Pre-exposure Prophylaxis Program within an STD Clinic:An innovative HIV prevention approach for MSM

State: MN Type: Model Practice Year: 2015

Hennepin County is located in east central Minnesota and is the most populated county with approximately 1.1 million residents. Minneapolis, the state’s largest city, is within Hennepin County. The 2010 U.S. Census found that in Minneapolis, 36.2 percent of the population was nonwhite, and 10.5 percent was Hispanic or Latino. Hennepin County’s mission is to enhance the health, safety, and quality of life of its residents and communities in a respectful, efficient, and fiscally responsible way. The Public Health Clinic (PHC) is housed in the Public Health line of business. The PHC is a multilingual, multicultural clinic that comprises Red Door Services, Tuberculosis Control, Refugee Health Screening Services, and a Health Care for the Homeless Program. Clinic services include screening and treatment for STDs, HIV testing, TB control services, refugee health screening, immigration exams, family planning, and Ryan White Early Intervention Services for qualified individuals who are HIV-positive and not currently in care. The Public Health Clinic – Red Door Services (PHC – RDS) is the largest STD/HIV testing and counseling site in Minnesota, diagnosing more STDs and HIV than any other single site in the state. In 2013 there were 27,993 visits to the clinic with over half of those for STD/HIV care. The PHC clientele is made up of the traditionally underserved populations at greatest risk for HIV infection including men who have sex with men (MSM), individuals with low or no income, persons of color, foreign-born clients, and individuals with history of substance use.   The PHC’s Health Interventions for Men (HIM) Program targets young and adult men who have sex with men (MSM). The HIM Program is a multilevel, sexual health program providing opportunities for MSM to receive HIV counseling, testing, and referral, internet and environmental outreach, individually tailored risk reduction counseling, and group level education.  In Hennepin County (2013), the MSM population accounted for 69% of new HIV infections. MSM is the only risk group in the United States in which infections have been steadily increasing since the early 1990s. In April 2013, the HIM Program added pre-exposure prophylaxis (PrEP) to their current program structure of existing HIV prevention efforts. We proposed to provide PrEP to MSM at significant, ongoing risk for acquiring HIV. The program consists of two HIM Program staff members who work in conjunction with a lead Nurse Practitioner. A PrEP team was formulated that concentrates on developing work flow and enhancing service delivery. The HIM program staff provides program promotion, client intake, medication adherence support, and overall coordination.  The program serves individuals with medical insurance and utilizes a pharmaceutical based patient assistance program that provides medication to individuals who don’t have insurance. Our program’s objective was to serve 60 clients in a 12 month period. We have met and exceeded this objective by completing 168 PrEP assessments in a 17 month period and have 114 currently enrolled patients as of October, 2014. There are many factors that lead to the program’s success. The HIM Program received a grant from the Minnesota Department of Health through the HIV Prevention with Positives funding stream. The Public Health Clinic contributes Nurse Practitioner time and lab costs to provide services to uninsured individuals. A critical partnership was formed with a local specialty pharmacy that facilitates insurance processing and offers ongoing follow up and patient support.   The HIM Program and other prevention staff members have a long history of providing quality services, and the PHC is known as a trusted place to go to receive honest and quality sexual health care. The HIM Program is well-suited to promote PrEP because of the long history of providing services and established credibility within high risk MSM populations. Being located within the PHC provides a seamless "in-house" referral to PrEP for HIM Program clients presenting with needs for comprehensive STD evaluation, treatment, and care. Patient privacy and confidentiality are critical to service delivery and building trust with populations of MSM that experience stigma and discrimination. These characteristics allow effective engagement and enrollment of MSM with higher risk of contracting HIV. PrEP dramatically changes the landscape of HIV prevention and is an innovative tool when exclusive prevention messaging to use condoms and limit sexual partners doesn’t resonate. The PrEP program engages high risk individuals in ongoing sexually transmitted infection testing. PrEP reduces stigma by engaging and educating individuals about HIV which can decrease fear of becoming infected. PrEP reduces the likelihood of transmission which can also reduce the anxiety level of individuals living with HIV concerned about transmitting HIV to their sexual partners.  
