2


Indicators Related to Continuous HIV
Care and Access to Supportive Services

This chapter addresses the committee’s charge to “provide recommendations for the most critical data and indicators to gauge the impact of the National HIV/AIDS Strategy (NHAS) and the Patient Protection and Affordable Care Act (ACA) in improving HIV/AIDS care” in the United States (statement of task). The chapter presents the committee’s choice of core and additional indicators related to continuous HIV care and access to supportive services, such as housing, for people living with HIV/AIDS (PLWHA); the process by which the committee identified and prioritized the indicators; the committee’s rationale for selecting each indicator; and the data (elements) needed to measure the indicators. The committee recognizes the importance of efforts to increase access to HIV testing and the number of HIV-infected individuals who are aware of their serostatus (IOM, 2010, 2011b,c), as well as the need to reduce the transmission of HIV through efforts to reduce risk behaviors among all persons. Based on its statement of task, however, the committee focused its attention on linkage and access to and provision of appropriate HIV care and related supportive services for people already diagnosed with HIV/AIDS.1

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1Although the committee did not focus on indicators specifically related to reducing the transmission of HIV by people in care for HIV (e.g., condom use), some indicators, such as those related to undetectable viral load, also promote transmission reduction. Preliminary results from a large HIV Prevention Trials Network randomized clinical trial (HPTN 052) indicate that early use of antiretroviral therapy (ART) in PLWHA reduces sexual transmission of HIV to an uninfected partner by 96 percent (Cohen et al., 2011). Likewise, the committee did specifically address the use of ART to reduce mother-to-child transmission in pregnant women with HIV as part of the prenatal care provided to HIV-infected pregnant women.



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2 Indicators Related to Continuous HIV Care and Access to Supportive Services This chapter addresses the committee’s charge to “provide recommen- dations for the most critical data and indicators to gauge the impact of the National HIV/AIDS Strategy (NHAS) and the Patient Protection and Affordable Care Act (ACA) in improving HIV/AIDS care” in the United States (statement of task). The chapter presents the committee’s choice of core and additional indicators related to continuous HIV care and access to supportive services, such as housing, for people living with HIV/AIDS (PLWHA); the process by which the committee identified and prioritized the indicators; the committee’s rationale for selecting each indicator; and the data (elements) needed to measure the indicators. The committee recognizes the importance of efforts to increase access to HIV testing and the number of HIV-infected individuals who are aware of their serostatus (IOM, 2010, 2011b,c), as well as the need to reduce the transmission of HIV through efforts to reduce risk behaviors among all persons. Based on its statement of task, however, the committee focused its attention on linkage and access to and provision of appropriate HIV care and related supportive services for people already diagnosed with HIV/AIDS.1 1 Although the committee did not focus on indicators specifically related to reducing the transmission of HIV by people in care for HIV (e.g., condom use), some indicators, such as those related to undetectable viral load, also promote transmission reduction. Preliminary results from a large HIV Prevention Trials Network randomized clinical trial (HPTN 052) indicate that early use of antiretroviral therapy (ART) in PLWHA reduces sexual transmission of HIV to an uninfected partner by 96 percent (Cohen et al., 2011). Likewise, the committee did specifically address the use of ART to reduce mother-to-child transmission in pregnant women with HIV as part of the prenatal care provided to HIV-infected pregnant women. 39

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40 MONITORING HIV CARE IN THE UNITED STATES The chapter also discusses different types of data relevant to patient care and their usefulness for evaluating the continuity (and quality) of HIV care and access to supportive services. The relative merits of each type of data are discussed, as well as whether the differences among data types (in particular claims data and clinical data) “encompass gaps in measures for HIV care” (statement of task question 1b). The chapter ends with the committee’s conclusions and recommendations for “the most critical data and indicators for gauging the impact of the National HIV/AIDS Strategy (ONAP, 2010) and the Patient Protection and Affordable Care Act [P.L. 111-148] in improving HIV/AIDS care.” INDICATORS OF CLINICAL HIV CARE AND ACCESS TO MENTAL HEALTH, SUBSTANCE ABUSE, AND SUPPORTIVE SERVICES The Institute of Medicine (IOM) letter report Leading Health Indica- tors for Healthy People 2020 (IOM, 2011d, p. 8) defined the term “indica- tor” as “a measurement” and “leading health indicators” as “quantitative expressions of health-related concepts that reflect major public health con- cerns.” For the purposes of the present report, indicators of HIV care and access to supportive services are defined as quantitative expressions (measurements) pertaining to the state of HIV care and the availability of supportive services for PLWHA (and subgroups thereof) in the United States. “Core indicators” are those indicators deemed by the committee to be fundamental both to assessing the extent to which persons diagnosed with HIV are connected to appropriate medical care, are maintained in care over time, and have access to needed supportive services in the United States and to gauging the impact of the NHAS and the ACA in improving HIV/AIDS care. Indicators may include process measures and outcome measures. Pro- cess measures pertain to processes of care, such as regular visits for routine care, lab tests and screening performed, and therapies initiated. Outcome measures pertain to the actual health outcomes or status of patients. Mor- tality and morbidity are ultimate outcome measures for tracking access to quality HIV care for people diagnosed with HIV. Intermediate outcome measures include CD4+ T-cell counts (CD4 counts) and plasma HIV RNA levels (viral loads), which reflect disease progression and infectivity. Pro- cess measures are important indicators of quality of care and treatments received, which research has shown are directly associated with good clini- cal outcomes (Kitahata, 1996; Kitahata et al., 2000, 2003; Landon et al., 2005). For example, regular monitoring of CD4 counts implies good- quality HIV care, with the expectation of good outcomes. Indicators often are defined in terms of a percentage, proportion, or other relative measure and are not synonymous with the data elements

