Ending the HIV Epidemic for Persons Left Behind in the Advances of HIV: Intervention Studies Addressing the HIV Continuum of Care

Abstract

The advent of antiretroviral therapy and biomedical prevention has transformed HIV from a fatal disease to a chronic condition where people with HIV (PWH) can live long, healthy lives. Yet, there remains a subset of PWH left behind from receiving timely HIV diagnosis and care. Striking inequalities in access to resources, socioeconomic disparities, and social forces have prevented certain PWH from achieving significant health and quality of life (QOL) improvements experienced by those who secure life-saving treatment. For decades, our multidisciplinary team developed a collaborative scientific portfolio focused on helping those left behind advance along the HIV continuum of care. In this manuscript, we highlight some of our U.S.-based social interventions that have addressed the disparities and sub-optimal QOL encountered by overlooked populations with the goal of achieving timely HIV diagnosis, care, and sustained viral suppression. We then outline our many lessons learned and vision for the next crucial steps ahead.

Keywords

HIV intervention studies

With the advent of antiretroviral therapy (ART) in 1996, the clinical landscape of the HIV/AIDS epidemic was transformed from one associated with debilitation and fatality to one of chronic management and longevity (Gulick et al., 1997). Akin to what we have seen recently with the pandemic-altering advent of vaccines and therapies for the SARS CoV-2 COVID-19 virus, ART coupled with the availability of care services—such as those provided by the Ryan White Care Act, including harm reduction and ancillary social services—has the potential to greatly reduce HIV/AIDS-related morbidity and mortality and improve treatment outcomes and quality and length of life for people with HIV (PWH). Despite these advances, access to, availability, and adherence to ART has proved to be uneven with underserved and marginalized populations of PWH being left behind. Thus, there has been and continues to be a tale of “two HIV epidemics” between those who receive treatment and experience dramatic health improvement and quality of life (QOL) and those who are left behind, including PWH who are Black, men who have sex with men (MSM), poor, using drugs, and/or living in the South (HIV.gov, 2022; Jeffries & Henny, 2019; Kaiser Family Foundation, 2020; Mayer et al., 2021; Metsch et al., 2009; Sullivan et al., 2021). Striking differences in HIV/AIDS mortality have resulted, and it has become evident that PWH with access to resources and social capital—money, healthcare, education, and social connections—are disproportionately on the receiving end of this life-saving treatment (American Psychological Association, 2010; Cunningham et al., 2005; Enriquez et al., 2019; Leddy et al., 2019; Pellowski et al., 2013; Shacham et al., 2010; Spinelli et al., 2017).

The epidemic's disparate impacts are also notable in HIV/AIDS prevention. Underserved, vulnerable PWH have often been left behind in early HIV testing efforts, leading to late HIV diagnoses, while those who do not have HIV but may benefit from biomedical prevention efforts encounter sub-optimal access to pre-exposure prophylaxis (PrEP). Late HIV diagnosis has severe clinical implications for the individual (e.g., increased likelihood of AIDS progression, reduced response to ART), as well as significant public health implications for the community through increased HIV transmission when individuals are unaware of their HIV serostatus (Centers for Disease Control andPrevention, 2003; Hall et al., 2012; Mannheimer et al., 2014; Marks et al., 2006; May et al., 2007; Schwarcz et al., 2006) or are aware of their HIV status but living with uncontrolled viremia. Additionally, in the earlier days of the HIV epidemic, prevention efforts were directed more toward secondary prevention, or the prevention of HIV progression to AIDS, as opposed to the primary prevention of HIV. While there was an early success with syringe services programs (SSPs) leading to the reduction of HIV incidence among persons who inject drugs, behavioral interventions targeting sexual risk behavior were largely not effective (Koblin et al., 2004; Weinhardt et al., 1999). HIV prevention efforts early in the epidemic promoted the high effectiveness of male condom use in reducing HIV incidence when used properly and consistently; yet, by failing to address confounding gender/power relations, socioeconomic inequalities, incorrect condom use, and the lack of evidence-based education in schools, the success of this strategy has been limited (Dworkin & Ehrhardt, 2007; National Institute of Allergy and Infectious Diseases, 2018; Remis et al., 2014; Rotheram-Borus et al., 2009). Furthermore, early behavioral prevention approaches, including counseling at the time of HIV testing, also framed HIV as a preventable condition with a high degree of individual-level controllability. Consequently, PWH were often seen through a lens of blame in which they were responsible for their own infection, leading to perpetuating HIV-related judgment, stigma, and discrimination, particularly for MSM, women who exchanged sex for drugs/money, and/or people who inject drugs (Halkitis, 2012; Powell et al., 1998). These individual approaches failed to consider external factors that contribute to HIV incidence, namely social context (e.g., neighborhoods, social networks, and social relationships) and system, social, and structural forces (e.g., poverty, health insurance, racism, and mass incarceration) (Blankenship et al., 2015, 2021; Blankenship & Koester, 2002; Dailey et al., 2022; Duncan et al., 2019; Latkin et al., 2010; Marshall et al., 2012).

