Pre-exposure Prophylaxis (PrEP)
Pre-exposure Prophylaxis (PrEP) is when people at very high risk for HIV take HIV medicines daily to lower their chances of getting infected. PrEP delivery in the United States includes a system of prevention and support services, or the PrEP Care System, that contributes to making PrEP available, accessible, and acceptable.
The Centers for Disease Control and Prevention (CDC) recommends pre-exposure prophylaxis (PrEP) as an HIV prevention strategy. For those at very high risk for HIV, daily PrEP is highly effective for preventing HIV from sex or injection drug use. In July 2012, the FDA approved the combination pill, emtricitabine and tenofovir disoproxil fumarate, or Truvada®external icon, for use as HIV PrEP. Taking Truvada® every day, as prescribed reduces the risk of getting HIV via sexual contact by more than 90% and reduces the risk of getting HIV by over 70% among persons who inject drugs (PWID).
The PrEP Care System includes a system of prevention and support services for HIV-negative persons who are at risk of HIV infection. Health departments, community-based organizations (CBOs), and healthcare organizations can form partnerships to support PrEP delivery within this system to prevent HIV infection in high-risk populations.
The PrEP Care System includes:
- Engaging persons at risk;
- Assessment of indications for PrEP use;
- Laboratory and testing services;
- Risk-reduction support;
- Provision of clinical services; and adherence support.
Providing Care within the PrEP Care System
The PrEP Care System encompasses three phases: Screening, PrEP initiation, and Follow-Up.
Screening is the first phase in the delivery of PrEP. The screening phase includes the steps engagement, navigation, and an initial clinical evaluation. Screening is often the most time-intensive phase within the PrEP Care System.
- Engagement includes an HIV risk assessment to identify persons who may benefit from PrEP. It also includes education about PrEP basics, including how PrEP works, the importance of medication adherence, and medication side effects.
- Navigation services should be offered at the time of PrEP engagement to guide persons in need of PrEP to clinical services and insurance options that will pay for PrEP. If the client does not have insurance, navigators or clinic staff should assist the client in obtaining insurance or access to medication assistance programs.
- The initial clinical evaluation is the final step in the screening phase and is performed by a medical provider. It occurs before prescribing PrEP and includes a brief history, including signs or symptoms of acute HIV or STD, history of kidney disease, a medication review and an assessment of indications for PrEP. The provider also should conduct an HIV blood test, evaluate kidney function, check hepatitis B virus (HBV) and hepatitis C virus (HCV) serology, test for STDs, and conduct a pregnancy test for women.
II. PrEP Initiation
Where the initial clinical evaluation is an assessment of indications for PrEP including an assessment of laboratory values, PrEP initiation refers to when the PrEP medication, Truvada®, is prescribed. Laboratory testing and service capabilities may vary by location.
For locations where laboratory testing results, including an HIV test, are available on the same day as drawn, the initiation phase may occur on the same day as the initial clinical evaluation. When it is not possible to rule out HIV and normal renal function on the same day as the initial clinical evaluation, it is recommended to initiate PrEP within seven days of the HIV test to minimize the risk of HIV acquisition between the time of HIV testing and PrEP initiation. The U.S. Public Health Service’s Preexposure Prophylaxis for the Prevention of HIV Infection in the United States – 2017 Update pdf icon[PDF – 2 MB] provides additional instruction on ruling out HIV infection prior to starting PrEP.
At the time of PrEP initiation, PrEP basics are reviewed and PrEP medication is prescribed. Medication can be provided directly by the clinic or by providing a prescription to an outside pharmacy. Financing for PrEP is part of this phase. Some insurers may require a prior authorization to cover the cost of medication or services. Medication can be accessed through a patient assistance programexternal icon in certain cases where Truvada® is not covered by insurance. Clinics will often need to complete paperwork for the patient for the appropriate financing option. The Implementation and Marketing Materials section has links to additional resources on paying for and financing PrEP.