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41 INDICATORS necessary to assess them. Multiple data elements may be required to gener- ate an indicator. For example, “the proportion of PLWHA in the United States who have a CD4+ cell count above X” is an indicator, while the data needed to assess that indicator are CD4 counts (specifically the number of people with a CD4+ cell count above X) and the total number of HIV- infected individuals in the United States. Background A number of important sets of performance measures (Horberg et al., 2010), health objectives (HHS, 2010), and indicators (PEPFAR, 2009) re- lated to HIV screening and care have been developed or revised in recent years. The NHAS also identifies several specific targets, in addition to its three general goals of “reducing the number of people who become in- fected with HIV; increasing access to care and optimizing health outcomes for people living with HIV; and reducing HIV-related health disparities” (ONAP, 2010, p. 1). These sources provide a basis for the committee’s development of a set of indicators for measuring HIV care and access to mental health, substance abuse, and supportive services in the United States (Appendix Table 2-1).2 HIV Care Quality Measures Michael Horberg and colleagues (2010) describe the development of a set of 17 performance measures for HIV care (Table 2-1), most of which have been endorsed by the National Quality Forum (NQF), a nonprofit or- ganization that sets national consensus standards on performance in health care (see NQF, 2011a). The measures represent a consensus among members of a working group of experts convened by the National Committee for Quality Assur- ance, in conjunction with the Health Resources and Services Administration (HRSA), the Physician Consortium for Performance Improvement of the American Medical Association, and the HIV Medicine Association of the Infectious Diseases Society of America. The effort to produce a single set of 2 All indicators considered by the committee are population-aggregated individual measures, such as the proportion linked to care within 3 months of diagnosis and mortality rate. The committee recognizes the importance of system-level indicators, such as the structural dimensions of system comprehensiveness, capacity, integration, and accessibility described in the Health Resources and Services Administration (HRSA) System Assessment Project (Conviser, 2007). System-level indicators are important because they are related to getting diagnosed individuals linked to, engaged in, and retained in care. However, the committee understood its charge to be recommendations for indicators to measure the quality as well as the continuity of HIV care received by PLWHA in the United States.

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42 MONITORING HIV CARE IN THE UNITED STATES TABLE 2-1 HIV Care Quality Measures Level of Care Impacteda Level of Evidenceb Measure Process of care 1. Retention in care (seen at least twice P Level II and QM annually at least 60 days apart) 2. CD4+ cell count measurement (mea- P Level II and QM sured at least twice annually) Screening 3. Gonorrhea/chlamydia screening (at least P Level II once) 4. Syphilis screening (annually) P Level II and QM 5. Injection drug use screening (annually) P Level II 6. High-risk sexual behavior screening P Level I and QM (annually) 7. Tuberculosis screening (at least once) P Level I and QM 8. Hepatitis B screening (at least once) P Level III and QM 9. Hepatitis C screening (at least once) P Level III and QM Immunization 10. Influenza immunization (annually) B Level III 11. Pneumococcal immunization (at least B Level II and QM once) 12. Hepatitis B vaccination first dose re- P Level II and QM ceived (if appropriate) 13. Hepatitis B vaccination series completed S Level II and QM (if appropriate) Prophylactic therapy 14. PCP prophylaxis if CD4+ cell count B Level I and QM <200 cells/µL ART prescription 15. Appropriately prescribed ART P Level I and QM Viral control (at least 6 months post-ART initiation) 16. Achieving maximal viral control if S Level II and QM prescribed ART 17. Achieving maximal viral control if P Level II and QM prescribed ART or treatment plan documentation if maximal viral control not achieved NOTE: ART, antiretroviral therapy; PCP, Pneumocystis jiroveci pneumonia. aLevels of care are as follows: P, physician; S, system; B, both. bLevels of evidence are as follows: I, evidence from ≥1 randomized controlled trial; II, evidence from ≥1 clinical trial, multiple cohort studies, or multiple times series or dramatic results of uncontrolled experiments; III, expert opinion only; QM, previous quality measure data indi- cating gaps in care. SOURCE: Adapted from Horberg et al., 2010, Table 1.

