Abstract
Introduction
Despite major pharmaceutical advances creating regimens of decreased burden and increased tolerability over the past several years, adherence continues to pose a major challenge for a sizable portion of people living with HIV (PLWH) on antiretroviral therapy (ART), with the consequences of insufficient adherence including poorly controlled viral load (VL) and the development of resistant strains of HIV. 1–3 Given its well-documented and dire consequences, it is not surprising that numerous leading institutions and groups have included the need to monitor and support patient adherence in their guidelines and training for clinicians providing ART to adult and adolescents living with HIV. For example, AIDS Education and Training Centers 4 suggest that adherence monitoring and counseling accompany every clinic visit; the Health Resources and Services Administration (HRSA) 5 suggests that all patients be provided with some degree of support for ART adherence; and monitoring adherence and providing support for it and consistent access to HIV care are part of the World Health Organization’s draft strategic report for 2011-2015. 6 In many respects, providing some level of adherence monitoring and support is considered a part of standard HIV care. Further, as the influence of retention in HIV care becomes well recognized, 7 monitoring and support retention in HIV care is likely to become a part of standard practice in the very near future.
Frequently, in HIV care and other fields focused on life-threatening, infectious epidemics, the need for practice communities to implement intervention approaches and strategies to promote the self-directed patient behaviors that will lead to positive individual and public health outcomes outpaces the availability of strong, research-based guidance. Although over a decade of targeted research on ART adherence has resulted in numerous successful adherence intervention approaches, 8–10 the real-world utility of evaluated interventions continues to be lacking. 11 Thus, while there is great consistency in recommendations from guiding organizations to do something, there is far less agreement or clarity in recommendation regarding what to do. In practice, available information, resources, and amassed clinical experience are often used to craft structural and individual-based approaches for what will work feasibly within a given community and patient population. This results in a “standard of care” (SOC) that is highly variable and arguably a source of considerable guidance to the research community in terms of practice-based evidence. 12
“Standard of care” for adherence support or retention strategies is not well characterized in the available literature. In 2005, Harman and colleagues 13 polled clinics in the northeastern United States on the adherence support services they offer their patients. This study found that almost 50% of the clinics samples offered the lowest level of adherence support (typically characterized as ad hoc discussions with providers) and generally only in response to well-recognized treatment failure. Anecdotally, it was also reported that many clinics voice frustration over minimal resources to launch structured intervention approaches and the frequent experience of having high-quality adherence support only in the context of, and for the duration of, clinical and behavioral intervention trials. A more optimistic picture of standard of care can be extracted from the results of the work of de Bruin and colleagues. 9 This research evaluated the impact of standard of care, defined as the kinds of adherence support provided in the control comparison arms in RCTs of adherence interventions, on adherence and clinical outcomes. The standard quality of care measure developed and validated in de Bruin et al 9 demonstrated that control arms in research trials had substantial variability in the kinds of adherence care they were providing and that higher levels of quality of care related to more positive clinical outcomes. If the control arms in these trials were in fact representative of standard of care more generally, their research suggests that standard of care for adherence support can be quite comprehensive and effective. However, the extent to which this is the case, or whether or not the earlier report from Harman et al 13 continues to characterize standard care, is largely unknown because little has been published that documents characteristics of current standard of care for supporting patient behaviors that contribute to positive clinical outcomes.
The current research project sought to provide some information concerning standard of care, recognizing that the considerable variability between clinics, communities, and countries in terms of providing adherence support are well beyond the scope of a small survey-based project. Our goal was to make a small advance toward better understanding what strategies characterize the kind of monitoring or intervention to promote ART adherence that occurs in general clinical care. With no real explorations available to date on the extent to which retention in care strategies have been incorporated into SOC, we also sought to characterize retention in care approaches in clinical care. To provide an initial characterization of support for adherence and retention in HIV-care support services offered as SOC, we asked direct-care providers attending the 5th International Conference on HIV Treatment Adherence, co-sponsored by the International Association of Physicians AIDS Care (IAPAC) and the National Institute of Mental Health (NIMH) in May 2010 to voluntarily and anonymously complete a very brief survey. Our results are intended to provide an overview of the standard practices for adherence support and retention in HIV care of the clinics represented by this subsample of delegates of the conference, and our interpretation of these findings are appropriately reflective of this.
