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HIV Screening and Access to Care: Exploring Barriers and Facilitators to Expanded HIV Testing HIV Screening and Access to Care: Exploring Barriers and Facilitators to Expanded HIV Testing The White House Office of National AIDS Policy (ONAP) is tasked with coordinating government efforts to reduce the number of HIV infections in the United States (ONAP, 2010a). These efforts have included the development of a National HIV/AIDS Strategy (NHAS), released July 13, 2010, the primary objectives of which are to (1) reduce HIV incidence, (2) increase access to care and optimize health outcomes for people living with HIV, and (3) reduce HIV-related health disparities (ONAP, 2010b).1 To supplement other efforts to inform the development and implementation of the NHAS, in the fall of 2009, ONAP commissioned an Institute of Medicine (IOM) committee to evaluate barriers to implementation of an expanded HIV testing and treatment program. Specifically, the committee was asked to examine the extent to which federal and state laws and policies and health insurance policies pose a barrier to expanded HIV testing; the capacity of the health care system to administer a greater number of HIV tests and to accommodate new HIV diagnoses; and federal and state policies that inhibit entry into clinical care or the provision of continuous and sustained clinical care for people with HIV/AIDS. The statement of task includes more specific questions for the committee to consider within each of these three areas as well (see Box 1). 1 For further details on the NHAS, visit http://www.whitehouse.gov/administration/eop/onap/nhas.
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HIV Screening and Access to Care: Exploring Barriers and Facilitators to Expanded HIV Testing BOX 1 Statement of Task What is the extent to which federal, state, and private health insurance policies pose a barrier to expanded HIV testing? Issues for the committee to consider include the following: What are the current federal and state laws, private health coverage policies, or other policies that impede HIV testing? What effective HIV testing methods and/or policies should be implemented by federal, state, or local agencies, federal programs, or private insurance companies that can be used to reach populations with a high HIV prevalence and/or high prevalence of undiagnosed HIV infection? What has been the impact of opt-out HIV testing? What federal and state policies and private insurance policies/practices (such as pharmaceutical coverage limits) inhibit entry into clinical care for individuals who test HIV-positive or inhibit the provision of continuous and sustained clinical care for HIV-positive persons? Issues for the committee to consider include How can federal and state agencies provide more integrated HIV care services? What policies promote/inhibit clinical care services among agencies at the federal level, at the state level, or between state and federal agencies? What are federal and state agency policies in funding HIV medication adherence programs? What HIV medication adherence programs work? Will insurance companies and other payors pay for the treatment of an HIV-infected person who tests positive in this theoretical new, expanded testing program, but whose CD4+ T cell count and/or viral load does not fall within the “official guidelines” of starting antiretroviral therapies? What can be done to promote access to HIV treatment for HIV-positive individuals with CD4+T cell counts greater than “official guidelines”? What is the current capacity of the health care system to administer a greater number of HIV tests and to accommodate new HIV diagnoses? Issues for the committee to consider include system, workforce, and private sector issues: Where do HIV-positive patients currently get care? What is the HIV-related training or experience of most HIV care providers (medical doctor, nurse practitioner, physician’s assistant, registered nurse)? What manpower or training/experience improvements are needed to absorb more newly diagnosed HIV-positives from expanded HIV testing services? Is the age profile of providers compatible with sustainability of the HIV care delivery system? That is, are younger clinicians and/or students receiving adequate training/experience to meet future needs? What are the impediments to professionals entering into, or continuing to provide, AIDS care? What policies inhibit or enhance the movement of health care professionals into HIV/AIDS specialties? Are there adequate financial or professional incentives to promote HIV/AIDS as a specialty among the health care professions?
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HIV Screening and Access to Care: Exploring Barriers and Facilitators to Expanded HIV Testing A 15-member committee, the Committee on HIV Screening and Access to Care, was formed to carry out this study. The committee comprises experts in the areas of HIV/AIDS testing and care policy, HIV/AIDS ethics, epidemiology and biostatistics, HIV/AIDS clinical care and care services research, HIV/AIDS care financing, state HIV/AIDS service programming and implementation, and the behavioral sciences (see Appendix A). ONAP asked the committee to plan and host three public workshops and perform other limited data-gathering activities, such as review of the literature, to address each of the three areas described in the statement of task and prepare three brief reports on those issues. ONAP requested that the reports not include recommendations because it thought that committee summaries of the presentations and discussions at the workshops and other data gathered would be the most helpful way of informing the implementation of the NHAS. The committee held a planning meeting December 15–16, 2009, at which it discussed the details of the statement of task with representatives from ONAP. From this discussion it was agreed that although the emphasis of the task is the impact of laws and policies on access to HIV testing and HIV/AIDS care, in planning the workshops and other information gathering activities it would be appropriate for the committee to give some consideration to the impact of factors that may fall outside this realm (such as HIV/AIDS stigma, low-self-perceived risk, provider knowledge, etc.) that have been cited as potential barriers to HIV testing and care. This is the first of three reports that will be prepared by the committee. It focuses on the first part of the committee’s task: the extent to which federal and state laws and policies, private health insurance policies, and other factors pose a barrier to expanded HIV testing. The committee hosted a public workshop during April 15–16, 2010, in Washington, DC, to explore the extent to which federal, state, and private health insurance policies pose a barrier to expanded HIV testing (see agenda, Appendix B). The committee convened experts from academia, government, the insurance industry, provider groups, and foundations to offer expert testimony (see Appendix C). Also in attendance were more than thirty workshop registrants representing patients, providers of HIV testing and care services, researchers, policy organizations, and others with an interest in this topic (see Appendix D). Invited experts were asked to present their evidence and perspectives. Following each panel, questions were entertained from the committee and the audience. This report begins with a background section describing the rationale for an expanded HIV testing program. The report then summarizes information from the expert presentations and discussion from the public workshop, as well as information from policy documents and research literature, relevant to the questions posed to the committee in the first part of the statement of task (see number 1 in Box 1).
