- Email: [email protected]
A Model for Increasing Access to Preexposure Prophylaxis (PrEP) Services in the Substance Use Population
The Journal for Nurse Practitioners xxx (xxxx) xxx
Contents lists available at ScienceDirect
The Journal for Nurse Practitioners journal homepage: www.npjournal.org
A Model for Increasing Access to Preexposure Prophylaxis (PrEP) Services in the Substance Use Population Nancy S. Goldstein, DNP, ANP-BC, Ellen C. Seymour, MSN, AGNP-C, Jared B. Carter-Davis, MSN, AGNP-C a b s t r a c t Keywords: HIV risk screening tool human immunodeficiency virus (HIV) model development preexposure prophylaxis (PrEP) substance use disorder
In 2017, a low-resource substance use treatment center in Baltimore, Maryland, noted that at least 38% of patients, ranging from 18 to 76 years old, with substance use disorders (SUD) met the criteria for preexposure prophylaxis (PrEP) therapy. PrEP therapy consists of a daily medication to prevent transmission of human immunodeficiency virus. A conceptual framework model was developed linking eligible patients with SUD to PrEP services based on current Centers for Disease Control and Prevention PrEP recommendations. Three tools were developed for PrEP service planning, implementation, and evaluation. The focus of this report is to increase access to and uptake of comprehensive PrEP services in those with SUD who are at risk for acquiring human immunodeficiency virus. © 2019 Elsevier Inc. All rights reserved.
Background
test result, absence of acute HIV infection, adequate renal function, and documented hepatitis B virus and vaccination status.1
Overview of Preexposure Prophylaxis in Substance Use Overview of a Systematic Review Tenofovir disoproxil fumarate (Truvada; Gilead Sciences, Inc, Foster City, CA) was approved by the United States Food and Drug Administration in 2012 for use as a preexposure prophylaxis (PrEP) for human immunodeficiency virus (HIV) infection in men having sex with men.1 In 2014, Truvada was approved for use in those at risk for HIV acquisition from intravenous, injection, and intranasal drug use.1 This once-daily regimen has significant prevention efficacy in all high-risk groups. PrEP reduces the risk of HIV transmission by more than 90% in men who have sex with men and by more than 70% in those who inject drugs.1 PrEP has an overall risk reduction profile of up to 92%.2 Despite PrEP’s efficacy in those with high-risk sexual and drug use behaviors, including noninjection substance use,3 access to and uptake of comprehensive PrEP services in the population with substance use disorder (SUD) has severely lagged behind uptake among other high-risk groups.3-5 In the US, the criteria for establishing eligibility for PrEP are determined by the Centers for Disease Control and Prevention (CDC). The most current CDC guidelines for HIV prevention and use of PrEP (2017) indicate that patients with SUD must have a substantial risk for HIV acquisition and meet clinical eligibility criteria. Substantial risk categories include participation in a serodiscordant sexual relationship, a high number of sexual partners, inconsistent condom use, sexual encounters in the presence of substance use, injection drug use, sex work, or a recent sexually transmitted infection.1 Clinical eligibility is established by a recent HIV-negative https://doi.org/10.1016/j.nurpra.2019.10.026 1555-4155/© 2019 Elsevier Inc. All rights reserved.
In 2017, it was noted at a low-resource substance use treatment center in Baltimore, Maryland, that many patients with SUD had indications for PrEP therapy. We define a low-resource center as lacking 1 or more factors that are necessary to expand service offerings. As a result, a systematic review was conducted examining the current evidence on PrEP in SUD treatment settings. The review revealed a lack of research on the implementation of a PrEP access program in SUD treatment.4-6 In the literature pertaining to PrEP and SUD, several notable themes were dominant, including a lack of PrEP awareness in substance use populations, a high level of interest in and acceptance of once informed, and perceived and actual barriers to PrEP uptake.6,7 These barriers consisted of the stigma associated with taking an HIV medication, a lack of access to PrEP services, adherence concerns, and providers’ hesitance to prescribe PrEP.6,7 Clinic-Based Needs Assessment After the systematic review was completed, a clinic-based needs assessment was conducted over a 3-month period. This assessment studied demographics, HIV status, type of substance and use method, and high-risk behaviors, including sexual activity, type of sex, and sharing of equipment. Sample characteristics were 79% male, 50% white, and 49% African American. PrEP-related findings indicated that 85% reported HIV-negative status, and 44% reported
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Level 4
Level 3
Level 2
Level 1
2
Awareness: Visible PrEP Literature PrEP research study posters Educaonal during group meengs Paent educaon during intake Staff HIV trainings / PrEP training Awareness: Visible Literature PrEP research study posters Educaonal during group meengs Paent educaon during intake Staff HIV trainings / PrEP training Awareness: Visible Literature PrEP research study posters Educaonal during group meengs Paent educaon during intake Staff HIV trainings / PrEP training Awareness: Visible Literature PrEP research study posters Educaonal during group meengs Paent educaon during intake Staff HIV trainings / PrEP training
Screening: Risk factor screening HIV test
Referral: Prep navigator PrEP clinic Other PrEP access iniaves
Screening: Risk factor screening HIV test
PrEP Rx & Follow-ups: Baseline Tesng: CMP Prescribing Truvada + HAV, HBV, HCV, pregnancy, Q3 month follow-ups w/ GC/chlamydia and syphilis RPR labs
Screening: Risk factor screening HIV test
PrEP Rx & Follow-ups: Baseline Tesng: PrEP Administraon: CMP Prescripon of Truvada Adherence support HAV, HBV, HCV, pregnancy, Q3 month follow-ups w/ Given w/ MAT medicaon GC/chlamydia and syphilis RPR labs
Figure 1. Preexposure prophylactic (PrEP) Services: Levels of Organizational Intervention, which can be customized to fit an organization’s individual context and infrastructure for PrEP linkage to care. CMP ¼ comprehensive metabolic panel; GC ¼ gonococcal; HAV ¼ hepatitis A virus; HBV ¼ hepatitis B virus; HCV ¼ hepatitis C virus; HIV ¼ human immunodeficiency virus; MAT ¼ medication-assisted treatment; RPR ¼ rapid plasma reagin.