Currently in the United States approximately 56,300 new HIV infections occur annually, which is greatly reduced from the 130,000 annual HIV infections that this country witnessed during the 1980’s and 1990’s. This drastic drop in HIV infections throughout the decades is a direct result of local programs that adopted the newest HIV prevention methods like HIV screening, rapid testing, condom distribution, Highly Active Antiretroviral Therapy (HAART) for people living with HIV, Post-Exposure Prophylaxis (PEP), and more recently Treatment as Prevention (TasP) and Pre-Exposure Prophylaxis (PrEP). All of these tools when implemented by people living with HIV and those most at risk for acquiring the virus will help our communities reach the UNAIDS vision of “Getting to Zero (new HIV infections)” and the National HIV/AIDS Strategy, which states that “The United States will become a place where new HIV infections are rare….” Continually reducing new HIV infections will require the public health field to reconsider prevention methodologies that are supported by the growing body of HIV prevention research. In 2010, the iPrex study was released demonstrating that men who have sex with men (MSM) who were taking a daily dose of antiretroviral medication known as Truvada were 44-92% less likely to become infected with HIV. The advent of this research resulted in Pre-Exposure Prophylaxis (PrEP), which uses antiretroviral HIV medication previously reserved only for people living with HIV. This is the newest prevention tool for individuals at greatest risk for acquiring HIV. PrEP prevention methodology was adopted by the Health Interventions for Men (HIM) Program of Hennepin County Public Health Clinic- Red Door Services (PHC-RDS).We believe our PrEP program is a model practice because it was integrated into an existing HIV prevention program within the local health department’s STD clinic.Incorporating a PrEP program provided PHC-RDS with programmatic autonomy without a predetermined termination date or other requirements that accompanied previous PrEP demonstration projects. In addition, our program had the liberty to respond to the local epidemiological data in order to target individuals who are high risk for acquiring HIV and un- or underinsured patients. The specific goal of this new program is to reduce the rate of new HIV infections within the MSM population of the Minneapolis-St. Paul area. Minnesota has over 7,700 people living with HIV and had 301 new HIV infections in 2013 of which 82% occurred in the Minneapolis-St. Paul metro area. Men who have sex with men comprise 74% of all HIV infections in Minnesota and 67% of new infections in 2013; therefore, demonstrating a need for additional HIV prevention methods. The HIM Program and PHC-RDS determined that PrEP may be an additional way to respond to our clinics rising HIV and STD rates. Analysis of our data from 2011 drove our application for PrEP funding in 2012. In 2011 there were over 31,000 visits to the clinic with over half of those for STD/HIV care. In 2011 the clinic performed 7,359 HIV tests of which 114 were positive. This positivity rate for the clinic overall was 1.55% with a higher rate in the HIM Program. Comparatively in the 2011 MMWR report, there was a .6% positivity rate among STD clinics in the CDC’s 2007-2010 expanded HIV testing initiatives in 25 jurisdictions. The HIM Program specifically targets and excels at reaching high risk MSM. During 2011, HIM Program staff conducted 628 rapid HIV tests in the clinic and through outreach with over a 3.5% sero-positivity rate. Of those tested, 15% reported an HIV+ sexual partner during the last year and 5% disclosed Intravenous Drug Use (IDU) within the past year. In 2011, the HIM Program was responsible for diagnosing 22 (19 percent) of the 114 newly diagnosed, HIV-positive individuals within the PHC – RDS. Of the 628 tests, 250 individuals received HIV testing in the community through our HIM outreach activities. Three individuals (1.2 percent) were identified as HIV-positive through these testing efforts. In addition to the HIM Program’s successful HIV prevention outreach to the Minneapolis-St. Paul metro area’s MSM population, the program desired to provide more than the traditional HIV prevention strategies (e.g. testing in the public health clinic, testing in the community, condom distribution, educational workshops, online outreach, and CDC Social Network Testing) to help reduce new HIV infections within the MSM community. The plan to expand the program with this new intervention was also requested and supported by the target population based on informal key informant interviews. So the HIM Program applied for a new HIV prevention grant in 2012 through the Minnesota Department of Health (MDH) which is directly funded through the CDC. This grant proposal was unique because it was submitted under the category Prevention with Positives because HIV infections often result from someone being unaware of their HIV positive status. Additionally, internal program data demonstrated that 15% of our newly diagnosed individuals had HIV positive partners. This additional funding source allowed the HIM Program to devote staff time and resources to research, plan, implement and monitor a new PrEP program in partnership with the PHC-RDS clinical staff. The new PrEP service fit well within the existing HIV prevention portfolio of Red Door Services and further coalesced the HIM Program prevention staff and the Public Health Clinic’s nurse practitioner team. The PrEP program allowed both prevention staff and nurse practitioners to increase their prevention toolbox offerings and referrals for those individuals who indicated a much higher than normal HIV infection risk because other prevention services and tools were not working for them. The collaborative PrEP program began in April, 2013 at Red Door Services; eight months after the FDA approved the drug Truvada to be used as Pre-Exposure Prophylaxis. The approval of this biomedical prevention strategy was the most innovative HIV prevention tool since the CDC published the 1998 and 2005 MMWR, which approved the use of non-occupational Post-Exposure Prophylaxis to supplement an individual’s use of barriers and condoms. The HIM Program of Red Door Services based its support for implementation of this new HIV prevention program on various external resources. First and foremost, the 2010 study and subsequent clinic research on PrEP demonstrated the efficaciousness of Truvada as a biomedical HIV prevention tool. This study showed that individuals, who took Truvada daily as prescribed, could reduce their risk of HIV infection by 92%. Secondly, The National HIV/AIDS Strategy outlined a national goal to reduce new HIV infections by 25% through innovative strategies like PrEP. In 2012, the FDA approved the drug Truvada for clinical use as Pre-Exposure Prophylaxis. This action was named TIME’s top ten medical breakthroughs for that year. Lastly, our program connected with the San Francisco City Clinic to learn from their local health department’s existing PrEP demonstration project. Combining the scientific research, federal approval of Truvada’s clinical use, the National HIV attention and practice protocols from another local health department helped with the support and implementing of the PrEP program at Red Door Services. After being launched, this program was further supported through evidence-based practices when the CDC published the 2014 Clinical Guidelines for Pre-Exposure Prophylaxis thus supporting the CDC’s “Winnable Battles” for HIV in the United States.