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HIV Screening and Access to Care: Exploring Barriers and Facilitators to Expanded HIV Testing Between the time that ONAP commissioned the study and the committee’s first workshop, comprehensive health care reform—the Patient Protection and Affordable Care Act (P.L. 111-148)—was enacted into law. Although the effect of health reform on HIV testing was not part of the specific charge to the committee, the committee is aware that health care reform will have significant implications for the health care environment in the United States. To the extent possible, the committee tried to identify places where changes were likely that could impact HIV testing/screening and access to care.2 The Centers for Disease Control and Prevention (CDC) issued revised HIV testing guidelines in 2006 recommending routine testing in health care settings for people ages 13 to 64. Because of their relevance to the discussion of facilitators and barriers to expanded HIV testing, the revised CDC guidelines were frequently brought up by workshop participants and are discussed in several places throughout this report. This is not meant to imply an endorsement by the committee of the CDC’s HIV testing guidelines over those issued by the U.S. Preventive Services Task Force (USPSTF) or others. BACKGROUND An estimated 56,300 adolescents and adults are newly infected with HIV in the United States each year (CDC, 2008a). Some populations bear a disproportionate burden of the HIV epidemic. For example, 53 percent (28,700) of the new HIV infections that occurred in 2006 were among men who have sex with men (MSM). Comparing racial and ethnic groups, the rate of new HIV infections among non-Hispanic blacks was seven times the rate among whites (83.7 versus 11.5 new infections per 100,000 population) and the rate of new infections among Hispanics in 2006 was three times the rate among whites (29.3 versus 11.5 per 100,000). African Americans also accounted for the largest share of new infections (45 percent, or 24,900) that occurred in 2006 (CDC, 2008a). Twenty-one percent of the approximately 1.1 million people in the United States living with HIV/AIDS are unaware that they are HIV infected (CDC, 2008b). People who are unaware of their HIV status may unknowingly transmit the virus to others. One study estimated that unrecognized HIV infection is the source of more than half of new HIV infections (Marks et al., 2006). Behaviors that increase risk for HIV transmission may be 2 It is important to note that multiple states have brought cases in federal and state courts challenging provisions of the Act, such as an individual health insurance mandate that requires all citizens and legal residents to have health insurance or pay a tax penalty, among others (e.g., State of Florida, et al. v. United States Department of Health and Human Services, et al., Case No. 3:10-cv-91-RV/EMT). The extent to which such challenges could diminish the Act’s impact in years ahead is unknown.
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HIV Screening and Access to Care: Exploring Barriers and Facilitators to Expanded HIV Testing more common among people who are unaware that they are HIV infected (Marks et al., 2005), and there is evidence that people often reduce their risk behaviors following an HIV diagnosis (Eaton and Kalichman, 2009). According to a 2010 study that used back calculation to estimate prevalence of undiagnosed HIV infection at the end of 2006, whites had the lowest percentage of undiagnosed cases (18.8 percent), compared with Hispanics/Latinos (21.6 percent), blacks/African Americans (22.2 percent), American Indians/Alaska Natives (25.8 percent), and Asians/Pacific Islanders (29.5 percent). In addition, MSM had a significantly greater percentage of undiagnosed HIV infection (23.5 percent) compared with the overall percentage undiagnosed (21 percent), although heterosexual males had the highest overall percentage of undiagnosed HIV infection (26.7 percent) (Table 1). The study also showed that minority MSM and minority heterosexual women had significantly greater percentages of undiagnosed HIV cases than whites in the same categories (Campsmith, 2010). Developments in the treatment of HIV/AIDS, such as the introduction of highly active antiretroviral therapy (HAART) in the mid-1990s, have TABLE 1 Estimated Number and Percent of Undiagnosed HIV Cases, by Race/Ethnicity and Transmission Category Number Percent Total 232,700 21 Race/Ethnicity White 72,000 18.8 Black/African American 113,100 22.2 Hispanic/Latino 41,900 21.6 Asian/Pacific Islander 4,500 29.5 American Indian/Alaska Native 1,200 25.8 Transmission category MSM 124,900 23.5 IDU-male 19,000 14.5 IDU-female 10,000 13.7 MSM/IDU 6,700 12.1 High-risk heterosexual contact-male 27,900 26.7 High-risk heterosexual contact-female 42,700 21.1 Other* 1,600 17.6 *Includes hemophilia, blood transfusion, perinatal exposure, and risk factors not reported or not identified. SOURCE: Campsmith et al., 2010
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HIV Screening and Access to Care: Exploring Barriers and Facilitators to Expanded HIV Testing resulted in dramatic improvements in HIV-related morbidity and mortality. After increasing steadily during the 1980s, HIV-related mortality rates dropped 70 percent between 1995 and 2005 (KFF, 2009c). People who are unaware of their HIV status cannot reap the benefits of these therapies, however. Many people are tested late in the course of HIV infection after symptoms have already developed and by which time therapy may not be as effective. For example, a 2009 CDC study of 281,421 new HIV diagnoses that occurred in 34 U.S. states between 1996 and 2005 found that 38.3 percent had progressed to an AIDS diagnosis within 1 year of their HIV diagnosis. Progression from HIV infection to AIDS without treatment generally takes about 10 years (CDC, 2009b). Besides improving health outcomes for the individual, knowledge of one’s HIV status and receipt of care may help to prevent HIV transmission. Viral load or the level of active HIV in the blood and/or genital fluid of someone with HIV appears to be a predictor of HIV transmission.3 There is evidence that timely initiation of antiretroviral therapy (ART), which reduces viral load, can reduce transmission risk. The effectiveness of ART in reducing transmission has been demonstrated by a decrease of perinatally-acquired infection in the United States. This is due in large part to routine screening of pregnant women for HIV infection and the institution of ART as a means of prevention of mother to child transmission (CDC, 2006a).4 