injection drug use in the last 6 months. In addition, 13% reported sharing injection equipment in the last 6 months, and 53% were unsure of equipment sharing status. Overall, 38% were found to have substantial risk for HIV acquisition based on current CDC guidelines.1 However, clinical eligibility, as outlined by the CDC, was not assessed. It is important to note that these findings likely underestimate the number of patients who are eligible for PrEP therapy. First, this assessment did not consider risk of HIV acquisition from high-risk sexual behaviors, because intake screenings did not previously include in-depth questions on sexual behavior. On the basis of current evidence, patients with SUD likely have increased levels of risk for sexual transmission of HIV.3 Furthermore, a subset of the population evaluated indicated that they were unsure whether they had shared injection equipment. Therefore, many of these patients may also be eligible for further risk exploration. As indicated by the results of the systematic review and clinic-based needs assessment, there is a significant and justifiable need to link eligible patients with SUD to PrEP services. PrEP Services Model The PrEP Services Model framework consists of 3 documents (defined below) developed to assist with creating a PrEP services program and application in an outpatient substance use treatment center. These documents can assist leadership and practitioners in planning, implementing, and evaluating an organization’s PrEP services. Model Framework The model framework includes the Levels of Organizational Intervention (LOI) tool (Figure 1), the HIV Acquisition Risk Screening (HIVARS) tool (Figure 2), and the PrEP Eligibility Algorithm (Figure 3).
The LOI tool is a visual representation of different levels for potential PrEP services that an organization can integrate into its existing structure. In the LOI tool, there are 4 PrEP service outlines, from most basic to most comprehensive. The LOI should be presented to leadership to determine which program outline is organizationally accepted and feasible to implement based on capacity and ability. Collaboration with community partners will need to occur for those elements of comprehensive PrEP services the organization cannot integrate into its PrEP service to patients with SUD. The LOI can be customized to fit an organization’s individual context and infrastructure. The HIVARS tool is designed for the health care team (nurse practitioners [NPs] and physicians) to easily identify patients eligible for referral to PrEP services. The HIVARS tool is a 4-question screening designed to be integrated into an organization’s patient intake process. Each question is a binary (yes or no) response. If the patient’s answer is highlighted in red, this indicates that the patient is eligible for PrEP services based on current risk behaviors. Questions that do not have a red answer indicate that a follow-up question is needed to determine eligibility. The PrEP Eligibility Algorithm is a flowchart for providers to determine the next steps based on patient HIV status and HIVARS tool results. The HIVARS tool and the PrEP Eligibility Algorithm were developed to allow for expeditious screening and linkage to PrEP services and are based on the current CDC PrEP guidelines.1 These tools were revised based on expert feedback. Evaluation of the Organization Before tool integration and implementation, a baseline evaluation of the organization should occur. Evaluation of the organization’s capacity to integrate components of a comprehensive PrEP service should include performing a clinic-based needs assessment and obtaining leadership consent and support. As a team, use of the LOI to ascertain which level of PrEP services the organization can
N.S. Goldstein et al. / The Journal for Nurse Practitioners xxx (xxxx) xxx
3
Human Immunodeficiency Virus Acquisition Risk Screening Tool Script: (To be read before completing the screening) “The following questions can be very personal. I want you to know, we ask these questions to everyone and it is so that we can provide you with the best possible care. The information you share remains private and confidential and will not be shared with others without your consent in accordance with HIPAA. I also want you to know if at any time you are uncomfortable, you may refuse to answer a question. Do I have your permission to continue?” 1. Have you ever been tested to see if you have HIV? Yes / No If Yes: (a) How long ago was your last HIV test?
.
(b) Was the result HIV-positive or HIV-negative? HIV-positive / HIV-negative If HIV-positive: confirm provider managing HIV care. SCREENING COMPLETE. If HIV-negative: go on to question 2. If No: Register patient for next HIV testing session. Go on to question 2. 2. Have you injected drugs that were not prescribed to you within the past 6 months? Yes / No If Yes: (a) In the past 6 months, have you shared any needles, syringes, or other drug preparation equipment that had already been used by another person? Yes / No If No: Go on to question 3. 3. Have you been sexually active in the last 6 months? Yes / No If No: SCREENING COMPLETE If Yes: If the client is: (a) Male: Do you have sex with men, women, or both? If MSM: (1) Have you had sex without a condom in the past 6 months? Yes / No (2) Have you had sex in exchange for money or drugs? Yes / No (3) Have you had syphilis, gonorrhea, or chlamydia in the last 6 months? Yes / No If MSW only: (1) Have you had sex with someone who is HIV+ in past 6 months without using a condom? Yes / No
(2) Have you had syphilis, gonorrhea, or chlamydia in the last 6 months? Yes / No Figure 2. The Human Immunodeficiency Virus (HIV) Acquisition Risk Screening (HIVARS) Tool is designed for the nurse practitioners, physicians, and the health care team to easily identify patients with substance use disorder eligible for referral to preexposure prophylactic services. HIPAA ¼ Health Insurance Portability and Accountability Act of 1996; MSM ¼ men having sex with men; MSW ¼ men having sex with women.
