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Decrease HIV Risk Through Use of Pre-Exposure Prophylaxis (PrEP)
Jacqueline "Nikki" Rhodes Montgomery, MPH
HIV Prevention Programs Performance Manager & Special Projects Coordinator
Caroline.Bartha@flhealth.gov
954-847-8087
Fort Lauderdale
Florida
33315
Your summary must address all the questions below:
Overview
Broward County is the second most populous county in Florida, and the seventeenth largest county in the nation. The population of over 1.9 million residents, accounts for 10% of Florida's population. Broward County is a minority/majority county demonstrated by its population by race (Black 28.5%, Asian 3.6%, Hispanic 26.9%, more than one race 0.2%, and White 40.8%). The Florida Department of Health in Broward County (DOH-Broward), is the official lead Public Health Agency in Broward County. The organization provides core public health functions and essential services as part of a complex public health system.
According to the Centers for Disease Control and Prevention (CDC), the Fort Lauderdale Division of the Miami Metropolitan Statistical Area (MSA) has the second highest rate of new HIV infections (40.1/100,000 persons) and the third highest AIDS case rates in the United States (18.9/100,000 persons) with Broward County having an estimated 21,048 people living with HIV (PLWH). Following CDC guidance, the Florida Department of Health (DOH) encourages use of pre-exposure prophylaxis (PrEP), which is an effective, evidence-based, biomedical intervention that is a key element of the HIV prevention. PrEP serves as a harm reduction intervention for those at sexual and/or injection risk of HIV when used in combination with condoms, treatment as prevention (TasP), HIV testing, and STD testing and treatment.
The goal of the DOH-Broward PrEP Program is for patients at risk of acquiring HIV to receive HIV counseling and testing including labs for PrEP and STD screening, be seen by a medical provider, offered PrEP, dispensed PrEP, and accept PrEP Navigation services on the same day of their clinic visit. DOH-Broward developed a Rapid-PrEP Program Development Action Plan to address reducing the high rates of HIV in Broward County. The Action Plan was championed by the DOH-Broward Communicable Disease Director using the approach laid out in the Program Collaboration Service Integration Model (PCSI). To achieve the goals and objectives, DOH-Broward utilized an Incident Command System (ICS), a component of the National Incident Management System (NIMS), to provide organizational structure, meeting formats, Incident Action Plans (IAP’s), Situation Reports, After Action and Improvement Planning to manage a non-emergency response across multiple internal and external programs.
In partnership with the AIDS Healthcare Foundation (AHF), DOH-Broward provides Rapid-PrEP Services through the Broward Wellness Center (BWC), a government/non-profit partnership clinic that provides sexual health and wellness services. The PrEP Program includes navigation services to address the social determinants of health and provides, under the guidance of the CDC’s PS 18-1802 funding announcement, essential support services for those at highest risk of acquiring HIV. Essential support services include, but are not limited to, screening and active referrals for healthcare benefits, behavioral health, and other medical and social services (e.g. housing, mental health services, substance use treatment services, employment, transportation, and other social services). The Rapid-PrEP Program provided same-day, ten-day starter packs of PrEP to 2477 high risk individuals. Of those that received a starter-pack, 1886 (76%) were enrolled into PrEP Navigation services. A unique aspect of the DOH-Broward PrEP program is utilizing Customer Relationship Management (CRM) software to manage client interactions during the one-year navigation period. The software can be customized to evolve with the needs of the patients, the navigators, or the program itself.
The specific factors that led to the success of Rapid-PrEP were the following: 1) utilization of incident command system; 2) ongoing engagement in training of navigators, HIV testing counselors, and stakeholders; 3) leveraging and on-site pharmacy; 4) intensive monitoring and client engagement during the first thirty days.
Website: https://getprepbroward.com/
A Model Practice must be responsive to a particular local public health problem or concern. An innovative practice must be -
Responsiveness and Innovation
DOH-Broward understood the need for community provider support in order for this program to be effective and contacted AIDS Healthcare Foundation (AHF) to form a partnership to operationally achieve the state of Florida’s programmatic mandate to provide PrEP services by December 31, 2018. This innovative approach focused on synergistically leveraging the existing partnership between DOH-Broward and AHF through shared operation of the sexual health wellness clinic; Broward Wellness Center (BWC). The Rapid-PrEP Program represents a successful public/private sector collaboration that attains core operational efficiencies via utilization of: 1) existing physical STD clinic sexual health and wellness resources to incorporate same-day PrEP services; 2) trained STD clinic counseling/testing staff and physicians, as well as; 3) a newly constructed on-site pharmacy, PrEP via-mail services and pharmacy staff to process/obtain third-party PrEP financial support. In addition, Rapid-PrEP Program representatives demonstrate value-added innovation in the delivery of PrEP client services by providing linkage to ancillary to essential support services for those at highest risk of acquiring HIV, as prioritized by CDC funding announcement PS 18-1802.