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43 INDICATORS national performance standards for HIV care was precipitated by a prolif- eration of HIV performance measures developed by different bodies over a number of years (Horberg et al., 2010)3 and heeds the call from the 2004 IOM report Measuring What Matters: Allocations, Planning, and Quality Assessment for the Ryan White CARE Act for a standard set of quality measures that are applicable across the range of delivery systems (IOM, 2004). Most of the performance measures endorsed by NQF are process measures. Research has shown that patients who receive more routine of- fice visits; appropriate initiation and prescription of antiretroviral therapy (ART); and appropriate screenings, prophylaxis, and immunizations have better outcomes than those who do not (Kitahata, 1996; Kitahata et al., 2000, 2003; Landon et al., 2005).4 However, other factors (e.g., untreated non-HIV comorbidities, including mental illness; contextual factors such as food and/or housing insecurity) can result in poorer outcomes even under conditions of the most expert care and perfect treatment adherence. For this reason, outcome measures (e.g., the results of CD4 counts, mortality) are more definitive markers of successful management of HIV disease, al- though even with outcome indicators there are numerous factors that can affect HIV quality care and may not be able to be assessed. In addition, despite their usefulness, outcome measures generally are more difficult to obtain than process measures, although the increasing use of electronic health records (EHRs) has significantly advanced the collection of health outcomes data. Taken together, process measures and outcome measures provide a strong basis for the development of associated HIV care indicators and are important for assessing the impact of the NHAS and ACA in improving HIV/AIDS care in the United States. With appropriate care and treatment, HIV is a chronic disease with long disease progression time. Policies that improve HIV care may have an immediate impact on some process indica- tors (such as frequency of CD4 testing), but a delayed impact on certain outcome indicators (particularly mortality and secondary infections). The goal of any public health intervention is to improve outcomes, but process indicators can provide early feedback about whether the policy guiding 3 See, e.g., New York State Department of Health AIDS Institute, HIV Quality of Care Program, (NYSDHAI, 2011); Veterans Health Administration, HIV-QUERI (Bozzette et al., 2000); Kaiser Permanente (Horberg et al., 2011); Ryan White Program, HRSA, HIV/AIDS Bureau, HIVQUAL (HRSA, 2011a,b). 4 Studies such as these suggest that provider experience in caring for PLWHA improves quality of care and patient outcomes. As the number of individuals with HIV who are in care continues to increase, and with the evolution of HIV as a chronic condition, there will be a continued need for HIV care to move away from infectious disease (HIV) specialists toward nonspecialist primary care providers who have experience in treating HIV patients (IOM, 2011c).

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44 MONITORING HIV CARE IN THE UNITED STATES that intervention works. This may be especially important for particular subpopulations of PLWHA, for whom conditions may moderate the effect of a given intervention. For example, a particular group might be linked to care sooner and receive more quality care, but have less change in mortality (compared to other groups) due to chronic housing and social service needs or even different sets of HIV-related risk environments or risk clusters. Process indicators also can provide insights into why a policy is or is not working. If mortality remains the same despite improvements in certain areas (e.g., linking people to care, routine CD4 testing, appropriate ART initiation), the collection of additional process indicators may highlight other areas that need to be addressed (e.g., screening and immunization for certain coinfections). Healthy People 2020 Objectives Healthy People 2020 is the most recent incarnation of an initiative be- gun more than 30 years ago to identify data-based objectives for improving health among Americans (HHS, 2011a). Healthy People 2020 identifies 18 objectives relating to HIV: 14 relate to HIV prevention, testing, and diag- nosis, and 4 relate to health care, survival, and death following diagnosis (HHS, 2010). In keeping with the committee’s focus on HIV care following diagnosis, three of the latter four objectives (HIV.9, HIV.10, and HIV.12), in addition to one pertaining to mother-to-child transmission (HIV.8), served as a basis for associated HIV care indicators (see Box 2-1). PEPFAR Indicators Indicators developed by the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR) provided another basis for the indicators recommended by the committee. Originally authorized by the U.S. Congress in 2003 and reauthorized in 2008, PEPFAR is an unprecedented federal government investment to address the HIV/AIDS epidemic around the world. Now a cornerstone of President Obama’s Global Health Initiative, PEPFAR pro- vides support for national programs and strategies in more than 85 host countries to treat adults and children currently living with HIV/AIDS and to reduce the transmission of HIV (PEPFAR, 2011). PEPFAR has developed a set of essential reported indicators to gather information for planning, monitoring, and management purposes (PEPFAR, 2009). The PEPFAR indicators that pertain to the treatment of PLWHA and the provision of supportive services, such as food assistance, also provided a basis for the committee’s development of core indicators related to con- tinuous care and access to supportive services for PLWHA in the United States (Box 2-2).