implement should occur. Furthermore, additional program planning tools, such as developing a program Logic Model and SMART (Specific, Measurable, Attainable, Relevant, and Time Bound) goals and objectives, can be useful in developing successful and sustainable programs. Lastly, an Institutional Review Board review may be obtained, if appropriate, for the individual context, setting, and purpose of program development and implementation.
education on the benefits of starting PrEP, evidence-based prevention, and care and support for persons at risk for living with HIV and associated comorbidities. Advantages of community support can include the provision of clinical care, technical assistance, skills building training, and implementation science and clinical trial assistance. Discussion
Identification of Community Partnership Once the PrEP service level has been selected, collaboration with community partners provides those components that an organization is unable to integrate into its practice. Early identification and access to care through community-based assistance is a key factor in providing support to the population with SUD. Community-based support can facilitate health care providers with
The PrEP Services Model framework was created using generally accepted program development tools including a Logic Model, S.W.O.T (Strengths, Weaknesses, Opportunities, and Threats) Analysis, and SMART (Specific, Measurable, Attainable, Relevant, and Time Bound) goals and objectives. In the development of the PrEP services model, approval from the substance use treatment center leadership was sought and obtained by the development
4
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(b) Female: Do you have sex with men, women, or both? (1) Have you had sex in exchange for money or drugs in the past 6 months? Yes / No (2) Have you had sex with someone who is HIV - positive in the past 6 months? Yes / No (3) Have you had sex without using a condom with anyone who is at high risk for HIV infection, meaning a person who inject drugs, a man who has sex with men, or a person who has had other sexually transmitted infections? Yes / No
(c) Trans: Do you have sex with men, women,both? (1) Have you had sex in exchange for money or drugs in the past 6 months? Yes / No (2) Have you had sex with someone who is HIV - positive in the past 6 months? Yes / No
4. If eligible for PrEP (indicated by a red yes), what do you know about PrEP for HIV prevention? Figure 2. (continued).
team to initiate a PrEP services program. An Institutional Review Board review was obtained through the organization’s review board. This organization used the LOI tool to determine that it was feasible for it to implement a level 2 PrEP service. This resulted in the need to collaborate with a community partner. Potential
partnerships were identified, and The Johns Hopkins University School of Nursing REACH (Research, Education, Advocacy, Community, and Health) Initiative was selected based on its purpose and experience with HIV prevention. After development, the HIVARS tool was integrated into the electronic health record, and intake providers (NPs and physicians)
PrEP Eligibility Algorithm
> Benefits of care > Resources discussion > Recommend ART initiation
NOT in care Chart OR patient indicates: Past HIV-positive diagnosis
Intake interview performed WITHOUT HIVARS
Where does Patient receive HIV care? Document provider of HIV care in Chart
IS in care
Patient admitted from: (1) Walk-in; (2) Holding; or (3) Direct admit from inpatient
PrEP community Navigator works with patient and links to PrEP provider
Chart reviewed by medical provider, including prior HIV testing results
HIVARS is Positive Chart review indicates: HIV-negative test result OR No test result found
Patient is PrEP ineligible due to baseline lab HIV-positive test result
Intake interview performed WITH HIVARS HIVARS is Negative
> Brief description of PrEP (see fact sheet) > Request patient’s consent for referral for PrEP consultation > Is patient insured & insurance info
Inform patient about next HIV testing event
CDC: Centers for Disease Control and Prevention HIV: Human Immunodeficiency Virus
Link to PrEP community navigator
PrEP provider performs initial baseline labs
Patient is PrEP ineligible due to contraindications other than HIV-positive status
Patient is PrEP eligible
Initiate ART
Refer to PCP if already established. If not established, initiate PCP referral
Initiate PrEP (Truvada) and schedule follow-up
Every 3 month monitoring (per CDC guidelines)
If consent is not provided, document refusal for referral
ART: Antiretroviral Therapy PCP: Primary Care Provider
HIVARS: Human Immunodeficiency Virus Acquisition Risk Screening
Figure 3. The Peexposure Prophylaxis (PrEP) Eligibility Algorithm is a flowchart for providers to determine next steps based on patient human immunodeficiency virus status and Human Immunodeficiency Virus Acquisition Risk Screening tool results.