Statement of the problem/public health issue
According to the CDC, the Fort Lauderdale Division of the Miami Metropolitan Statistical Area (MSA) has the second highest rate of new HIV infections (40.1/100,000 persons) and the third highest AIDS case rates in the United States (18.9/100,000 persons). In 2018, Broward County had an estimated 21,048 people living with HIV (PLWH).
The CDC’s PS18-1802 funding announcement outlines activities for the prevention and treatment of HIV, which includes targeted HIV prevention efforts to HIV-negative persons at risk for infection are also important. These efforts supplement prevention efforts among persons living with HIV to help prevent new HIV infections as well as other sexually transmitted infection not protected by anti-retroviral (ART) medications. This includes support for community-level HIV prevention activities, PrEP, and other targeted prevention strategies. PrEP is a highly effective intervention that can reduce the number of new HIV infections when supported by behavioral and structural strategies.
What target population is affected by problem (please include relevant demographics)
The top priority populations based on persons living with HIV disease (HIV incidence surveillance data) are the following:
What is the target population size?
The DOH-Broward/AHF contract to provide services at Broward Wellness Center (BWC) for 7,200 Rapid-PrEP clinical visits annually which included follow-up visits at no cost to the client. An adherent client would receive and average of three follow-up visits in a 12-month period including the initial visit. Therefore, our target population for this project period has a baseline of 1,800 new patients. Benchmarking with national averages of approximately 40% adherence (e.g. San Francisco and New York City), DOH-Broward will continuously enroll new clients, monitor and track adherence.
What percentage did you reach?
Broward County is a minority/majority county demonstrated by its population by race (Black 28.5%, Asian 3.6%, Hispanic 26.9%, more than one race .2%, and White 40.8%)
From June 1, 2018 to November 8, 2019, a total of 2,477 individuals received same-day starter packs of PrEP during their initial visit to our clinic through the Rapid-PrEP Program. Of those that received a starter-pack, 1,886 (76%) were eligible for and enrolled into PrEP Navigation services. Return for follow-up visits and pharmacy pick up is the current best indicator for adherence and currently, which shows a 40% adherence rate.
Of those that initiated the program, 82.8% were Male (29.0% non-Hispanic White, 22.5% non-Hispanic Black and 43.9% Hispanic); 15.3% Female (16.9% non-Hispanic White, 52.1% non-Hispanic Black, and 29.1% Hispanic); and 1.9% Transgender (19.6% non-Hispanic White, 26.1% non-Hispanic Black, and 50.0% Hispanic). Most individuals were between the age ranges of 20-29 (43.5%), 30-39 (28.3%) and 40-49 (12.9%) and 44% had private insurance while 56% received patient assistance program (PAP) medication assistance.
The specific factors that led to the success of Rapid-PrEP were the following: 1) utilization of incident command system; 2) ongoing engagement and training of navigators, HIV testing counselors, and stakeholders; 3) Leveraging an on-site pharmacy; 4) intensive monitoring and client engagement during the first thirty days; 5) provision of transportation services, and; 6) one-stop shop services location 7) no cost regardless of the ability to paid (no sliding fee scales).
What has been done in the past to address the problem?
The Nation’s first comprehensive National HIV/AIDS Strategy (Strategy) for the United States was released in 2010. In the subsequent five years, people and organizations have joined together around its vision and goals. The Strategy has changed the way the American people talk about HIV, prioritize and organize prevention and care services locally, and deliver clinical and non-clinical services that support people living with HIV to remain engaged in care, and has helped to achieve many things, but namely the introduction of PrEP (pre-exposure prophylaxis), a much-needed new biomedical prevention tool that helps people reduce their risk of HIV infection by taking a daily pill. Based on evidence from multiple clinical trials released from 2011 to 2013, the Food and Drug Administration (FDA) approved PrEP in 2012. In 2014, the U.S. Public Health Service issued clinical practice guidelines for PrEP. Based on scientific and technological advances in the past five years, new guidelines and recommendations have expanded the number of options for prevention. CDC issued guidance to providers recommending PrEP be considered for those at substantial risk for HIV. In addition, guidelines from the U.S. Department of Health and Human Services (HHS) now recommend that all persons with HIV be offered treatment not only for their own health, but also because antiretroviral treatment significantly reduces the risk of HIV transmission to others. Additionally, the U.S. Preventive Services Task Force (USPSTF) recommends that all people aged 15 to 65 years and all pregnant women be screened for HIV. CDC also provided guidance for the adoption of new testing technologies that enhance the ability to diagnose HIV soon after infection, broadening the window of opportunity for effective interventions during the acute phase of infection—a time when HIV is most likely to be transmitted to others. Over the next five years sustained effort is required to realize the promise of these and other scientific advances, and to adopt and embrace emerging beneficial research findings. These may include the availability of sustained release antiretroviral agents either for PrEP or for treatment, new developments in microbicides or vaccines, or more effective delivery of HIV care services.
