cascade to Continuum to Control.
Clinical Infectious Diseases, 53(8),1164-1171.Retrieved from
https://doi.org/10.1093/cid/cit420.Melnyk, B.M., & Fineout-Overholt, E. (2015). Evidence-
based practice in nursing & healthcare: A guide to best practice (3rd ed.). Philadelphia,
PA: Wolters Kluwer Health.
Mugavero, M.J., Amico, K.R. Westfall, A.O., Crane, H.M., Zincky, A. Willing, J.H.,
Dombrowski, J.C., Norton, W.E., Rapper, J.L, Kitahata, M.M.& Saag, M.S. (2012) Early
retention in HIV care & Viral load suppression: Implications for a Test and Treat approach
to HIV Prevention. Journal of Acquired Deficiency Syndrome,59(1), 86-93. Retrieved from
doi:10.1097/qAI.0b013e318236f7d2.
National Institutes of Health, U.S. Department of Health and Human Services. (2017). Retrieved
July 2, 2018, from http://aidsinfo.nih.gov/guidelines/html/1/adult-and-adolescent-arv/30/
adherenc.
Pathways of resistance in subjects failing dolutegravir monotherapy (2017).CROI Conference,
Retrieved from http://www.croiconference.org/sessions/initiating-art-patient%C2%92s-
first-clinic-visit-rapit-randomized-trial
Pilcher, C.D., Ospina-Norvell, C., Dasgupta A., Jones, D., Hatrogenesis, W., Torres,
S., Calderon, F., Demico, E., Geng, E., Gandhi, M., Havir, D.V., & Hatano, H (2015)
Providing Same Day, Observed ART to newly diagnosed HIV+ out patients are associated
with improved virology suppression. Journal of Acquired Deficiency Syndrome,59(1), 86-
93.doi:10.1097/QAI.0000000000001134
PROMOTING LINKAGE TO CARE AMONG HIV POPULATION: 38
Poe, S. S., & White, K. M. (2010). Johns Hopkins nursing evidence-based
practice: Implementation and Transition. Indianapolis, IN: Sigma Theta
Tau International.
Rosen, S., Maskew, M., Fox, M.P., Nyonic, C., Mallet, G., Sannel, L., Bokaba, D., Saul, C., &
Long, L. (2016). Initiating Antiretroviral Therapy for HIV at a Patients First Clinical Visit:
The RAPID IT Randomized Control Trial. PLoS Med. 13(5), e1002015.doi:10.1371.
San Francisco Program for RAPID ART Initiation and Linkage to Care, Standard Operating
Procedures (2016). Retrieved June 28, 2018, from https://www.gettingtozerosf.org/wp-
content/uploads/2016/09/20160822 citywide rapid protocolv2.pdf.
World Health Organization. “Towards Universal Access: Scaling up Priority HIV/AIDS
Interventions in the Health Sector. Progress Report (2008).” Retrieved June 30, 2018
from http://www.who.int/hiv/pub/towards universal access report 2008.pdf.