HIV in the U.S.
The overall clinical goal of the PrEP program within the Public Health Clinic - Red Door Services (PHC-RDS) is to reduce the incidence of new HIV infections within the Minneapolis-St. Paul metro area. In order to achieve this broad goal, Red Door Services had to undergo a paradigm shift, which saw the addition of HIV biomedical interventions to its standard HIV and STI testing and treatment services. This necessitated a goal of developing and implementing a Pre-Exposure Prophylaxis program that collaboratively combines the efforts of staff members from both the Red Door Services’ Health Interventions for Men (HIM) Prevention Program and the Hennepin County Public Health Clinic. These two overarching goals and corresponding objectives were outlined as follows: Goal #1: To develop and implement a Pre-Exposure Prophylaxis program in 2013 that collaboratively combines the work of the Hennepin County Public Health Clinic and the Health Interventions for Men (HIM) Prevention Program. Objective #1: Research and obtain data on PrEP effectiveness and clinical protocols.Objective #2: Collaborate with Public Health Clinic’s Medical Director to determine PrEP program feasibility.Objective #3: Develop buy-in from executive management in public health department and clinical staff within the Public Health Clinic. Objective #4: Apply for grant funding within existing HIV prevention grants (e.g. Minnesota Department of Health’s community-based HIV Prevention Projects).Objective #5: Develop clinic protocol for PrEP program, including roles and responsibilities for HIM Program staff and clinical practitioners. Objective #6: Partner with Gilead Pharmaceutical to access patient assistance program for uninsured and underinsured patients. Objective #7: Collaborate with electronic health record team to develop templates and capture reporting data for reporting. Objective #8: Train all staff on PrEP clinic protocol within the Public Health Clinic (front desk, registration staff, program staff, and clinicians).Objective #9: Create marketing material for PrEP program.Objective #10: Launch program and enroll target population. Goal #2: The PrEP program will reduce the incidence of new HIV infections within the Minneapolis-St. Paul metro area. Objective #1: Educate men who have sex with men regarding the PrEP program and effectiveness for preventing HIV.Objective #2: Market PrEP program to MSM population with a special emphasis to online venues.Objective #3: Build PrEP referral system within public health clinic and external community organizations. Objective #4: Enroll and retain 60 highest risk MSM individuals. As is indicated in the first goal and first three objectives, many collaborative discussions and presentations were organized to engage various levels of the Hennepin County Public Health Department. This internal stakeholder engagement was championed by a team of staff that included a front line worker in the HIM Program, the supervisor of the HIM Program and a public health clinician. This team educated themselves about PrEP, about the newest science regarding HIV prevention, and about how the demonstration projects across the country were delivering this program. This team of three individuals worked together through informal individual conversations with peers, supervisors and executive management to educate other staff and to develop the ground work for building a PrEP program. This education and consensus building around the science and efficacy of PrEP was crucial in order to catalyze the paradigm shift from a standard HIV test and referral model within an STI clinic to a comprehensive HIV prevention model. In addition to laying this groundwork, PHC-RDS had many pre-existing elements in place to make a PrEP program successful. The medical director of the PHC-RDS is also the medical director of the Positive Care Center (HIV/AIDS specialty care) of Hennepin County Medical Center (HCMC), with which PHC-RDS have a shared electronic health record (EHR) system. This decades-long partnership between PHC-RDS and HCMC Positive Care Center has facilitated a continuity of care for many patients and a trusting relationship between the two medical system’s clinical staff. The medical director was already familiar with prescribing PrEP within his clinical practice to partners of positive patients. This facilitated confidence within the clinical staff of PHC-RDS, providing the opportunity to consult with the medical director if any concerns developed while administering PrEP. Having the medical director support the PrEP program through clinical consultation and protocol development was instrumental in launching the program. After the necessary internal decision makers and stakeholders were in agreement and supportive of a PrEP program, the next steps included determining how a program would be funded and figuring out how to fit it into the existing clinic services and patient flow (goal 1, objective 3-4). The decision to undertake and implement a PrEP program was timely due to the Minnesota Department of Health’s (MDH) upcoming HIV Prevention Projects application cycle for the 2013-2016 grant period. Historically the HIM Program received MDH HIV prevention grant funds to specifically work with MSM and YMSM (young MSM) individuals; however, the PrEP program may potentially include prospective clients that did not necessarily fit the demographics for these project areas. Therefore, the grant application submitted highlighted the intervention within the HIM Program and focused on serving high risk MSM. The grant request included the cost of one full-time HIM Program Community Health Specialist, marketing and program promotional costs, and other incidentals. The grant proposal outlined the collaboration between the HIM Program’s prevention staff, PHC-RDS clinical staff, and patient flow within the entire HIM program service spectrum. Also described was the partnership with HCMC’s laboratory and EHR, which demonstrated the clinic’s ability to leverage resources internally and externally in order to maximize efficiency to deliver this new