Observational studies of sexual transmission of HIV in heterosexual couples and MSM show that individuals who are on and adherent with ART are less likely to transmit the virus to HIV-negative partners (Castilla et al., 2005; Donnell et al., 2010; Porco et al., 2004). The dramatic effect of ART on viral load has led to discussion of the potential benefit of increased HIV testing and earlier initiation of therapy, although many questions remain5 (Dieffenbach and Fauci, 2009; Granich et al., 2009; Holtgrave, 2010; Wagner and Blower, 2009). In 2006, the CDC issued revised HIV testing guidelines that recommend routine testing in health care settings for individuals between the ages of 13 and 64 (see the following section on the CDC’s revised HIV testing guidelines). However, data from the Kaiser Family Foundation (KFF) show that the percentage of adults aged 18 to 64 who report having been tested for HIV in the last 12 months has remained relatively flat from 2000 to 3 Blood and genital fluid viral load are often but not always correlated, however. Additional factors, such as the presence of other sexually transmitted diseases, may increase genital fluid viral load (Kalichman, 2008). 4 Estimates of the number of perinatal HIV infections peaked in 1991 at 1,650 and declined to an estimated range of 144–236 in 2002 (CDC, 2006b). 5 Current treatment guidelines recommend that ART be initiated when patients reach specific measures of disease progression, such as CD4 T-cell counts, and are based on analysis of the benefits to costs (e.g., drug resistance) of treatment.
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HIV Screening and Access to Care: Exploring Barriers and Facilitators to Expanded HIV Testing 2009 (Figure 1). Possibly due to risk-based approaches to HIV testing, certain population groups who may be at higher risk for HIV, such as young adults aged 18 to 29, African Americans, and Latinos, have been more likely to report having been tested in the past 12 months (KFF, 2009f). In a 2009 survey of a nationally representative random sample of more than 2,500 adults, 53 percent of 18 to 64 year olds reported having ever received an HIV test (up from 43 percent in 1997), with African Americans (73 percent) and Latinos (60 percent) being more likely than whites (40 percent) to report having ever been tested.6 Individuals ages 65 and older are much less likely to have been tested; in 2009, just 16 percent of people ages 65 or older reported they had ever been tested for HIV, compared with 54 percent and 61 percent of 28 to 29 year olds and 30 to 49 year olds, respectively (KFF, 2009f). In 2008, more than half (54.5 percent) of all individuals who were tested for HIV were tested in private doctor or health maintenance organization (HMO) settings, followed by hospital, emergency room and outpatient clinics (16.5 percent), and public health department clinics (5.6 percent). Fifteen percent of individuals were tested in non-clinical settings, such as AIDS clinics or counseling and testing sites. Almost 1 in 5 individu- FIGURE 1 Percentage of people who reported being tested for HIV in past 12 months, by year. SOURCE: Adapted from KFF, 2009f. 6 In another large survey conducted in 2008, 40 percent of adults aged 18 and older reported having ever been tested for HIV (CDC, 2008d).
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HIV Screening and Access to Care: Exploring Barriers and Facilitators to Expanded HIV Testing als who were tested were tested at primarily public funded sites7 (CDC, 2008c). Although most testing occurs in private doctor and HMO settings, the proportion of individuals who test HIV positive may be higher in hospital settings (such as emergency departments [EDs]) and in public community clinics where patients may be higher-risk or more likely to have already developed symptoms of HIV infection (CDC, 2006b; KFF, 2009b). CDC Revised HIV Testing Guidelines The 2006 CDC HIV testing guidelines recommend routine opt-out HIV screening in health care settings of individuals between the ages of 13 and 64, unless prevalence of undiagnosed HIV infection in that setting is documented to be less than .1 percent.8 The guidelines also recommended yearly screening for individuals in high-risk groups,9 and that opt-out HIV screening be included in the routine panel of prenatal screening tests for pregnant women (CDC, 2006c).10 (See Box 2 for key definitions.) The 2006 CDC guidelines differed from previous guidelines in several ways including recommending that testing be done on an opt-out basis whereby testing is done after notifying the patient unless he or she declines; that general consent for care should be considered sufficient for HIV testing and that separate written consent for testing should not be required; and that pretest counseling should not be a requirement for HIV testing (CDC, 2006c).11 In their rationale for the new guidelines, the CDC cited research showing that testing on the basis of risk behaviors has failed to identify a substantial number of HIV-infected individuals, even among people who visit health care providers (Alpert et al., 1996; Klein et al., 2003; Liddicoat et al., 2004), and the changing demographics of the HIV epidemic to in- 7 Publicly-funded sites include health care settings (such as public health department clinics, drug treatment facilities, family planning clinics, prenatal clinics, STD clinics, community health clinics) and non-health care settings (AIDS clinic/counseling and testing sites). 8 The guidelines go on to state that in the absence of existing data on the prevalence of HIV infection, health care providers should initiate screening until they establish that the diagnostic yield is under 1 per 1,000 individuals screened (CDC, 2006c). 9 High-risk groups as defined in the current CDC guidelines are injection drug users and their sex partners, persons who exchange sex for money or drugs, sex partners of HIV infected persons, men who have sex with men, and heterosexual persons who themselves or their sex partners have had >1 sex partner since their last HIV test (CDC, 2006c). 10 Separate guidelines are being developed by CDC for non-health care settings. See http://www.cdc.gov/hiv/topics/testing/resources/other/consultation.htm. 11 Prior guidelines from the CDC recommended routine counseling and testing for persons at high risk for HIV and for those in acute-care settings where HIV prevalence was ≥1 percent (CDC, 1993, 2001). The current USPSTF guidelines strongly recommend screening of high risk groups and make no recommendation for or against routine screening of those who are not at increased risk for HIV (USPSTF, 2007).