N.S. Goldstein et al. / The Journal for Nurse Practitioners xxx (xxxx) xxx
were trained on its use as well as how to properly follow the PrEP Eligibility Algorithm. This program then began its implementation phase where each intake provider screened every patient using the HIVARS tool. Patients who were identified as eligible, and were interested, were immediately referred to the REACH Initiative for education on PrEP and linkage to an appropriate PrEP provider. It was recognized early in the planning and development phase that for this model to have optimal efficacy, it would need to identify PrEP eligibility quickly, upon a patient’s entrance into the substance use treatment center. Once a patient was identified as PrEP eligible, there needed to be an expeditious linkage to the REACH Initiative and subsequent PrEP services. The REACH Initiative acts as a community navigator, linking each PrEP-eligible patient with an appropriate PrEP provider based on location, insurance status and type, and patient preference. Partnership with the REACH Initiative ensures the patient’s PrEP eligibility will not be overlooked in the health care providers’ intake/treatment process. The REACH Initiative also performs most of the education surrounding PrEP, because providers at the substance use treatment center are under time constraints and have limited resources to do so. In addition, the substance use treatment center does not have the capacity to perform PrEP laboratory work, and for this reason, this program relies on PrEP providers to perform the necessary baseline clinical eligibility laboratory work. The use of a standardized screening tool and process algorithm as part of a PrEP services program has numerous benefits. These tools allow for immediate eligibility recognition and timely subsequent referral to the community navigator for education and PrEP linkage. An additional benefit of having a uniform screening tool and process algorithm is the ability to standardize the level of care provided across all clinic health care providers and external collaborators. Furthermore, standardized screening for PrEP eligibility that is integrated into the electronic health record documentation results in provider and clinic accountability to the patient. Likewise, documentation of patient interest, patient agreement to services, and linkage to the REACH Initiative results in patient accountability. Some limitations and constraints existed in the development of this model. First, the questions asked on the HIVARS tool are considered highly personal, and many incoming patients may not feel comfortable fully answering the HIVARS assessment, especially if they have not yet established a strong rapport with the NPs and physicians. Thus, it is imperative that all members of the health care team performing this screening be trained in taking a sexual history in a compassionate, culturally sensitive manner. Second, because PrEP-eligible patients are referred out to community navigators, collecting follow-up information, such as initial and follow-up appointment attendance, PrEP prescription, and PrEP regimen adherence, may be difficult. Another constraint of the program is the low-resource nature of the substance use treatment center. This model does not assess for clinical eligibility of PrEP. Therefore, it is possible that patients referred for risk behavior eligibility may not be prescribed PrEP due
5
to the later determination of clinical ineligibility. This could result in frustration for patients who follow this process and are ultimately unable to use PrEP as an HIV prevention modality. Although these constraints do exist, measures have been taken to mitigate their impact. Conclusion There is a significant need for increased access to and uptake of comprehensive PrEP services in the SUD community. Early data analysis indicates that this model has increased the number of patients identified as eligible for PrEP and is a promising intervention to address the inequity of PrEP access to substance use populations. In addition, there is the potential for adaptability and generalizability of the program tools to other low-resource clinics and substance use treatment centers. This will assist the NPs and physicians in the achievement of central components of the HIV care continuum. Acknowledgment The authors acknowledge The Johns Hopkins University School of Nursing R.E.A.C.H Initiative and the Broadway Center for Addiction in the development of this model. References 1. U.S. Department of Health and Human Services & Centers for Disease Control and Prevention. Preexposure Prophylaxis for the Prevention of HIV Infection in the United Statese2017 Update. March 2018. Accessed August 26, 2019. https:// www.cdc.gov/hiv/pdf/risk/prep/cdc-hiv-prep-guidelines-2017.pdf. 2. Centers for Disease Control and Prevention. HIV/AIDS: PrEP. 2018. Accessed August 26, 2019. https://www.cdc.gov/hiv/basics/prep.html. 3. Shrestha R, Karki P, Altice FL, et al. Correlates of willingness to initiate pre-exposure prophylaxis and anticipation of practicing safer drug-and sex-related behaviors among high-risk drug users on methadone treatment. Drug Alcohol Depend. 2017;173:107-116. https://doi.org/10.1016/ j.drugalcdep.2016.12.023. 4. Coleman RL, McLean S. Commentary: the value of PrEP for people who inject drugs. J Int AIDS Soc. 2016;19(7 Suppl 6):21112. https://doi.org/10.7448/ IAS.19.7.21112. 5. Escudero DJ, Lurie MN, Kerr T, Howe CJ, Marshall BD. HIV pre-exposure prophylaxis for people who inject drugs: a review of current results and an agenda for future research. J Int AIDS Soc. 2014;17:18899. https://doi.org/10.7448/ IAS.17.1.18899. 6. Goldstein NS, Carter-Davis JB, Seymour EC. Pre-exposure Prophylaxis for HIV prevention in those with substance use disorders. J Nurs. 2018;8(2):7-13. https://doi.org/10.26634/jnur.8.2.14022. 7. Centers for Disease Control and Prevention. HIV and Substance Use in the United States. 2016. Accessed August 26, 2019. https://www.cdc.gov/hiv/risk/ substanceuse.html.
Nancy S. Goldstein, DNP, ANP-BC, RN-C is an assistant professor at Johns Hopkins University School of Nursing, Baltimore, MD, and can be contacted at [email protected]. Ellen C. Seymour, MSN, MPH, AGNP-C, is a nurse practitioner at Great Lakes Bay Health Centers, Saginaw, MI. Jared B. Carer-Davis, MSN, AGNP-C, is a nurse practitioner in internal medicine, Greater Philadelphia Health Action, Philadelphia, PA. In compliance with national ethical guidelines, the authors report no relationships with business or industry that would pose a conflict of interest.