biomedical prevention program. The PrEP program grant was funded in January 2013 and the program launch was planned for early spring. It is possible that there were unappreciated, or difficult to identify costs to the Public Health Clinic with the implementation of PrEP but there were no specific start-up costs. In-kind costs included staff time to plan, develop and implement the intervention. Existing staff were re-allocated requiring the adjustment to routine workflows and this may have resulted in some inefficiency early on in the project. However, it is our perception that overall, savings will eventually be realized for the broader health care system through the decreased incidence of HIV infection. The next step was to develop the protocol for serving clients in the clinic. Through previous research and discussions with other clinics across the country, the PrEP designated Nurse Practitioner wrote the clinical protocol after several team meetings where it was reviewed and discussed in detail (see below, Appendix A). The roles, responsibilities and clinic flow for the PHC-RDS clinic and staff were clearly outlined in order to ensure patient care was seamless and comprehensive. In addition, a patient flow chart was developed to help funders and staff members understand the PrEP program integration within the HIM Program at PHC-RDS Click here for patient flow chart. During the development of the clinical protocol, many other program activities were identified that would support the PrEP program. The protocol development was not viewed as a means to an end to deliver a PrEP program, but rather a process that had to be flexible in order to incorporate adjustments and learning activities that would make the PrEP program a success. One of these activities was working with Gilead Pharmaceutical to understand and utilize their patient assistance and co-pay assistance programs. HIM Program staff worked with Gilead to train and educate PHC-RDS staff regarding the science and delivery of the medication Truvada, which is the only approved medication for PrEP at the present. The HIM Program PrEP coordinators worked with the Gilead representative to obtain necessary paperwork (Agreement form for initiating Truvada for Pre-Exposure Prophylaxis, Checklist for prescribers: Initiating Truvada for Pre-Exposure Prophylaxis) and conducted self-training on accessing the Gilead patient assistance program for uninsured individuals and co-pay assistance for individuals with high out of pocket co-pay costs. It was integral for effective implementation to understand the specific income qualifications for these programs ( The HIM Program PrEP coordinators additionally needed to be willing and able to navigate private and public insurance programs to determine eligibility for PrEP medication costs. Each insurance plan covers PrEP differently and educating patients while working with them to navigate their insurance coverage has become easier with repeated practice. As the PrEP program was being implemented, HIM Program staff learned of various other program activities that needed to be undertaken. The first involved working with the EHR team to ensure we could appropriately capture clinical data and corresponding billing information. Utilizing the clinical protocol and staff roles and responsibilities as a reference, various EHR fields were developed to accurately capture the essence of the client’s visit. Since the PHC-RDS clinic had an existing EHR system it shared with HCMC, it was an easy transition to add the PrEP-specific fields. Secondly, it was imperative, as with any new program, that all staff that interacts with patients - including front desk, scheduling and registration staff - be trained on PrEP, relevant to their job duties and scope of work. Lastly, PrEP program materials were created for specific outreach venues. Brochures were created for internal referral use by PHC-RDS clinical practitioners and HIM Program outreach staff. The HIM Program conducts outreach on several online social networking websites and phone-based applications specific to MSM individuals. In each of these web-based profiles we promoted PrEP and informed our target community that we now offer this new program. Another way PrEP was promoted was via higher-profile community members like Mr. Minneapolis Leatherman, who agreed to partner with our program and help advertise this new HIV prevention method. Other marketing strategies included the use of Facebook, our HIM Program website, educational programs within the community and promotion during community-based HIV testing events. It took the HIM Program’s PrEP coordinators and supervisor three months to complete the program planning and foundational administrative work before the first patient was enrolled in April 2013. In order to be efficient with the grant funding, many of the planning activities were undertaken before the official funding grantees were announced. Once the HIM Program received the grant, both planning and implementation objectives, as outlined above, were undertaken at the same time in order to launch the PrEP program in a timely manner. The proposed clinical goal was to offer PrEP to 60 patients within 2013. Despite the program’s efforts to promote, educate and enroll patients into PrEP we ended up being 17 patients shy of reaching this goal in 2013. Interest in the program has continued to grow. In the 17 months that the PrEP program has been fully operational, there have been a total of 168 assessments completed with 114 active patients on PrEP. APPENDIX A: SUBJECT: Pre-Exposure Prophylaxis (PrEP) for the prevention of HIV infection with men and transgender individuals who have sex with men DESCRIPTION: The Centers for Disease Control and Prevention issued final recommendations for Pre-Exposure Prophylaxis for the Prevention of HIV Infection in the United States. ( Recent findings from several clinical trials have demonstrated safety and a substantial reduction in the rate of HIV acquisition for men who have sex with men (MSM), men and women in heterosexual HIV-discordant couples, and