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Connecticut Continuing Medical Education
CONNECTICUT MEDICAL LICENSURE PROGRAM MANDATORY CME REQUIRED FOR CONNECTICUT LICENSE RENEWALS TOPICS INCLUDE: • DEA Requirement (NEW) • Infectious Diseases • Sexual Assault • Domestic Violence • Risk Management • Cultural Competency • Behavioral Health
INCLUDES: DEA’s New One-time MATE Requirement
InforMed is Accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.
CME FOR:
AMA PRA CATEGORY 1 CREDITS ™ MIPS MOC STATE LICENSURE
COMPLETE ENCLOSED PROGRAM TO SATISFY ANY OR ALL OF THESE REQUIREMENTS
AVAILABLE ONLINE AT: CT.CME.EDU
CONNECTICUT PHYSICIAN
NEW MANDATORY REQUIREMENT FOR DEA-REGISTERED PRACTITIONERS
Dear Colleagues, Effective June 27, 2023, renewing DEA-registered practitioners must complete eight (8) hours of one-time training on the treatment and management of patients with opioid or substance use disorders. Licensed physicians applying for renewal in Connecticut must earn a minimum of fifty (50) hours of qualifying continuing medical education (CME) within the preceding twenty-four (24) month period, unless exempt. Additionally, during the first applicable renewal period and not less than once every six (6) years thereafter, the CME must include at least one (1) hour in each of the following topics: infectious diseases, sexual assault, domestic violence, risk management, cultural competency and behavioral health. The InforMed Connecticut Medical Licensure Program is designed to fulfill these mandatory CME requirements for physicians (MD/DO) in the state of Connecticut. Completion of the program satisfies at least one (1) hour in each of the required topics mandated by Connecticut Gen Stat § 20-10b as well as eight (8) hours on the DEA’s new one-time MATE requirement.
Thank you for choosing lnforMed as your CME provider. We strive to create a high quality, streamlined program for our colleagues. Please contact us with any questions, concerns, or suggestions.
Best Regards, The lnforMed CME Team
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DATA REPORTING: Federal, State, and Regulatory Agencies require disclosure of data reporting to all course participants. InforMed abides by each entity’s requirements for data reporting to attest compliance on your behalf. Reported data is governed by each entity’s confidentiality policy. To report compliance on your behalf, it’s mandatory that you must achieve a passing score and accurately fill out the learner information, activity and program evaluation, and the 90-day follow up survey. Failure to accurately provide this information may result in your data being non-reportable and subject to actions by these entities.
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BOOK CODE: CT24CME
What’s Inside 01
HIV/AIDS UPDATE FOR CLINICIANS COURSE ONE | 1 CREDIT SATISFIES MANDATORY CME REQUIREMENT IN INFECTIOUS DISEASES
The purpose of this course is to provide the fundamentals of acute and chronic pain management and a contextual framework for the safer prescribing of opioid analgesics that includes consideration of a full complement of nonopioid treatment options. INTIMATE PARTNER VIOLENCE COMPASSIONATE CARE, EFFECTIVE ASSESSMENT COURSE TWO | 2 CREDITS SATISFIES MANDATORY CME REQUIREMENTS IN DOMESTIC VIOLENCE AND SEXUAL ASSAULT The purpose of this course is to improve physician understanding of and competence in addressing intimate partner violence in their patient populations. It will provide information on evidence-based screening tools, and instructions for responding in compassionate and effective manners to their affected patients. Instructions for assisting patients in creating safety plans will be reviewed, and suggestions to identify resources helpful to victims of intimate partner violence. RESPONSIBLE OPIOID PRESCRIBING PRACTICES COURSE THREE | 1 CREDIT SATISFIES MANDATORY CME REQUIREMENT IN RISK MANAGEMENT/PAIN MANAGEMENT This CME learning activity is designed to increase physician knowledge and skills about topics concerning responsible prescribing practices for managing and treating pain, including opioids and alternative treatments. Aspects of opiate misuse will be explored including opiate use disorder. IMPROVING ACCESS TO CARE FOR LGBTQ PATIENTS COURSE FOUR | 2 CREDITS SATISFIES MANDATORY CME REQUIREMENTS IN BEHAVIORAL HEALTH AND CULTURAL COMPETENCY The purpose of this course is to help improve care and health outcomes of the LGBTQ population by recognizing the existing disparities and increased health risks present in this population. This course will Physicians and Physician Assistants (PAs), care for patients with disorders in many healthcare settings. Individuals may seek care for an acute illness or worsening of a chronic condition. Often, pain is the leading reason for seeking medical care. Appropriate prescribing practices are critical for all medications, but controlled substances require special attention. The Drug Enforcement Agency (DEA), the Food and Drug Administration (FDA), and the U.S. Department of Health and Human Services (HHS) all have a role in controlled medication schedules. Prescribers must understand federal and state requirements for all controlled substances. This course will provide a general review of federal and state-controlled substance regulations and the prescribing practices for controlled substances. Additionally, substance use disorders are complex phenomena affecting many lives. This course also reviews common substance use disorders, including alcohol, anxiolytics, stimulants, hallucinogens, and tobacco/vaping. However, the focus is on clinical safety considerations when prescribing non-cancer-related opioid medications for acute/chronic pain in adults. LEARNER RECORDS: ANSWER SHEET & EVALUATION REQUIRED TO RECEIVE CREDIT examine system and provider/client barriers to equality in healthcare. SUBSTANCE USE DISORDERS: A DEA REQUIREMENT COURSE FIVE | 8 CREDITS SATISFIES THE DEA’S NEW ONE-TIME MATE REQUIREMENT
14
38
49
65
107
MOC/MIPS CREDIT INFORMATION
Table 1. MOC Recognition Statements Successful completion of certain enclosed CME activities, which includes participation in the evaluation component, enables the participant to earn up to the amounts and credit types shown in Table 2 below. It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting MOC credit. Board Programs ABA American Board of Anesthesiology’s redesigned Maintenance of Certification in Anesthesiology TM (MOCA®) program, known as MOCA 2.0® Participants can earn MOC points equivalent to the amount of CME credits claimed for designated activities. InforMed currently reports to the following specialty boards: ABA, ABIM, ABOHNS, ABPath and ABP. To be awarded MOC points, you must obtain a passing score, complete the corresponding activity evaluation, and provide required information necessary for reporting.