According to PrEP clinical practice guidelines:
- Every three months:
- Conduct HIV blood test and assess for signs or symptoms of acute HIV infection
- Conduct a symptom review of STDs, acute HIV infection, and side effects
- Conduct HIV risk behavior assessment
- Screen for STDs in sexually active adults and adolescents with signs or symptoms of an STD and in men who have sex with men (MSM) at high risk, defined as those with a recent bacterial STD or those with multiple sex partners
- Provide adherence counseling and answer questions
- Assess pregnancy intent and conduct a pregnancy test (if applicable)
- Provide a new 3-month prescription for PrEP
- Every six months:
- Screen for STDs in sexually active adults and adolescents who do not meet the criteria for more frequent screening
- Assess kidney function
Health departments, CBOs, and healthcare organizations each play a role. PrEP delivery can be done using the clinic-based model or the collaborative model.
I. Clinic-Based Model
This model consists of a clinic that offers the full spectrum of services within the PrEP Care System at a single location. The model will need skilled personnel, adequate equipment, and access to lab services; it also requires a broad spectrum of resources available under one roof to address each phase of the PrEP Care System.
Who is involved: Healthcare organizations would manage most or all aspects of the PrEP Care System under the clinic-based model, but CBOs might provide in-house counseling and health departments may assist with lab services, such as HIV and STD testing.
Advantages: This model is easiest for clients as all their medical care needs for PrEP are provided at one location. Furthermore, clients have access to the clinic resources and provider networks.
Challenges: Maintaining adequate resources to meet clients’ needs could be costly and burdensome if not already existing before PrEP care is initiated.
II. Collaborative Model
In the collaborative model, local health departments, CBOs, and healthcare organizations work together to provide services.
Who is involved: Health departments, CBOs, and healthcare organizations coordinate efforts in an efficient and sustainable way. The graphic illustrates the variety of combinations of services that can be provided within the three phases of the PrEP care system by health departments, CBOs, and healthcare organizations.
Advantages: The collaborative model provides a particularly useful strategy when linking harder-to-reach individuals to PrEP, such as persons who either do not have insurance or may not routinely seek care. This is accomplished through the collaboration between trusted, population-specific, CBOs and partner services for persons at particularly high risk for HIV infection.
Challenges: Collaborations and service agreements are needed between these providers. Due to competing priorities and constrained resources, establishing these agreements can be challenging and time consuming. Identifying a PrEP champion can help facilitate partnerships and streamline processes.
PrEP is listed as an essential component of the notice of funding opportunity (NOFO), “Integrated HIV Surveillance and Prevention Programs for Health Departments,” pdf icon[PDF – 2 MB] or PS18-1802. According to this NOFO, health departments should work to expand awareness of and access to PrEP through:
- Screening for PrEP eligibility;
- Linkage and support for PrEP;
- Supporting adherence to PrEP;
- Increasing consumer knowledge, access, and use of PrEP; and
- Enhancing provider knowledge and support for PrEP.
Funds from PS18-1802 cannot be used to pay for medications, clinical care, or labs other than HIV or viral hepatitis screening. However, jurisdictional health departments can also use non-CDC funds to implement PrEP services within STD clinics. These can range from counseling and referral services to the provision of clinical services for PrEP. States may also consider implementing PrEP assistance programs for the uninsured to assist with payment for clinic visits and laboratory costs related to PrEP.
Screening for PrEP Eligibility
PrEP services and referrals can be worked into health departments’ pre-existing HIV preventions strategies. At the time of HIV testing, presentation for an STD, or when accessing post-exposure prophylaxis services, patients should be evaluated for PrEP eligibility and linked to a PrEP provider, as appropriate.
Linkage and Support for PrEP
Health departments can help educate and motivate on PrEP implementation using social and behavioral strategies and interventions, such as PrEP navigation, education, and counseling services. Health departments should evaluate the availability of PrEP services in their jurisdictions to determine areas of need to scale up services and increase use.