In response to the development of the 2010 National HIV/AIDS Strategy for the United States (US) and the growing evidence supporting HIV treatment as a prevention approach (Cohen et al., 2011), President Obama introduced the HIV Care Continuum Initiative in 2013 to prioritize public health efforts that address improved health outcomes at all steps of the HIV care continuum: testing and diagnosis, linkage to care, retention in care, and viral suppression (Centers for Disease Control and Prevention, 2019a; HIV.gov, 2015). This care continuum then became the framework for the goals of the Joint United Nations Programme on HIV/AIDS's “End the AIDS Epidemic” initiative, which established targets for 2020 whereby 90% of all PWH would be aware of their HIV serostatus, 90% of all PWH would receive ART, and 90% of all PWH on ART would achieve viral suppression (Joint United Nations Programme on HIV/AIDS, 2014). Since the late 1990s, our long-standing, multidisciplinary research team—a collaborative and interdisciplinary effort forged among Columbia University, the University of Miami, Emory University, and the San Francisco Department of Health—has built a scientific portfolio aimed to address the disparities and suboptimal QOL encountered by underserved and overlooked populations as they advance along this HIV continuum from diagnosis to viral suppression. Representing expertise in medical sociology, epidemiology, biostatistics, social work, psychology, dentistry, and infectious disease, our research agenda has developed, implemented, and tested U.S.-based social interventions that aim to support specific subpopulations of PWH as they progress along the HIV continuum of care, improve QOL, and work toward ending the HIV epidemic in the US. As we observed with the advent of ART, clinical and medical advances can indeed bring disparities to light—this is when we saw the racial disparities most profoundly—as the existing system does not currently serve all people well. There are changes needed to ensure the needs of those left behind are adequately and appropriately addressed. Therefore, the focus of our portfolio has therefore been to ensure that those who are most affected by these exacerbated HIV disparities have access to, and engagement with, the best treatment and support systems. In the sections below, we first describe our body of work and its public health implications as guided by the HIV continuum of care (HIV.gov, 2021b). We then use this review of our collective body of work to outline our vision for research and practice in the future ahead based on the lessons we have learned and the scientific voids we have identified.

HIV Continuum of Care

HIV Testing

In 2006, the updated HIV testing guidelines from the Centers for Disease Control and Prevention (CDC) emphasized offering routine, streamlined HIV testing in health care settings (Branson et al., 2006) with—in recognition of the advances in HIV treatment—the goal of both expanding testing opportunities and reducing the time needed to conduct each individual test. These guidelines uncoupled counseling at the time of HIV testing and instead suggested that counseling efforts support engagement in care for persons newly diagnosed with HIV. Notably, this recommendation of uncoupling counseling and testing was challenged by some in the HIV prevention field due to the absence of empirical data to support this change. In 2019, the U.S. Preventative Service Task Force found convincing evidence to recommend—as a level A recommendation—screening for HIV infection in adolescents and adults aged 15 to 65 years (Owens et al., 2019). As a result of these initiatives, the percentage of PWH who are unaware of their status has decreased and is now approximately 13% (HIV.gov, 2021a).