ABIM
American Board of Internal Medicine’s Maintenance of Certification (MOC) program
ABOHNS American Board of Otolaryngology – Head and Neck Surgery’s Continuing Certification program (formerly known as MOC)
ABPath American Board of Pathology’s Continuing Certification Program
ABP
American Board of Pediatrics’ Maintenance of Certification (MOC) program
Table 2. Credits and Type Awarded
AMA PRA Category 1 Credits TM 1 AMA PRA Category 1 Credit T M
Activity Title
ABA ABIM ABOHNS ABPath ABP
1 Credit LL
1 Credit MK
1 Credit SA
1 Credit LL
1 Credit LL+SA
HIV/AIDS Update for Clinicians
Intimate Partner Violence Effective Assessment, Compassionate Care
2 AMA PRA Category 1 Credits TM
2 Credits LL
2 Credits MK
2 Credits SA
2 Credits LL
2 Credits LL+SA
Responsible Opioid Prescribing Practices Improving Access to Care for LGBTQ Patients
1 AMA PRA Category 1 Credit TM 2 AMA PRA Category 1 Credits TM
1 Credit LL 2 Credits LL
1 Credit MK 2 Credits MK
1 Credit SA 2 Credits SA
1 Credit LL 2 Credits LL
1 Credit LL+SA 2 Credits LL+SA
Table 3. CME for MIPS Statement Completion of each accredited CME activity meets the expectations of an Accredited Safety or Quality Improvement Program (IA PSPA_28) for the Merit-based Incentive Payment Program (MIPS). Participation in this Clinical Practice Improvement Activity (CPIA) is optional for eligible providers. 8 Credits LL+SA Legend: LL = Lifelong Learning, MK = Medical Knowledge, SA = Self-Assessment, LL+SA = Lifelong Learning & Self-Assessment, PS = Patient Safety Substance Use Disorders: A DEA Requirement 8 AMA PRA Category 1 Credits T M 8 Credits LL 8 Credits MK 8 Credits SA 8 Credits LL
How to complete
Please read these instructions before proceeding. Read and study the enclosed courses and answer the self-assessment questions. To receive credit for your courses, you must provide your customer information and complete the man- datory evaluation. We offer two ways for you to complete. Choose an option below to receive credit and your certificate of completion.
ONLINE FASTEST AND EASIEST! • Go to BOOK.CME.EDU and enter code CT24CME in the book code box, then click GO. • Proceed to your exam. If you already have an account, sign in with your username and password. If you do not have an account, you’ll be able to create one now. • Follow the online instructions to complete your self- assessment. Complete the purchase process to receive course credit and your certificate of completion. Please remember to complete the online evaluation.
Enter book code
CT24CME
GO
IF YOU’RE ONLY COMPLETING CERTAIN COURSES IN THIS BOOK: • Go to BOOK.CME.EDU and enter code that corresponds to the course below, then click GO. Each course will need to be completed individually, and the specified course price will apply.
BY MAIL Complete the answer sheet and evaluation found in the back of this book. Include your payment information and email address. Mail to: InforMed, PO Box 997432, Sacramento, CA 95899
Mailed completions will be processed within 2 business days of receipt, and certificates emailed to the address provided. Submissions without a valid email address will be mailed to the postal address provided.
Program Options
Option
Price
Code
Credits
ENTIRE PROGRAM (Includes all courses in this book) HIV/AIDS Update for Clinicians Intimate Partner Violence: Effective Assessment, Compassionate Care Responsible Opioid Prescribing Practices Improving Access to Care for LGBTQ Patients
$150 CT24CME 14 Credits
$90 CT24CME-90
6 Credits
HIV/AIDS Update for Clinicians
$30 $30 $30 $30 $80
CT24CME-301 CT24CME-302 CT24CME-303 CT24CME-304 CT24CME-80
1 Credit
Intimate Partner Violence Compassionate Care, Effective Assessment
2 Credits
Responsible Opioid Prescribing Practices Improving Access to Care for LGBTQ Patients Substance Use Disorders: A DEA Requirement
1 Credit
1-800-237-6999 2 Credits
8 Credits
HIV/AIDS UPDATE FOR CLINICIANS
COURSE DATES:
MAXIMUM CREDITS:
FORMAT:
Release Date:10/1/2021 Exp. Date: 9/30/2027
1 AMA PRA Category 1 Credit ™
Enduring Material (Self Study)
TARGET AUDIENCE This course is designed for all physicians (MD/DOs), physician assistants, and nurse practitioners. COURSE OBJECTIVE The purpose of this course is to update physicians on the current status and epidemiology of the HIV pandemic in the United States and provide information on the most recent guidelines regarding screening, testing, and managing persons living with HIV and the barriers that prevent optimal care in the primary care setting.
HOW TO RECEIVE CREDIT: ● Read the course materials. ● Complete the self-assessment questions at the end. A score of 70% is required. ● Return your customer information/ answer sheet, evaluation, and payment to InforMed by mail, phone, fax or complete online at BOOK.CME.EDU .
