Delaying Initiation of ART for Eligible HIV+ Patients
Delaying Initiation of ART for Eligible HIV+ Patients
Among a national sample of HIV providers from a large number of diverse care facilities, we found that reasons for delaying ART for clinically eligible patients were consistent with current guidelines, which strongly recommend that barriers to patient adherence be addressed before prescribing ART and on an ongoing basis after ART initiation. Providers reported concerns about patient adherence, patient refusal or lack of readiness to start treatment, and structural barriers to accessing treatment among their patients as reasons to delay ART for otherwise clinically eligible patients. Provider and practice characteristics were associated with reasons for delaying ART, and these findings provide information that can be used to direct appropriate training and education to providers to assist them in addressing specific barriers among their patients.
Concerns about patient adherence were cited by more than two-thirds of providers as reasons to delay ART. Providers identified mental health, substance abuse, appointment adherence, and unstable lifestyle as reasons for concerns about patient adherence, which have all been found to be associated with nonadherence to ART or poorer health outcomes. However, research has shown that providers have poor ability to predict which patients will be adherent. For patients not taking ART, administration of a brief medication beliefs assessment has been found to predict future adherence in ART-naive populations. Providers must balance concerns about adherence with the benefits of starting treatment so that they do not exclude persons who may clinically benefit from ART. However, in order to correctly assess those who are most likely to be adherent to ART, providers must have adequate supports to monitor and address nonadherence among patients taking ART.
Recent guidelines for improving ART adherence strongly recommend routine collection of self-reported adherence from all HIV-infected patients taking ART, and tools have been developed to assist providers in implementing these recommendations and linking patients to adherence support services. The Centers for Disease Control and Prevention has identified 10 efficacious evidence-based adherence interventions, although more operational research may help answer important questions about which adherence interventions are best in specific populations and settings. To complement these intervention efforts, providers now have expanded options for once-daily ART regimens and fixed-dose combinations to reduce pill burden that are recommended to improve adherence among persons taking ART.
Being less than 50 years of age, white, and seeing more than 50 HIV-infected patients per month were provider characteristics found to be independently associated with citing adherence concerns. This might reflect differences in how these providers view patient behaviors or, alternately, that these providers have patients who are more likely to be nonadherent. Regarding the former, unmeasured generational variation in how providers assess patients might account for the association between provider age and adherence concerns. Regarding the latter, we found that white providers were more likely than nonwhite providers to have majority patient populations who are more likely to be adherent (ie, non-IDU, white, and MSM). Thus, differences in patient demographic factors between white and nonwhite providers likely do not account for the association between provider race and adherence concerns. We did not collect information that would allow us to assess racial differences among providers in patient assessment, but others have found an association between provider and patient race and ART prescription. Further exploration might provide insights into the role of cross-cultural competency in prescribing practices among white providers. Having a large number of HIV-infected patients might be associated with practicing at large public HIV care facilities, such as those funded by the Ryan White HIV/AIDS Program. Because these facilities may have a higher proportion of patients with mental health and substance abuse comorbidities, which are associated with nonadherence, it is not surprising that providers in these settings would more often cite adherence concerns as reasons to delay ART. Regardless of the reasons for the association between these characteristics and adherence concerns, younger providers, white providers, and those who see more than 50 patients per month may benefit from enhanced training on the adherence screening and intervention options mentioned earlier, which could allow them to better identify patients likely to be nonadherent and provide them with the resources and tool to address adherence concerns with their patients.
The majority of providers also mentioned patient acceptance barriers to prescribing ART, citing patient lack of readiness for ART and refusal of ART. These concerns were commonly cited, but there are few studies of how providers address these barriers and whether the methods they use are effective. Problems with trust, acceptance, and readiness to start ART may become more prevalent as providers adopt guidelines to consider ART initiation for patients with higher CD4 counts. Also, increased testing, linkage, and engagement have the potential to increase the numbers of patients seen at an earlier stage of illness who are not experiencing the physical symptoms of HIV infection, which has been found to be associated with decreased engagement in care and reluctance to take ART.
Regarding readiness to take ART, Grimes and Grimes reviewed the treatment guidelines of 5 internationally recognized expert panels and 5 review articles on readiness, trust, and adherence and concluded that readiness is not adequately defined or measured and that evidence is lacking that readiness predicts future adherence. Moreover, after review of the published evidence they conclude that there are no clinically useful interventions to improve readiness. More work in this area could help determine whether readiness can be accurately assessed in the clinical setting and how best to improve readiness among patients.