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45 INDICATORS BOX 2-1 Healthy People 2020 Summary of Objectives: HIV Diagnosis of HIV Infection and AIDS [HIV-1–HIV-7] HIV-8. Reduce the number of perinatally acquired HIV and AIDS cases Death, Survival and Medical Healthcare After Diagnosis of HIV Infection and AIDS HIV-9. Increase the proportion of new HIV infections diagnosed before progres- sion to AIDS HIV-10. Increase the proportion of HIV-infected adolescents and adults who re- ceive HIV care and treatment consistent with current standards HIV-11. Increase the proportion of persons surviving more than 3 years after a diagnosis with AIDS HIV-12. Reduce deaths from HIV infection SOURCE: HHS, 2010. NHAS Goals As discussed in Chapter 1, the NHAS lists three primary goals: (1) reduction of HIV transmission; (2) increased access to care and optimized health outcomes for PLWHA; and (3) reduction of HIV-related health dis- parities (ONAP, 2010, p. 1). Within these three general goals, the NHAS identifies a number of specific measurable objectives to be met by 2015. Of particular interest for the committee’s work are the specific targets pertain- ing to increased access to HIV care, improved health outcomes, and reduced HIV-related health disparities. The NHAS (ONAP, 2010, p. 21) lists three targets regarding increased access to care: • Increase the proportion of newly diagnosed patients linked to clinical care within 3 months of their HIV diagnosis from 65 to 85 percent. • Increase the proportion of Ryan White HIV/AIDS Program clients who are in continuous care (at least two visits for routine HIV

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46 MONITORING HIV CARE IN THE UNITED STATES medical care in 12 months at least 3 months apart) from 73 to 80 percent. • Increase the percentage of Ryan White HIV/AIDS Program clients with permanent housing from 82 to 86 percent. (This serves as a measurable proxy of [ONAP’s] efforts to expand access to [U.S.] Department of Housing and Urban Development [HUD] and other housing supports to all needy people living with HIV.) Although the NHAS does not specify it explicitly, the text makes clear that the continuous care target for Ryan White clients serves as a measur- able proxy of efforts to ensure that all diagnosed HIV-infected persons are maintained in care (ONAP, 2010, pp. 23-25). The NHAS (ONAP, 2010, p. 31) also lists three targets in support of the goal of reducing HIV-related health disparities: BOX 2-2 PEPFAR Essential Reported Indicators Prevention P1.2.D Number of HIV-positive pregnant women who received antiretrovirals to reduce risk of mother-to-child transmission Care C2.1.D Number of HIV-positive adults and children receiving a minimum of one clinical service C2.4.D Percentage of HIV-positive patients who were screened for tuberculosis (TB) in HIV care or treatment settings C2.5.D Percentage of HIV-positive patients in HIV care or treatment (pre-ART or ART) who started TB treatment C5.1.D Number of eligible clients who received food and/or other nutrition services Treatment T1.2.D Number of adults and children with advanced HIV infection receiving ART [current] SOURCE: Adapted from PEPFAR, 2009, Table 1.

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47 INDICATORS • Increase the proportion of HIV-diagnosed gay and bisexual men with undetectable viral load by 20 percent. • Increase the proportion of HIV-diagnosed blacks with undetectable viral load by 20 percent. • Increase the proportion of HIV-diagnosed Latinos with undetect- able viral load by 20 percent. As discussed in more detail later, these six specific strategy targets pro- vided the basis for several of the indicators recommended by the committee. Since the issue of continuity of care clearly is not limited to Ryan White HIV/AIDS Program clients, the continuity-of-care indicator identified by the committee is directed toward the general population of PLWHA but can also be applied to Ryan White HIV/AIDS Program clients or any other subpopulation. The same is true for the indicators relating to permanent housing and undetectable viral load. Selection of Indicators of HIV Care and Access to Supportive Services In addition to the HIV-related performance measures, health objec- tives, indicators, and NHAS goals discussed in the preceding sections, the committee’s selection of core indicators “to gauge the impact of the Na- tional HIV/AIDS Strategy and the Patient Protection and Affordable Care Act in improving HIV/AIDS care” (statement of task) was informed by the identification of two overarching goals for the provision of HIV care: (1) to optimize health outcomes for PLWHA and (2) to reduce the risk of transmitting the virus to others. These goals of HIV care are best achieved through full engagement of PLWHA in clinical HIV care, as depicted in Figures 2-1 and 2-2. Primary barriers to optimal outcomes for PLWHA include late diag- nosis, delayed linkage to care, poor retention in care, delayed initiation of ART, and poor adherence to ART (i.e., discontinuing or intermittent ART), as well as untreated non-HIV comorbidities and unmet basic needs (Castilla et al., 2002; Gardner et al., 2011; Justice, 2006; Lo et al., 2002). Figure 2-3 shows the number of people lost to care at various points along the care continuum. Identification of benchmarks and points at which di- agnosed PLWHA are lost along the continuum of engagement in HIV care from diagnosis to death served as a basis for the committee’s selection of process and outcome indicators of quality clinical HIV care. Throughout its deliberations, the committee, in keeping with its charge to recommend in- dicators that “capture the care experiences of people living with HIV with- out substantial new investments” and mindful of the need not to increase reporting burden unduly, sought to balance the numerous facets of quality HIV care against the need for parsimony in its selection of core indicators;