LEARNING OBJECTIVES Completion of this course will better enable the course participant to: 1. Describe the current status of the HIV pandemic in the United States and the emerging role of primary care for persons living with HIV. 2. Describe modes of HIV transmission and the importance of universal precautions in the healthcare setting. 3. Review current guidelines on prevention, diagnoses, and management of HIV in primary care. 4. Describe barriers to optimal care, including stigma. ACCREDITATION STATEMENT InforMed is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians. IMPLICIT BIAS IN HEALTHCARE Implicit bias significantly affects how healthcare professionals perceive and make treatment decisions, ultimately resulting in disparities in health outcomes. These biases, often unconscious and unintentional, can shape behavior and produce differences in medical care along various lines, including race, ethnicity, gender identity, sexual orientation, age, and socioeconomic status. Healthcare disparities stemming from implicit bias can manifest in several ways. For example, a healthcare provider might unconsciously give less attention to a patient or make assumptions about their medical needs based on race, gender, or age. The unconscious assumptions can lead to delayed or inadequate care, misdiagnoses, or inappropriate treatments, all of which can adversely impact health outcomes. Addressing implicit bias in healthcare is crucial for achieving equity in medical treatment. Strategies to combat these biases involve education and awareness programs for healthcare professionals. These programs help individuals recognize and acknowledge their biases, fostering a more empathetic and unbiased approach to patient care. Additionally, implementing policies and procedures prioritizing equitable treatment for all patients can play a pivotal role in reducing healthcare disparities. Ultimately, confronting implicit bias in healthcare is essential to creating a more just and equitable healthcare system where everyone receives fair and equal treatment regardless of their background or characteristics. DESIGNATION STATEMENT InforMed designates this enduring material for a maximum of 1 AMA PRA Category 1 Credit™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
Book Code: CT24CME
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FACULTY W. David Hardy, MD Adjunct Clinical Professor of Medicine Division of Infectious Diseases Keck School of Medicine of USC Donna M. Moccio, BS Medical Writer InforMed
COURSE SATISFIES 1 Infectious Diseases (HIV/AIDS) SPECIAL DESIGNATION This course satisfies one (1) credit hour on the topic of infectious diseases (HIV/AIDS). Physicians (MD/DO) applying for license renewal in Connecticut must earn a minimum of fifty (50) hours of CME within the preceding twenty-four (24) month period. During the first required renewal period and once every six (6) years thereafter, the 50 hours must include at least one (1) hour in each of the following topics: infectious diseases, risk management, sexual assault, domestic violence, cultural competency, and behavioral health.
ACTIVITY PLANNER Michael Brooks CME Director InforMed
DISCLOSURE OF INTEREST In accordance with the ACCME Standards for Commercial Support of CME, InforMed implemented mechanisms, prior to the planning and implementation of this CME activity, to identify and resolve conflicts of interest for all individuals in a position to control content of this CME activity.
FACULTY/PLANNING COMMITTEE DISCLOSURE The following faculty and/or planning committee members have indicated they have no relationship(s) with industry to disclose relative to the content of this CME activity: ● Michael Brooks ● Donna M. Moccio, BS The following faculty and/or planning committee members have indicated they have relationship(s) with industry to disclose: ● W. David Hardy, MD has received honoraria from Gilead, Merck, and ViiV Healthcare. STAFF AND CONTENT REVIEWERS InforMed staff, input committee and any content validation reviewers involved with this activity have reported no relevant financial relationships with commercial interests. DISCLAIMER *2024. All rights reserved. These materials, except those in the public domain, may not be reproduced without permission from InforMed. This publication is designed to provide general information prepared by professionals in regard to the subject matter covered. It is provided with the understanding that InforMed, Inc is not engaged in rendering legal, medical or other professional services. Although prepared by professionals, this publication should not be utilized as a substitute for professional services in specific situations. If legal advice, medical advice or other expert assistance is required, the service of a professional should be sought.
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INTRODUCTION
A timeline of the HIV epidemic in the United States June 2021 marks the 40th anniversary of the first recognition and first official report of the HIV/AIDS epidemic in the US and around the world. 1 The historic Centers for Disease Control and Prevention (CDC) report published on June 5, 1981 described biopsy-confirmed Pneumocystis carinii pneumonia in 5 previously healthy gay men aged 29 to 36-years- old at 3 different Los Angeles hospitals. 2 Since then, the US has passed through numerous important, and groundbreaking, milestones in the ongoing epidemic (Table 1). 3 Although substantial progress has been in the past 40 years towards the goal of ending the HIV epidemic through advancements in prevention and treatment, 5 many challenges remain. The world’s attention has moved away from HIV/AIDS as an acute, immediately life-threatening disease with almost certain death to a chronic, manageable and treatable health condition. In addition, the COVID-19 pandemic has resulted in declines in HIV testing and prevention services. 1
Ending the HIV epidemic: A Plan for America In response to the remaining challenges presented by the HIV/AIDS epidemic, the US Department of Health and Human Services (HHS) launched “Ending the HIV Epidemic: A Plan for American” 4 in 2019. This cross-agency initiative leverages scientific advances in HIV prevention, diagnosis, treatment, and outbreak response by coordinating highly successful programs, resources, and infrastructure of many HHS agencies (CDC, NIH, HRSA, IHS). The goal of this initiative is to reach a 75% reduction in new HIV diagnoses by 2025 and at least a 90% reduction by 2030. HHS is working with both urban and rural communities to establish local teams to tailor and implement strategies to test all persons and diagnose those with HIV as early as possible after infection, initiate treatment rapidly and effectively to achieve sustained viral suppression, prevent new transmissions using proven interventions, including pre-exposure prophylaxis (PrEP) and syringe services programs, and respond quickly to potential HIV outbreaks to begin prevention and treatment services to people who need them. 5 The initiative is initially focusing resources on areas where HIV transmission occurs most frequently.