Contents lists available at ScienceDirect
The Journal for Nurse Practitioners journal homepage: www.npjournal.org
A Model for Increasing Access to Preexposure Prophylaxis (PrEP) Services in the Substance Use Population Nancy S. Goldstein, DNP, ANP-BC, Ellen C. Seymour, MSN, AGNP-C, Jared B. Carter-Davis, MSN, AGNP-C a b s t r a c t Keywords: HIV risk screening tool human immunodeficiency virus (HIV) model development preexposure prophylaxis (PrEP) substance use disorder
In 2017, a low-resource substance use treatment center in Baltimore, Maryland, noted that at least 38% of patients, ranging from 18 to 76 years old, with substance use disorders (SUD) met the criteria for preexposure prophylaxis (PrEP) therapy. PrEP therapy consists of a daily medication to prevent transmission of human immunodeficiency virus. A conceptual framework model was developed linking eligible patients with SUD to PrEP services based on current Centers for Disease Control and Prevention PrEP recommendations. Three tools were developed for PrEP service planning, implementation, and evaluation. The focus of this report is to increase access to and uptake of comprehensive PrEP services in those with SUD who are at risk for acquiring human immunodeficiency virus. © 2019 Elsevier Inc. All rights reserved.
Background
test result, absence of acute HIV infection, adequate renal function, and documented hepatitis B virus and vaccination status.1
Overview of Preexposure Prophylaxis in Substance Use Overview of a Systematic Review Tenofovir disoproxil fumarate (Truvada; Gilead Sciences, Inc, Foster City, CA) was approved by the United States Food and Drug Administration in 2012 for use as a preexposure prophylaxis (PrEP) for human immunodeficiency virus (HIV) infection in men having sex with men.1 In 2014, Truvada was approved for use in those at risk for HIV acquisition from intravenous, injection, and intranasal drug use.1 This once-daily regimen has significant prevention efficacy in all high-risk groups. PrEP reduces the risk of HIV transmission by more than 90% in men who have sex with men and by more than 70% in those who inject drugs.1 PrEP has an overall risk reduction profile of up to 92%.2 Despite PrEP’s efficacy in those with high-risk sexual and drug use behaviors, including noninjection substance use,3 access to and uptake of comprehensive PrEP services in the population with substance use disorder (SUD) has severely lagged behind uptake among other high-risk groups.3-5 In the US, the criteria for establishing eligibility for PrEP are determined by the Centers for Disease Control and Prevention (CDC). The most current CDC guidelines for HIV prevention and use of PrEP (2017) indicate that patients with SUD must have a substantial risk for HIV acquisition and meet clinical eligibility criteria. Substantial risk categories include participation in a serodiscordant sexual relationship, a high number of sexual partners, inconsistent condom use, sexual encounters in the presence of substance use, injection drug use, sex work, or a recent sexually transmitted infection.1 Clinical eligibility is established by a recent HIV-negative https://doi.org/10.1016/j.nurpra.2019.10.026 1555-4155/© 2019 Elsevier Inc. All rights reserved.
In 2017, it was noted at a low-resource substance use treatment center in Baltimore, Maryland, that many patients with SUD had indications for PrEP therapy. We define a low-resource center as lacking 1 or more factors that are necessary to expand service offerings. As a result, a systematic review was conducted examining the current evidence on PrEP in SUD treatment settings. The review revealed a lack of research on the implementation of a PrEP access program in SUD treatment.4-6 In the literature pertaining to PrEP and SUD, several notable themes were dominant, including a lack of PrEP awareness in substance use populations, a high level of interest in and acceptance of once informed, and perceived and actual barriers to PrEP uptake.6,7 These barriers consisted of the stigma associated with taking an HIV medication, a lack of access to PrEP services, adherence concerns, and providers’ hesitance to prescribe PrEP.6,7 Clinic-Based Needs Assessment After the systematic review was completed, a clinic-based needs assessment was conducted over a 3-month period. This assessment studied demographics, HIV status, type of substance and use method, and high-risk behaviors, including sexual activity, type of sex, and sharing of equipment. Sample characteristics were 79% male, 50% white, and 49% African American. PrEP-related findings indicated that 85% reported HIV-negative status, and 44% reported
N.S. Goldstein et al. / The Journal for Nurse Practitioners xxx (xxxx) xxx
Level 4
Level 3
Level 2
Level 1
2
Awareness: Visible PrEP Literature PrEP research study posters Educaonal during group meengs Paent educaon during intake Staff HIV trainings / PrEP training Awareness: Visible Literature PrEP research study posters Educaonal during group meengs Paent educaon during intake Staff HIV trainings / PrEP training Awareness: Visible Literature PrEP research study posters Educaonal during group meengs Paent educaon during intake Staff HIV trainings / PrEP training Awareness: Visible Literature PrEP research study posters Educaonal during group meengs Paent educaon during intake Staff HIV trainings / PrEP training
Screening: Risk factor screening HIV test
Referral: Prep navigator PrEP clinic Other PrEP access iniaves
Screening: Risk factor screening HIV test
PrEP Rx & Follow-ups: Baseline Tesng: CMP Prescribing Truvada + HAV, HBV, HCV, pregnancy, Q3 month follow-ups w/ GC/chlamydia and syphilis RPR labs
Screening: Risk factor screening HIV test
PrEP Rx & Follow-ups: Baseline Tesng: PrEP Administraon: CMP Prescripon of Truvada Adherence support HAV, HBV, HCV, pregnancy, Q3 month follow-ups w/ Given w/ MAT medicaon GC/chlamydia and syphilis RPR labs
Figure 1. Preexposure prophylactic (PrEP) Services: Levels of Organizational Intervention, which can be customized to fit an organization’s individual context and infrastructure for PrEP linkage to care. CMP ¼ comprehensive metabolic panel; GC ¼ gonococcal; HAV ¼ hepatitis A virus; HBV ¼ hepatitis B virus; HCV ¼ hepatitis C virus; HIV ¼ human immunodeficiency virus; MAT ¼ medication-assisted treatment; RPR ¼ rapid plasma reagin.