heterosexual men and women recruited as individuals who were prescribed daily oral antiretroviral Pre-Exposure Prophylaxis (PrEP) with a fixed-dose combination of tenofovir disoproxil fumarate (TDF) and emtricitabine (FTC). In addition, one clinical trial among injection drug users (IDU) and one among men and women in heterosexual HIV-discordant couples have demonstrated substantial efficacy and safety of daily oral PrEP with TDF alone. The demonstrated efficacy of PrEP was in addition to the effects of repeated condom provision, sexual risk-reduction counseling, and the diagnosis and treatment of sexually transmitted infection (STI), all of which were provided to trial participants, including those in the drug treatment group and those in the placebo group. In July 2012, after reviewing the available trial results, the U.S. Food and Drug Administration (FDA) approved an indication for the use of Truvada (TDF/FC) in combination with safer sex practices for PrEP to reduce the risk of sexually acquired HIV in adults at high risk. On the basis of these trial results and the FDA approval, the U.S. Public Health Service recommends that clinicians evaluate their male and female patients who are sexually active or who are injecting illicit drugs and consider offering PrEP as one prevention option to those whose sexual or injection behaviors and epidemiological context place them at substantial risk of acquiring HIV infection. Clinical Indication  Patients presenting for services at the Hennepin County Public Health Clinic/Red Door Services (PHC/RDS) and outreach testing efforts, that meet the following criteria, will be referred to the PrEP Program Coordinator for PrEP consultation: Adult man or transgender individual, Without acute or established HIV infection, Reporting male sex partners within the past 12 months, Not in a monogamous partnership with a recently tested HIV negative partnerand at least one of the following: Any vaginal or anal sex without condoms (as a top or a bottom) in the past 6 months Any rectal or urethral bacterial infection, diagnosed in the past 6 months Is in a sexual relationship with an HIV positive partner Currently injects drugs Patient Program Access—phone & hours of operation Whenever possible, candidates should receive a direct referral to a PrEP coordinator for enrollment. Patients, who are not directly referred, should be provided with a PrEP referral packet. Walk-in patients should be scheduled with the PrEP Coordinator. HIM Program phone line, 612-348-9100, operates as an access point for the PrEP intervention. The HIM Program phone is monitored during PHC/RDS clinic hours of operation. All men and transgender individuals who have sex with men, regardless of risk, will be provided with the internal general PrEP brochure. Monday & Wednesday: 8am-7pmTuesday, Thursday & Friday: 8am-4pm PrEP Enrollment: Initial/intake visit with PrEP coordinator Prior to a PrEP clinical visit with a Nurse Practitioner, PrEP candidates will meet with a PrEP Coordinator and complete the following: Verify negative HIV status Provide PrEP educational materials Discuss testing requirements Verify insurance status Determine out of pocket costs Complete high risk evaluation Initial Clinical Visit with NP Assess risk factors for HIV infection Assess for acute HIV infection Past/present medical history. Assess for potential or current renal or liver dysfunction. Assess medications Assess birth control method for females Review risks and benefits of PrEP Assess for vaccinations needed and give as indicated Verify patient contact information (phone, email and MyChart) Assess which pharmacy to send prescription Complete check list and consent form Give NP contact information Physical Examination Height, weight, blood pressure Targeted STI exam Laboratory STI exam  Rapid HIV test  Serum creatinine Calculated estimated creatinine clearance  HBV surface antibody and HBV surface antigen USR HIV RNA if symptoms of acute HIV present HCV surface antibody and reflex PCR if indicated Pregnancy test for female Laboratory Review All labs to be reviewed by NP prior to prescription for PrEP sent to pharmacy. PrEP Prescription Truvada (tenofovir disoproxil fumarate (TDF) 300mg and emtricitabine (FTC) 200mg), take one pill daily. #30. Total of 3 months.  Send electronic prescription to pharmacy of patient’s choice or to Gilead. Send MyChart or phone message to patient when prescription sent. Medication Refills Every three months following repeat negative HIV test. Accessing Prescription Medications Insured PrEP Coordinator will evaluate out of pocket costs per Pts insurance plan. Uninsured Uninsured Pts will work with the PrEP coordinator to apply for Medication Assistance Program. Complications Acquiring HIV: If a PrEP patient tests positive for HIV, PrEP will be discontinued and patient to be referred for HIV care.  Chronic HBV: Patients with HBV will be referred to Primary care for PrEP. Severe Adverse Reaction: Discuss with Medical Director. Woman who becomes pregnant: Discuss with Medical Director and refer for prenatal care or pregnancy option counseling. Consultations Clinicians who have extenuating circumstances not outlined in this protocol should page the Public Health Clinic’s Medical Director. Clinicians who do not have access to experienced HIV clinicians should call the National Clinicians’ Consultation Center Perinatal Line at 1-888-448-8765. Discontinuing PrEPDocument: HIV status at time of discontinuation Reason for PrEP discontinuation Recent medication adherence and reported sexual behavior  
