Rapid Identification of HIV Among People Who Inject Drugs: Tampa, FL, 2024

Abstract

Syringe Service Programs (SSPs) have proven effective in reducing HIV transmission among people who inject drugs (PWID). However, early HIV detection remains an underutilized opportunity for preventing transmission and curbing outbreaks. This paper emphasizes the impact of implementing routine, opt-out HIV screening within SSPs as a strategy to enhance early detection and prevention efforts. In 2022, the IDEA Exchange Tampa, Florida’s second legally sanctioned SSP, transitioned from an opt-in to a routine opt-out screening model. This shift identified six anonymous participants with acute and untreated HIV, including three confirmed seroconversions (within 59 days of a prior negative test), two individuals diagnosed during their first HIV screening at the SSP with ‘unknown infection duration’, and one previously diagnosed individual who had been out of care. Through a robust linkage-to-care framework, all six participants were linked to care within an average of 7.5 days (100% linkage rate). Clinical counseling sessions revealed that these individuals were part of an interconnected 26-person risk network involving needle-sharing and sex exchange behaviors. These findings underscore the critical role of systematic opt-out screening in SSPs for accelerating case detection and facilitating rapid linkage-to-care. Expanding routine, opt-out HIV screening at SSPs is essential to improving detection, curbing outbreaks, and advancing the goals of the Ending the HIV Epidemic (EHE) initiative.

Introduction

The federal Ending the HIV Epidemic (EHE) initiative aims to reduce new HIV infections in the United States by 90% by 2030 [1]. This comprehensive national effort is structured around four key pillars: early HIV diagnosis, rapid and effective treatment to achieve sustained viral suppression, prevention of new transmissions through proven interventions, and quick responses to potential HIV outbreaks [2]. Syringe Services Programs (SSPs) are essential components of this strategy, particularly among people who inject drugs (PWID) [3], a population at heightend risk for HIV. In 2022, PWID accounted for approximately 7% (2300 cases) of the estimated 31,800 new HIV infections in the U.S [3]., underscoring the critical need for targeted interventions in this population.

SSPs serve as low-barrier community programs that provide PWID with sterile injection equipment, overdose prevention education, naloxone distribution, wound care, and access to treatment, such as medications for opioid use disorder (MOUD) [3]. These resources serve as lifelines for individuals marginalized by structural harm, discrimination, and the stigma associated with drug use [4, 5]. SSPs reduce the risk of blood-borne infections such as HIV, hepatitis B (HBV), and hepatitis C (HCV) by acting as vital entry points for HIV testing and linkage-to-care [6–9]. SSPs with integrated on-site HIV testing and immediate linkage-to-care significantly enhance the identification of new cases and streamline access to treatment [9–13]. For instance, Behrends et al. (2017) highlighted the impact of integrated services in New York SSPs in identifying new HIV cases [14], while Ti et al. (2017) found that such models facilitated faster initiation of antiretroviral therapy (ART) and improved rates of viral suppression [15]. Similarly, Des Jarlais et al. (2020) reviewed multiple SSPs across various U.S. cities and found that programs with integrated HIV testing identified 1–2% more undiagnosed HIV cases compared to SSPs without such services [16].

The HIV Testing Gap

The importance of early HIV detection cannot be overstated. Early initiation of ART suppresses viral loads, reduces the risk of transmission, and prevents outbreaks within high-risk communities [17, 18, 21–25]. Studies involving discordant couples, such as those by Reynolds et al. (2011) have demonstrated that ART reduces transmission rates by up to 81% [19]. Achieving undetectable viral loads offers significant public health benefits, including the near elimination of HIV transmission, as well as individual health advantages, such as preserved CD4 counts and improved organ function [20]. However, despite the proven benefits, HIV testing uptake among PWID remains low. Many PWID face barriers such as stigma, mistrust of healthcare systems [21, 26–32], fear of criminalization [32, 34, 35], inaccurate perception of HIV risk, and competing survival priorities, including housing instability and substance use [32–36]. These compounding factors underscore the need for innovative approaches to engage PWID in HIV testing and care.