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HIV Screening and Access to Care: Exploring Barriers and Facilitators to Expanded HIV Testing BOX 2 Key Definitions Targeted HIV testing: Performing an HIV test for subpopulations of persons at higher risk, typically defined on the basis of behavior, clinical, or demographic characteristics. Diagnostic HIV testing: Performing an HIV test for persons with clinical signs or symptoms consistent with HIV infection. HIV screening: Performing an HIV test for all persons in a defined population. Opt-out screening: Performing HIV screening after notifying the patient that (1) the test will be performed and (2) the patient may elect to decline or defer testing. Assent is inferred unless the patient declines testing. Informed consent: A process of communication between patient and provider through which an informed patient can choose whether to undergo HIV testing or decline to do so. Elements of informed consent typically include providing oral or written information regarding HIV, the risks and benefits of testing, the implications of HIV test results, how test results will be communicated, and the opportunity to ask questions. HIV-prevention counseling: An interactive process of assessing risk, recognizing specific behaviors that increase the risk for acquiring or transmitting HIV, and developing a plan to take specific steps to reduce risks. SOURCE: Branson et al., 2006. clude more individuals such as women, people who live outside of cities, heterosexual men and women, and others who may not be aware they are at risk (CDC, 2006c). The CDC’s HIV testing recommendations differ from the current USPSTF guidelines, which recommend routine screening for pregnant women and high-risk groups, and make no recommendation for or against routine screening for adolescents and adults who are not known to be at increased risk for HIV infection (USPSTF, 2007). Despite widespread agreement that knowing one’s HIV status is critical and that increased testing is needed, a number of concerns have been expressed about the CDC guidelines and opt-out testing. For example, some have argued that one of the best opportunities to provide prevention counseling and information, which has been found in several intervention studies to prevent HIV infection, is at the HIV testing encounter and cite less counseling before and after testing as a major drawback to the revised CDC guidelines (for example, Holtgrave and McGuire, 2007). In addition,
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HIV Screening and Access to Care: Exploring Barriers and Facilitators to Expanded HIV Testing the costs and consequences of routine testing relative to other prevention strategies are not yet well understood (Holtgrave, 2007). As will be described later in the report, several ethical concerns have also been raised about opt-out HIV testing and the removal of the requirement for specific written consent. Nevertheless, there is widespread interest in the potential benefits of a more comprehensive testing and treatment strategy. Thus, it is important to understand the facilitators and barriers to the implementation of such a program. PUBLIC WORKSHOP AND LITERATURE REVIEW In the following sections, the committee summarizes expert presentations and discussions at the first public workshop and information from policy documents and research literature relevant to the questions posed to the committee. The committee attempted to provide evidence supporting the assertions made by experts, but in many cases there are not studies addressing these issues. Therefore, unless supported by relevant studies, testimony provided by expert witnesses on barriers to HIV testing should be interpreted as opinion by knowledgeable individuals that has not been verified. Laws, Health Coverage Policies, and Other Policies That Impede HIV Testing The first specific question posed to the committee was “What are the current federal and state laws, private health coverage policies, and other policies that impede HIV testing?” Laws and policies that can impede HIV testing include state legal requirements for HIV testing; discordant federal HIV testing recommendations; public and private health insurance policies; policies inhibiting use of rapid HIV tests; and policies and practices in corrections settings. A lack of programs and policies to promote clinician education and training and reduce constraints on practice environments, as well as policies to reduce HIV stigma and discrimination, are also barriers to expanded HIV testing. State Legal Requirements for HIV Testing State laws, in particular written informed consent and pretest counseling laws, are often cited in the discussion about barriers to routine HIV testing per the CDC’s revised HIV testing guidelines (GAO, 2009; Mahajan et
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HIV Screening and Access to Care: Exploring Barriers and Facilitators to Expanded HIV Testing al., 2009). Since the release of the CDC’s revised recommendations in 2006, restrictions on HIV testing and informed consent requirements have been removed in a number of states, and other states have proposed legislation to remove these requirements (CDC, 2009d). In the 2 years following the release of the revised guidelines, nine states passed laws that moved them from inconsistent to consistent with CDC’s recommendations (Mahajan et al., 2009). Laura Bogart of Harvard University described the continuing variation across states with regard to requirements for pretest counseling and written informed consent. Five states require written informed consent for HIV testing, and at least six states require pretest counseling (see Table 2). Additional states require that pretest counseling or written informed consent be provided under certain testing conditions. For example, in Colorado, written informed