Methods
Procedure
A brief, check-list type survey was included in the conference packet provided to all conference attendees, with a written explanation and request for individuals providing direct service to PLWH in clinical care to complete and return the survey prior to the end of the 3-day conference. A survey-return box was placed on the conference registration/information table for return of the anonymous surveys. Institutional Review Board (IRB) oversight for the procedure and measure for this exempted project was provided by the University of Connecticut. No compensation for survey completion was provided, and completion of the survey was completely voluntary. At least 1 brief announcement was made concerning the survey, but it was principally advertised through dissemination in conference packets and through a small stand near the main auditorium. Thus, only delegates who reviewed their conference packets during the conference would have seen the request for survey completion. A total of 51 surveys were returned of the over 200 packets disseminated, although response rate is difficult to determine as the conference is well attended by those in the research community who would have been ineligible to complete the service-based survey.
Measures
In collaboration with IAPAC and their NIMH partner for this conference, we crafted a brief survey asking participants to “check off” strategies that are provided to their HIV-positive patients in clinical care relative to adherence support and to retention in care strategies. The options provided in the check-list were based on strategies that have been identified or otherwise proposed in the research literature as well as numerous listservs. An “other” option was also provided. The remaining items of the survey asked attendees about the population they served, satisfaction and perceptions of the standard of care for adherence offered in their clinic, how intervention approaches are resourced, and how and whether adherence is consistently monitored.
Analysis
Survey responses were evaluated for descriptive purposes, using point descriptors (proportions and averages), to provide a characterization of standard practices among the sample of respondents. Preliminary analyses included review of clinic descriptors to identify potential duplicates or redundancy in representing a single clinic with more than 1 survey. No inferential analyses were planned or conducted with this small convenience sample.
Results
A total of 51 surveys were returned from conference participants. Of these, most (86%) were completed by individuals providing care in the United States. The distribution of regions in the United States represented was dominated by the east coast (39%), followed by southern states (30%) and west coast (14%). Inspection of clinic location reported on the surveys suggested only 1 pair where the location of the clinics suggested potential, but not definitive, overlap. Each survey was retained in the analyses. Respondents served in clinics that predominantly offered care to mixed or urban-only populations (61%); with only 39% working in clinics or agencies serving patients in strictly rural areas. Only 20% served in small clinics (50 to 200 patients), while 41% practiced in medium size (200 to 1000 HIV-positive patients) and 39% in large clinics (over 1000 HIV-positive patients). Using the lower end of these ranges, this sample of providers of HIV care offered their perceptions of adherence and retention in care services provided to over 25 000 patients in care.
Adherence Monitoring
Almost all respondents indicated that adherence was monitored at each clinic visit once ARV medications were initiated (78%), with the remainder indicating that adherence was monitored closely in response to a specific noted problem or at providers’ determination/discretion. Strategies to monitor adherence predominately included conversations with patients and providing VL or CD4 monitoring (Figure 1).
Proportion of respondents reporting that their clinic used the specified adherence monitoring approach.
Adherence Support
As indicated in Figure 2, individual discussion/counseling, systems navigation support, and provision of pill boxes/organizers appeared to be the most commonly adopted adherence support strategies among respondents. Examination of the open-ended “other” option added several intervention approaches not characterized in the response options provided, including clinical pharmacist support, in-clinic DOT, and on-site comprehensive adherence counselors offering a compendium of strategies. On average, at least 4 different strategies were endorsed, and 98% endorsed 2 or more. Additionally, 43% reported that patients complete a pre-ART training program, training, or visit prior to initiating ART. Most respondents reported feeling that the adherence promotion strategies currently available at their care sites were “generally adequate but need improvement” (53%), although a quarter rated them to be “inadequate” (26%) followed by those perceiving current standard of care for adherence support as “adequate” (22%). The survey also asked about the funding source for the adherence support provided as part of the clinic’s standard of care. The strategies and approaches offered for adherence support were predominantly supported by grant funds but not those tied to a specific research project (57%), followed by clinic- or hospital-provided funds (43%), research-project funded (22%), or done by volunteers (2%), although 10% noted that funding was not applicable because the clinic’s adherence support approach was not an actual service or program.