Table 1: Major Milestones in the HIV/AIDS Epidemic 3,4 Year Milestone 1981
CDC reports first cases of rare pneumonia and persistent HSV in previously healthy young gay men. Viral cause proposed (CMV). French researchers publish first paper describing the new retrovirus as cause of AIDS. Two American researchers confirm their discovery. FDA licenses first commercial blood test, ELISA, to detect HIV in blood. Blood banks begin screening US blood supply. HHS and WHO host the first International AIDS Conference in Atlanta, GA.
1983
1985
1987 1989
FDA approves the first antiretroviral drug, zidovudine (AZT).
CDC reports that the number of reported AIDS cases in the US has reached 100,000. 1990 Congress enacts the Ryan White Comprehensive AIDS Resources Emergency (CARE) Act of 1990. 1992 AIDS becomes the number one cause of death for American men aged 25 to 44. 1993 Two large RCTs from US and Europe confirm that AZT monotherapy’s effect on the virus is not durable. 1994 AIDS becomes the leading cause of death for all Americans aged 25 to 44 years old. 1995 Polymerase chain reaction (PCR) is used to accurately detect and quantitate HIV in blood (viral load). Untreated HIV is never quiescent or latent. FDA approves the first protease inhibitor. This ushers in a new era of highly active antiretroviral therapy (HAART) 1996 The number of new AIDS cases diagnosed in the U.S. precipitously declines for the first time since the beginning of the epidemic. Prophylaxis for opportunistic infections and HAART are major factors. 1998 CDC reports that African Americans account for 49% of U.S. AIDS-related deaths. AIDS-related mortality for African Americans is almost 10 times that of Whites and three times that of Hispanics.
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Table 1: Major Milestones in the HIV/AIDS Epidemic 3,4 Year Milestone 2008
JAMA reports that the incidence of HIV infection among gay men in the U.S. is again increasing, following an encouraging period of decline. 2012 HHS issues new HIV treatment guidelines recommending that all adults and adolescents start antiretroviral therapy regardless of CD4+ T cell count or viral load. 2016 CDC reports that only 1 in 5 sexually active high school students has been tested for HIV Cohort study of ART-naïve, HIV patients in Kenya who initiated tenofovir DF indicates that subsequent virologic failure and resulting HIV drug resistance necessitates universal viral load monitoring and prompt drug resistance testing. 2019 HHS launches “Ending the HIV Epidemic: A Plan for American” with the goal of reaching a 75% reduction in new HIV infections by 2025 and at least a 90% reduction by 2030. Evolving role of primary medical care for HIV patients
Success in achieving the goals of the HHS Plan for America will be hampered, in part, by the diminishing number of HIV clinicians in the United States. 6 It is estimated that between 33% and 50% of existing HIV clinicians will stop practicing HIV medicine over the next 10 years. 6 The HIV provider shortage in the US is likely to continue. To address this shortage, it has been suggested that primary care providers (PCPs) be offered additional training and physician assistants (PAs) and family nurse practitioners (NPs) be encouraged to become involved with HIV medicine. 6
Currently, there are approximately 294,834 PCPs in the US, and, of these, 3101 provide care to HIV- positive patients. 6 A 2020 article that sought to answer the question “Are Primary Care Physicians Prepared for Their New Role?” found that 71% of surveyed PCPs believed PCPs should take care of HIV patients. In addition, more than 50% of PAs and NPs believed they could be ready to manage HIV patients with some training. 6 In the past, persons with HIV have been cared for by infectious disease or HIV specialists. However, when patients are treated in primary care, HIV patients are also managed for other chronic medical conditions. Therefore, these patients receive more comprehensive care.
EPIDEMIOLOGY
Scope and impact According to statistics from the HIV.gov website, approximately 1.2 million persons in the US are estimated to be living with HIV and about 13% of these people are not diagnosed and need testing. 7 In 2019, there was an estimated 34,800 new HIV diagnoses. 7
Although there has been an overall decrease in new diagnoses from 2015 to 2019 (Figure 1), HIV diagnoses are not evenly distributed across states/ regions. The highest rates of new infections continue to occur in the southern and southeastern regions of the US. 7
Figure 1: Annual HIV Diagnoses in the US, 2015-2019
Life expectancy in persons with HIV is approaching that of the general population with early diagnosis and prompt initiation of treatment. Despite the fact that deaths attributable to HIV are preventable, in 2017, HIV was still among the top 10 leading causes of death among certain populations. 8
Between 2010 and 2018, both the prevalence of HIV infection and the number of HIV-related deaths were greatest amongblack persons and by US region in the South. 8
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Book Code: CT24CME
● Hispanic/Latinx person represented 18% of the population, but accounted for 30% of new HIV diagnoses. New diagnoses of HIV in 2019 were highest among persons 25 to 29 years of age. 7 The greatest overall illness burden across all diseases occurs in people at the lowest socioeconomic status. 9 These healthdisparities are exaggerated in people with HIV. Poverty, discrimination, health inequity, and other social conditions facilitateHIV transmission by influencing local HIV prevalence and individual risk behaviors. High prevalence rates of smoking, obesity,empty calorie/low nutrient diets, substance abuse, and other poor health behaviors, which are also over-represented amongthe poor and disenfranchised, lead to multiple comorbidities. Many of these factors promote HIV infection and impede accessto health care. 9 Most HIV diagnoses are now highly concentrated in certain geographic locations. 7 The Ending the HIV Epidemic: A Plan for America initiative is focusing on the 48 counties in the US, Washington, DC, and San Juan, Puerto Rico that accounted for 50% of new diagnoses in 2016-2017, in addition to 7 states with a high rural burden (Figure 2). 4
In 2019, there were 15,815 deaths among adults and adolescents diagnosed with HIV. 7 Over time, HIV has increasingly become more prevalent among marginalized and stigmatized communities such as men whohave sex with men (MSM), transgender persons, people who inject drugs, adolescents, and prisoners. 1 MSM are the populations most affected by HIV in the US. Between 2015 and 2019, MSM accounted for approximately 69% of new HIV diagnoses. Groups that accounted for the highest prevalence of new HIV diagnoses in 2019 were: 7 ● Black/African American MSM: 26% ● Black/African American heterosexual persons: 23% (men: 7%; women: 16%) ● Hispanic/Latino MSM: 22% ● People who inject drugs: 7% (men: 4%; women: 3%) ● Transgender people: 2% When examined by race/ethnicity, Black/African American and Hispanic/Latinx persons continue to be disproportionately impacted by HIV. 7 In 2019: ● Blacks/African Americans represented 13% of the US population, but accounted for 44% of new HIV diagnoses.