consent and pretest counseling are required for HIV testing provided at public health testing sites (NCCC, 2010). Carlos del Rio of Emory University pointed out that even when a state’s HIV testing laws are changed, hospitals within the state do not necessarily change their practices. For example, the state of Georgia does not require written informed consent for HIV testing, but does require that a patient consent to an HIV test and that all individuals be counseled before and after testing. For legal protections, hospitals may continue to administer written consent to provide proof that the clinician has consented the patient. All 50 U.S. states and the District of Columbia allow minors to consent for sexually transmitted disease (STD) services, but several do not explicitly include HIV testing and treatment among these services (Guttmacher Institute, 2010). Some states have specific provisions requiring that minors be at least 14 years old to consent for HIV testing (see Table 2). In South Carolina, minors must be at least 16 years old to consent for HIV testing, and in Montana only emancipated minors can consent for testing. Several states allow, but do not require, physicians to inform a minor’s parent or guardian of HIV test results. In Iowa, a physician must notify the parent or guardian if a minor tests HIV positive (NCCC, 2010). Donna Futterman of the Albert Einstein College of Medicine identified confidentiality and consent concerns as being particularly problematic for adolescents and youth. Although young people have legal rights and protections, many providers and youth may be unaware of them. Some studies have shown that the availability of anonymous HIV testing, where a code is used rather than an individual’s name, can facilitate HIV testing (Lansky, 2002; Tesoriero et al., 2008). However, several states have legal requirements prohibiting anonymous HIV testing (see Table 2) (KFF and NASTAD, 2009; NCCC, 2010). States also regulate who can perform HIV testing, including who can order HIV tests and withdraw blood. Rear Admiral Scott Giberson of the Indian Health Service (IHS) described variation in state laws regarding
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HIV Screening and Access to Care: Exploring Barriers and Facilitators to Expanded HIV Testing appropriate social marketing messages and testing venues (Bucher et al., 2007; Erausquin et al., 2009; Galvan et al., 2006; Olshefsky et al., 2007; Rhodes et al., 2009). Strategies That Encourage HIV Testing by Providers Horberg identified two interventions that could greatly facilitate HIV testing by providers: (1) the establishment of a standard of care regarding HIV screening by national credentialing and accreditation bodies and (2) the development and adoption of quality metrics based on HIV testing and/or early detection. At present, there are no such nationally accepted metrics on HIV testing, such as measures in the Healthcare Effectiveness Data and Information Set (HEDIS) or the Physician Quality Reporting Initiative. Horberg described how the Veterans Administration and Kaiser Permanente are recording the stage of disease at time of HIV diagnosis as a quality measure related to HIV testing. He suggested that process measures be developed for monitoring the quality of care, such as retention in care, CD4 cell counts, appropriate Pneumocystis jirovecii pneumonia (PJP) (formerly known as Pneumocystis carinii) prophylaxis and ART, and immunization for influenza, pneumococcus, and Hepatitis B. HIV ribonucleic acid (RNA) control is an outcome quality measure that could be considered. Testing for HIV alone or concurrent with testing for other STDs could also serve as a performance standard. Carmichael suggested that issues pertaining to HIV testing be better integrated into postgraduate and continuing medical education. Clinicians may fail to perform HIV risk assessments for a variety of reasons, including comfort level with sexual health discussions, time constraints and competing demands, among other reasons. Some research shows that it is possible to change providers’ behavior to increase risk assessment and discussions regarding STD or HIV risk with patients using a systems approach (Bluespruce et al., 2001; Dodge et al., 2001). For instance, a systematized intervention of trainings that addressed knowledge needed for HIV prevention interactions with patients, identified specific roles for care team members, and used reinforcing factors, such as monthly HIV prevention updates, significantly improved how often providers performed HIV-risk assessments and counseling of patients in primary care (Dodge et al., 2001). Workshop participants also described administrative strategies such as the use of computer aids and other tools to reduce provider-side barriers to HIV testing. Branson mentioned an effective CDC-supported initiative at Jacobi Medical Center in the Bronx, New York, called Project B.R.I.E.F., that used portable kiosks to streamline HIV counseling in a high-volume ED (Calderon et al., 2009). Futterman suggested that a new paradigm is
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HIV Screening and Access to Care: Exploring Barriers and Facilitators to Expanded HIV Testing needed so that HIV testing is viewed in the same manner as the H1N1 vaccine and incorporated into routine medical care. She described a protocol that was developed by the Adolescent AIDS Program at Montefiore Medical Center in New York and the New Jersey AETC to facilitate HIV testing and streamline counseling. The approach, called “Advise, Consent, Test, and Support,” has been found to facilitate improvements in HIV testing in both clinical and community-based settings (AHRQ, 2010) (see Figure 4).26 FIGURE 4 ACTS pocket guide. SOURCE: Futterman et al., 2004. 26 For more information see http://www.aids-ed.org/pdf/p03-cf/acts/ACTS-total.pdf.