Proportion of respondents reporting that their clinic used the specified adherence support strategies.
Retention in HIV Care
The survey asked participants to estimate the proportion of clinic patients that were “lost to care”—absent completely from care for 6 or more months. The sample largely reported the rate of loss at or below 20% of their clinic sample (74%), followed by 20% to 30% of patients lost to care (22%). Only 4% of respondents reported that more than 30% of patients in their clinic are estimated to be “lost.” Retention in care appeared to be considered predominantly when some indication of failure occurred, such as a no-show or frequent cancellations (63%); and over a quarter reported discussing retention with their patients at each clinical visit (35%). In terms of discrete strategies implemented to promote retention in HIV care (Figure 3), over half of those responding included medical case management, counseling, monitoring, reminder calls, and transportation services. Open-ended responses to strategies used that were not represented on the check-list included extension of services to prisons/corrections facilities and use of pretermination letters advising patients to contact the clinic within a designated number of days to cease termination of their care. On average, respondents endorsed 4 strategies, 75% with 3 or more in place as part of standard care. Surveys did not ask clinicians about satisfaction with or funding for these approaches.
Proportion of respondents reporting that their clinic used the specified retention support strategies.
Discussion
The surveys completed voluntarily and anonymously concerning standard practices for adherence and retention in HIV care by attendees of the IAPAC adherence 2010 conference provided a snapshot of real-world approaches to supporting these critical self-directed patient behaviors. The convenience sample, low return rates, and small sample size prohibit generalization beyond this small subset of conference attendees, likely representing the higher end of services provided given their attendance to a US-based conference targeting adherence and issues germane to HIV care. Nonetheless, the data provided by this sample has value in providing information about standard of care practices that otherwise is largely unavailable. Furthermore, the variability and clear uptake of adherence and retention monitoring and intervention strategies even in this small, select sample suggest the appropriateness and timeliness of practice-based-evidence projects seeking to rigorously identify SOC practices, demonstration of their effectiveness, and steering scientific inquiry toward the evaluation of real-world innovations.
Results from the respondents in the current research, representing diverse clinical care settings around the world collectively serving some 25 000 patients in HIV care, strongly suggest that standard practice does appear to have adopted the recommendation to consistently monitor patient adherence, although the methods for that monitoring are variable. Methods for monitoring adherence in the current sample were dominated by patient-provider conversation and also biological markers (VL, CD4 counts). Only slightly over a quarter used a self-report measure or validated instrument. Because patient-provider conversation has not been well supported to date as an accurate strategy for assessing adherence, 14 and bio-markers, VL and/or CD4, may flag nonadherence only after negative consequences of nonadherence are identified, identifying better strategies to monitor adherence in clinical care is an area that could benefit from more focused collaborative research. There are several single-item or otherwise very brief self-report measures of adherence supported in research that may provide added benefit in use in clinical care, but these do not appear to have been adopted to date in practice. Additionally, identifying interview strategies that could be implemented by providers during their clinical care visits that promote accurate reporting regarding adherence would likely be of considerable interest. The value of practice-based-evidence could be leveraged to identify which strategies for interacting with patients on sensitive, highly charged issues such as adherence are presently in use, which appear most effective, and what can the wealth of research on communication strategies offer in refining or building on these real-world approaches.