Figure 2: The Ending the HIV Epidemic: A Plan for America Initiative Identified Areas Where Transmission Occurs Most Frequently 4
MODES OF TRANSMISSION
HIV is transmitted by direct contact with body fluids from a person with HIV who has a detectable viral load. Transmission occurs through contact with infected body fluids such as blood, semen, rectal
fluids, vaginal fluid, or breast milk. For transmission to occur, the virus must get into the bloodstream of an HIV-negative person through a mucous membrane, open cut or sore, or by direct injection. 10
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The most common modes of transmission include anal or vaginal sex, needle/drug injection sharing, perinatal transmission, and very, very rarely healthcare workplace transmission. However, oral sex, prechewed food for babies, biting, deep, open-mouth kissing, Anal or vaginal sex 11 HIV can be transmitted through sex with a person with HIV if there is no physical barrier protection such as a condom or pharmacologic barrier provided by antiretroviral treatment of an HIV+ person, or pre- exposure prophylaxis (PrEP) for persons at-risk for acquiring HIV. Condomless anal sex carries the greatest risk for transmitting HIV. The receptive partner (bottom) has a higher risk than the inserting partner (top) because the lining of the rectum is thin and if disrupted may allow the virus to enter the body. The inserting partner Needle/drug equipment sharing People who share needles, syringes, and other drug injection equipment with individuals who have HIV are Perinatal transmission HIV can be transmitted from mothers to babies during pregnancy, birth, or breastfeeding. This is the most common mode of transmission for children. 11 The prevention of mother-to-child HIV transmission is considered one of the great public health successes Healthcare setting Although HIV can be transmitted in the healthcare setting from patient to provider, or provider to patient, it is extremely rare. 13 Careful practice of infection control procedures, including universal precautions (See Prevention Section) protects patients and providers from potential transmission in medical and dental settings. 13 Global data show that the probability of HIV transmission from a healthcare worker to a patient is extremely rare and varies depending on the source from approximately 2.4 to 24 per million medical procedures. 14 Important factors that influence the overall risk for occupational exposures of healthcare workers to blood borne pathogens include the prevalence of HIV in a patient population and the type and number of blood contacts. 13 Blood is the major and the strongest source of transmission of not only HIV but also other pathogens (e.g., hepatitis B, hepatitis C) and is the
and tattoos/body piercings are potentially rare modes of transmission. The risk of contracting HIV from blood transfusions, blood products, or organ/tissue transplants is extremely rare now due to rigorous testing of donated blood, organs, and tissues. 11 is at-risk, but to a lesser extent, because HIV can enter through the urethra of the penis, the foreskin, if the penis is not circumcised, or potentially small cuts, scratches, or open sores anywhere on the penis. Condomless vaginal sex is less risky compared to receptive anal sex, although both partners are at risk during vaginal sex. Vaginal sex is the most common mode of HIV transmission in women. Men can also contract HIV during vaginal sex because vaginal fluid and blood can carry the virus.
at-risk for contracting HIV. Injection equipment may contain blood that can carry the virus. 11
over the past 28 years. By employing preventative strategies, notably treating the HIV+ pregnant woman with ART, the HIV transmission rate from mother-to- child was reduced from between 25% and 42% to less than 1%. 12 major route of transmission in healthcare workers. Infection through semen and vaginal secretions for healthcare workers seems to be irrelevant, because contact with these fluids is minimal, and even during contact, protective gloves are worn which are sufficient to prevent infection. 14 One study estimated the risk of HIV transmission from percutaneous exposure (needlestick, sharp injuries, splashes leading to exposure of the skin or mucosa to blood) to infected blood to be approximately 0.1% to 0.3% for each exposure. The CDC estimates one seroconversion for every 200 contaminated needlesticks. The literature suggests that the probability of HIV infection by needle injury ranges from 0.03% to 0.3%, which increases with the depth of injuries, volume of inoculated blood, and hollow-bore needle injuries. 14 infectious for HIV, hepatitis B virus, hepatitis C virus and other bloodborne pathogens. Universal precautions are intended to prevent parenteral, mucous membrane, and nonintact skin exposures of healthcare workers to bloodborne pathogens. 15 Universal precautions do not apply to sputum, feces, sweat, vomit, tears, urine, or nasal secretions unless they are visibly contaminated with blood. 16
PREVENTION Infection control/universal precautions in the healthcare setting Although the risk of HIV transmission in the healthcare setting is very low, all healthcare workers must
observe precautions to prevent transmission. Every patient that undergoes a medical procedure should be considered to be a possible carrier of several blood-borne infectious disease, including HIV. 14 Universal precautions were introduced by the CDC in 1987 and clarified in 1988 primarily in response to HIV. 15 Under universal precautions, blood and certain body fluids from all patients are considered potentially
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Protective barriers reduce the risk of exposure of the skin or mucous membranes to potentially infective materials. Examples of protective barriers include gloves, gowns, masks, and protective eyewear. Gloves should reduce the incidence of contamination of hands, but they cannot prevent penetrating injuries due to needles or other sharp instruments. Masks and protective eyewear or face shields reduce the incidence of contamination of mucous membranes of the mouth, nose, and eyes. 15 Universal precautions are intended to supplement rather than replace recommendations for routine infection control, such as hand washing and using gloves to prevent gross microbial contamination. As noted by the CDC, specifying the types of barriers needed for every possible clinical situation is impractical, so some judgment must be exercised. 15 The risk of transmission of HIV and other pathogens can be minimized if healthcare workers follow general guidelines (Table 2). The safe removal of protective equipment also follows a specific sequence that requires special attention to areas that are now considered contaminated: 15
1. Gloves should be removed by first grasping the palm of the other hand and peeling off the first glove, keep hold of the removed glove in the gloved hand, slide the fingers of the ungloved hand under the remaining glove and peel it off over the first glove. 2. Goggles or face shield should be removed by lifting from behind the head. 3. Gowns should be untied and removed by pulling away from the neck and shoulders, turning the gown inside out and only touching the inside. 4. Mask or respirator should be removed by reaching behind the head and grasping the bottom ties then the top ties and removing without touching the front. Alternatively, the gloves and gown may be removed at the same time by grasping the gown from the front and pulling away from the body, rolling the gown into a bundle, and removing the gloves at the same time using the inside of the gown. Hand hygiene should be performed after removal of all protective equipment and anytime during removal if they become contaminated. 16
Table 2: General Guidelines to reduce Risk of HIV Transmission in the Healthcare Setting 15 Risk Precaution Handling sharp objects (needles, scalpels, etc.)