injection drug use in the last 6 months. In addition, 13% reported sharing injection equipment in the last 6 months, and 53% were unsure of equipment sharing status. Overall, 38% were found to have substantial risk for HIV acquisition based on current CDC guidelines.1 However, clinical eligibility, as outlined by the CDC, was not assessed. It is important to note that these findings likely underestimate the number of patients who are eligible for PrEP therapy. First, this assessment did not consider risk of HIV acquisition from high-risk sexual behaviors, because intake screenings did not previously include in-depth questions on sexual behavior. On the basis of current evidence, patients with SUD likely have increased levels of risk for sexual transmission of HIV.3 Furthermore, a subset of the population evaluated indicated that they were unsure whether they had shared injection equipment. Therefore, many of these patients may also be eligible for further risk exploration. As indicated by the results of the systematic review and clinic-based needs assessment, there is a significant and justifiable need to link eligible patients with SUD to PrEP services. PrEP Services Model The PrEP Services Model framework consists of 3 documents (defined below) developed to assist with creating a PrEP services program and application in an outpatient substance use treatment center. These documents can assist leadership and practitioners in planning, implementing, and evaluating an organization’s PrEP services. Model Framework The model framework includes the Levels of Organizational Intervention (LOI) tool (Figure 1), the HIV Acquisition Risk Screening (HIVARS) tool (Figure 2), and the PrEP Eligibility Algorithm (Figure 3).
The LOI tool is a visual representation of different levels for potential PrEP services that an organization can integrate into its existing structure. In the LOI tool, there are 4 PrEP service outlines, from most basic to most comprehensive. The LOI should be presented to leadership to determine which program outline is organizationally accepted and feasible to implement based on capacity and ability. Collaboration with community partners will need to occur for those elements of comprehensive PrEP services the organization cannot integrate into its PrEP service to patients with SUD. The LOI can be customized to fit an organization’s individual context and infrastructure. The HIVARS tool is designed for the health care team (nurse practitioners [NPs] and physicians) to easily identify patients eligible for referral to PrEP services. The HIVARS tool is a 4-question screening designed to be integrated into an organization’s patient intake process. Each question is a binary (yes or no) response. If the patient’s answer is highlighted in red, this indicates that the patient is eligible for PrEP services based on current risk behaviors. Questions that do not have a red answer indicate that a follow-up question is needed to determine eligibility. The PrEP Eligibility Algorithm is a flowchart for providers to determine the next steps based on patient HIV status and HIVARS tool results. The HIVARS tool and the PrEP Eligibility Algorithm were developed to allow for expeditious screening and linkage to PrEP services and are based on the current CDC PrEP guidelines.1 These tools were revised based on expert feedback. Evaluation of the Organization Before tool integration and implementation, a baseline evaluation of the organization should occur. Evaluation of the organization’s capacity to integrate components of a comprehensive PrEP service should include performing a clinic-based needs assessment and obtaining leadership consent and support. As a team, use of the LOI to ascertain which level of PrEP services the organization can
N.S. Goldstein et al. / The Journal for Nurse Practitioners xxx (xxxx) xxx
3
Human Immunodeficiency Virus Acquisition Risk Screening Tool Script: (To be read before completing the screening) “The following questions can be very personal. I want you to know, we ask these questions to everyone and it is so that we can provide you with the best possible care. The information you share remains private and confidential and will not be shared with others without your consent in accordance with HIPAA. I also want you to know if at any time you are uncomfortable, you may refuse to answer a question. Do I have your permission to continue?” 1. Have you ever been tested to see if you have HIV? Yes / No If Yes: (a) How long ago was your last HIV test?
.
(b) Was the result HIV-positive or HIV-negative? HIV-positive / HIV-negative If HIV-positive: confirm provider managing HIV care. SCREENING COMPLETE. If HIV-negative: go on to question 2. If No: Register patient for next HIV testing session. Go on to question 2. 2. Have you injected drugs that were not prescribed to you within the past 6 months? Yes / No If Yes: (a) In the past 6 months, have you shared any needles, syringes, or other drug preparation equipment that had already been used by another person? Yes / No If No: Go on to question 3. 3. Have you been sexually active in the last 6 months? Yes / No If No: SCREENING COMPLETE If Yes: If the client is: (a) Male: Do you have sex with men, women, or both? If MSM: (1) Have you had sex without a condom in the past 6 months? Yes / No (2) Have you had sex in exchange for money or drugs? Yes / No (3) Have you had syphilis, gonorrhea, or chlamydia in the last 6 months? Yes / No If MSW only: (1) Have you had sex with someone who is HIV+ in past 6 months without using a condom? Yes / No
(2) Have you had syphilis, gonorrhea, or chlamydia in the last 6 months? Yes / No Figure 2. The Human Immunodeficiency Virus (HIV) Acquisition Risk Screening (HIVARS) Tool is designed for the nurse practitioners, physicians, and the health care team to easily identify patients with substance use disorder eligible for referral to preexposure prophylactic services. HIPAA ¼ Health Insurance Portability and Accountability Act of 1996; MSM ¼ men having sex with men; MSW ¼ men having sex with women.