In terms of adherence support strategies, widely adopted strategies to promote adherence included providing pill-boxes or organizers, offering individual counseling, and offering medical case management. Most respondents indicated that multiple strategies were available at their clinic, with primary funding for these strategies coming from nonresearch-related grants, although almost a quarter offered interventions as part of a controlled trial. The vast majority of respondents reported their clinic’s adherence support approach as adequate but in need of improvement, although a quarter of the sample rates them as inadequate for their patient populations. The kinds of adherence support strategies in place share some consistency with de Bruin et al’s 9 findings concerning characteristics of control comparison arms in trials of behavioral adherence interventions. Generally, the clinics represented in the current survey had several standard of care adherence activities that would likely result in high “quality of adherence care” scores. In comparison to results of Harman et al, 13 it appears that intervention approaches are presently more often the result of internal efforts as opportunity to being initiated as part of a research trial and subsequently withdrawn at the conclusion of the research.
Keeping in mind that the current sample most likely represents the upper end of the quality of care continuum, there does appear to be a considerable amount of adoption, adaptation, and innovation around adherence support strategies in clinical care. Affordable tools (pill-boxes) appear well adopted and supported by controlled research as effective, 15 while there is less uptake of more costly tools that may not provide unique services (eg, alarm devices where watches, cell phones, or other readily available devices may be used for alarm purposes). Use of ARV education training was reported by nearly half of the respondents, although the efficacy of such education classes is not well established or even included in current research on intervention approaches. In addition to evaluating the effects of such education programs on adherence, the research community could also gain considerable practice-based guidance through gaining an understanding of the kinds of individual or group counseling reportedly dominating adherence support strategies in practice. Presently, the types of individual or group counseling in use in practice, their active ingredients, or their impact on patients using them is largely unknown. Given that clinics are identifying these strategies as approaches worthy of uptake, and that behavioral intervention research has considerable guidance to offer in terms individual and group level intervention, 8 -10,16 this is an area that could greatly benefit from collaborative efforts.
Finally, retention in HIV care was explored in the current research to determine the extent to which strategies to promote use of HIV care once initiated are part of standard HIV care. While not clearly incorporated in current HIV care guidelines, results from this sample suggest that it is well recognized as critical in the practice community. Most respondents estimated that loss to care (a 6 month or longer absence in care among patients enrolled in care) was uncommon (20% or less of their patient populations). Nonetheless, all respondents indicated that their clinic had some strategy in place for attempting to retain patients in care, and more commonly, several strategies were in place. Structural barriers, such as transportation, appears to be aggressively addressed in clinical care and systems navigation assistance in place at most clinics in this sample. However, it does appear that efforts to promote retention in care are in response to known or suspected problems. With retention in care intervention research only now emerging in the literature, gaining a better understanding from practice in terms of what kinds of system navigation approaches are being adopted in care and working collaboratively to identify how to prevent inconsistent care use, versus reengaging people already lost to or tenuously engaged in care, would be a valuable and efficient synergy between scientific and practice communities.
Keeping the boundaries of the reach and representativeness of the current results in clear view, the snapshot into standard practice offered suggests that much can be learned from the ongoing efforts from the practice community. In line with practice-based-intervention approaches, results support that a considerable wealth of real-world experience and innovation exists even in this small sample of care providers. The extent to which the intervention approaches adopted by these HIV care clinics and organizations are a representation of diffusion of research, versus innovation that would well-advise the research community, is not known nor is it necessarily the most efficient use of the current state of affairs. What does seem clear is that ART adherence is recognized as critical in clinic care, without exception, and the monitoring and support of it were part of the standard of care for all respondents. The quality of adherence monitoring and support are less clear and should be the focus of targeted, collaborative research efforts. This charge applies squarely to retention in care monitoring and support strategies as well. As we move into an era that expects to see drastic increases in the enrollment of PLWH into care and similar increases in access to and receipt of ART, the distance from science to practice must be abbreviated and the diffusion of practice into science is a radical rethinking of scientific progress 12 that deserves continued discussion. Future research efforts to comprehensively and representatively characterize the standard of care for ART adherence and retention in care are critically needed to push toward a more integrated, systematic progression of scientific inquiry in this field that has immediate and relevant real-world value.
Footnotes
Acknowledgments
Special thanks to Michael Stirratt for his contributions to this work and Laramie Smith for assistance in data management, as well as the delegates of the 5th International Conference on HIV Treatment Adherence, 2010.
The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
The author(s) received no financial support for the research, authorship, and/or publication of this article.