NCSD developed resources and toolkits to guide sexual health clinics through the process of operationalizing the 340B program and supporting STD clinics in expanding their HIV services, including increasing capacity to provide PrEP services.
Health departments and sexual health clinics offer a range of sexual health services, including HIV and STD screening, diagnosis, and treatment, and are uniquely equipped to play a critical role in the Ending the HIV Epidemic (EHE). Sexual health clinics can work towards ending the HIV epidemic by expanding and scaling up HIV services including the implementation of pre-exposure prophylaxis (PrEP).
Sexually Transmitted Disease (STD) Clinics provided more than one-third of all CDC-funded HIV tests conducted among healthcare settings in 2018. STD clinics also identified approximately 20% of all people newly diagnosed with HIV in these settings . In 2020, CDC issued Recommendations for Providing Quality Sexually Transmitted Disease Clinical Services which includes the provision of PrEP within STD specialty care settings.
STD clinics are a promising setting for increasing PrEP engagement among individuals vulnerable to HIV who may otherwise have limited access to the healthcare system . Furthermore, individuals attending STD clinics have reported high interest in PrEP and numerous studies have indicated the initiation of PrEP in an STD clinic would be a highly acceptable, feasible, and safe model to engage individuals at risk for HIV into PrEP Care .
Results from one survey of Local Health Departments (LHDS) in 2015 reported 74% of clinics were engaged with patients to provide PrEP referrals, and 51% were conducting community education and outreach to communities vulnerable to HIV . Only 29% reported directly providing PrEP clinical services while 41% reported it to be unlikely their organization would pursue PrEP implementation . Efforts are needed to provide resources to STD clinics to provide implementation capacity for PrEP.
The United States has significant challenges in scaling up PrEP to meet the goals and objectives of EHE. To address these challenges STD clinics must not only use data-driven approaches to identify populations at increased risk for HIV but also recognize and address organizational barriers within the setting of STD clinics to promote HIV prevention and PrEP use . STD clinics must build capacity and identify resources to scale up PrEP implementation in a timely and cost-effect way. While numerous implementation studies have provided STD clinics tools associated with increasing patient engagement, clinical education, and PrEP navigation, few have provided information on organizational development and funding resources to address capacity needs [5-7]. Many federal funding sources have restrictive funding requirements that limit the ability to provide direct clinical care, covering costs of medications, labs, and other medical needs involved in providing PrEP services.
Since 1992, the 340B Drug Pricing Program has been a critical resource for providing financial support to safety-net hospitals and clinics in order to stretch scarce federal resources and extend medication discounts directly to patients engaged in care. The result can generate revenue to reinvest into program services and promote the scope of federal grants under which the entity is eligible. Despite these benefits, many sexual health clinics have expressed challenges with implementing the 340B Program due to knowledge and capacity as well as HRSA requirements for compliance and oversight.
NCSD has developed resources and toolkits to guide sexual health clinics through the process of operationalizing the 340B program, supporting STD clinics in expanding their HIV services including increasing capacity to provide PrEP services. These tools aim to provide organizational decision-makers with a 340B roadmap, outlining key activities from policy and procedure development, contract pharmacy operations, and best practices for compliance and related oversight. With access to these resources and ongoing technical assistance from NCSD, STD clinics should consider 340B implementation as a means of revenue to implement PrEP services.
2. Kamis K, Marx G, Scott K, Gardner E, Wendel K, Scott M Montgomery A, Rowan S (2019) Same-Day HIV Pre-Exposure Prophylaxis (PrEP) Initiation During Drop-in Sexually Transmitted Diseases Clinic Appointments Is a Highly Acceptable, Feasible, and Safe Model that Engages Individuals at Risk for HIV into PrEP Care. Open Forum Infectious Diseases 6(7) https://doi.org/10.1093/ofid/ofz310
3. Weiss G, Smith DK, Newman S, Wiener J, Kitlas A, Hoover KW (2018) PrEP implementation by local health departments in US cities and counties: Findings from a 2015 assessment of local health departments. PLoS ONE 13(7): e0200338. https://doi.org/10.1371/journal.pone.0200338.
4. Tordoff D, Barbee L, Khosropour C, Hughes J, Golden M. (2020) Derivation and Validation of an HIV Risk Prediction Score Among Gay, Bisexual, and Other Men Who Have Sex With Men to Inform PrEP Initiation in an STD Clinic Setting. JAIDS 85(3): p263-271. doi: 10.1097/QAI.0000000000002438
5. Smith DK , Van Handel M, Wolitski RJ, et al. Vital signs: estimated percentages and numbers of adults with indications for preexposure prophylaxis to prevent HIV acquisition–United States, 2015. MMWR Morb Mortal Wkly Rep2015; 64:1291–5.
6. Hoover KW , Ham DC, Peters PJ, et al. Human immunodeficiency virus prevention with preexposure prophylaxis in sexually transmitted disease clinics. Sex Transm Dis 2016; 43:277–82.
7. Marcus JL , Volk JE, Pinder J, et al. Successful implementation of HIV preexposure prophylaxis: lessons learned from three clinical settings. Curr HIV/AIDS Rep2016; 13:116–24.