Our research team has conducted many studies to enhance the delivery of HIV testing in clinical settings and sought to test the effectiveness of counseling at the time of HIV testing for reducing HIV and other sexually transmitted infections (STIs). First, we conducted the “HIV Rapid Testing and Counseling Study” in 2009 through the National Institute on Drug Abuse (NIDA) Clinical Trials Network (CTN) to examine substance use disorder treatment as a potentially viable setting for HIV testing. Specifically, this study (CTN 0032) investigated the effectiveness and cost-effectiveness of on-site rapid testing (in getting people tested) and the efficacy of risk-reduction counseling in reducing HIV risk behaviors (Metsch et al., 2012). Notably, at the time of trial initiation, the majority of U.S. substance use treatment programs did not offer on-site HIV testing (Brown et al., 2007; Pollack & D’Aunno, 2010). Through this trial, patients recruited from 12 community-based outpatient substance use treatment programs throughout the US were randomized to (1) referral for off-site HIV testing (i.e., standard of care), (2) brief, participant-tailored risk-reduction counseling with the offer of an on-site rapid HIV test, or (3) offer of streamlined on-site rapid HIV testing. Study findings demonstrated that offering streamlined on-site HIV rapid testing in these substance use treatment programs significantly increased patient receipt of testing results; however, there was no substantial effect of brief counseling on reducing sexual and injection drug use risk (Metsch et al., 2012; Schackman et al., 2013). The study's economic analysis found that offering on-site streamlined HIV rapid testing in substance use treatment programs increased QOL at a cost-effectiveness ratio of less than $100,000/quality-adjusted life-year and recommended policymakers and treatment leaders seek funding to implement on-site streamlined rapid HIV testing in substance use treatment programs for clients not recently tested. Further, the results of this study spurred the development of a NIDA/Substance Abuse and Mental Health Services Administration (SAMHSA) Initiative geared to support the implementation of on-site rapid HIV testing (Technology Transfer Centers, 2018).

Building on the findings from CTN 0032, we sought to provide further data with biological outcomes on the effectiveness of counseling at the time of HIV testing. We also replicated the CDC Project RESPECT HIV risk reduction counseling trial (Kamb et al., 1998) from the mid-1990s and extended it in the current era of HIV rapid testing and effective ART. We also strengthened that research by powering our study to be able to examine the effectiveness of counseling with sub-groups including MSM (Metcalf et al., 2005). This group accounted for nearly two-thirds of new HIV infections in the US at that time and this continues today. Notably, the original RESPECT study conducted in the 1990s (before the advent of ART) was conducted with people who were thought to be at risk of heterosexual transmission and did not include MSM (Kamb et al., 1998). In our 2010 randomized controlled trial (RCT), “Project AWARE” (Metsch et al., 2013), over 5,000 patients attending nine different U.S. STI clinics were randomized to receive a rapid HIV test with either (1) patient-centered, evidence-based HIV risk-reduction counseling or (2) streamlined testing (information only). We then compared the cumulative incidence of pre-specified and prospectively tested STIs, including HIV, over a six-month period in the counseling + testing versus the streamlined testing group. Study findings suggested that there was no added benefit from risk-reduction counseling plus rapid HIV testing, as the intervention group did not significantly differ in their STI acquisition compared to the streamlined testing group in these STI clinics. As a result, our well-conducted RCT led to a significant change in how HIV testing was conducted in the US; the CDC ultimately defunded Project RESPECT and instead supported expanded HIV rapid testing with reduced counseling (Johns et al., 2016).