Support Adherence to PrEP
PrEP users should be provided all the information and support needed to ensure they take PrEP daily as directed. Health departments can support clinics and CBOs with adherence-related activities by providing PrEP education to clinical providers and providing resources for patients. Section 10 of the Clinical Providers Supplement pdf icon[PDF – 2 MB] in the Preexposure Prophylaxis for the Prevention of HIV Infection in the United States – 2017 Update pdf icon[PDF – 2 MB] contains details on counseling patients on adherence. Partnership for Health-Medication Adherence is a medication adherence strategy for persons who are HIV positive, and can also be used to improve adherence to PrEP.
Health departments can also address PrEP access, which may vary among jurisdictions. Currently, CDC funds may not be used to pay for Truvada®, but health departments may be able to establish PrEP assistance programs within their jurisdictions. Californiaexternal icon, Virginiaexternal icon, Massachusettsexternal icon, the District of Columbiaexternal icon, New Yorkexternal icon, and Washingtonexternal icon have implemented PrEP drug assistance programs, or “PrEP DAP,” to increase access to and use of PrEP using state funds.
Increase Consumer Knowledge and Support for PrEP
Health departments can help increase knowledge of PrEP within the community to accept PrEP use among HIV-negative persons at risk of HIV infection. Community-wide education on PrEP can occur in a variety of complementary ways, including:
- Visuals, brochures, and pamphlets;
- Media campaigns, including the use of social media;
- Radio and television public service announcements; and
- Partnering with community members, key stakeholders, and peers to build trust and credibility.
Enhance Provider Knowledge and Support of PrEP
Health departments can develop their own educational materials for PrEP and provide training for local clinicians through public health detailing and implementation workshops.
Compiling and maintaining a directory for PrEP providers and PrEP-related services is a great way to provide information to providers, the public, and partner organizations on the availability of services. This directory information can also be shared with PrEP Locatorexternal icon to help build the database of this online resource provided by CDC’s National Prevention Information Network.
Health departments seeking to increase their capacity around PrEP can utilize CDC’s Capacity Building Assistance (CBA) Tracking System (CTS), a web-based application that allows CDC-funded organizations to request CBA services. A user ID and password are required to access the application.
Non-clinical CBOs play an important role in the PrEP care system.
CBOs can provide the following key services in support of PrEP:
- Promotion and education;
- Engagement, identification, and recruitment;
- Evidence-based interventions supporting PrEP uptake;
- Navigation; and
- Directories of health and prevention services.
Promotion and Education
CBOs have an important role in promoting PrEP and providing education on PrEP to populations in need. Individualized education on PrEP should be routine and integrated into community-based prevention services, such as outreach and testing services for HIV and STDs. Community-wide education on PrEP can occur in a variety of complementary ways, including:
- Visuals, brochures, and pamphlets;
- Media campaigns, including the use of social media;
- Radio and television public service announcements; and
- Partnerships with community members, key stakeholders, and peers to build trust and credibility.
Engagement, Identification, and Recruitment
Persons at high risk for HIV acquisition can be identified for PrEP clinical services through outreach, testing, and other program contact, services, and interventions. Those who are at highest risk of HIV acquisition often encounter barriers, such as stigma, medical mistrust, and perceived payment barriers, that prevent them from receiving health services. Targeted recruitment and other PrEP service efforts can be used to reach those who are at highest risk and traditionally underserved by HIV prevention efforts. Refer to the Implementation and Marketing Materials section for more information.
In addition to education about PrEP, candidates may need motivation to use it. Motivational interviewing or counseling may be beneficial in influencing persons to accept PrEP as a prevention method.
Evidence-Based Interventions Supporting PrEP Uptake
There are several appropriate high-impact prevention, or HIP, interventions for promoting PrEP.
- PROMISE for HIP promotes PrEP by creating and distributing community- and population-specific role model stories to spread educational messages and modeling community member experiences and endorsements.