Patient refusal to take ART was another common subtheme. Recent studies of ART refusal among patients are limited, but in a clinical trial assessing the effectiveness of early ART initiation for reducing sexual transmission of HIV, investigators found that 19% of participants in the control arm declined to start ART even after early treatment was shown to be effective for reducing sexual transmission and was recommended for them by study investigators and that not being "ready" to start ART was the most common reason for refusal. Other work has found that patients not in HIV care frequently mention concerns about taking medications. Among patients who are receiving HIV care, lower acceptance of ART has been found to be associated with concerns about side effects, mistrust of medications and health care providers, perceived effect of medications on quality of life, and a preference for alternative medicine and self-care. Additional work may be helpful to understand what motivates patients to take ART, particularly when they are healthy. At least 1 study has found that the majority of persons with CD4 counts above 349 cells/mm who were not taking ART were interested in starting ART to prevent HIV transmission to partners.
Nurse practitioners and PAs were more likely than physicians to mention patient acceptance barriers to ART initiation, which might reflect differences in patient–provider interaction. It may also be the case that patients are more comfortable refusing ART when offered by providers who are not doctor of medicine. Providers with majority MSM patients were also more likely to cite acceptance barriers. This could be due to differing communication styles among providers in MSM-focused versus non-MSM-focused facilities, or because MSM are more vocal about acceptance barriers to ART use than other populations. Regardless, our findings suggest that non-MD providers and those working in MSM-focused facilities might benefit from training that provides them with the skills needed to discuss and resolve patient acceptance barriers to ART.
A third of providers mentioned structural barriers to ART initiation, including concerns about payment for ART and homelessness. Although providers may be less able to directly address these types of barriers, referrals to case managers can help alleviate structural barriers for patients. For example, case managers can facilitate access to programs such as the ADAP, which provides medications for those without other coverage, and the Housing Opportunities for Persons with AIDS program, which provides housing assistance and related supportive services. Although as of June 2013, 15 states had current or anticipated ADAP cost-containment measures, including 3 states with waiting lists (http://www.nastad.org/docs/ADAP_Watch/ADAP-Watch-June-2013.html), the implementation of the Affordable Care Act (ACA) might increase access to medications for more persons through Medicaid expansion. Ensuring that providers have access to case management referrals may allow them to feel more comfortable prescribing ART to unstably housed persons, who according to studies can be adherent with proper support.
In multivariable analysis, we found Hispanic providers were less likely to cite structural barriers as reasons to delay ART. Because the Hispanic population and ADAP funding and eligibility vary considerably among US states (http://www.pewhispanic.org/2013/08/29/mapping-the-latino-population-by-state-county-and-city/, http://kff.org/hivaids/fact-sheet/aids-drug-assistance-programs/), this finding may reflect geographic differences across states rather than differences in how structural barriers are perceived by Hispanic providers compared to non-Hispanic providers, although we did not collect data that would allow us to fully assess this.
Our analysis is subject to limitations. First, our response rate of 42% is lower than optimal, although it is comparable to or higher than other recent studies of HIV care providers. Despite low response, our sample was drawn from a population-based frame and includes providers from a large number of facilities with diverse characteristics (eg, public and private, small, and large), which gives us confidence in our findings. Another limitation is that the survey did not assess the number of patients for whom providers encounter barriers to ART initiation or their perceptions about the relative importance of those barriers. However, because the reasons we identified were so commonly reported, this suggests these issues are seen regularly, although possibly affecting few patients, as most patients sampled through MMP were prescribed ART. Finally, in response to the evidence of the clinical and prevention benefits of early initiation of ART, US treatment guidelines in the years since the provider survey was administered have steadily moved toward recommending ART be offered to all patients regardless of disease stage, and more tolerable single-tablet regimens have been developed. In light of these changes, compared to the providers we surveyed in 2009, providers practicing now may be more willing to prescribe ART to patients about whom they have adherence or acceptance concerns. However, although providers may now initiate ART for a higher proportion of their patients, this does not necessarily mean they will no longer consider patient adherence or acceptance when making these decisions. The guidelines continue to note that adherence, patient willingness to take ART, and other psychosocial factors are among the reasons providers may choose to postpone therapy, indicating these concerns should still be considered by providers. In fact, as changes in clinical guidelines for ART initiation increase the numbers of persons whom providers consider clinically eligible for ART, the issues described in this analysis may be more prevalent, as healthier persons may be less motivated to take ART.