Finally, another healthcare setting for offering rapid HIV testing that piqued our research team's interest is the dental care setting, given the availability of the saliva-based point-of-care test and data showing that people visit the dentist more frequently than other healthcare providers (Strauss et al., 2012). In our National Institute of Dental and Craniofacial Research-funded grant, “HIV Testing in Dental Care Settings,” the overall goal was to identify factors associated with dentists” willingness to offer HIV testing as well as other medical preventive and screening services in the dental setting. The main study activity was to conduct a national survey (administered from 2010 to 2011) with a stratified random sample representative of U.S. general dentists. We supplemented the survey by conducting qualitative interviews with dentists to identify barriers and facilitators to offering rapid HIV testing in their clinical setting. Survey findings found that dentists who agreed with the importance of annual testing for high-risk persons and who were familiar with the CDC's routine HIV testing recommendations were more willing to conduct such screening (Pollack et al., 2014). Subjective norms, or patients’ acceptance of HIV testing and colleagues’ positive perception of them as dentists, were positively associated with this willingness. Qualitative analyses of interviews with dentists indicated that most accepted, in principle, the idea of their profession's involvement in rapid HIV testing and recognized its public health benefit (Parish et al., 2018; Siegel et al., 2012). However, many concerns about offering this testing were noted, including fear of false positives, negative reactions from patients, insufficient reimbursement, and perceived incompatibility with the scope of practice.

Our next study funded by the CDC, “Minority AIDS Research Initiative: Patient Acceptance of HIV Rapid Testing in the Dental Care Setting,” was able to demonstrate that these concerns over patient acceptance may in fact be overstated. We implemented rapid HIV testing from 2014 to 2015 in two South Florida community health centers both located in an HIV prevalent region—and evaluated patient acceptance. Study findings showed that overall acceptance by dental patients was actually quite high (84.5%). Therefore, the next steps in the broader implementation of rapid HIV implementation in dental settings—as well as other preventive health screenings—may benefit from focusing on expanding society's view of the traditional role of the dentist to one that embraces systemic population health.

Linkage to HIV Care

It is estimated that there were many people who were not linked to HIV care in the years following the advent of ART (Andersen et al., 2000; Cunningham et al., 2000; Shapiro et al., 1999). This continues to the present, as approximately 20% of PWH are not linked to HIV care within one month of diagnosis (HIV.gov, 2021b). This initial linkage is the first fundamental step in obtaining ART and decreasing HIV mortality and transmission. The CDC-funded Antiretroviral Treatment Access Study (ARTAS) study, conducted from 2001 to 2002, was the first RCT to assess the efficacy of a brief case management intervention aimed at linking PWH to HIV care (Gardner et al., 2005). The intervention was developed to help those newly diagnosed with HIV address the numerous barriers that impede timely linkage to care through a strengths-based case management approach. This approach specifically drew on empowerment, self-efficacy, and internal strengths as essential tools to acquire needed resources. Prior cross-sectional survey data had shown the benefit of case management services in reducing unmet health needs and increasing ART use by disadvantaged populations once in HIV care (Katz et al., 2001); in comparison, this RCT implemented the case management intervention shortly after diagnosis. The case management intervention was also designed to prioritize cost-efficiency and widespread use by limiting contact to a maximum five contacts over a period of 90 days. Study results showed that, compared to passive referral, the intervention was associated with a significantly higher rate of successful linkage to HIV care (40% relative increase and 15% absolute increase linkage to HIV care at 6 and 12 months). Further research showed that the ARTAS intervention could be implemented in real-world settings (Craw et al., 2008) and used to link PWH to other medical services (Metsch et al., 2015).

Even with this success, one significant barrier to linkage to HIV care that was noted in this ARTAS trial was the use of crack cocaine, which was consistent with other studies associating drug use with delayed entry into timely HIV care (Bhatia et al., 2011; Brewer et al., 2007; Craw et al., 2008). Secondary analyses of the ARTAS trial specifically examined the effect of the linkage to care intervention in the context of recent drug use (defined as having used drugs during the 30 days prior to study enrollment) and receipt of drug use treatment. Among trial participants who reported recent drug use, those who had received drug use treatment experienced a greater ARTAS intervention effect (i.e., shorter time to linkage to first HIV care visit) than those who had not received drug use treatment (Gardner et al., 2016b). Such findings underscore the importance of specialized integrated interventions that help PWH who use drugs access both HIV care and substance use treatment. Overall, the ARTAS study showed how a relatively modest, affordable, and brief case management approach could improve the linkage and use of HIV care for newly diagnosed, underserved PWH and could serve as a resource for local health departments to implement in conjunction with HIV testing and education campaigns.