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48 MONITORING HIV CARE IN THE UNITED STATES FIGURE 2-1 Continuum of engagement in care. SOURCE: Cheever, 2007. Figure 2-1 Bitmapped--poor quality Virologic Testing Diagnosis Primary Care Treatment Suppression FIGURE 2-2 Continuum of HIV care arrow. SOURCE: Adapted from Das, 2011. hence, the core indicators reflect Figure 2-2 aspects of clinical HIV care, New more general while more specific aspects are included in the additional indicators. In ad- dition, the committee was specifically asked to address indicators related to access to supportive services, such as housing. Consideration of signifi- cant mediators of continuous engagement and optimal health outcomes in HIV care, including receipt of needed mental health and substance abuse services, homelessness and housing instability, food insecurity, and lack of transportation needed to access medical and supportive services, informed the committee’s selection of core and additional indicators in these areas. A recent series of IOM reports discusses policies, facilitators, and bar- riers surrounding expanded HIV testing and access to care (IOM, 2010, 2011b,c). The present report focuses on adults who have been diagnosed with HIV and on indicators pertaining to the provision of HIV care and supportive services from diagnosis forward. Although the indicators for clinical HIV care and mental health and substance abuse are targeted to- ward adults, they apply to adolescents (≥13 years) as well. There are tens of thousands of new diagnoses annually among the group of individuals

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49 INDICATORS 1,400,000 100% 1,200,000 100% Population of People Living with HIV/AIDS in the United States 1,000,000 80% 79% 1,178,350 800,000 941,950 62% 59% 1,106,400 874,056 600,000 725,302 41% 40% 655,542 36% 400,000 480,395 28% 24% 426,590 437,028 19% 328,475 200,000 262,217 209,773 0 HIV-Infected HIV-Diagnosed Linked to HIV Retained in HIV On ART Suppressed Viral Load (≤200 copies Care Care /mL) Gardner MMWR FIGURE 2-3 Engagement in HIV care cascade. SOURCE: Adapted from CDC, 2011c; Gardner et al., 2011. 13 and older, with the highest rates between the ages of 20 and 49 years (CDC, 2012, Table 1a).5 In contrast, the use of ART to reduce or prevent perinatal transmission of the virus has resulted in a relatively small number of newly diagnosed pediatric HIV cases in the United States each year. In 2008, 218 children under the age of 13 were diagnosed with HIV; by 2010, the number had dropped to 185 (CDC, 2012, Table 1a). Although some of the indicators, such as screening for sexually trans- mitted infections (STIs) and mental health and substance use disorders, generally do not apply to children under the age of 13, others, such as mortality rate, apply equally to all ages; indicators that reflect treatment guidelines apply to children as well, once they are adapted to reflect pedi- atric guidelines for HIV care (HHS, 2011e). The indicators crafted by the committee reflect the current science and guidelines for the practice of HIV care at the time of writing. Although the specific details of the indicators (e.g., threshold CD4+ cell counts) may evolve over time as the science and practice of HIV care changes, the prin- 5 Although there is a low rate of new HIV diagnoses among 13- to 14-year-olds (CDC, 2012, Table 1a), adolescents 13 and older fall within the same treatment guidelines as adults (HHS, 2011d) and therefore are included in the group. In addition, the current Centers for Disease Control and Prevention HIV screening guidelines also focus on individuals age 13 and older (Branson et al., 2006).