Historically, PrEP has been more accessible by individuals with commercial insurance and higher social-economic statuses than Broward County’s priority populations. Even with drug manufacturer reduced co-pay cards, the cost of PrEP and subsequent follow-ups has been a major deterrent for individuals seeking PrEP services. Few medical providers in Broward County treat indigent or uninsured patients. Federally Qualified Healthcare Centers (FQHC’s) and Local Health Departments (LHD’s) needed innovative ways to address the growing demand of the community seeking to access PrEP Services, thus causing excessive burden and saturation of services for the public sector and its resources. Lastly, early PrEP program data nationally demonstrated that PrEP adherence was extremely low. A deterent factor was the necessity for individuals to return every three months to their medical provider and take a daily medication was a major barrier in justifying the efficacy of early PrEP programs.
Why is the current/proposed practice better?
The Rapid-PrEP model is effective because it eliminates key barriers to the access of PrEP at point of care, especially for members of the priority populations at highest-risk of acquiring HIV in Broward County. By providing same-day PrEP medication and laboratory tests at no-cost to the patient, individuals are more likely to request, accept, or re-enroll in PrEP Services at the Broward Wellness Center (BWC). Another key element of the Rapid-PrEP program is that it uses highly-trained service navigators that, during the initial intake, provide adherence counseling, motivational interviewing techniques for risk-reduction, and thoroughly review and submit necessary documentation required to continue to provide the medication at no-cost to the patient (i.e. third party or manufacturer assistance programs). Additionally, the Rapid-PrEP program has an on-site pharmacy (a key element of our public/private partnership in the community) that can offer services such as free delivery of medication, renewal of assistance programs, and supply the feedback mechanism to monitor and measure adherence such as client pick up at months 1, 2, 3, etc. Once enrolled in the PrEP Program, PrEP Navigators closely monitor clients by completing a 3-day and 1-month follow-up contact within the first 30-days of PrEP initiation. During these interactions with the clients, adherence, side-effects, and any additional barriers are assessed and mitigated. Additionally, PrEP Navigators provide referral and linkage services for individuals that request or need such services that include transportation, housing, mental health, substance use treatment, employment and other services.
In this way, the DOH-Broward PrEP Program combined the CDC’s PS 18-1802 funding announcement guidance, the Florida’s Plan to eliminate HIV-transmission and HIV-related deaths, and the NHAS 2020 guidance in order to establish benchmark goals and objectives based on national leaders’ such as New York City Department of Health and Mental Hygiene and San Francisco Department of Public Health, which innovated PrEP service delivery in our county and subsequently the state of Florida.
Please see CDC’s MMWR Reports for Providers for additional information on these programs:
https://www.cdc.gov/mmwr/preview/mmwrhtml/mm6446a4.htm?s_cid=mm6446a4_w https://www.cdc.gov/mmwr/preview/mmwrhtml/mm6446a5.htm?s_cid=mm6446a5_w
Clinical Guidelines for providers can be found here:
https://www.cdc.gov/hiv/pdf/risk/prep/cdc-hiv-prep-guidelines-2017.pdf
The LHD should have a role in the practice’s development and/or implementation. Additionally, the practice should demonstrate broadbased involvement and participation of community partners (e.g., government, local residents, business, healthcare, and academia). If the practice is internal to the LHD, it should demonstrate cooperation and participation within the agency (i.e., other LHD staff) and other outside entities, if relevant. An effective implementation strategy includes outlined, actionable steps that are taken to complete the goals and objectives and put the practice into action within the community.
LHD and Community Collaboration
DOH-Broward worked closely with AHF to explore and develop a viable operational structure for the Rapid-PrEP Program at the Broward Wellness Center (BWC) with a main focus of positive health outcomes for its clients. This collaborative exercise involved staff from all levels of both organizations and ultimately resulted in both a mutually acceptable contractual framework with minimum service standards as well as action steps to complete identified program development goals and objectives. To fully achieve this unique public/private collaboration, a concrete joint commitment to programmatic innovation was achieved through a concentrated and sustained effort.
