Anonymous Opt-Out HIV and hepatitis C screening at a syringe services program in Florida

Abstract

This paper outlines the implementation of opt-out HIV and Hepatitis C (HCV) screening at a syringe services program (SSP) in Florida, highlighting its effectiveness in reducing the transmission of these infectious diseases. Historically, many SSPs have utilized opt-in testing models, which require participants to actively choose testing and often result in low participation rates. Recognizing the need for a more effective approach and to comply with Florida’s regulatory requirements under the Infectious Disease Elimination Act, we transitioned to an opt-out testing model at our SSP. This model integrates routine, anonymous, and voluntary testing into standard care, normalizing the process and reducing stigma associated with infectious disease screening. Initially, our policy tied testing to access to specific services, including syringe exchange, to meet compliance with Florida Department of Health mandates. However, after feedback from participants, staff, and community members, we revised our approach to allow all participants to access all services, regardless of their decision to participate in testing. Importantly, this policy change did not decrease testing rates, with only 6 out of 226 new enrollments (3%) opting out since the implementation of opt-out screening. By fostering a trusting, non-coercive environment and normalizing screening as part of routine care, we achieved high rates of participation while maintaining participant autonomy. Since transitioning to an opt-out model, we have conducted nearly 3,000 HIV and HCV tests, with seropositivity rates of 3.8% and 54%, respectively. These efforts have facilitated early detection, rapid linkage to care, and reduced transmission within the community. Our findings underscore the importance of comprehensive, repeat testing in high-risk populations and demonstrate the potential for opt-out models to serve as a scalable framework for SSPs nationwide. This approach not only fulfills regulatory and public health objectives but also strengthens the role of SSPs as critical interventions in combating HIV and HCV transmission.

Background

Injection drug use is the leading driver of new Hepatitis C Virus (HCV) infections and accounts for approximately 10% of new HIV cases annually in the United States [1,2,3,4]. These risks are exacerbated by practices such as needle sharing and other injection equipment, including cookers, cotton filters, and water, which can become contaminated with bloodborne pathogens [1, 3]. Additionally, unprotected sexual practices, including those associated with sex work, further increase the risk of HIV and HCV transmission among people who inject drugs (PWID) [1, 3]. Syringe Service Programs (SSPs) play a critical role in mitigating these risks by providing sterile injection equipment and comprehensive harm reduction services aimed at reducing the transmission of infectious diseases [5, 6]. These practices highlight the importance of comprehensive harm reduction strategies, including education on safe injection practices and access to sterile equipment, as well as routine, opt-out screening for HIV/HCV.

In Florida, the establishment and operation of SSPs are governed by the Florida Infectious Disease Elimination Act (IDEA), which emphasizes the prevention of HIV and HCV transmission as a cornerstone of harm reduction efforts [7]. These programs are required to integrate infectious disease testing and prevention into their services and comply with public health mandates. While many SSPs have traditionally employed an ‘opt-in’ testing model, which requires participants to actively choose testing, this approach often results in low screening rates. Opt-in programs report participation rates of approximately 30–40%, which limit their ability to detect infections early and prevent outbreaks [8]. Opt-out testing, in contrast, normalizes and integrates infectious disease screening into routine care, significantly increasing participation rates. The Centers for Disease Control (CDC) has long recommended opt-out testing as a best practice for HIV screening, citing its effectiveness in improving detection and linkage to care [9]. Montoy et al. demonstrated that opt-out HIV testing in the emergency department increased the acceptance rate to 66%, compared to only 38% for opt-in testing [8]. A systematic review by Haukoos et al. emphasized that opt-out testing in various healthcare settings consistently resulted in higher testing rates and earlier diagnosis of HIV compared to opt-in approaches [10]. Within SSPs, opt-out testing has been shown to yield participation rates of up to 85%, compared to lower uptake seen with opt-in models [11].