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APPENDIX TABLE 2-1 Continued 116 Indicator Data Elements Needed Proxy/Alternative Data Elements Rationale Proportion of people with Yes/no documentation of influenza HIV-infected individuals are D • ate of influenza immunization diagnosed HIV infection who immunization within reporting considered to be at greater risk have received an influenza period can be used if specific date for serious influenza-related immunization during the of influenza immunization is not complications. CDC recommends preceding 12 months available. annual prophylactic vaccination (inactive) for influenza. Proportion of people with Yes/no documentation of HIV-infected individuals are D • ate of HIV diagnosis/treatment diagnosed HIV infection who pneumococcal immunization considered to be at greater risk for or documentation of infection have received a pneumococcal in medical record or yes/no contracting and developing serious prior to immunization immunization at least once documentation of pneumococcal complications from pneumococcal D • ate of pneumococcal since HIV diagnosis immunization within reporting pneumonia. CDC recommends immunization period can be used if specific prophylactic vaccination as soon as dates of HIV diagnosis and possible following diagnosis, followed pneumococcal immunization are by a one-time revaccination 5 years not available. later. Proportion of people with Yes/no documentation of hepatitis HIV and hepatitis B coinfection is D • ate of hepatitis vaccine/date of diagnosed HIV infection who B vaccination or documented associated with accelerated liver documented immunity have received a hepatitis B immunity can be used if specific damage and the development of vaccination, or who have dates of HIV diagnosis and chronic hepatitis and serious liver- documented immunity hepatitis B vaccination are not related morbidity and mortality. CDC available. recommends prophylactic vaccination against hepatitis B for susceptible individuals with HIV.

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Proportion of ART-naïve Documentation of drug resistance Drug resistance testing prior to D • ate of drug resistance testing people with diagnosed HIV testing for persons receiving the initiation of ART permits the D • ate of ART initiation infection who receive drug ART can be used if dates of drug identification of the appropriate resistance testing (genotypic) resistance testing and/or ART treatment regimen and therefore prior to ART initiation initiation are not available. improves health outcomes and reduces viral transmission. Proportion of people with Number of people with any of HHS recommends that HIV-infected D • iagnosis or test results for HIV- diagnosed HIV infection and these conditions who are not on individuals with HIV-associated associated nephropathy, hepatitis HIV-associated nephropathy, ART can be used if information nephropathy, hepatitis B virus B, and TB hepatitis B (when treatment is about all three conditions is not coinfection (when treatment is A • RT status (whether on ART indicted), or active TB, who available. indicated), or active TB receive ART or ART prescription/dispensing are not on ART* to improve health outcomes. dates) Proportion of pregnant Number of births during reporting Use of combination ART in HIV- P • regnancy status women with diagnosed HIV period to women not on ART can positive pregnant women significantly A • RT status (whether on ART infection who are not on be used if complete information reduces mother-to-child transmission or ART prescription/dispensing ART* about pregnancy status is not of the virus. dates) available. Additional Indicators for Mental Health, Substance Abuse, and Supportive Services Indicator Data Elements Needed Proxy/Alternative Data Elements Rationale Proportion of people with Yes/no evidence of screening for Undiagnosed, and therefore D • ate of mental health screening diagnosed HIV infection who mental health disorders or referral untreated, mental health disorders were screened for mental for treatment during reporting can negatively affect adherence to health disorders at least once period can be used if dates of treatment and health outcomes for during the preceding 12 mental health screening are not PLWHA and increase their risk of months available. transmitting the virus to others. *In contrast to the other indicators, the estimate for this indicator should decrease with improved access to care and supportive services. continued 117

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APPENDIX TABLE 2-1 Continued 118 Indicator Data Elements Needed Proxy/Alternative Data Elements Rationale Proportion of people with Yes/no evidence of screening for Undiagnosed, and therefore D • ate of screening for substance diagnosed HIV infection who substance use disorders or referral untreated, substance use disorders use were screened for substance for treatment during reporting can negatively affect adherence to use disorders at least once period can be used if dates of treatment and health outcomes for during the preceding 12 substance use screening are not PLWHA and increase the risk of months available. transmitting the virus to others. Proportion of people with Yes/no evidence of housing Assessment of housing stability is D • ate of housing needs diagnosed HIV infection who assessment or referral for housing important because housing instability assessment were assessed for need for assistance during reporting period can negatively affect adherence to housing at least once during can be used if dates of housing treatment and health outcomes for the preceding 12 months assessment are not available. PLWHA and increase the risk of transmitting the virus to others. Proportion of people with Yes/no evidence of food security Assessment of food security is D • ate of food security assessment diagnosed HIV infection assessment or referral for food or important because food insecurity who were assessed for need meal assistance during reporting can negatively affect adherence to for food or nutrition at least period can be used if specific dates treatment; effectiveness of treatment, once during the preceding 12 of assessment are not available. including ART; and health outcomes months for PLWHA and increase the risk of transmitting the virus to others. Proportion of people with Yes/no evidence of assessment for Assessment of transportation need D • ate of transportation needs diagnosed HIV infection transportation need or referral is important because an unmet need assessment who were assessed for need for transportation services during for transportation to access clinical for transportation at least reporting period can be used if HIV care and related services can once during the preceding 12 specific dates of assessment are negatively affect treatment access and months not available. health outcomes for PLWHA and increase the risk of transmitting the virus to others.