Opt-out HIV testing offers a promising solution to these barriers by normalizing HIV screening and making it routine unless a patient explicitly declines. Unlike opt-in models, which require active consent and often results in lower participation rates, opt-out testing reduces stigma and encourages disclosure of risk behaviors [37, 38]. Large-scale SSPs in New York and San Francisco have demonstrated the success of opt-out testing, achieving substantial increases in testing rates and improved linkage-to-care outcomes [39, 40]. A systematic review by Soh et al. (2022) found that opt-out models significantly increased the identification of new HIV cases compared to opt-in approaches, while Bartholomew et al. (2020) showed that routine opt-out HIV and HCV screening in SSPs led to greater testing uptake [41]. Additionally, Tookes et al. (2020) demonstrated that opt-out HIV screening at a SSP in Miami, FL facilitated rapid HIV case identification and efficient linkage-to-care [42]. These findings demonstrate the transformative potential of integrating routine, opt-out testing in SSPs to overcome barriers to detection, facilitate early linkage to treatment, and strengthen public health responses to HIV. This paper provides actionable insights into enhancing HIV prevention and care among PWID, advancing the goals of the EHE initiative.

Methods

SSP Setting and Operations

The IDEA Exchange Tampa is a mobile SSP that visits set locations throughout the greater Tampa Bay area. The program is staffed by a multidisciplinary team including peer support specialists, HIV navigators, social scientists, licensed mental health practitioners, and medical staff. Since inception, the program has averaged approximately 97 client visits per week and operates under Florida Statute 381.00384 (Infectious Disease Elimination Act (IDEA)). Established in 2021 after the state-wide expansion of IDEA, the program provides comprehensive harm reduction services integrated with healthcare access points.

HIV Screening Protocol

The IDEA Exchange Tampa implemented a rapid opt-out HIV screening program in January 2022 designed to integrate routine infectious disease screening into its SSP. Upon initial enrollment, participants were offered baseline infectious disease screening, including HIV and hepatitis C (HCV). Unless a participant opted-out, HIV screening was repeated every three months, with additional screenings available upon request. HIV screenings were conducted by SSP HIV care navigators trained in Counseling, Testing, and Referral (CTR). The initial HIV screening was performed using the OraQuick Advance Rapid HIV 1/2 Antibody Test (Orasure Technologies), a point-of-care rapid test chosen for its effectiveness and high acceptability among PWID, owing to its immediacy and privacy [43].

Screening results are collected and managed in REDCap, a HIPAA-compliant cloud-based data management platform. IDEA Exchange Tampa operates as an anonymous exchange, meaning no personal information is collected for program participation. The program is one of the few sites in Florida permitted by the Florida Department of Health (FLDOH) to conduct anonymous testing, a designation that underscores a critical recognition of the unique needs of PWID. Participants are assigned a unique identifier upon enrollment, which also facilitates retrieval of test results without compromising anonymity. For participants receiving reactive screening results, post-test counseling and peer support are provided, along with the opportunity to transition to confidential services for confirmatory testing and linkage-to-care. Confirmatory testing involves a blood draw for HIV RNA, conducted onsite via field-based phlebotomy, with samples processed at a nearby partnering hospital laboratory. Results are typically available within 24–48 h and were communicated to participants during their subsequent visit to the SSP in accordance with FLDOH CTR protocols.

Testing of Participants with Known HIV Status

The opt-out screening protocol included participants who self-identified as people living with HIV (PLHIV). This approach was implemented for several reasons: (1) many participants were unsure of their current viral load status, (2) some had been out of care for extended periods, (3) rapid testing served as the first step towards care re-engagement opportunity, and (4) the anonymous setting allowed re-entry into care without judgement. Of the 33 participants who self-identified as PLHIV during the study period, 12 (36%) were not currently engaged in care and were successfully linked through our services.

Case Definitions and Linkage-to-Care

Seroconversion was defined according to the Council of State and Territorial Epidemiologists (CSTE) case definition as a documented negative HIV test followed by a positive test within six months after March 2023. Participants with confirmed HIV diagnoses were provided with two linkage-to-care options including onsite care at the SSP or offsite care through a local AIDS Service organization (ASO). Both options were explained in detail to participants.