Miami, Florida, was one of the original sites in the ARTAS RCT (other sites included Atlanta, Georgia, Baltimore, Maryland, Los Angeles, and California) and had the lowest rate of linkage to care in the standard of care (control arm). There were notable barriers recognized in Miami at that time and that continues today in linking persons to HIV care, including lack of transportation, poverty, unmet mental health and substance use needs, and other individual- and system-level barriers (Glynn et al., 2019; Rojas et al., 2021; Wawrzyniak et al., 2015). Moreover, Miami-Dade County has historically had one of the highest prevalence and case rates of HIV/AIDS nationally, given its unique, heterogeneous culturally and sexually diverse population (2017–2021 CDC/HRSA Integrated HIV/AIDS Prevention and Care Plan, 2016; Centers for Disease Control and Prevention, 2019b; Escudero et al., 2019; Florida Department of Health HIV/AIDS Section, 2020; Forrest et al., 2019). Within this context, Drs. Rodriguez, Kolber, Tookes, and team at the University of Miami designed and implemented another linkage to care approach in 2016, the Test and Rapid Response Treatment (Rodriguez et al., 2019). In collaboration with the Florida Department of Health, this rapid response initiative was designed to facilitate prompt linkage to care for patients diagnosed with HIV in settings where people are newly diagnosed (i.e., Miami STI clinic, syringe services). Through the assistance of a linkage navigator, newly diagnosed patients were able to either receive same-day ART or schedule a follow-up care appointment within one week of the reactive test result. By mitigating many of the cited barriers (e.g., transportation) that have historically hindered timely linkage to care, this approach demonstrated not only high feasibility and patient acceptance (Harkness et al., In Press; Rodriguez et al., 2019), but also favorable rates of retention in care and viral suppression.

Retention in Care

Despite consistent research documenting the association between regular, ongoing HIV medical care and improved health outcomes, only 50% of PWH in the US are currently retained in care, defined by the CDC as the receipt of at least two CD4 or viral load tests in a three-month period (Centers for Disease Control and Prevention, 2018; HIV.gov, 2021b). Once diagnosed and linked to HIV care, a myriad of factors impede retention in care, including the presence of competing comorbidities (e.g., substance use and mental health disorders), perceived lack of need, and structural barriers (e.g., homelessness, poverty, and lack of transportation) (Centers for Disease Control and Prevention, 2018; Dombrowski et al., 2015; Hall et al., 2017). One approach assessed through our participation in the 2008 – 2010 CDC-HRSA-funded Retention in Care Study Group is tailored messaging that promotes HIV primary care attendance and continuation of care through printed media and verbal encouragement (Gardner et al., 2012). Conducted at 6 national HIV-specialty clinics throughout the US, the intervention significantly improved HIV care attendance compared to the prior pre-intervention year, particularly for patients who were young, new, or re-engaging in care, or who had elevated viral loads. Along with its ability to impact HIV care retention, the minimal cost and effort expenditure required to implement this simple systematic messaging underscored its feasibility and sustainability (Gardner et al., 2012, 2015). An additional intervention approach tested in an RCT by the Retention in Care Study Group is enhanced personal contact (EC), whether on its own or in combination with brief patient-centered behavioral skill training (Gardner et al., 2014). Study findings were the first evidence from an experimental study of an efficacious intervention for improving retention in HIV care. While the EC approach was designed to facilitate personal contact and basic HIV education between a patient and a dedicated trained staff member, the addition of a behavioral skills arm was intended to see the potentially complementary impact of enhancing awareness, motivation, and self-efficacy surrounding HIV primary care visit attendance. EC with patients improved HIV care visit consistency and adherence. The addition of the behavioral skills component did not improve retention above and beyond the EC approach. Notably, patients living with HIV and substance use had the lowest retention rates among subgroups and benefited minimally from the intervention efforts, underscoring the need for a more intensive, direct approach when it comes to this particularly vulnerable group of individuals left behind (Gardner et al., 2016a).