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119 APPENDIX TABLE 2-2 follows on next page

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120 APPENDIX TABLE 2-2 Indicators of Clinical HIV Care and Mental Health, Substance Abuse, and Supportive Services, Mapped to Entry and Engagement in Care Engagement & Diagnosis Linkage Retention Primary Care Indicators and Type (Process/Outcome) • rocess/ P • rocess P • rocess/ P • rocess P Outcome Outcome • roportion P • roportion P • roportion in P In the preceding 12 with a CD4+ linked to care continuous months: cell count >200 for HIV within care (two or • roportion who P cells/mm3 3 months of more visits in received two or and without diagnosis the preceding more CD4 tests a clinical 12 months at diagnosis of least 3 months • roportion who P AIDS apart) received two or more viral load • roportion in P tests continuous care for 12 or • roportion P more months screened for with CD4+ cell chlamydia, count ≥350 gonorrhea, and cells/mm3 syphilis • roportion P screened for hepatitis C • roportion P immunized for influenza Since diagnosis: • roportion P screened for tuberculosis • roportion P screened for hepatitis B • roportion P immunized for hepatitis B (if needed) • roportion P immunized for pneumococcal pneumonia • roportion who P received drug resistance testing (genotypic) prior to ART initiation NOTE: The committee’s recommended core indicators are written in bold text.

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121 Virologic Treatment Suppression Mediators Disparities • rocess P • utcome O • rocess/Outcome P • rocess/Outcome P • roportion with a • P P roportion on ART • roportion with P • ll indicators A measured CD4+ cell for 12 or more mental health related to count <500 cells/ months who have disorder referred diagnosis, linkage, mm3 who are not an undetectable for mental health engagement and on ART viral load services who retention, primary received these care, treatment, • ll-cause mortality A services within 60 • roportion with P and virologic rate days HIV-associated suppression, nephropathy, stratified by • roportion with P hepatitis B (when subpopulation substance use treatment is disorder referred indicated), or active • ll mediators, A for substance abuse tuberculosis who stratified by services who receive subpopulation are not on ART these services within 60 days • roportion of HIV- P infected pregnant • roportion with an P women who are not unmet need for on ART • housing • food • transportation In the preceding 12 months: • roportion screened P for mental health disorders • roportion screened P for substance use disorders • roportion assessed P for need for • housing • food • transportation continued

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122 APPENDIX TABLE 2-2 Continued Engagement & Diagnosis Linkage Retention Primary Care Data Elements • ate of HIV D • ate of HIV D • ates of D • ates of CD4 D diagnosis diagnosis routine HIV- tests care visits • D4 test C • ate of first D • ates of viral D results at visit for • ates of CD4 D load tests diagnosis/first HIV care (or tests visit for HIV proxy of first • ate of HIV D care or second • esults of at R diagnosis/ CD4 or viral least one CD4 treatment or • iagnosis of D load test date) test within documentation AIDS or AIDS- time period of infection defining illness specified (e.g., OIs) • ates of D chlamydia, gonorrhea, and syphilis screenings • ate of hepatitis D C screening • ate and results D of tuberculosis screening • ate hepatitis B D screening or date of documented immunity • ate of influenza D immunization • ate of D pneumococcal immunization • ate of hepatitis D vaccine/date of documented immunity • ate of drug D resistance testing • ate of ART D initiation

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123 Virologic Treatment Suppression Mediators Disparities • ates of CD4 D • ates of ART D • ate of diagnosis D • ll data elements A tests prescription or or evidence of for indicators and dispensing mental health mediators • esults of CD4 R disorder tests • ates of viral D • dditional data A load tests • ate of referral D elements pertaining • ates of ART D for mental health to subpopulations: prescription or • esults of viral R services • Race dispensing load tests • Ethnicity • ate of first visit D • Sex • iagnosis or D • ate of death D for mental health • Gender identity test results for services • Sexual orientation HIV-associated • Date of birth nephropathy, • ate of diagnosis D • Zip code/other hepatitis B, and or evidence of geographic marker tuberculosis substance use disorder • regnancy status P • ate of referral D for substance abuse services • ate of first visit D for substance abuse services • ousing status H • ood security F status • ransportation T need • ate of mental D health screening • ates of D screening for substance use • ates of D housing, food security, and transportation needs assessment