This approach has the added benefit of reducing stigma around testing by framing it as a standard part of health care services, rather than a separate, ‘add-on’ activity [12]. Metsch et al. demonstrated that combining HIV testing with routine health services, such as wound care, hepatitis vaccination, mental health services and substance use counseling led to increased acceptance rates and facilitated earlier detection and linkage to care [12, 13]. In response to these challenges and opportunities, our SSP adopted an opt-out testing model to align with Florida’s legal requirements and improve public health outcomes. By integrating routine, anonymous HIV and HCV screenings into the syringe exchange process, our program aims to normalize testing, identify infections early, and link participants to timely treatment. This model not only fulfills the regulatory mandates required for SSP operation in Florida but also enhances the broader goals of harm reduction by demonstrating the impact of these programs on infectious disease prevention.

Integrating an Opt-out HIV/HCV screening model as a routine part of SSP care

In Florida, SSPs exist legally to decrease HIV and HCV transmission (Florida Infectious Disease Elimination Act [IDEA] FS381.00384) [14]. The establishment and operation of SSPs are intrinsically tied to public health mandates and legal stipulations under the Florida Department of Health (FDOH). IDEA authorizes SSPs to operate only within a framework that explicitly prioritizes infectious disease testing and prevention as key components of harm reduction. This regulatory context reflects both the public health commitment to curbing the transmission of HIV and HCV among PWID and the political sensitivity surrounding harm reduction services in the state. By integrating opt-out HIV and HCV screening as a routine component of SSP services, programs not only align with DOH requirements but also secure their operational legitimacy within this regulated environment. This dual necessity—fulfilling public health goals and adhering to state mandates—underscores the importance of maintaining robust, anonymous, and voluntary testing mechanisms. While this framework can present challenges, it also offers an opportunity to strengthen the narrative around SSPs’ contributions to public health outcomes, demonstrating their value beyond harm reduction by actively addressing Florida’s infectious disease burden.

At the inception of our SSP, we interpreted the FDOH requirements to mean that opt-in or opt-out HIV and HCV testing needed to be closely tied to the provision of syringe exchange services. As such, in our initial policy, participants who declined testing could still access a range of other harm reduction services, including food distribution, hygiene kits, insurance navigation, mental health counseling, primary care referrals, and addiction treatment. However, they were unable to participate in the needle exchange itself without undergoing testing. This interpretation was intended to align with what we understood to be necessary for maintaining compliance with state regulations and ensuring the long-term viability of our program.

After ongoing reflection, a careful review of the requirements, and invaluable feedback from participants, staff, and community members, we revised our policy to allow all participants—regardless of their testing decision—to access every service we offer, including the needle exchange. Importantly, this change did not lead to a decline in testing rates. On the contrary, we observed that testing participation remained consistent, suggesting that the sense of trust, community, and respect cultivated within our program, combined with the normalization of opt-out testing as a routine aspect of health care, contributed to its continued acceptance. This approach ensured that testing was perceived not as a prerequisite or coercive condition but as an integrated, non-stigmatizing, and voluntary part of the comprehensive care offered through our SSP.

We have demonstrated that opt-out testing models can be extended successfully to SSPs to meet public health goals. We adopted the opt-out screening model at our SSP based on the success of our HIV/HCV screening program at a Level-1 academic urban quaternary care emergency department (ED), where we have screened over 120,000 people for HIV and HCV since 2016 using an opt-out model. We notify participants that opt-out screening is occurring in accordance with FS 381.004¹⁴ via signs posted throughout the department. Normalizing HIV/HCV screening utilizing an opt-out model makes sense in this context, as during routine medical care, many lab tests and procedures are opt-out. Additionally, public health (e.g., reducing transmission of disease) is not a programmatic goal. For example, checking vital signs at the beginning of a visit is assumed to be a normal part of care. However, a patient could decline this step of the encounter and that request would be honored if the patient has decision making capacity, even if the decision to opt-out limits or alters the individual benefit of the clinical encounter.

Our approach aligns with CDC guidelines, which recommend routine opt-out testing as a best practice for increasing the detection of infectious diseases and improving linkage to care [9]. From April 2021 to January 2025, 2,937 HIV tests (3.8% seropositivity) and HCV tests (54% seropositivity) were conducted. Among these, 1,313 unique individuals were tested. The majority of participants were only tested once (64%) and were lost to follow up. However, 24% were tested between two to four times, and 11% were tested five times or more. Currently, our SSP serves around 2,000 (1,806) unique participants, with the majority (96%) retained in long-term engagement. Every participant receives a baseline HIV/HCV test at enrollment unless they opt out, and then a repeat screen at maximum every month, but more often around every three months. Since amending our opt-out policy to include all harm reduction services, including needle exchange, 6 out of 226 new enrollments (3%) have opted out of HIV/HCV screening.