Successful linkage-to-care was defined as attendance at an initial appointment with a clinical provider qualified to manage HIV and prescribe antiretroviral therapy (ART). Participants who elected onsite care were enrolled in an integrated care model that provided same-day linkage with an HIV provider and immediate access to co-located behavioral and mental health services. The onsite care model was supported in part by the Tele-Harm Reduction (THR) intervention, an integrated care intervention under evaluation through the concurrent T-SHARP (Telehealth Solution for HIV and Addiction-Related Problems among People who Inject Drugs) clinical trial (NCT05208697) [44]. A dedicated care pathway was also available for participants co-infected with HCV. Participants who elected offsite care, were navigated to an ASO. Linkage for these participants was facilitated through a concierge-style “red carpet” system designed to rapidly connect uninsured, newly diagnosed, or out-of-care individuals to collaborating community partners. This process included a direct “warm handoff” to the selected ASO, personal introductions to care navigation staff, expedited intake and appointment scheduling (often the same day), and transportation assistance through the SSP’s Mobility Program. HIV care navigators monitored participants during the first 30 days post-diagnosis to ensure engagement and attendance at their initial medical visit. To support seamless care transitions, all medical documentation was securely transferred to the ASO selected by the participant.

Clinical Counseling and Documentation

HIV pre-and post-test counseling was conducted by trained HIV care navigators who had established rapport with participants through ongoing SSP interactions. Standard HIV counseling protocols routinely include assessment of risk behaviors and social connections as part of established public health practice. During counseling sessions with the 6 participants diagnosed with acute or untreated HIV, network information and participant experiences with HIV testing barriers emerged organically as participants voluntarily disclosed details about their social connections, shared injection practices, survival strategies, and factors that facilitated their engagement with the SSP.

Field notes were documented in real-time rather than audio recordings to maintain consistency with routine clinical documentation practices, preserve the informal counseling atmosphere, and address participant concerns about being recorded when discussing sensitive and potentially stigmatized behaviors. Because these conversations occurred across multiple encounters as participants returned for ongoing services, recording would have been impractical and disruptive to the natural development of trust and rapport that facilitated disclosure. This approach was particularly important given participants’ heightened sensitivity to surveillance due to their experiences with marginalized status and potential legal concerns related to drug use.

Clinical documentation captured both network connections and participant perspectives, which were later analyzed as part of program evaluation to understand the interconnected risk network and participant experiences with opt-out HIV screening services.

Ethical Considerations

This analysis was conducted under exempt research determination (STUDY008511, IDEA Exchange Testing Review) and involved secondary analysis of de-identified program data collected during routine HIV testing and counseling services. Network information emerged organically during standard HIV pre-and post-test counseling sessions, which routinely includes assessment of risk behaviors and social connections as part of established public health practice. No additional research consent was required as all data were collected during routine service provision and analyzed in de-identified form.

Measures

Demographics (age, sex, race, and ethnicity), housing status, syringe-sharing status, and substance use data were obtained from the IDEA Exchange Tampa SSP enrollment surveys collected through REDCap during initial program enrollment. Clinical characteristics and outcomes, including baseline viral load, time to linkage-to-care, and reported Hepatitis C co-infection data were also collected from REDCap during follow-up testing encounters.

Initial enrollment data collection takes approximately 10–15 min, while follow-up data collection is integrated into routine service provisions during each testing encounter. HIV/HCV testing, results and linkage outcomes are collected as each testing encounter and entered into REDCap within 24 h. Time to linkage-to-care was defined as the number of days from the participants positive confirmatory HIV test at the SSP to the day they were linked to a clinical provider, either onsite or offsite.

Results

Program Overview and Study Context

During a three-year period between January 2021 and December 2024, IDEA Exchange Tampa enrolled 1846 participants, facilitated 21,154 visits, exchanged 927,830 syringes, distributed 18,469 boxes of nasal naloxone and conducted 3106 HIV and 3362 HCV screening tests, achieving an 85% linkage-to-care rate for individuals diagnosed with HIV. The program transitioned from an opt-in to an opt-out screening model in 2022. This transition led to the identification of six individuals living with HIV, including three seroconversions, two individuals diagnosed during their first HIV screening, and one previously diagnosed individual who had been out of care. Notably, the three seroconversions had previously engaged with the SSP but have never undergone testing under the opt-in-model, highlighting missed opportunities for earlier detection. The remaining three participants only engaged with the SSP for HIV screening due to the normalization and accessibility of the opt-out approach, underscoring its role in reducing barriers to testing.