Development of a new and innovative RAPID-PrEP Program in Broward County, necessitated an extensive review of existing digital program-management platforms to evaluate capabilities vis-a-vis mandatory operational requirements. Foundational program research identified four key digital platform characteristics essential for operational success; (a) flexibility in adapting to an evolving point-of-care biomedical HIV prevention services model (ex. best practices); (b) cloud-based structure to permit efficient interoperability among multiple external/internal consumers and data systems; (c) secure platform to ensure protection of consumer data and Protected Health information (PHI), as well as; (d) expansive data capture and reporting capabilities to satisfy unique public sector needs with regard to client identification, participation and adherence (ex. quality assurance). In review, primary RAPID-PrEP Program external consumers include eligible and/or participating clients, AIDS Healthcare Foundation (AHF), pharmacies, clinical care providers, Patient Assistance Programs, etc. With, primary internal consumers consisting of program staff, DOH-Broward and the Florida Department of Health (FDOH). Ultimately, Microsoft 365 was chosen, as meeting all mandatory RAPID-PrEP Program operational requirements in a much more cost-effective package -- than other more expensive and less capable clinical care practice management software options on the market. Specifically, the extensive adaptability of the Microsoft 365 Customer Relationship Management (CRM) component, operating within a secure cloud-based platform was considered as essential. DOH-Broward purchased Microsoft consultant services to develop a CRM tailored specifically to the Rapid-PrEP Program and its data management needs. In addition, Microsoft 365 Enterprise digital consultant services were contracted to assist, as in-house platform development resources were then limited. This software development consultant support is ongoing and meets evolving programmatic data-management requirements.
The RAPID-PREP Program continues to evolve as it incorporates lessons learned and new best practices, within the maturing service model of biomedical HIV prevention. Feedback from program navigation and management staff is continually solicited and evaluated, in order to implement enhancements within the program's Microsoft 365 platform. This ongoing process of Continuous Quality Improvement (CQI) ensures that the program will achieve continued success in promoting client PrEP services adherence and reducing the incidence on new HIV infections within Broward County. Examples, of program enhancements include fine-tuning client follow-up processes, to include the adjustment of protocols and client contact timeframes, utilization of an ancillary client portal and mobile application program to improve retention, as well as, ensuring the success of client adherence during drop-in visits by monitoring medication blood levels (i.e. TDF/Truvada). Additional CRM enhancements have included streamlining client data field management for program staff and correcting data collection issues. Moreover, extensive development work continues in improving data capture and reporting accuracy with regard to long-term client adherence.
Goal(s) and objectives of practice
The goal of the Rapid-PrEP Program at Broward Wellness Center (BWC) is for patients at risk of acquiring HIV to receive HIV counseling and testing which includes labs for PrEP and STD screening, a medical provider visit and exam, offered PrEP, dispensed PrEP, and accept PrEP Navigation services on the same day at no cost to the client.
Eligibility for PrEP
The PrEP Program consists of the provision of PrEP in three basic patient scenarios. The general overview is:
Scenario 1: New or self-identified R-PREP patient based on patient’s request:
Scenario 2: Testing counselor identified based on PrEP assessment or patient request:
Scenario 3: Medical provider identified based on PrEP assessment or patient request, history of sexually transmitted infections (STIs), or history of nPEP:
Follow-Up all patients
Initial Pharmacy Pick-Up:
Long-Term Follow-Up (3, 6, 9 months)
DOH Broward PrEP Navigators will link insured clients to medical provider for PrEP follow-up.
If uninsured, PrEP patients will have routine follow-up visits every 3 months:
Below are the detailed steps regarding clinic visit flow of PrEP patient’s follow-up visits:
PrEP Navigation
The initial PrEP navigation session is a critical component of a PrEP visit and the duration ranges between 15-30 minutes.
During the initial PrEP navigation session, BWC PrEP Navigators will:
Follow-Up PrEP Navigation
Benefits Navigation
One of the main components of the initial navigation session is to ensure that insured PrEP patients are linked to primary medical home after initiating PrEP at Broward Wellness Center (BWC). Patients who are uninsured will be navigated to BWC for continued follow-up. PrEP Navigators will complete applications for the Gilead co-pay assistance card, Gilead Advancing Access (AA), or Patient Advocate Foundation (PAF), etc. PrEP navigators will also assist insured patients in selecting a provider who fully accepts their health insurance plans, as requested.