implement should occur. Furthermore, additional program planning tools, such as developing a program Logic Model and SMART (Specific, Measurable, Attainable, Relevant, and Time Bound) goals and objectives, can be useful in developing successful and sustainable programs. Lastly, an Institutional Review Board review may be obtained, if appropriate, for the individual context, setting, and purpose of program development and implementation.
education on the benefits of starting PrEP, evidence-based prevention, and care and support for persons at risk for living with HIV and associated comorbidities. Advantages of community support can include the provision of clinical care, technical assistance, skills building training, and implementation science and clinical trial assistance. Discussion
Identification of Community Partnership Once the PrEP service level has been selected, collaboration with community partners provides those components that an organization is unable to integrate into its practice. Early identification and access to care through community-based assistance is a key factor in providing support to the population with SUD. Community-based support can facilitate health care providers with
The PrEP Services Model framework was created using generally accepted program development tools including a Logic Model, S.W.O.T (Strengths, Weaknesses, Opportunities, and Threats) Analysis, and SMART (Specific, Measurable, Attainable, Relevant, and Time Bound) goals and objectives. In the development of the PrEP services model, approval from the substance use treatment center leadership was sought and obtained by the development
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(b) Female: Do you have sex with men, women, or both? (1) Have you had sex in exchange for money or drugs in the past 6 months? Yes / No (2) Have you had sex with someone who is HIV - positive in the past 6 months? Yes / No (3) Have you had sex without using a condom with anyone who is at high risk for HIV infection, meaning a person who inject drugs, a man who has sex with men, or a person who has had other sexually transmitted infections? Yes / No
(c) Trans: Do you have sex with men, women,both? (1) Have you had sex in exchange for money or drugs in the past 6 months? Yes / No (2) Have you had sex with someone who is HIV - positive in the past 6 months? Yes / No
4. If eligible for PrEP (indicated by a red yes), what do you know about PrEP for HIV prevention? Figure 2. (continued).
team to initiate a PrEP services program. An Institutional Review Board review was obtained through the organization’s review board. This organization used the LOI tool to determine that it was feasible for it to implement a level 2 PrEP service. This resulted in the need to collaborate with a community partner. Potential
partnerships were identified, and The Johns Hopkins University School of Nursing REACH (Research, Education, Advocacy, Community, and Health) Initiative was selected based on its purpose and experience with HIV prevention. After development, the HIVARS tool was integrated into the electronic health record, and intake providers (NPs and physicians)
PrEP Eligibility Algorithm
> Benefits of care > Resources discussion > Recommend ART initiation
NOT in care Chart OR patient indicates: Past HIV-positive diagnosis
Intake interview performed WITHOUT HIVARS
Where does Patient receive HIV care? Document provider of HIV care in Chart
IS in care
Patient admitted from: (1) Walk-in; (2) Holding; or (3) Direct admit from inpatient
PrEP community Navigator works with patient and links to PrEP provider
Chart reviewed by medical provider, including prior HIV testing results
HIVARS is Positive Chart review indicates: HIV-negative test result OR No test result found
Patient is PrEP ineligible due to baseline lab HIV-positive test result
Intake interview performed WITH HIVARS HIVARS is Negative
> Brief description of PrEP (see fact sheet) > Request patient’s consent for referral for PrEP consultation > Is patient insured & insurance info
Inform patient about next HIV testing event
CDC: Centers for Disease Control and Prevention HIV: Human Immunodeficiency Virus
Link to PrEP community navigator
PrEP provider performs initial baseline labs
Patient is PrEP ineligible due to contraindications other than HIV-positive status
Patient is PrEP eligible
Initiate ART
Refer to PCP if already established. If not established, initiate PCP referral
Initiate PrEP (Truvada) and schedule follow-up
Every 3 month monitoring (per CDC guidelines)
If consent is not provided, document refusal for referral
ART: Antiretroviral Therapy PCP: Primary Care Provider
HIVARS: Human Immunodeficiency Virus Acquisition Risk Screening
Figure 3. The Peexposure Prophylaxis (PrEP) Eligibility Algorithm is a flowchart for providers to determine next steps based on patient human immunodeficiency virus status and Human Immunodeficiency Virus Acquisition Risk Screening tool results.