HIV Testing Outcomes

Between March 2023 to April 2024, IDEA Exchange Tampa administered 1,124 anonymous, rapid HIV tests. A total of 648 unique individuals were tested, of whom 431 (66.5%) underwent opt-out screening once, while 217 (33.5%) engaged in serial testing, completing two or more HIV tests. Among these individuals, 39 (6.0%) screened positive for HIV, resulting in an overall seropositivity rate of 3.2% across both single and serial testers. Of those who tested positive, 33 (85%) self-identified as PLHIV who were already aware of their status and/or reported being engaged in care. Additionally, 6 individuals were identified as having acute or untreated HIV (Fig. 1). On average, participants completed two HIV screenings at the SSP. Among these 6 individuals, three (50%) met the case definition of acute HIV infection, defined by documented seroconversion between SSP testing encounters. The median baseline viral load among these individuals (133,466 copies/mL) was consistent with the high-level viremia characteristic of early HIV infection, further supporting classification. Two additional individuals received their initial HIV diagnosis at the IDEA Exchange Tampa SSP with no prior screening records available, making the duration of their infection unknown. One individual reported a prior HIV diagnosis received while incarcerated but subsequently fell out of care upon release. Notably, three individuals who were either “out of care” or had “unknown treatment duration” sought HIV testing at the SSP after learning that members of their social network had been diagnosed with HIV. The average viral load for all 6 individuals was 141,006 copies/mL The median time from a participant’s initial positive confirmatory HIV test to linkage-to-care was 7.5 days. All individuals were linked to the SSP’s HIV care navigators upon confirmation of their positive status. Of the six individuals, two opted for onsite linkage via telemedicine at the SSP, while four individuals were provided with a ‘warm hand off’ to offsite care at an ASO (Table 1).

Fig. 1.

Identification of acute and untreated HIV cases through routine opt-out screening at IDEA Exchange Tampa, March 2023–April 2024

Table 1.

HIV screening outcomes under the routine opt-out testing protoccol at IDEA Exchange Tampa, March 2023–April 2024

Among the 6 participants, 2 (33.3%) identified as male and 4 (66.7%) identified as female. All participants reported being non-Hispanic White, 5 (83.3%) indicated current homelessness or unstable housing, and all 6 (100%) reported being unemployed. All participants reported injection drug use (IDU) as an HIV risk factor, and 3 (50%) reported frequent sharing of syringes. Heroin and methamphetamine were the most reported substances injected (83.3% each), followed by fentanyl/carfentanil (42.9%) and speedball (14.3%). 5 participants (83.3%) were found to be co-infected with HCV (Table 2).

Table 2.

Characteristics of the 6 individuals identified through routine screening services provided by IDEA Exchange Tampa, March 2023–April 2024

Demographics	Individuals identified living with HIV (n = 6)
Age – mean (range)	37 (25–46)
Sex – n (%)
Female	4 (66.67)
Male	2 (33.33)
Race – n (%)
Asian	0
Black	0
Pacific Islander	0
Other	0
White	6 (100)
Ethnicity – n (%)
Hispanic	0
Non-Hispanic	6 (100)
Experiencing Homelessness – n (%)
Yes	5 (83.33)
No	1 (16.67)
Unknown	0
Self-Reported HIV exposure risk – n (%)
Heterosexual Contact	4 (66.67)
IDU	6 (100)
Syringe Sharing – n (%)
All of the time	2 (33.33)
Most of the time	1 (16.67)
Some of the time	0
None of the time	3 (50.0)
Reported drug use – n (%)
Fentanyl/carfentanil	3 (50.0)
Heroin	5 (83.33)
Methamphetamine	5 (83.33)
Speedball	1 (16.67)
HIV clinical characteristics
Baseline viral load (copies/mL) – median (range)	141,006 (1440–382,000)
Time to linkage- to-care – median days (range)	7.5 (5–12)
HCV co-infection – n (%)
Yes	5 (83.33)

During routine HIV pre-and post-testing counseling sessions with these six individuals, care navigators documented that participants described being part of an interconnected 26-person risk network involving needle-sharing and sex exchange behaviors. As part of standard HIV counseling protocols, participants disclosed information about their social connections, shared injection practices, and survival strategies. This information emerged naturally during routine risk assessment and counseling conversations, where participants voluntarily shared details about needle-sharing partnerships, sources of injection equipment, informal networks for drug acquisition, and survival strategies including sex exchange. This network highlighted complex social and economic dependencies that facilitated high-risk behaviors, increasing participants’ vulnerability to HIV transmission. During counseling sessions, many participants described challenges in accessing sterile syringes prior to their membership at the SSP, often relying on informal networks or secondary distribution for injection equipment. This lack of reliable access led to frequent syringe reuse and sharing, increasing the likelihood of exposure to contaminated supplies. Additionally, some participants disclosed engaging in sex exchange as a means of survival, further compounding their susceptibility to HIV and other health risks. Participants described how socioeconomic instability, housing insecurity, and substance use-related stigma contributed to their reliance on sex exchange for financial resources and basic needs.