Given the newness of the PrEP program at PHC-RDS, it was determined that assessing the program’s operations, implementation, and service delivery was best suited prior to launching an outcome evaluation. This would help the PrEP program staff and management to ensure the target audience was reached, to monitor the quality of the intervention according to the outlined goals and objectives, and, to make necessary refinements to improve the intervention. After the program was operational for 14 months, the PrEP team decided to conduct a process evaluation with the following questions: 1. Who delivers the program? 2. How is the program received by internal stakeholders and staff?3. How often is the program delivered? 4. How is the program received by the target population?5. To what extent was the program implemented as planned? 6. What are barriers to program delivery? 7. To what extent has the data been used to make program improvements/refinements? What changes were made? These process evaluation questions were asked in direct relationship with the follow goals and objectives: Goal #1: To develop and implement a Pre-Exposure Prophylaxis program in 2013 that collaboratively combines the work of the Hennepin County Public Health Clinic and the Health Interventions for Men (HIM) Prevention Program. Objective #1: Research and obtain data on PrEP effectiveness and clinical protocols.Objective #2: Collaborate with Public Health Clinic’s Medical Director to determine PrEP program feasibility.Objective #3: Develop buy-in from executive management in public health department and clinical staff within the Public Health Clinic. Objective #4: Apply for grant funding within existing HIV prevention grants (e.g. Minnesota Department of Health’s community-based HIV Prevention Projects).Objective #5: Develop clinic protocol for PrEP program, including roles and responsibilities for HIM Program staff and clinical practitioners. Objective #6: Partner with Gilead Pharmaceutical to access patient assistance program for uninsured and underinsured patients. Objective #7: Collaborate with electronic health record team to develop templates and capture data for reporting. Objective #8: Train all staff on PrEP clinic protocol within the Public Health Clinic (front desk, registration staff, program staff, and clinicians).Objective #9: Create marketing material for PrEP program.Objective #10: Launch program and enroll target population. Goal #2: The PrEP program will reduce the incidence of new HIV infections within the Minneapolis-St. Paul metro area. Objective #1: Educate men who have sex with men regarding the PrEP program and effectiveness for preventing HIV.Objective #2: Market PrEP program to MSM population with a special emphasis to online venues.Objective #3: Build PrEP referral system within public health clinic and external community organizations. Objective #4: Enroll and retain 60 highest risk MSM individuals. A HIM Program staff member was the catalyst for researching, advocating for and initiating the PrEP program within the PHC-RDS. This staff person was a natural fit to begin delivering the PrEP program given his research and advocacy efforts for spearheading the program within PHC-RDS. He first met and collaborated with the San Francisco City Clinic PrEP demonstration project and then gradually acquired support from executive management and clinical staff to begin outlining the prospective goals and objectives of the PrEP program for the PHC-RDS. The PrEP program started with one nurse practitioner with a strong interest in PrEP and two HIM Program prevention staff members who were willing to pioneer the intervention. After conducting the PrEP program’s process evaluation in winter of 2014, it was determined that another clinical practitioner was needed and added in winter of 2014 to keep up with the demand for PrEP. The nurse practitioner who provides the initial labs and care for the PHC-RDS’s early intervention patients who are newly diagnosed with HIV was a natural fit given her level of HIV expertise. This nurse practitioner was increasingly supportive of the PrEP program and agreed to join the PrEP team. This gradual receptivity of the nurse practitioners was evident through their willingness to refer their patients to the PrEP program after it was launched. The PrEP program grew rapidly largely due to the work of PrEP program staff to engage some of the most challenging clients who, prior to program enrollment, rarely tested for HIV or other STIs. Determining how often the PrEP intervention would be delivered was dependent on available funding to support a new program and tailoring the intervention to the target population. Executive management applied for and received grant funding for one full time HIM Program staff (1 FTE designation, split between two HIM Program staff members at .5 FTE) to deliver the PrEP intervention. The nurse practitioners assumed the PrEP responsibilities within existing funding and job responsibilities.  The process evaluation also determined that the HIM Program’s historical work with the MSM population in Minneapolis-St. Paul supported recruitment for the PrEP program through existing program services like HIV testing and counseling and both online and gay bar outreach. Internal referrals to the PrEP program were established through the clinic from either a HIM Program staff member or nurse practitioners. However, the target population had to meet certain criteria. A PrEP candidate needed to report being MSM with at least one of the following risk factors within the last year: inconsistent condom use, a rectal STI infection, being in a sero-discordant relationship with an individual living with HIV, or an injection drug user. The work of the PHC-RDS’s PrEP program targeting the MSM population was additionally supported by the Hennepin County epidemiological data demonstrating the MSM population was disproportionately affected with 69% of all new HIV infections. As of October 1, 2014, all 114 active PrEP clients are MSM and have one of the previously listed risk factors demonstrating the program’s success in reaching goal two (specifically objective four: enroll and retain 60 highest risk MSM individuals).  Since commencing the PrEP program in April 2013, 168 PrEP assessments have been conducted. As of October 1, 2014 there are 114 active PrEP patients. We have had zero HIV conversions among program participants.  