For Fiscal year 18-19, the budget allocation for PrEP is $973,498.82
Employee salaries and benefits = $629,972.12
Other expenses = $11,027.70
Collocated, Risk Management and HR Expenses = $35,100.00
Broward Wellness Center Clinical Encounter =$297,399.00
Total = $973,498.82
Evaluation assesses the value of the practice and the potential worth it has to other LHDs and the populations they serve. It is also an effective means to assess the credibility of the practice. Evaluation helps public health practice maintain standards and improve practice. Two types of evaluation are process and outcome. Process evaluation assesses the effectiveness of the steps taken to achieve the desired practice outcomes. Outcome evaluation summarizes the results of the practice efforts. Results may be long-term, such as an improvement in health status, or short-term, such as an improvement in knowledge/awareness, a policy change, an increase in numbers reached, etc. Results may be quantitative (empirical data such as percentages or numerical counts) and/or qualitative (e.g., focus group results, in-depth interviews, or anecdotal evidence).
Evaluation
What did you find out? To what extent were your objectives achieved? Please re-state your objectives. Did you evaluate your practice?
Among the central PrEP program objectives is to increase the number of individuals at high risk for HIV who receive PrEP, with the long-term goal of decreasing the incidence of HIV infection and reducing health disparities in the community. The central objective of increasing PrEP prescriptions among at risk individuals to reduce the spread of HIV infections are several other objectives including: increase trainings and presentations about PrEP for community members (community outreach) and medical providers (academic detailing), utilize a partnership with AHF to provide same-day PrEP and navigation services, develop capacity for active and passive monitoring of PrEP clients. DOH-Broward staff work in conjunction with AHF staff at BWC to ensure at risk individuals have access to PrEP on a same day basis. Metrics are monitored and reported on at monthly business review meetings and cumulatively for all objectives.
List any primary data sources, who collected the data, and how? (if applicable) List any secondary data sources used. (if applicable)
The secure CRM that was developed for the tracking of clients enrolled directly in the PrEP program, with demographic and behavioral risk data collected by health services representative’s interviews with clients in person and by phone. DOH-Broward is unaware of the use of a CRM to monitor and track a client’s progress and use of PrEP in another program. This data is supplemented by HIV test records and electronic health records to monitor HIV/STD status and TDF levels. AHF charts were reviewed by DOH-Broward health services representatives to identify gaps and disparities among at-risk individuals who did not enroll in PrEP, supplemented by observation and recording of demographics and dispositions during HIV testing sessions in which PrEP services are offered. Community outreach team measures number and demographics of community members reached, and academic detailers record PrEP knowledge, attitudes, and behaviors among physicians.
List performance measures used. Include process and outcome measures as appropriate. Describe how results were analyzed.
Within the PrEP clinical partnership process measures include total number of clients receiving same-day PrEP, total number of PrEP recipients eligible for navigation services, % of eligible clients who complete 3-day, 1 month, 3, 6, 9,12 month follow-ups, percent of clients who fill PrEP prescriptions. Outcome measures include TDF levels at 3, 6, & 9 months, and number of clients who seroconvert/become HIV positive. Process metrics for community outreach, and for academic detailing will utilize a pre-and post-survey investigating changes to sexual health history talking, PrEP prescribing, and PrEP referrals by providers.
Were any modifications made to the practice as a result of the data findings?
Observation and recording of demographics and dispositions during HIV testing sessions at AHF was implemented in order to develop a better understanding of client experiences and needs. Lack of knowledge and desire to do more research were cited, and community outreach presentations and efforts were subsequently redoubled.
Metrics:
R-PrEP Program Totals as of: June 1, 2018 – November 8, 2019
Total Number of R-PREP Clinical Visits: 2477
Total Number Who Received 10-day Starter Pack Enrolled in PrEP Navigation: 1886 (76%)
Private Insurance: 824 (44%)
PAP Assistance: 1062 (56%)
Ineligible for Navigation: 588 (24%)
OOJ: 557 (95%)
Walk Outs: 31 (5%)
Sustainability is determined by the availability of adequate resources. In addition, the practice should be designed so that the stakeholders are invested in its maintenance and to ensure it is sustained after initial development (NACCHO acknowledges that fiscal challenges may limit the feasibility of a practice's continuation.)
Sustainability
Lessons learned in relation to practice
Lessons learned in relation to partner collaboration (if applicable)
Did you do a cost/benefit analysis? If so, describe.
As the Rapid-PrEP continues, further data will be collected to assess the cost/benefit of the program.
Is there sufficient stakeholder commitment to sustain the practice?
Stakeholder Engagement:
Having the right stakeholders and subject matter experts from the appropriate organizations is necessary to establish community ownership for a plan that impacts such a large number of people.
Describe sustainability plans:
This program has been funded through DOH-Broward internal budget process and will continue.
2019 Sealing and Educating All Little Smiles, Model Practice