• Do not recap used needles by hand; do not remove used needles from disposable syringes by hand; and do not bend, break, or otherwise manipulate used needles by hand. • Place used disposable syringes and needles, scalpel blades, and other sharp items in puncture-resistant containers for disposal. • Locate the puncture-resistant containers as close to the use area as is practical. • Use protective barriers to prevent exposure to blood, body fluids containing visible blood, and other fluids to which universal precautions apply. • Ensure that the type of protective barrier(s) is appropriate for the procedure being performed and the type of exposure anticipated. • Immediately and thoroughly wash hands and other skin surfaces that are contaminated with blood, body fluids containing visible blood, or other body fluids to which universal precautions apply.
Potential exposure to body fluids Contaminated skin surfaces
Screening/testing About 40% of new HIV infections are transmitted by people undiagnosed and unaware that they are HIV positive. 17 Diagnosing HIV quickly and linking people to treatment immediately are crucial to reducing new HIV infections. A 2017 MMWR report noted that more than 75% of patients at high risk for HIV infection who saw a PCP in the last year were not offered an HIV test during their visit. 18 According to the CDC, PCPs are the front line for detecting and preventing the spread of HIV.19-21 The CDC recommends that all PCPs: ● Conduct routine HIV screening at least once for all of their patients between the ages of 13 and 64. ● Conduct more frequent screenings for patients at greater risk of infection; patients at high risk should be screened at least annually. ● Link all patients who test positive for HIV to medical treatment, care, and prevention services.
● Provide prevention counseling for patients at-risk for acquiring HIV (this should not be required for general testing). Routine screening should be implemented using an “opt-out” approach. 21 When an opt-out approach is implemented, patients should be informed, through a patient brochure, practice literature/form, or discussion, that an HIV test will be included in the standard preventive screening tests, and that they may decline the test (opt-out). A patient’s decision to decline testing should be noted in their medical record. 21 Laboratory tests to detect HIV RNA (or DNA), antigens and antibodies to the virus have improved substantially over the years and are now easier, less expensive, and are associated with a more rapid turnaround time. 19 Three types of tests are available: 21 ● Nucleic acid tests (NATs): detects HIV ribonucleic acid (RNA).
Book Code: CT24CME
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● Antigen/antibody combination tests: detects HIV p24 antigen as well as HIV immunoglobulin M (IgM) and immunoglobulin G (IgG) antibodies. ● Antibody tests: detects HIV IgM and/or IgG antibodies. The “eclipse period” is the time period after infection, but before any diagnostic test is capable of detecting HIV following an exposure. 21 The “window Pre-exposure prophylaxis (PrEP) Antiretroviral PrEP is a way of preventing HIV transmission and should be prescribed for people at- risk for acquisition of infection. 22 PrEP to prevent HIV transmission was first approved by the FDA in 2012. Although PrEP has been shown to reduce the risk of new infections, uptake of PrEP is lagging, particularly among populations with a disproportionate burden. 22 According to the PrEPWatch website, only between 200,000 and 205,000 Americans currently use PrEP. 23 The FDA has approved 2 combination anti-HIV drugs in a single pill for use as PrEP: 24 ● Emtricitabine (F) 200 mg in combination with tenofovir disoproxil fumarate (TDF) 300 mg (F-TDF) is recommended for all adults and adolescents at risk for HIV through sex or injection drug use. ● Emtricitabine (F) 200 mg in combination with tenofovir alafenamide (TAF) 25 mg (F-TAF) is recommended for adults and adolescents at risk for HIV through sex, excluding people at risk through vaginal sex (cis-women/ transgender men). F-TAF has not yet been studied for HIV prevention for receptive vaginal sex.