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HIV Screening and Access to Care: Exploring Barriers and Facilitators to Expanded HIV Testing Wheeler stated that increased community-based and culturally sensitive care could facilitate HIV testing for some populations, such as black and African American MSM. Randall suggested that patient/client attitudinal barriers could also be addressed through enhanced provider training and education programs. Such programs could improve providers’ cultural competence and communication skills related to risk behaviors and attitudes that limit acceptance of HIV tests. Blank pointed out that individuals coming from the community in which patients reside may be viewed as less threatening and without the “social distance” often seen between patients and their physicians. He went on to describe how community health workers and health care paraprofessionals (e.g., certified nurse assistants, etc.) may be needed to reach and provide care to the estimated 30 million currently uninsured individuals who will have health insurance and better access to care following the implementation of health reform. Strategies to Increase HIV Testing in Corrections Settings Flanigan identified corrections, particularly jails, as providing great opportunities for the expansion of HIV/AIDS interventions within high-risk groups. Devon Brown, the head of the District of Columbia Department of Corrections since 2006, characterized the corrections system as the nexus between public safety and public health and as an optimal environment in which to routinely test clients for HIV. Models for routine jail-based HIV testing are emerging. The committee heard from Flanigan of the experience in Rhode Island where from 2000 to 2007, 169 new cases were identified, representing 15.3 percent of all new diagnoses within the state. Risk assessment conducted as part of this jail-based screening program found that 76 percent of those testing positive did not consider themselves to be at risk for HIV despite reporting risk behaviors. Rapid testing has also been mainstreamed in jails in four CDC-funded states (Florida, Louisiana, New York, Wisconsin). In this project, 269 of 33,211 jail detainees (or .08 percent) tested for HIV in jails during 2004 to 2006 were newly identified with HIV. Almost half (46 percent) of these new diagnoses were among persons with heterosexual risk or no reported risk. Brown described the automatic HIV testing program that has been instituted in the District of Columbia, which has become an award-winning model that other corrections systems have attempted to replicate. All entries into the corrections system are given the opportunity to be tested for HIV, other STDs, and TB, and are tested unless they refuse. Most clients are African American males, a group with high rates of HIV and often without access to primary care. Brown highlighted the successes of the program—87 percent of clients agree to be tested. Some of those who refuse
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HIV Screening and Access to Care: Exploring Barriers and Facilitators to Expanded HIV Testing testing already know of their HIV-positive status. Any inmate who refuses testing without knowledge of his or her HIV status is counseled and encouraged to be tested. Individuals who test positive also receive counseling. An additional HIV screening is routinely administered as inmates are released. Sexual activity within the jail is acknowledged, and condoms are provided through the facility. A distinctive aspect of the program is that the same medical providers within the prison are available to inmates following their discharge from prison. A private organization provides health care within the prison and in 34 clinics throughout the city. HIV-positive individuals are provided with a 30-day supply of “bridge” medications to allow them time to get into community-based care. Two case managers are available to encourage appropriate follow-up. Privacy and Discrimination Laws Federal and state laws have been established to protect health information, including information about HIV testing. The Privacy Rule under HIPAA, for example, sets rules and limits on who can look at and receive an individual’s health information (HHS, 2010).27 In addition, most states have HIV-specific privacy laws in place, many of which offer greater protections than the HIPAA privacy rule. Under these privacy laws, health information can be disclosed without authorization from the individual only in certain circumstances, including but not limited to health oversight and for public health purposes. The existence of confidentiality protections may help to facilitate HIV testing for some individuals (Chou et al., 2005; Ford et al., 2008). The Supreme Court affirmed an interpretation of the Americans with Disabilities Act (ADA) that broadly protects persons with disabilities, which includes individuals with HIV. In their first review of a case involving HIV, the court ruled that health care professionals can legally refuse to offer health care services to a patient only if there is objective, scientific data for concluding there is a significant health threat to the safety of the provider (Gostin et al., 1999). Individuals with HIV are protected from discrimination in employment, use of public accommodations (such as use of hospitals, schools, etc.), and by state and local governments under the ADA. The ADA also offers such protections to persons who are discriminated against because they are regarded as being HIV positive and persons who have a 27 Covered entities are health plans (e.g. health insurance companies, HMOs, Medicare and Medicaid, etc.); health care providers, including Ryan White Care Act grantees, who transmit health information electronically in connection with a transaction for which HHS has adopted a standard; and health care clearinghouses (HHS, 2010).
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HIV Screening and Access to Care: Exploring Barriers and Facilitators to Expanded HIV Testing known association or relationship with an individual who is HIV positive. Individuals with both asymptomatic and symptomatic HIV are considered to be disabled under the ADA (DOJ, 2004). Webber and Gostin (2000) note the argument of some commentators that “despite the apparent protection of federal law, states have a significant role in addressing HIV-based discrimination.” There is, however, a great deal of variation in coverage of HIV in state statutes. A recent review of state disability laws was not available to the committee. A review of state disability laws in 1999 concluded that the states can be divided into three categories, depending on their state level statutes. First, there are states with clearly specified protections for people infected with HIV. Second, there are the states that base their antidiscrimination statutes on the federal definition of disability, allowing a reasonable inference that HIV is covered under disability laws. And third, there are several states that provide little to no protection for HIV-infected residents. The ADA and state disability laws may help to counteract HIV discrimination, although they clearly cannot prevent all cases of HIV discrimination. Efforts to increase testing highlight the need to better assess and improve the effectiveness of laws and institutions addressing HIV discrimination. Gostin and colleagues note that judicial inquiry should primarily focus not on whether individuals are disabled, but on whether they have experienced discrimination because of their health status (Gostin et al., 1999). Conclusions Several strategies show promise for increasing identification of individuals with HIV, including rapid HIV testing (including in community settings); partner notification for identifying individuals who are undiagnosed and at high risk for HIV; social network strategies (further research may be needed to account for the potential bias in studies due to repeat testing by individuals already aware of their HIV status); integration of HIV testing with other services, such as testing for other STDs; and HIV/AIDS campaigns. Strategies that might help to promote HIV testing by providers, include the establishment of standards of care and quality metrics based on HIV testing or early detection of HIV; provider education and training related to cultural competency and communication with patients about risk behaviors; and administrative strategies to help streamline counseling and testing in busy practice environments. Corrections settings provide an excellent public health opportunity for HIV testing and successful models can be replicated broadly with appropriate resources and leadership.