We have had three individuals test positive for HIV during their initial enrollment to PrEP. Early identification of individuals living with HIV is an unexpected benefit to the intervention. A quality improvement project is underway to determine reasons for patients terminating or not continuing with the program (e.g. change in risk status, change in partners, medication side effects, relocation).This information will provide data on patient barriers to commence or continue with PrEP, which will then provide an opportunity for the PrEP program to identify strategies to strengthen follow-up support. The process evaluation identified another gap in data collection with respect to how many initial patient referrals were made to the PrEP program by either the clinical or HIM Program staff. An internal referral could involve an in-person introduction to one of the PrEP coordinators of the HIM Program or providing the patient with the business card and PrEP brochure for follow up with a PrEP coordinator. patients who did not reach out to one of the coordinators or follow up to schedule an initial screening were then not specifically assessed for PrEP and were not reflected in our current data. As a result, we cannot determine the proportion of patients who qualify for PrEP, the number of PrEP referrals and the resulting PrEP assessments. A data collection process to capture this information is being developed. Obtaining the number of referrals per qualifying patients by each staff member would be another way to assess how supportive staff members are of the PrEP program and allow for staff supervision and coaching to ensure patients with the highest risk are appropriately targeted.  The target population’s receptivity of the PrEP program can be demonstrated through the 114 currently enrolled patients, averaging approximately 80 patients a year (although the program has only been operational for 17 months). The adoption and utilization of PrEP by the Minneapolis-St. Paul metro area MSM population is considered a success based on these assessment numbers and qualitative anecdotal reports. As an example, during the process evaluation it was determined that 35% of online outreach questions and 36% of phone calls to the HIM Program were regarding PrEP inquiries and requests for initial PrEP assessments. Secondly, a local AIDS Service Organization invited our PrEP coordinators to partner with them to promote PrEP and develop a referral system for their clients who test for HIV. In 2014, Mr. Minneapolis Eagle incorporated PrEP and our program into his efforts to support his platform to educate the MSM community locally and internationally at the International Mr. Leather competition in Chicago. To demonstrate the anecdotal success of PrEP, the following message was sent to the HIM Program through one of the five online hook-up websites we conduct outreach to promote our services: “Hey HIM guys! Just a quick note to thank you for your efforts to get the word out on PrEP! I went on PrEP last month after 25 years of living in fear of contracting HIV. I hope that everyone whom PrEP could benefit is able to and willing to get on it, and your work is helping that immensely. Just wanted you to know that your work is appreciated!”  The entire PrEP program currently operates as initially planned with only a few minor changes. The goals and objectives outlined above served as an outline for the sequence of events that needed to be in place prior to launching PrEP. While the first goal’s objectives were not necessarily followed sequentially, many of the planning objectives were worked on concurrently in order to maximize time. The planning step that experienced the most changes was the roles and responsibilities for HIM Program staff and clinical practitioners, which necessitated a few minor changes in patient flow. For instance, the PrEP coordinators need to complete a full assessment to determine the patient’s eligibility versus the clinician determining eligibility through a traditional clinic visit assessment. This full assessment is deemed necessary to devote adequate time to explore risk factors in-depth and ensure the patient agrees to the regular testing schedule (every 3 months receiving HIV testing, every 6 months receiving full STI testing and creatinine level). However, this in-depth assessment does not replace the nurse practitioner’s clinical judgment to prescribe Truvada as PrEP to individual patients. The delineation of roles and responsibilities were tantamount to the success of the PrEP program to ensure both patient and staff had enough time to obtain answers to their questions and complete the necessary tasks. Other changes involved providing prospective patients with educational materials prior to their first PrEP visit to ensure they are well educated on this biomedical intervention. This involves a high level of organization on behalf of both referral sources and PrEP coordinators to help ensure patients follow a sequence of events, which is believed to help increase the successfulness of medication adherence and overall intervention.  There were two barriers that were identified during the program evaluation. First, the number of proposed patients to be enrolled into the PrEP program (n=60) for the MDH grant application was staff’s best estimate as an annual enrollment rate. After the PrEP program assessed 168 clients for PrEP and the workload doubled, this data was used to evaluate the initial MDH grant proposal and negotiate potential changes to the program regarding new enrollees and retaining or referring existing PrEP patients. The HIM Program and PHC-RDS will need to assess how many additional PrEP patients can be served without overloading the staff and clinic. Therefore, additional resources to continue enrolling patients are needed. Secondly, a data tracking system for our internal and external referrals is needed as mentioned above. This will require a new system to be developed and implemented. Currently, the electronic health record system is utilized in conjunction with a Microsoft Access database system to track patient progress. Although, these two systems collect different data points with different capabilities to analyze data, one of these two systems may be suitable for capturing and analyzing referral data. 