Despite these challenges, participants consistently emphasized during their counseling sessions that the SSP served as a rare and trusted resource within their community. Beyond providing harm reduction supplies, the SSP fostered a supportive and non-punitive environment where they felt encouraged to engage in healthcare services. Several participants indicated that the welcoming and respectful approach of SSP staff was instrumental in their willingness to access HIV testing, something they had previously avoided in traditional healthcare settings due to concerns about stigma and judgment. As documented in clinical notes one participant stated:

I wouldn’t have gotten tested anywhere else, but here, it felt safe.

Further, IDEA Exchange Tampa’s integrated supported network—consisting of HIV care navigators, mental health practitioners, and peer support specialists—played a pivotal role in fostering participant engagement and retention. During counseling sessions, individuals described the value of having a team-based support system that provided not only HIV screening but also guidance, emotional support, and assistance with accessing additional health services. Participants highlighted that the trust and accessibility of the SSP created an environment where they felt comfortable receiving care. One individual shared:

I never felt pressured or judged here. The team made it easy to talk about my health, which helped me feel like I wasn’t just another number.

Another participant emphasized the importance of continuity of care during their counseling sessions, stating:

It wasn’t just about getting tested. They made sure I had a plan; that I wasn’t alone in figuring things out.

For many, the opt-out testing model was key in reducing hesitation about HIV screening. During pre-test counseling, several individuals noted that offering testing as a standard practice rather than a separate or optional service helped alleviate discomfort. One participant explained:

I was nervous about testing before, but when they said, ‘We do this for everyone,’ it didn’t feel personal or scary anymore.

The availability of wraparound services also contributed to participant retention. Individuals described how the presence of mental health practitioners and peer support specialists made them more likely to return for follow-up care. One participant shared during a counseling session:

Having someone to talk to—who actually understood what I was going through—made all the difference. It wasn’t just about the test. It was about feeling supported.

Discussion

The IDEA Exchange Tampa’s integration of an opt-out HIV screening protocol within an SSP underscores the transformative potential of routine, accessible HIV testing in high-risk populations, particularly among PWID. Shifting from an opt-in to an opt-out model increased testing uptake and enabled the early identification of 6 acute or untreated HIV cases. Notably, 3 of these cases (participants 2–4) had previously engaged in SSP services without screening for HIV when the opt-in model was in place. The opt-out model embedded screening as a routine part of SSP services and enabled systematic screening and early detection. For the remaining 3 participants (participants 1, 5, and 6), the universality and normalization of the opt-out testing model—where every participant is offered screening—was a key motivator for engagement in the SSP and onsite infectious disease screening. They reported that knowing they would not be singled out for testing helped them feel more comfortable accessing services and undergoing HIV screening.

Early HIV diagnosis through opt-out testing allows for prompt initiation of ART, improving individual health outcomes while reducing onward transmission within high-risk networks. The program’s integration of same-day consultations and a “red carpet” service further enhanced early care engagement. The same-day option at the SSP—supported by the Tele-Harm Reduction (THR) intervention—enabled immediate linkage with HIV specialists, allowing care initiation without requiring participants to leave the SSP site. The “red-carpet” service provided a participant with a personalized “warm handoff” to offsite ASOs, complete with transportation assistance and expedited intake appointments. Together, these rapid linkage strategies minimized barriers and facilitated timely treatment initiation.

Further, the IDEA Exchange Tampa’s multidisciplinary support team was instrumental in fostering participant engagement and retention. This team-based approach enabled participants to access comprehensive services without fear of stigma, reinforcing the effectiveness of the opt-out model in engaging individuals who might otherwise avoid healthcare settings. The normalization of testing within SSP services helped establish a culture of trust, positively influencing participants’ perceptions and making participants more receptive to care. This atmosphere proved to be particularly impactful for individuals with limited prior engagement in health care, underscoring the critical role of low-barrier participant-centered HIV prevention strategies.