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HIV Screening and Access to Care: Exploring Barriers and Facilitators to Expanded HIV Testing Efforts to increase HIV testing highlight the need to better assess and improve the effectiveness of laws and institutions in addressing HIV discrimination. Impact of Opt-Out HIV Testing The third specific question posed to the committee was “What has been the impact of opt-out HIV testing?” Branson described how the CDC’s 2006 updated guidance on HIV testing attempted to counter some of the barriers to testing experienced by clinicians, such as the administration of prevention counseling and written informed consent, by recommending that HIV testing be conducted routinely and on an opt-out basis. The CDC defines opt-out testing as notifying a patient that testing will be performed unless he or she declines or defers testing. The revised recommendations specify that HIV testing become routine when the expected yield within the facility or community was greater than 1 positive diagnosis per 1,000 tested (Branson et al., 2006). As discussed previously, most states have HIV testing laws that are consistent with the CDC’s opt-out HIV testing guidelines, while a few require written informed consent. Since the publication of the revised CDC recommendations, several studies conducted in settings such as Veterans’ Affairs Medical Centers, EDs, and community health clinics have demonstrated that patients are accepting of opt-out HIV testing (e.g., Bokhour et al., 2009; Burrage et al., 2008; Freeman et al., 2009; Haukoos et al., 2008; Minniear et al., 2009). One study of routine opt-out HIV testing in an urban community health center found that just 35 percent of 300 patients told they “would be tested for HIV unless they declined testing” agreed to be tested, however (Cunningham et al., 2009). Fewer studies have evaluated the effects of the presence or absence of informed consent requirements on HIV testing rates or the identification of individuals with HIV. There is some evidence that increased HIV testing has occurred where the written informed consent process was simplified or eliminated. A 2009 study of respondents to the 2004 Behavior Risk Factor Surveillance System survey found that residents in states with written informed consent statutes were somewhat less likely to report having been tested for HIV in the past 12 months (OR = .85; 95 percent CI = .80, .90). The association was significant among respondents who were non-Hispanic white (OR = .77; 95 percent CI = .71, .82) or Asian (OR = .73, 95 percent CI = .53, .99), but not for respondents who were non-Hispanic black (OR = .99; 95 percent CI = .86, 1.14) or Hispanic (OR = 1.14; 95 percent CI = .94, 1.40). In addition, the association of the requirement for written informed consent was greater among respondents who had graduated from college or technical school (OR = .79; 95 percent CI = .72, .88
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HIV Screening and Access to Care: Exploring Barriers and Facilitators to Expanded HIV Testing for college/technical school graduates) than for non-high school graduates (OR = 1.06; 95 percent CI =.86, 1.31) (Ehrenkranz et al., 2009). Bogart and Tsoi noted a study of HIV testing in the San Francisco Department of Health Medical Care System that found the average monthly rate of HIV tests per 1,000 patient-visits increased by 4.38 (or 44 percent) over a 12-month period following elimination of a policy requiring patient written consent for testing. Populations facing the highest barriers to testing (such as men, the homeless, and the uninsured) experienced the highest increases in monthly HIV testing rates. The monthly average number of new positive HIV tests also increased, from 8.9 to 14.9 infections identified per month (Zetola et al., 2007, 2008). del Rio cited a recent study that found that the probability of diagnosis of HIV-positive individuals in 2006 was 24.9 percent in states with opt-out consent laws compared with 19.9 percent in states with opt-in consent laws (April, 2009). Using these testing rates in a mathematical model,28 the study authors concluded that the mean lifespan of people with HIV was higher in opt-out compared with opt-in states (801.2 months compared with 792.1 months, respectively). Implementation of opt-out testing nationwide was estimated to produce 549,437 life-years saved over the lifetime of the current HIV-positive population (April, 2009). In one of the largest studies of opt-out HIV testing to date, nontargeted opt-out HIV screening in an ED was associated with a modest increase in the number of patients newly diagnosed with HIV infection, compared with physician-directed diagnostic HIV testing. The prevalence of new HIV diagnoses in the opt-out phase (including those diagnostically tested) and in the diagnostic phase was 15 in 28,043 (.05 percent) and 4 in 29,925 (.01 percent) respectively. Nontargeted opt-out screening did not increase identification of patients earlier in the course of disease, however; the median CD4 cell count for those with new HIV diagnoses in the opt-out phase (including those diagnostically tested) and in the diagnostic phase was 69/µL and 13/µL, respectively, suggesting that patients in both groups were identified late in the course of disease (Haukoos et al., 2010).29 Studies on HIV testing in pregnant women have shown that an opt-out approach can increase testing among pregnant women, increase the number of HIV-infected women who are offered treatment, and reduce mother-to-child transmission (CDC, 2008c). Cramer described the success of opt-out testing as part of the Expanded Testing Initiative (ETI), implemented in 2007. As part of this program, $111.2 million was allocated to 25 jurisdictions to target HIV testing to 28 The model assumed a .09 percent prevalence of undiagnosed infection, .02 percent annual HIV incidence rate, and treatment efficacy based on studies of ART (April, 2009). 29 The CD4+ T-cell count (or CD4 count) serves as the major clinical indicator of immune function in patients who have HIV infection.
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HIV Screening and Access to Care: Exploring Barriers and Facilitators to Expanded HIV Testing FIGURE 5 Implementation of opt-out testing in health care settings by 65 state, territorial, and local health departments after the Expanded Testing Initiative (as of February 2008). * = ≥ 80 percent increase. NOTE: ED = emergency department, OB = obstetrics, STD = sexually transmitted diseases, Sub Abuse TX = substance abuse treatment, TB = tuberculosis. SOURCE: Adapted from KFF and NASTAD, 2009. African Americans with the goals of conducting 1.5 million HIV tests to identify 20,000 new HIV positive individuals (NASTAD, 2009). Figure 5 shows implementation of opt-out testing in health care settings by state, territorial, and local health departments as of February 2008, after the ETI was implemented. Integration of pretest counseling and separate written informed consent for HIV testing into practice may be challenging for providers in terms of time and staffing needs. In his presentation on barriers to HIV testing in emergency departments, Jeremy Brown described the potential challenges of meeting state requirements for pretest counseling and informed consent in hectic emergency department settings, where providers often do not have much time to interface with patients. He noted that it used to be the case under Maryland law, for example, that more than 30 separate issues had to be discussed before an HIV test could be performed (Brown, 2008).30 This law has since been changed to simplify the testing process. 30 See Code of Maryland Regulations (COMAR) 10.18.08.06. Requirements for pretest counseling. B(3)(a)–(q).