Viral Suppression

Viral suppression is the penultimate outcome on the HIV care continuum as this is a marker of a person's HIV RNA being undetectable and thus un-transmissible. Members of our clinical team had long recognized that persons who present in the hospital setting with HIV-related conditions had a high likelihood of having a detectable viral load, not being engaged with HIV care and also having significant social disadvantages (Metsch et al., 2009). Our team conducted research at the safety net hospitals in Miami, Florida (Jackson Memorial Hospital) and Atlanta, Georgia (Grady Memorial Hospital) and established that approximately one-third of the PWH admitted to the hospital setting had used crack cocaine (Metsch et al., 2009). Consistent with other studies, it was also recognized that hospitalized patients with uncontrolled HIV were sick, poor, experiencing homelessness and food insecurity (Doshi et al., 2012; Vogenthaler et al., 2011), and not engaged with an HIV provider. Recognizing that the hospital visit served as an opportunity for prevention and engagement, the NIDA CTN launched the Project HOPE (CTN 0049) study from 2012 to 2014 that was conducted in 11 hospitals throughout the US (Metsch et al., 2016). The CTN0049 study enrolled hospitalized adult PWH who had a detectable or unknown viral load in the past six months, a baseline CD4 count lower than 350 cells/uL and opioid, stimulant, or heavy alcohol use within the past year. This study was a 3-arm RCT comparing treatment as usual to two 6-month-long interventions, patient navigation + financial incentives (PN + FI) versus patient navigation-only (PN-only), in achieving HIV viral suppression (≤ 200 copies/mL) at the 12-month assessment (six months after completion of the interventions). Findings demonstrated that while at the a-priori primary outcome of 12 months (six months after completing the intervention) there were no differences between the treatment arms, short-term efficacy was observed as the completion of the six-month PN + FI approach showed significant increases in HIV care engagement and viral load suppression among PWH and substance use. In other words, the intervention was effective as long as it was implemented but, not surprisingly, when the intervention was removed, the impact also disappeared.

The subsequent analysis also demonstrated that participants in the PN + FI arm had increased self-efficacy, which provides support for the overall rationale for the design of the trial (Traynor et al., 2021). Specifically, we developed the intervention under the hypothesis that, over the six-month study period, intrinsic motivation and self-efficacy would be enhanced by the PN + FI intervention and subsequently lead to improved health-seeking behaviors and treatment adherence. As such, by the study's end, we expected to see high engagement in both HIV care and substance use treatment, as well as viral suppression and high levels of HIV care provider support, on account of participants’ increased self-efficacy. Based on post-hoc mediation analysis, these goals were indeed achieved at six months but not sustained at 12 months. Follow-up studies should assess the impact of the continued, long-term PN + FI approach on sustaining self-efficacy and its downstream effects; whether alternatively or in combination, such outcomes may be better achieved through approaches including a focus on enhanced clinical services, such as the delivery of integrated HIV and substance use treatment.

Co-Infection

HIV-HCV coinfections are common and, of concern, as co-infection is associated with faster progression of liver disease (Greub et al., 2000; Limketkai et al., 2012; Weber et al., 2006). Our research team conducted a follow-up study to CTN 0049 that sought to test a care facilitation intervention with participants with HIV and Hepatitis C (HCV) co-infection. In launching this study in the era of direct-acting antiviral (DAA) medication that offers the opportunity for a cure for HCV, we recognized that persons who use drugs face disadvantages in accessing HCV treatments and that there are numerous steps and barriers that have to be overcome including obtaining HCV viral load results, having an HCV (liver) evaluation, receiving an offer of HCV medications, initiating HCV medications, completing HCV treatment, and achieving sustained viral response at 12 weeks (SVR12) in addition to steps to ensure continued engagement in HIV care. The CTN 0064 study (2016–2017) tested the efficacy of a six-month care facilitation intervention (vs. standard of care) to move participants with HCV/HIV co-infection along the HCV care continuum (Metsch et al., 2021). Results showed that the care facilitator intervention resulted in a statistically significant, yet modest, intervention effect of increased forward movement among intervention participants. Across both groups, approximately 12% of those who were RNA positive achieved sustained viral response by the 12-month follow-up period.