Key to our public health approach to reduce viral transmission is this repeat screening among participants. Regular repeat screening in a high-risk population accomplishes multiple aims, including to normalize and destigmatize routine screening, early identification of disease, and rapid linkage of new infections, all of which demonstrate the effectiveness of SSPs in preventing disease transmission through program participation. Further, our transition to include the syringe exchange component even when participants opt out of HIV/HCV testing further accomplishes the public health goal of reducing transmission of infectious diseases, since providing sterile injection equipment works to decrease community transmission of these diseases whether participants are informed regarding their status or not. Finally, the impact of HIV/HCV treatment upon the public health aim of Ending the HIV Epidemic is paramount. By early linkage to care for HIV/HCV infection we can potentially reduce risk of transmission. We believe opt-out and repeat screening are necessary program tools to demonstrate the impact of SSP programs across the United States in accomplishing the goals of Ending the HIV Epidemic and the elimination of HCV [15, 16].

Conclusion

The CDC and other public health entities have consistently emphasized the critical role of SSPs in reducing the incidence of HIV and HCV, providing a strong justification for their legalization and funding. However, the effectiveness of SSPs in achieving these public health goals relies heavily on their ability to gather and utilize data from comprehensive screening programs. Without baseline screenings at enrollment and regular, routine follow-up testing, SSPs face significant challenges in tracking infection trends, identifying outbreaks early, and evaluating their impact on transmission rates. Opt-in testing models, which require active participant engagement, often yield low uptake rates, further limiting the ability to generate actionable data and fully demonstrate program success. This lack of comprehensive data weakens the case for SSPs as essential public health interventions from an infectious disease perspective.

In contrast, our implementation of an opt-out screening model has proven to be a highly effective strategy for overcoming these barriers. By normalizing HIV and HCV testing as a routine component of care, we have created a low-barrier, non-stigmatizing environment that fosters participant trust and encourages high rates of engagement. The high level of participation observed in our program—evidenced by a 3% opt-out rate—illustrates that integrating opt-out testing into the fabric of SSP operations can achieve widespread acceptance while maintaining participant autonomy. This approach not only fulfills regulatory requirements set forth but also aligns with broader public health objectives, including the CDC’s recommendations for routine infectious disease screening. Beyond compliance, the implementation of opt-out screening at our SSP has had tangible impacts on public health outcomes. The consistent screening of participants has enabled early detection of HIV and HCV infections, ensuring rapid linkage to care and reducing the risk of further transmission. Repeat screening, especially in high-risk populations, is instrumental in identifying new cases, providing timely interventions, and ultimately achieving the goals of Ending the HIV Epidemic and HCV elimination. Further, the success of our opt-out model demonstrates the potential for this approach to be scaled to SSPs nationwide, providing a robust framework for other programs seeking to enhance their impact.

The lessons learned from our program underscore the importance of balancing regulatory compliance with community-centered care. By revising our policies to ensure that all participants, regardless of testing decisions, could access every service we offer—including syringe exchange—we strengthened the trust and inclusivity of our program while maintaining high testing participation and better accomplishing public health goals. This adaptability highlights the critical role of feedback from participants, staff, and community members in refining harm reduction practices to meet both regulatory and ethical standards. In conclusion, routine, anonymous, and voluntary opt-out infectious disease screening integrated within SSPs is not only a practical public health strategy but also a powerful tool for demonstrating the effectiveness of harm reduction programs. Our experience highlights the potential for SSPs to act as critical points of intervention in the fight against HIV and HCV transmission. By fostering trust, ensuring accessibility, and normalizing testing as a routine health practice, SSPs can significantly enhance their impact, contribute to public health goals, and solidify their role as indispensable components of harm reduction efforts nationwide.