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HIV Screening and Access to Care: Exploring Barriers and Facilitators to Expanded HIV Testing The Ethics of Opt-Out HIV Testing In the mid-1980s, when HIV antibody tests became widely available, there was debate between those who asserted that the threat of the HIV epidemic justified wide-scale routine testing and those who saw in the new diagnostic assay a grave threat to the privacy of individuals with or at-risk for HIV infection. At that time, when there was little that medicine could offer people with HIV, and discrimination threatened to deny people with HIV the opportunity to work, to go to school, and to obtain life and health insurance, the HIV antibody test was viewed by many in the HIV/AIDS activist community, and by many ethicists, to have substantial risks that were not justified by the benefits of testing (Bayer and Edington, 2009; Gostin, 2006). It was in this context that exacting standards of consent for HIV testing were developed. Careful pretest counseling was deemed essential to inform those who might be tested about both the risks and the benefits of testing. Individuals, it was argued, should be given the opportunity to provide explicit consent and to assert that they wanted to be tested. Such consent should be documented in a written form. That approach to diagnostic testing was very different from the approach to other clinical encounters where it was assumed that a request for care and treatment by patients entailed a willingness to be subject to appropriate diagnostic testing. But in the mid-1980s, AIDS was widely viewed as different from other medical conditions. The disease was considered “exceptional” and to require policies and practices that were “exceptional” (Bayer and Fairchild, 2006). Dramatic transformations in therapeutic prospects for people with HIV disease, a less hostile social climate, and the recognition that upward of 21 percent of those with HIV infection remain unaware of their status have radically altered the context of HIV testing. Starting with availability of effective treatment and the fact that the effective clinical management of HIV infection requires early identification, and that the prevention of HIV transmission necessitates a reduction in the number of individuals who are unaware of their HIV status, some began to assert that the standards of consent that defined HIV testing in the earliest stages of the HIV epidemic should be rethought (Bayer and Fairchild, 2006). The decision on the part of the CDC in 2006 and subsequent action by states to substitute opt-out for written consent to HIV testing sparked an important debate about the ethics of HIV testing and screening in clinical settings. The ethical challenge addressed in this more recent discussion is whether an opt-out approach to testing is compatible with fundamental principles of biomedical and public health ethics. Proponents of moving to an opt-out approach to consent have argued that such a standard would facilitate testing and identification of indi-
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HIV Screening and Access to Care: Exploring Barriers and Facilitators to Expanded HIV Testing viduals with HIV by reducing the provider burden of administration of HIV-specific written informed consent (Das-Douglas et al., 2008). In addition, by removing the assessment of sexual and drug using risk for HIV, routine testing may help to reduce the stigma associated with HIV testing (Earnshaw and Chaudoir, 2009). Advocates for opt-out HIV testing have also asserted that the ethics of public health warrants an approach to testing that, by increasing the proportion of the infected who know their status, could result in behavioral change and increased timely initiation of care, thus improving health outcomes for individuals diagnosed with HIV and reducing transmission (Gostin, 2006). Opponents of the shift to opt-out testing have challenged the interpretation of available evidence that suggests that written consent is an impediment to expanded HIV testing. For example, it has been argued that there is insufficient evidence to make the claim that the interests of individuals and the public’s health are compromised by written consent. Furthermore, opponents of opt-out approaches have noted that such approaches begin with an assumption of an “informed right of refusal” where individuals would be told that they would be tested unless they refused, but would ultimately end with situations where individuals would be routinely tested without being told that that was the standard of care. Under those circumstances the “right of refusal” would in fact be dependent on foreknowledge about testing and of the right to say no. Such routinely undertaken testing would, it is argued, be voluntary in name only (ACLU, 2007). Others have questioned the value of an opt-out HIV testing framework unless access to care can be ensured for all individuals who are newly identified as HIV positive (Hanssens, 2007). Conclusion While further research is needed, available studies suggest that routine opt-out HIV testing can facilitate HIV testing, probably by reducing some of the administrative barriers to testing experienced by clinicians. Bodies considering adoption of opt-out HIV testing might consider the ethical pros and cons of opt-out testing that have been identified by ethicists and advocates. CLOSING REMARKS Expanded HIV testing would help to reduce the number of individuals in the United States who are unaware that they are infected, and thereby facilitate earlier care and better clinical outcomes for those individuals, as well as reduce HIV transmission. Several laws, policies, and procedures in settings where HIV tests are administered may impede expanded HIV test-
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HIV Screening and Access to Care: Exploring Barriers and Facilitators to Expanded HIV Testing ing. The absence of programs and policies to support clinician education and training on HIV testing and to reduce HIV-related stigma and discrimination are also barriers to expanded HIV testing. There are evidence-based approaches to facilitate HIV testing that may be considered as part of an expanded HIV testing strategy. Before implementation of a program of expanded HIV testing, consideration should be given to whether individuals who are diagnosed as HIV positive can be provided timely access to care. Federal and state policies and private health insurance policies/practices that inhibit entry into clinical care or the provision of continuous and sustained clinical care for individuals with HIV will be explored in the committee’s second report.