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were trained on its use as well as how to properly follow the PrEP Eligibility Algorithm. This program then began its implementation phase where each intake provider screened every patient using the HIVARS tool. Patients who were identified as eligible, and were interested, were immediately referred to the REACH Initiative for education on PrEP and linkage to an appropriate PrEP provider. It was recognized early in the planning and development phase that for this model to have optimal efficacy, it would need to identify PrEP eligibility quickly, upon a patient’s entrance into the substance use treatment center. Once a patient was identified as PrEP eligible, there needed to be an expeditious linkage to the REACH Initiative and subsequent PrEP services. The REACH Initiative acts as a community navigator, linking each PrEP-eligible patient with an appropriate PrEP provider based on location, insurance status and type, and patient preference. Partnership with the REACH Initiative ensures the patient’s PrEP eligibility will not be overlooked in the health care providers’ intake/treatment process. The REACH Initiative also performs most of the education surrounding PrEP, because providers at the substance use treatment center are under time constraints and have limited resources to do so. In addition, the substance use treatment center does not have the capacity to perform PrEP laboratory work, and for this reason, this program relies on PrEP providers to perform the necessary baseline clinical eligibility laboratory work. The use of a standardized screening tool and process algorithm as part of a PrEP services program has numerous benefits. These tools allow for immediate eligibility recognition and timely subsequent referral to the community navigator for education and PrEP linkage. An additional benefit of having a uniform screening tool and process algorithm is the ability to standardize the level of care provided across all clinic health care providers and external collaborators. Furthermore, standardized screening for PrEP eligibility that is integrated into the electronic health record documentation results in provider and clinic accountability to the patient. Likewise, documentation of patient interest, patient agreement to services, and linkage to the REACH Initiative results in patient accountability. Some limitations and constraints existed in the development of this model. First, the questions asked on the HIVARS tool are considered highly personal, and many incoming patients may not feel comfortable fully answering the HIVARS assessment, especially if they have not yet established a strong rapport with the NPs and physicians. Thus, it is imperative that all members of the health care team performing this screening be trained in taking a sexual history in a compassionate, culturally sensitive manner. Second, because PrEP-eligible patients are referred out to community navigators, collecting follow-up information, such as initial and follow-up appointment attendance, PrEP prescription, and PrEP regimen adherence, may be difficult. Another constraint of the program is the low-resource nature of the substance use treatment center. This model does not assess for clinical eligibility of PrEP. Therefore, it is possible that patients referred for risk behavior eligibility may not be prescribed PrEP due
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to the later determination of clinical ineligibility. This could result in frustration for patients who follow this process and are ultimately unable to use PrEP as an HIV prevention modality. Although these constraints do exist, measures have been taken to mitigate their impact. Conclusion There is a significant need for increased access to and uptake of comprehensive PrEP services in the SUD community. Early data analysis indicates that this model has increased the number of patients identified as eligible for PrEP and is a promising intervention to address the inequity of PrEP access to substance use populations. In addition, there is the potential for adaptability and generalizability of the program tools to other low-resource clinics and substance use treatment centers. This will assist the NPs and physicians in the achievement of central components of the HIV care continuum. Acknowledgment The authors acknowledge The Johns Hopkins University School of Nursing R.E.A.C.H Initiative and the Broadway Center for Addiction in the development of this model. References 1. U.S. Department of Health and Human Services & Centers for Disease Control and Prevention. Preexposure Prophylaxis for the Prevention of HIV Infection in the United Statese2017 Update. March 2018. Accessed August 26, 2019. https:// www.cdc.gov/hiv/pdf/risk/prep/cdc-hiv-prep-guidelines-2017.pdf. 2. Centers for Disease Control and Prevention. HIV/AIDS: PrEP. 2018. Accessed August 26, 2019. https://www.cdc.gov/hiv/basics/prep.html. 3. Shrestha R, Karki P, Altice FL, et al. Correlates of willingness to initiate pre-exposure prophylaxis and anticipation of practicing safer drug-and sex-related behaviors among high-risk drug users on methadone treatment. Drug Alcohol Depend. 2017;173:107-116. https://doi.org/10.1016/ j.drugalcdep.2016.12.023. 4. Coleman RL, McLean S. Commentary: the value of PrEP for people who inject drugs. J Int AIDS Soc. 2016;19(7 Suppl 6):21112. https://doi.org/10.7448/ IAS.19.7.21112. 5. Escudero DJ, Lurie MN, Kerr T, Howe CJ, Marshall BD. HIV pre-exposure prophylaxis for people who inject drugs: a review of current results and an agenda for future research. J Int AIDS Soc. 2014;17:18899. https://doi.org/10.7448/ IAS.17.1.18899. 6. Goldstein NS, Carter-Davis JB, Seymour EC. Pre-exposure Prophylaxis for HIV prevention in those with substance use disorders. J Nurs. 2018;8(2):7-13. https://doi.org/10.26634/jnur.8.2.14022. 7. Centers for Disease Control and Prevention. HIV and Substance Use in the United States. 2016. Accessed August 26, 2019. https://www.cdc.gov/hiv/risk/ substanceuse.html.
Nancy S. Goldstein, DNP, ANP-BC, RN-C is an assistant professor at Johns Hopkins University School of Nursing, Baltimore, MD, and can be contacted at [email protected]. Ellen C. Seymour, MSN, MPH, AGNP-C, is a nurse practitioner at Great Lakes Bay Health Centers, Saginaw, MI. Jared B. Carer-Davis, MSN, AGNP-C, is a nurse practitioner in internal medicine, Greater Philadelphia Health Action, Philadelphia, PA. In compliance with national ethical guidelines, the authors report no relationships with business or industry that would pose a conflict of interest.