Discussion
Among a national sample of HIV providers from a large number of diverse care facilities, we found that reasons for delaying ART for clinically eligible patients were consistent with current guidelines, which strongly recommend that barriers to patient adherence be addressed before prescribing ART and on an ongoing basis after ART initiation. Providers reported concerns about patient adherence, patient refusal or lack of readiness to start treatment, and structural barriers to accessing treatment among their patients as reasons to delay ART for otherwise clinically eligible patients. Provider and practice characteristics were associated with reasons for delaying ART, and these findings provide information that can be used to direct appropriate training and education to providers to assist them in addressing specific barriers among their patients.
Concerns about patient adherence were cited by more than two-thirds of providers as reasons to delay ART. Providers identified mental health, substance abuse, appointment adherence, and unstable lifestyle as reasons for concerns about patient adherence, which have all been found to be associated with nonadherence to ART or poorer health outcomes. However, research has shown that providers have poor ability to predict which patients will be adherent. For patients not taking ART, administration of a brief medication beliefs assessment has been found to predict future adherence in ART-naive populations. Providers must balance concerns about adherence with the benefits of starting treatment so that they do not exclude persons who may clinically benefit from ART. However, in order to correctly assess those who are most likely to be adherent to ART, providers must have adequate supports to monitor and address nonadherence among patients taking ART.
Recent guidelines for improving ART adherence strongly recommend routine collection of self-reported adherence from all HIV-infected patients taking ART, and tools have been developed to assist providers in implementing these recommendations and linking patients to adherence support services. The Centers for Disease Control and Prevention has identified 10 efficacious evidence-based adherence interventions, although more operational research may help answer important questions about which adherence interventions are best in specific populations and settings. To complement these intervention efforts, providers now have expanded options for once-daily ART regimens and fixed-dose combinations to reduce pill burden that are recommended to improve adherence among persons taking ART.
Being less than 50 years of age, white, and seeing more than 50 HIV-infected patients per month were provider characteristics found to be independently associated with citing adherence concerns. This might reflect differences in how these providers view patient behaviors or, alternately, that these providers have patients who are more likely to be nonadherent. Regarding the former, unmeasured generational variation in how providers assess patients might account for the association between provider age and adherence concerns. Regarding the latter, we found that white providers were more likely than nonwhite providers to have majority patient populations who are more likely to be adherent (ie, non-IDU, white, and MSM). Thus, differences in patient demographic factors between white and nonwhite providers likely do not account for the association between provider race and adherence concerns. We did not collect information that would allow us to assess racial differences among providers in patient assessment, but others have found an association between provider and patient race and ART prescription. Further exploration might provide insights into the role of cross-cultural competency in prescribing practices among white providers. Having a large number of HIV-infected patients might be associated with practicing at large public HIV care facilities, such as those funded by the Ryan White HIV/AIDS Program. Because these facilities may have a higher proportion of patients with mental health and substance abuse comorbidities, which are associated with nonadherence, it is not surprising that providers in these settings would more often cite adherence concerns as reasons to delay ART. Regardless of the reasons for the association between these characteristics and adherence concerns, younger providers, white providers, and those who see more than 50 patients per month may benefit from enhanced training on the adherence screening and intervention options mentioned earlier, which could allow them to better identify patients likely to be nonadherent and provide them with the resources and tool to address adherence concerns with their patients.
The majority of providers also mentioned patient acceptance barriers to prescribing ART, citing patient lack of readiness for ART and refusal of ART. These concerns were commonly cited, but there are few studies of how providers address these barriers and whether the methods they use are effective. Problems with trust, acceptance, and readiness to start ART may become more prevalent as providers adopt guidelines to consider ART initiation for patients with higher CD4 counts. Also, increased testing, linkage, and engagement have the potential to increase the numbers of patients seen at an earlier stage of illness who are not experiencing the physical symptoms of HIV infection, which has been found to be associated with decreased engagement in care and reluctance to take ART.
Regarding readiness to take ART, Grimes and Grimes reviewed the treatment guidelines of 5 internationally recognized expert panels and 5 review articles on readiness, trust, and adherence and concluded that readiness is not adequately defined or measured and that evidence is lacking that readiness predicts future adherence. Moreover, after review of the published evidence they conclude that there are no clinically useful interventions to improve readiness. More work in this area could help determine whether readiness can be accurately assessed in the clinical setting and how best to improve readiness among patients.