period” is the time between potential exposure and an accurate test result. Improvements in testing continue to reduce the detection window period, and, therefore, the time to diagnosis and treatment of early HIV infection. Each type of HIV test has its own testing window, with the NAT capable of detecting HIV the earliest, followed by the antigen/ antibody combination test, and lastly, the antibody test. 21 PrEP medications are very effective at preventing HIV transmission. A retrospective analysis of the National HIV Surveillance System and national pharmacy data showed an independent and significant association between F/TDF PrEP use and a decline in the number of new HIV infections diagnosed in the US from 2012 to 2016 in communities where it was most widely used. 25 Unfortunately both provider and patient barriers limit the use of PrEP. These barriers include a lack of awareness of PrEP among at-risk individuals and providers, fear of stigma and/or side effects, provider implicit bias, distrust of the healthcare system, and a lack of access to medical care or financial assistance. 22 Even when PrEP is initiated, adherence is problematic. A study of 7148 individuals who initiated PrEP in 2015 at a national chain pharmacy reported only 56% persistence in year 1, 63% in year 2, and 41% from initiation to year 2, with the lowest persistence in women and individuals 18 to 24 years old.26 It is important to state also, that PrEP, unlike ART, which is currently recommended to be taken continuously for life, is designed to be taken during “seasons of risk” when acquisition of HIV is present. It may be stopped and started as frequently as needed depending on a person’s level of risk.
Case study 1 Instructions: Spend 5-10 minutes reviewing the case below and considering the questions that follow. Robert is a 24-year-old Latino male. He is new to your practice. Robert presents with general malaise and a slight fever. He is a cook at a restaurant and has not felt well enough to go to work for a couple of days. During the patient history taking, Robert discloses that he is gay and in a 6-month relationship with another male. At first, he is evasive when you ask about HIV status, but eventually admits that his partner is HIV-positive. He further states that they continue to practice insertive anal sex without using a condom. Robert understands the inherent risks but fears his partner will leave him if he insists on using a condom.When you ask if Robert would like to be tested today, he becomes defensive and says no. Questions 1. What is the best way to proceed in this case? _______________________________________________________________________________________________ 2. How would you convince Robert to get tested and start on PrEP immediately if his test is negative? _______________________________________________________________________________________________ 3. What information could you provide to Robert to increase the likelihood that he will use condoms in the future? _______________________________________________________________________________________________
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Book Code: CT24CME
CLINICAL MANAGEMENT
Symptoms/diagnosis Acute or primary HIV infection is the period
illness, comorbidities, economic factors, medical insurance status, and other factors that may impair adherence to therapy and increase the risk of transmission. Once evaluated, these factors should be managed accordingly. The baseline encounter should also include a discussion of the importance of risk or transmission reduction and disclosure of HIV status to sexual and/or needle- sharing partners, especially with untreated patients who are still at high risk of HIV transmission. Education about HIV risk behaviors and effective strategies to prevent HIV transmission should be provided at each patient visit. 27 During the initial history and physical examination, the clinicians should: 28 ● Identify possible clinical manifestations of HIV and related conditions. ● Elicit details about sexually transmitted infections, hepatitis, substance use, and sexual practices. ● Obtain a history of any previous HIV treatment. ● Review patient’s social and support networks. The presence of thrush, oral or anogenital ulcers or warts, generalized lymphadenopathy, rashes, or skin lesions identified during the physical exam should prompt further evaluation, especially when substantial immunosuppression is present. 28 HIV RNA (viral load) and CD4 cell count are the two surrogate markers used to monitor response to antiretroviral treatment (ART) and evaluate for HIV disease progression. These two tests provide the foundation for medical management and monitoring for persons with HIV infection. 27 Viral load is a surrogate marker of response to ART. The magnitude of a patient’s pre-ART viral load provides information about the probability and rapidity of subsequent disease progression. The key goal of ART is to achieve and maintain durable viral load suppression to a level of HIV RNA below the level of quantitation for currently available commercial laboratory assays. Therefore, the most important use of viral load is to monitor the effectiveness of therapy after initiation of ART. 27 Several systematic reviews established that decreases in viral load following initiation of ART are associated with reduced risk of progression to AIDS or death. 27 Measurement of CD4 cell count is particularly useful before and after initiation of ART. The CD4 cell count provides information on the overall cellular immune function of a person with HIV and is the strongest predictor of subsequent disease progression and survival. 27 Untreated HIV infection generally has a 10-year progression until opportunistic infections and malignancies appear, usually when the CD4 cell count decreases to <200 cells/mm 3 . 29 Normal ranges for CD4+ T cell counts vary from laboratory to laboratory, but in general are approximately 500
immediately after initial HIV exposure, generally before and during seroconversion. 27 Although some patients remain asymptomatic, acute HIV infection often presents with transient symptoms related to high levels of viral replication and subsequent immune response. Symptoms of acute HIV infection are nonspecific and can include fever, malaise, myalgias, and rash, making misdiagnosis common. A wide range of conditions may produce similar symptoms, so an accurate diagnosis of acute HIV infection involves a high index of suspicion, a thorough assessment of HIV exposure risk, and appropriate HIV-related laboratory tests. Between 50% and 90% of patients with acute infections develop symptoms although the timing and duration varies. 27 For most symptomatic patients, acute illness develops within one to four weeks after transmission, with symptoms persisting for two to four weeks. 27 Patients living with HIV infection often must cope with many social, psychiatric, and medical issues that are best addressed through a patient-centered, multidisciplinary approach. 27 The initial encounter should include an evaluation of the patient’s readiness to start ART, including an assessment of high-risk behaviors, substance use, social support, mental The following laboratory tests performed during the initial visit with the patient can be used to “stage” HIV infection and associated disease manifestations: 27 [A complete schedule of laboratory testing and monitoring of people with HIV before and after initiation of antiretroviral therapy can be found in reference 27 .] ● HIV antibody testing (if prior documentation is not available or if current HIV RNA is below the assay’s limit of detection. This is routinely done to confirm a history of HIV infection at the time of clinic transfer). ● CD4+ T lymphocyte cell count (CD4 cell count). ● Plasma HIV RNA by PCR (viral load). ● Complete blood count, chemistry profile, transaminase levels, blood urea nitrogen (BUN), and creatinine, urinalysis, and serologies for hepatitis A, B, and C viruses, sexually transmitted disease screening as appropriate. ● Fasting blood glucose and serum lipids. ● Genotypic resistance testing. This is recommended Treatment/monitoring Laboratory tests for all newly diagnosed persons with HIV or previously diagnosed and not receiving ART. A successful genotypic test requires a minimum of 500 copies/ mL of plasma HIV RNA. For patients who have HIV RNA levels <500 copies/mL, viral amplification for resistance testing may not always be successful. Genotypic tests drawn greater than 4 weeks after discontinuation of ART may not detect all resistance-associated mutations.