The IDEA Exchange Tampa further demonstrates that the success of the opt-out model can be replicated across various jurisdictions, emphasizing its adaptability. The program’s strategic partnerships with ASOs were critical in accelerating linkage-to-care and ensuring continuity. These relationships, established through memoranda of understanding (MOUs) and careful vetting of intake procedures, enabled the creation of tailored referral pathways. The streamlined pathways, often resulting in same-day linkages, underscore the scalability of the opt-out model as a robust, adaptable intervention for curbing HIV transmission in diverse geographic and social contexts, though sustaining integrated telemedicine components may require dedicated funding or infrastructure beyond a clinical trial setting.

Limitations and Future Directions

One limitation of this study is that the connection between the six anonymous participants with acute or untreated HIV, within the broader 26-person risk network, were identified through self-reported information obtained during routine HIV counseling, rather than through formal research interviews or molecular epidemiological confirmation. As such, network characterization was limited to information available through standard clinical care and is subject to recall and social desirability biases, which may have influenced the precision of inferred transmission relationships.

Although molecular epidemiological approaches and in-depth qualitative methods have been used in other settings to more comprehensively characterize HIV transmission dynamics, these tools were not employed here, as the primary objective of the IDEA Exchange Tampa program was rapid HIV detection and immediate linkage-to-care within a high-risk community. Future work should examine how established qualitative and molecular epidemiological approaches can be pragmatically integrated into SSP to enhance social network analysis, identify high-risk transmission clusters, and inform targeted interventions while maintaining low-barrier, participant-centered service delivery.

Additionally, the availability of onsite telemedicine linkage was supported in part by the THR intervention, under evaluation through the concurrent T-SHARP clinical trial, which may have enhanced the program’s capacity for rapid linkage-to-care beyond what would be typical at SSPs without similar infrastructure. Future replication efforts should consider strategies for sustaining integrated telemedicine services independent of clinical trial support.

Conclusion

The IDEA Exchange Tampa demonstrates the potential of SSPs to serve as comprehensive health hubs that not only provide screening and prevention services but also integrate on-site treatment options. Expanding the scope of SSPs to include services such as MOUD, pre-exposure prophylaxis (PrEP), and immediate ART initiation can further reduce barriers to care and optimize health outcomes. Embedding these services within SSPs, particularly in underserved and high-transmission areas, creates a seamless continuum of care that strengthens public health responses. Additionally, integrating on-site treatment aligns with the goals of the EHE initiative by positioning SSPs as critical access points for healthcare and supporting sustained viral suppression and overall well-being among vulnerable populations.

The transition from opt-in to opt-out HIV screening at IDEA Exchange Tampa reinforces three critical findings: (1) opt-out testing within SSPs effectively identifies undiagnosed HIV cases in high-risk networks, (2) normalizing HIV screening through an opt-out approach significantly increases detection rates, and (3) integrating routine screening with rapid linkage-to-care minimizes delays in treatment initiation, ensuring that diagnosed individuals are connected to care more quickly. The significance of this approach was first demonstrated in 2018 when IDEA Exchange Miami, Florida’s first legally sanctioned syringe exchange, identified an HIV outbreak that may have otherwise gone undetected. The adoption of an opt-out testing model played a crucial role in detecting new cases early and facilitating timely intervention. The success of IDEA Exchange Tampa in corroborating this evidence further underscores the critical role of SSPs in identifying and responding to emerging outbreaks. These findings highlight the necessity of embedding routine HIV screening into SSPs, not only as a harm reduction strategy but as an essential public health intervention to curb transmission, facilitate timely treatment, and advance HIV epidemic response efforts.

Author Contributions

All authors contributed to the study conception and design. Material preparation, data collection and analysis were performed by the corresponding author, Bernice McCoy and co-author, Alexa Mutchler. The first draft of the manuscript was written by the corresponding author and all authors commented on previous versions of the manuscript. All authors read and approved the final manuscript.

Declarations

Ethical Approval

The Institutional Review Board at the University of South Florida determined that the study met criteria for exemption from IRB review and qualified for a waiver of signed authorization under the HIPAA Privacy Rule (45 CFR 164.512(i)).

Consent to Participate

Verbal consent for HIV testing was obtained as part of routine clinical care. Data used in this study were de-identified prior to analysis to protect participant anonymity.