Lessons Learned and Future Directions

The overall objective of our research team's decades of social intervention work has been to help underserved populations—those left behind—move along the HIV Care Continuum and achieve the ultimate goal of accessing treatment, social services, and living a healthy life. With the understanding that medical and clinical advances can exacerbate existing health disparities, the focus of our research studies has been—and continues to be—that those who are most disproportionately affected by HIV have access to and engagement with the best care and care support services. Despite many of our interventions’ successes in expanding HIV testing to many different outpatient and unconventional clinical settings, facilitating early linkage to HIV care, and helping PWH be retained in care, there is still much work to be done to end the HIV epidemic in the US and to address long-standing social inequities and cumulative social disadvantage among the participants we have been honored to work with in our studies.

One perpetuating constantly in the lives of PWH is stigma. No longer is HIV a death sentence, but rather a treatable chronic condition. Yet, HIV-related stigma remains omnipresent and often induces social marginalization, lack of support, discrimination, and violence, which compound the many other cited factors impeding receipt of HIV prevention and treatment services (Algarin et al., 2019; Fields et al., 2022). Furthermore, HIV-related stigma notably manifests in multiple layering of stigmatized identities (Lekas et al., 2011); that is, when a PWH embodies an additional characteristic that is typically marginalized by society (e.g., MSM of color, a person who uses drugs, or a person who has been formerly incarcerated), there are resultant key populations left behind when it comes to the receipt of appropriate care (Arrington-Sanders et al., 2020; Batchelder et al., 2020; Fields et al., 2022). Patients may also internalize these stigmatizing experiences and be vulnerable to demoralization. Additionally, provider stigma—defined as the negative attitudes, perceptions, and behaviors that healthcare providers embody and enact (sometimes subtly or involuntarily) toward their patients (Charles, 2013)—can further exacerbate marginalization from HIV care. Our research team and the work of others have shown that some health care providers can have negative attitudes toward people who use drugs and may still be reluctant to start them on life-saving anti-retroviral treatment because of their concerns about treatment adherence (Beer et al., 2015; Loughlin et al., 2004; Westergaard et al., 2012). These provider concerns are also seen in the prescribing of life-saving HCV DAAs and more recently with PrEP (Castel et al., 2015; Edelman et al., 2017). As such, there is a continued need for stigma-reduction interventions and campaigns that raise awareness and address the various degrees of societal stigma experienced by those most vulnerable, particularly PWH with intersecting and devalued social identities (Arrington-Sanders et al., 2020; Batchelder et al., 2020). To inform these needed interventions at the provider level, we are currently examining provider stigma through our national survey study—“Healthcare Provider Stigma Related to Patients with Substance Use Disorders and its Impact on Treatment and Clinical Management” (CTN 0104)—of the primary care and emergency medicine workforces. By understanding the subjective norms and attitudes of providers as well as the way in which they view and address commonly stigmatized conditions such as drug use and HIV, we can effectively develop and implement stigma-reduction interventions for providers to address their perceptions and enhance prevention and treatment efforts. Additionally, provider interventions informed by harm reduction principles that promote patient autonomy, focus on improving the safety and health at the individual level and enhance patient–provider communication, are especially critical in destigmatizing receipt of HIV care (Calabrese & Mayer, 2020; Geter et al., 2018).