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124 MONITORING HIV CARE IN THE UNITED STATES APPENDIX TABLE 2-3 Co-Occurring Conditions and Etiological Cofactors with Link to Guidance for Optimal Management Condition Etiological Cofactors Guidance for Optimal Management Cervical/anal Human • Guidelines for Prevention and Treatment dysplasia papillomavirus of Opportunistic Infections in HIV- (HPV); HIV* Infected Adults and Adolescents (http:// www.aidsinfo.nih.gov/contentfiles/ Adult_OI.pdf) Chronic obstructive Cigarette smoking • Chronic obstructive pulmonary disease pulmonary disease and HIV (http://www.hiv.va.gov/provider/ manual-primary-care/copd.asp) HIV*; highly active Diabetes • Clinical Practice Recommendations antiretroviral therapy (http://care.diabetesjournals.org/ (HAART)*; diet; content/31/Supplement_1.toc) genetics; exercise Hepatoma Hepatitis B virus; • European AIDS Clinical Society (EACS) hepatitis C virus Guidelines for the Clinical Management and Treatment of Chronic Hepatitis B and C Coinfection in HIV Infected Adults (http://onlinelibrary.wiley.com/ doi/10.1111/j.1468-1293.2007.00535.x/ pdf) • EASL Clinical Practice Guidelines: Management of Chronic Hepatitis B (http://www.easl.eu/assets/application/ files/b73c0da3c52fa1d_file.pdf) • Care of Patients with Chronic Hepatitis B and HIV Co-Infection: Recommendations from an HIV-HBV International Panel (www.hem-aids.ru/system/files/ attachments/1659/aids_aids_pdf_183.pdf) Hyperlipidemia HIV; HAART; diet; • Third Report of the Expert Panel on genetics; exercise Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (ATP III Final Report) (http://www.nhlbi.nih. gov/guidelines/cholesterol/atp3_rpt.htm) • Guidelines for the Evaluation and Management of Dyslipidemia in Human Immunodeficiency Virus (HIV)-Infected Adults Receiving Antiretroviral Therapy: Recommendations of the HIV Medicine Association of the Infectious Diseases Society of America and the Adult AIDS Clinical Trials Group (http://cid. oxfordjournals.org/content/37/5/613.full)

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125 INDICATORS APPENDIX TABLE 2-3 Continued Condition Etiological Cofactors Guidance for Optimal Management HIV*; HAART*,**; Osteoporosis • Primary Care Guidelines for the lack of sun exposure; Management of Persons Infected with genetics; diet; Human Immunodeficiency Virus: 2009 substance use Update by the HIV Medicine Association of the Infectious Diseases Society of America (http://cid.oxfordjournals.org/ content/49/5/651.full) Renal disease Hypertension; • Guidelines for the Management of HAART**; HIV Chronic Kidney Disease in HIV-Infected Patients (http://cid.oxfordjournals.org/ content/40/11/1559.full) Hypogonadism Advanced HIV • Primary Care Guidelines for the disease Management of Persons Infected with Human Immunodeficiency Virus: 2009 Update by the HIV Medicine Association of the Infectious Diseases Society of America (http://cid.oxfordjournals.org/ content/49/5/651.full) Hepatitis Chronic hepatitis B • Primary Care Guidelines for the or C; antiretroviral Management of Persons Infected with hepatotoxicity Human Immunodeficiency Virus: 2009 Update by the HIV Medicine Association of the Infectious Diseases Society of America (http://cid.oxfordjournals.org/ content/49/5/651.full) • European AIDS Clinical Society (EACS) Guidelines for the Management and Treatment of Chronic Hepatitis B and C Coinfection in HIV-Infected Adults (http://onlinelibrary.wiley.com/ doi/10.1111/j.1468-1293.2007.00535.x/ pdf) Sexually transmitted Syphilis; gonorrhea; • Sexually Transmitted Diseases Treatment infections chlamydia; herpes Guidelines, 2010 (http://www.cdc.gov/ simplex; enteric std/treatment/2010/STD-Treatment- infections (via fecal 2010-RR5912.pdf) contact) Tuberculosis and HIV-associated • Guidelines for Prevention and Treatment other opportunistic immunodeficiency of Opportunistic Infections in HIV- infections Infected Adults and Adolescents (http:// www.aidsinfo.nih.gov/contentfiles/ Adult_OI.pdf) continued

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126 MONITORING HIV CARE IN THE UNITED STATES APPENDIX TABLE 2-3 Continued Condition Etiological Cofactors Guidance for Optimal Management Mental health Anxiety, depression, • HIV and Mental Health (http://www. disorders post-traumatic stress; hivguidelines.org/clinical-guidelines/ stigma; discrimination hiv-and-mental-health/) • Mental Health Disorders Among Substance-Using HIV-Infected Patients (http://www.hivguidelines.org/clinical- guidelines/hiv-and-substance-use/ mental-health-disorders-among- substance-using-hiv-infected-patients/) Substance use Anxiety, depression, • HIV and Substance Use (http://www. disorders post-traumatic stress; hivguidelines.org/clinical-guidelines/ stigma; discrimination hiv-and-substance-use/) • Mental Health Disorders Among Substance-Using HIV-Infected Patients (http://www.hivguidelines.org/clinical- guidelines/hiv-and-substance-use/ mental-health-disorders-among- substance-using-hiv-infected-patients/) Oral health Candida; oral hairy • HIV and Oral Health leukoplakia; herpes (http://www.hivguidelines.org/ simplex clinical-guidelines/hiv-and-oral-health/) * Connection between condition and cofactor not proven. ** Tenofovir most commonly associated with this finding.