Patient refusal to take ART was another common subtheme. Recent studies of ART refusal among patients are limited, but in a clinical trial assessing the effectiveness of early ART initiation for reducing sexual transmission of HIV, investigators found that 19% of participants in the control arm declined to start ART even after early treatment was shown to be effective for reducing sexual transmission and was recommended for them by study investigators and that not being "ready" to start ART was the most common reason for refusal. Other work has found that patients not in HIV care frequently mention concerns about taking medications. Among patients who are receiving HIV care, lower acceptance of ART has been found to be associated with concerns about side effects, mistrust of medications and health care providers, perceived effect of medications on quality of life, and a preference for alternative medicine and self-care. Additional work may be helpful to understand what motivates patients to take ART, particularly when they are healthy. At least 1 study has found that the majority of persons with CD4 counts above 349 cells/mm who were not taking ART were interested in starting ART to prevent HIV transmission to partners.
Nurse practitioners and PAs were more likely than physicians to mention patient acceptance barriers to ART initiation, which might reflect differences in patient–provider interaction. It may also be the case that patients are more comfortable refusing ART when offered by providers who are not doctor of medicine. Providers with majority MSM patients were also more likely to cite acceptance barriers. This could be due to differing communication styles among providers in MSM-focused versus non-MSM-focused facilities, or because MSM are more vocal about acceptance barriers to ART use than other populations. Regardless, our findings suggest that non-MD providers and those working in MSM-focused facilities might benefit from training that provides them with the skills needed to discuss and resolve patient acceptance barriers to ART.
A third of providers mentioned structural barriers to ART initiation, including concerns about payment for ART and homelessness. Although providers may be less able to directly address these types of barriers, referrals to case managers can help alleviate structural barriers for patients. For example, case managers can facilitate access to programs such as the ADAP, which provides medications for those without other coverage, and the Housing Opportunities for Persons with AIDS program, which provides housing assistance and related supportive services. Although as of June 2013, 15 states had current or anticipated ADAP cost-containment measures, including 3 states with waiting lists (http://www.nastad.org/docs/ADAP_Watch/ADAP-Watch-June-2013.html), the implementation of the Affordable Care Act (ACA) might increase access to medications for more persons through Medicaid expansion. Ensuring that providers have access to case management referrals may allow them to feel more comfortable prescribing ART to unstably housed persons, who according to studies can be adherent with proper support.
In multivariable analysis, we found Hispanic providers were less likely to cite structural barriers as reasons to delay ART. Because the Hispanic population and ADAP funding and eligibility vary considerably among US states (http://www.pewhispanic.org/2013/08/29/mapping-the-latino-population-by-state-county-and-city/, http://kff.org/hivaids/fact-sheet/aids-drug-assistance-programs/), this finding may reflect geographic differences across states rather than differences in how structural barriers are perceived by Hispanic providers compared to non-Hispanic providers, although we did not collect data that would allow us to fully assess this.
Our analysis is subject to limitations. First, our response rate of 42% is lower than optimal, although it is comparable to or higher than other recent studies of HIV care providers. Despite low response, our sample was drawn from a population-based frame and includes providers from a large number of facilities with diverse characteristics (eg, public and private, small, and large), which gives us confidence in our findings. Another limitation is that the survey did not assess the number of patients for whom providers encounter barriers to ART initiation or their perceptions about the relative importance of those barriers. However, because the reasons we identified were so commonly reported, this suggests these issues are seen regularly, although possibly affecting few patients, as most patients sampled through MMP were prescribed ART. Finally, in response to the evidence of the clinical and prevention benefits of early initiation of ART, US treatment guidelines in the years since the provider survey was administered have steadily moved toward recommending ART be offered to all patients regardless of disease stage, and more tolerable single-tablet regimens have been developed. In light of these changes, compared to the providers we surveyed in 2009, providers practicing now may be more willing to prescribe ART to patients about whom they have adherence or acceptance concerns. However, although providers may now initiate ART for a higher proportion of their patients, this does not necessarily mean they will no longer consider patient adherence or acceptance when making these decisions. The guidelines continue to note that adherence, patient willingness to take ART, and other psychosocial factors are among the reasons providers may choose to postpone therapy, indicating these concerns should still be considered by providers. In fact, as changes in clinical guidelines for ART initiation increase the numbers of persons whom providers consider clinically eligible for ART, the issues described in this analysis may be more prevalent, as healthier persons may be less motivated to take ART.