One of our foremost lessons learned is that the engagement in care interventions tested in our studies has not always worked for PWH who use drugs and has been limited by short-term success. Dr. Hansel Tookes is currently testing an innovative new linkage to care intervention for persons who use drugs—Tele-Harm Reduction—which integrates harm reduction with patient autonomy (Tookes et al., 2021). Rather than enlisting traditional health care systems, Dr. Tookes and team are focusing on trusted services—and specifically, SSPs—to deliver on-demand, concierge-driven, telehealth-enhanced access to care. Tele-Harm reduction will entail multi-modal (e.g., in-person, Zoom) on-demand access to infectious disease physicians who specialize in harm reduction as well as to phlebotomy, medication delivery and storage, and harm reduction counseling. In Dr. Tookes’ recently NIDA-funded Avenir study “Tele-Harm Reduction for Rapid Initiation of Antiretrovirals in People Who Inject Drugs: An RCT,” persons who inject drugs will be recruited from two SSPs in Florida and randomly assigned to receive either the tele-health intervention or standard care (i.e., linkage to a traditional HIV clinic) over 12 months, with the ultimate goal of achieving and sustaining viral suppression in this especially vulnerable population.

Another key lesson learned is the importance of integrated care models and testing comprehensive HIV intervention and treatment approaches in multiple settings—rather than a piecemeal approach that tests one aspect of the HIV continuum of care (i.e., HIV testing, linkage to HIV care) in a single setting. We are currently conducting a hybrid effectiveness-implementation study to compare and evaluate two strategies for delivering PrEP and HCV treatment to persons who inject drugs to determine the best method of providing care: (1) an on-site integrated care model, which provides opioid agonist therapy (OAT) clinics and harm reduction sites/SSPs with the tools to offer HIV prevention and HCV treatment on-site, or (2) an off-site referral to a specialized care model, which connects people who are at risk for HIV with patient navigators who help them access available HIV prevention care and, if necessary, HCV treatment. Notably, we are testing these implementation strategies in OAT and SSP settings in two contrasting cities—Miami, Florida and Montréal, Quebec—to demonstrate how structural and organizational factors interact with PrEP and HCV treatment uptake and adherence. Given these two urban areas both have high disease burdens juxtaposed against widely different healthcare system dynamics, we have the opportunity to increase the generalizability of our findings by demonstrating the efficacy and cost-effectiveness of offering PrEP and HCV treatment in healthcare venues widely attended by persons who inject drugs in two very different policy and care delivery environments. This whole care approach is also being tested in the HIV Prevention Trials Network in the HPTN 094 study led by Drs. Steve Shoptaw and Nabila-El Bassel that seeks to link persons who inject drugs to HIV, HCV, prevention, and treatment services as well as substance use treatment services, starting from one-stop-shop mobile vans. As we look to improve the current system for those left behind as a vision for the future, these studies give us the opportunity to understand how improving structural factors—as opposed to enhancing individual clinical services—may produce different clinical outcomes.

It has been over 40 years since the first cases of AIDS were identified by the CDC in the US (Centers for Disease Control,1981). Since that time, there have been ground-breaking advances in HIV treatment that now renders HIV disease a chronic disease with a similar life expectancy to persons without HIV. Our research projects recognized early on that engagement in care is essential and that social interventions that provide strengths-based case management that empower people and work to reduce and overcome barriers to care could be an important tool for PWH. Similarly, our research team has recognized the importance of focusing on supporting PWH at diagnosis through same-day initiation and also providing critical evidence to streamline the HIV testing process and to expand it to new clinical settings. With this said, there continue to be people who are left behind in these advances and these tend to be people who experience great social disadvantage and often live on the margins of society. Our team has sought to develop and rigorously test approaches to intervene and support people in navigating health services settings with a recognition that it is of critical importance to meet people where they are, both physically and mentally, and ensure that their experience is grounded in mutual respect, care, and partnership.

Footnotes

Author Note

This paper was submitted as a contribution to the special issue of Research on Social Work Practice, guest edited by Nabila El-Bassel and Louisa Gilbert. It consists of research originating within the Social Intervention Group, School of Social Work, Columbia University.

Declaration of Conflicting Interests

The authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Funding

The authors received no financial support for the research, authorship, and/or publication of this article.

ORCID iDs

Carrigan L. Parish

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