Book Code: CT24CME
Page 9
to 700 cells/mm 3 . 29 These measurements are critical for establishing thresholds for the initiation and discontinuation of opportunistic infection prophylaxis. Antiretroviral treatment (ART) HIV infection has become a treatable, chronic medical condition with increasingly near-normal life expectancy when patients receive ART early in the course of their disease or as soon as possible following diagnosis. 28 ART has reduced HIV-related morbidity and mortality at all stages of infection and reduces HIV transmission more potently than any prevention strategy other than celibacy. Maximal and durable suppression of plasma viremia prevents the selection of drug-resistance mutations, improves or at least preserves CD4 cell numbers, and confers substantial clinical benefits, all of which are important treatment goals. 27 Despite the proven benefits of ART, the HIV suppression rate in the US is only 56%––lowest among comparable high-income countries. For example, the United Kingdom and Switzerland have a suppression rate of 84%.30 While the reasons for this low US HIV suppression rate are multifactorial, it is known that it maps to undiagnosed HIV infection and failure to link or retain patients in care. 27 Adherence is a strong predictor of ART effectiveness, and suboptimal medication adherence can produce permanent resistance to an entire class of antiretroviral medications. 29 Linking patients with social services, case management, HIV education, and mental health counseling is critical. When there is reasonable concern that adherence will be a challenge, the clinician and patient should identify and address barriers to treatment (e.g., unstable hous- ing, behavioral health issues, overall patient readi- ness) and consider deferring treatment until there is a greater likelihood of adherence. 29 Current recommendations are to start ART as early as possible, particularly for patients with CD4+ T cell counts <200/mm 3 . Achieving viral suppression currently requires the use of combination ARV regimens that generally include two or three active drugs from two or more drug classes. 27 When initial HIV suppression is not achieved or not maintained, changing to a new regimen with at least two fully active drugs is often required. The increasing number of drugs and drug classes makes viral suppression below the limit of detection an achievable goal in most patients. 27 More than 30 drugs, in 5 classes, have been approved by the FDA for the treatment of HIV infection: 7 ● Nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs). ● Non-nucleoside reverse transcriptase inhibitors (NNRTIs). ● Protease inhibitors (PIs). ● Integrase strand transfer inhibitors (INSTIs): ○ Entry inhibitors.
In addition, two drugs, ritonavir and cobicistat are used as pharmacokinetic enhancers (or boosters) to improve the pharmacokinetic profiles of PIs and the INSTI, elvitegravir. 27 According to guidelines, the initial ART regimen for a treatment-naive patient generally consists of one or two NRTIs, most frequently or either tenofovir alafenamide/emtricitabine (TAF/FTC) or tenofovir disoproxil fumarate/emtricitabine (TDF/ FTC) or abacavir/lamivudine (ABC/3TC), plus a drug from one of three drug classes: an INSTI, an NNRTI, or a boosted PI. 27 This strategy for initial treatment has resulted in suppression of HIV replication and CD4 cell count increases in most people with HIV. Additional data now support the use of the two- drug regimen dolutegravir/lamivudine (DTG/3TC) for initial treatment of some people with HIV. 27 See the Boxed Copy for Key Considerations and Recommendations for Initial Combination Therapy from the Guidelines (For more detailed information on the drugs used for HIV treatment, access the Guidelines for the Use of Antiviral Agents in Adults and Adolescents with HIV). 27 Key considerations and recommendations for initial combination therapy in antiretroviral-naïve patients 27 ● An antiretroviral regimen for a treatment-naive patient generally consists of two nucleoside reverse transcriptase inhibitors (NRTIs) administered in combination with a third active drug from one of three drug classes: an integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI), or a protease inhibitor (PI) with a pharmacokinetic enhancer (also known as a booster; the two drugs used for this purpose are cobicistat and ritonavir). ● Data also support the use of the two-drug regimen, dolutegravir plus lamivudine, for initial treatment. ● Before initiating antiretroviral therapy in a person of childbearing potential, clinicians should discuss the person’s intentions regarding pregnancy and a pregnancy test should be performed. ● The Panel classifies the following regimens as Recommended Initial Regimens for Most People with HIV (in alphabetical order): ○ Bictegravir/tenofovir alafenamide emtricitabine. ○ Dolutegravir/abacavir/lamivudine—only for individuals who are HLA-B*5701 negative and without chronic hepatitis B virus (HBV) coinfection. ○ Dolutegravir plus (emtricitabine or lamivudine) plus (tenofovir alafenamide [TAF] or tenofovir disoproxil fumarate [TDF]). ○ Dolutegravir/lamivudine, except for individuals with HIV RNA >500,000 copies/mL, HBV coinfection, or when therapy is to be started before the results of HIV genotypic resistance testing for reverse transcriptase or HBV testing are available. ● To address individual patient characteristics and needs, the Panel also provides a list of Recommended Initial Regimens in Certain Clinical Situations (See Guidelines).
○ Fusion inhibitor (enfuvirtide). ○ CCR5 antagonist (maraviroc).
○ CD4 post-attachment inhibitor (ibalizumab). ○ gp120 attachment inhibitor (fostemsavir).
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Book Code: CT24CME
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