The PrEP program at PHC-RDS has been successful due to valuable collaboration and support from both internal and external stakeholders. The willingness of the San Francisco City Clinic PrEP demonstration project to share information and experiences during a site visit was an integral piece that made PrEP at PHC-RDS possible. Their patient assessment forms were useful for establishing our model of implementation and integration into our existing HIV prevention services and clinic flow. Writing a protocol to meet the unique needs of PHC-RDS illuminated issues the PrEP team needed to address during the planning and service delivery process. During protocol development several fruitful discussions ensued among the team members to clarify respective roles, finalize patient education materials, and establish patient flow through program elements.  Other stakeholders were integral to implementing and sustaining our PrEP program. These stakeholders included the medical director of PHC-RDS, who was already prescribing PrEP in his Hennepin County Medical Center specialty clinic practice; passionate and knowledgeable Public Health clinic staff (nurse practitioner, HIM Program prevention staff and corresponding supervisor), who diplomatically advocated for a PrEP program; and representatives from Gilead Pharmaceutical (Truvada manufacturer), who obliged our requests for staff educational presentations and supportive materials. One unexpected internal stakeholder included our internal disease investigation (DI) team, who recognized the opportunity to refer high risk patients into the clinic for PrEP.  This service integration, allowed our DI team to provide a service that will continually engage higher risk individuals and their partners, who have experienced multiple infections, into a comprehensive HIV prevention and routine STI testing process. All of these institutional factors helped the PrEP team proactively frame a public health position to advocate for the implementation of a PrEP program to internal stakeholders like executive management and clinicians.   In addition to these collaborative efforts that helped launch the PHC-RDS PrEP program, many lessons were learned throughout the implementation process. One noteworthy surprise was that we experienced an increase in new MSM patients coming to our clinic to enroll in PrEP. HIM staff members speculate this may be in part due to a shortage in availability of MSM specific primary care settings. In order to serve our patients in a safe and consistent manner, patient lists had to be developed in our EHR. These lists ensured we followed up every 3 months with each PrEP patient for HIV testing and other necessary lab tests. If patients did not schedule appointments or missed their quarterly appointment, we could not for the safety of our patients continue to prescribe Truvada as PrEP (per medication guidelines). This needed to be monitored closely and patients additionally needed to be educated concerning risks of sero-conversion, medication adherence, potential kidney function contraindication, and the requirement for routine STI testing.  In addition to the EHR data, a second Microsoft Access database was developed to store program information for each patient that included in-depth risk assessments, which are conducted every 3 months. The database was added as a tool that makes our mandatory monthly reporting requirement by current funders more efficient. The quarterly patient assessment process ensures we continue to reach our target population of highest risk MSM individuals. Through this deliberate assessment and monitoring process, we are learning that some of our clients appear to be reducing their risk over time (e.g. increased condom use, reduced number of partners, steady partner with undetectable viral load). If this becomes a trend we may need to build additional partnerships with local primary care physicians who are willing to continue prescribing PrEP for patients with medical insurance and reduced risk. Referring those who are not determined to have the highest risk in the MSM community will help sustain the PrEP program at PHC-RDS and maximize our current funding. The perpetual challenge lies in determining which patients should be referred out and which should continue with our program as well as ensuring a seamless referral process to a primary care setting.   As described in the evaluation section, we currently have 114 patients enrolled in PrEP. This number continues to grow weekly and will require additional resources as demand for this intervention increases. There is currently only one full-time HIM Program staff member devoted to PrEP. Therefore, the needed expansion of the program is being discussed and explored. Additional funds are being researched and leveraged. The Washington state PrEP Drug Assistance Program (DAP) model is a program that helps pay for Truvada copays for patients. This model is being used to help educate local state decision makers in Minnesota. The HIM Program and PHC-RDS would be able to expand its PrEP program if Minnesota would also implement a PrEP DAP model to become a potential funding source for the program. Given that PHC-RDS is part of the larger Hennepin County government, our program is restricted in the category of funders and size of grants we can apply for. Therefore, our Public Health Department management may consider the availability of county resources to sustain and expand our PrEP program going forward.  If our PrEP efforts continue to result in no new HIV cases from participants, this certainly contributes to reductions in long term costs to the overall health care system (i.e., Hennepin County Medical Center). A cost-benefit analysis has not been conducted for the PrEP program at PHC-RDS for several reasons. First, it is difficult to calculate the cost savings and discounted cost of preventing an HIV infection in a population-based sample across several years.  Secondly, it is difficult to determine (#1) the average number of years a person may use PrEP (based on risk longevity) with (#2) the average associated cost of PrEP in relationship to the various types of insurance companies. However, a cost-benefit analysis has been discussed with the Public Health Department’s assessment team to help understand program efficiency and effectiveness specifically regarding program expansion.   In summary, the PHC-RDS has garnered support from various internal and external stakeholders that have supported and sustained the PrEP program. The PrEP program has built long-standing relationships with other AIDS Service Organizations that also conduct HIV testing and counseling. These organizations promote our PrEP program by referring their higher risk clients to the service. The HIM Program continues to seek connections with individuals who are informally recognized as leaders in the MSM community and who are willing to promote our comprehensive range of HIV prevention services, including PrEP. We believe that building this trust through strong community ties has been a significant key to our program’s sustained success. The PrEP team continues to conduct prospect research for additional monetary support to expand the PrEP program. Program staff members are keeping abreast of the newest research and best practices to inform our program implementation. The next steps the program will undertake to ensure sustainability include conducting an outcome evaluation and possibly a cost-benefit analysis with the assistance of the Public Health Department’s assessment team. 
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