- Popular Opinion Leader (POL) focuses on identifying, recruiting, and supporting opinion leaders (persons who have influence in and across populations) to endorse an intervention like PrEP so that it becomes a prevention innovation through social network acceptance and uptake. This approach is similar to “viral marketing” within social networks.
- d-up: Defend Yourself! is targeted to black gay, bisexual, and other men who have sex with men (MSM). d-up: Defend Yourself! includes skills building for coping with community- and individual-level stigma.
- Mpowerment brings young MSM together into a dedicated community space, and empowers them to educate, organize, support, and promote innovations like PrEP.
Navigation for PrEP includes identifying and linking persons in need of PrEP to healthcare systems, assisting with health insurance, identifying and reducing barriers to care, and tailoring education to the client to influence his or her health-related attitudes and behaviors.
CBOs are often in a position to identify and guide PrEP candidates because they work with persons in need of PrEP during existing services delivery. Integrating PrEP education and referrals into program services is an effective way to promote PrEP to those who are likely candidates. Examples include STD services, HIV testing services, and partner services.
CBOs that do not provide clinical services should develop working relationships with PrEP clinicians to facilitate linkage of community members to PrEP services. Clinical programs may also want to involve staff from CBOs to help to manage PrEP patients. Working relationships with behavioral health clinics, substance abuse treatment clinics, and other clinical service providers may be beneficial in proving services to persons in need of PrEP.
PrEP candidates may also need assistance in navigating payment coverage, transportation, and communication with clinicians, among other services. Developing a comprehensive directory of available, accessible, and acceptable services can help CBOs refer individuals to these services.
Directories of Health Services including PrEP
A comprehensive directory of available, accessible, and acceptable services should support navigation and guidance of clients. The local health department or other local CBOs may have already created such a directory. Jurisdictional planning groups routinely create and maintain resource directories. If none are available in your jurisdiction, you may want to create a directory for serving your PrEP clients. Providers in local directories should also be registered at PrEP Locatorexternal icon, an online PrEP provider resource maintained by the CDC’s National Prevention Information Network (NPIN). CBOs may also need to have memoranda of agreement with service providers to facilitate engaging clients with their services.
CBOs seeking to increase their capacity around PrEP can also utilize CDC’s Capacity Building Assistance (CBA) Tracking System (CTS), a web-based application that allows CDC-funded organizations to request CBA services. A user ID and password are required to access the application.
Healthcare organizations can directly provide PrEP services to patients. The U.S. Public Health Service’s Clinical Practice Guideline pdf icon[PDF – 2 MB], updated in 2017, provide the framework for delivering high-impact prevention of HIV with the use of emtricitabine/tenofovir disoproxil fumarate, or Truvada®. PrEP can be offered in conjunction with primary care services and does not need to be prescribed by a specialist.
Healthcare organizations can provide the following key services in support of PrEP:
- Assessment of indications for PrEP;
- Prescription for Truvada®;
- HIV/STD testing;
- Adherence support;
- Education and assistance; and
- Additional testing and follow-up.
Assessment of Indications for PrEP
PrEP is indicated for HIV-negative persons who:
- Have shared injection or drug preparation equipment in the last 6 months;
- Have condomless anal or vaginal sex; and/or
- Had a bacterial STD within the last 6 months.
PrEP can be used by:
- Gay, bisexual, and other MSM;
- Women or men in heterosexual relationships;
- Transgender persons; and
PrEP should be used when the HIV status of the partner or partners is either unknown or positive (especially if the positive partner is not on HIV treatment or has a detectable viral load). Sections 6 and 7 of the U.S. Public Health Service’s Clinical Practice Guideline pdf icon[PDF – 2 MB] contain tools clinicians may use to determine whether MSM or PWID are at high risk for HIV acquisition and likely candidates for PrEP.
Prescription for Truvada®
Truvada® is currently the only FDA-approved medication for PrEP. It takes 7 days to build protective levels of PrEP in anal and rectal tissues and 20 days to achieve protective levels in the vagina and in the blood. Patients must take PrEP daily to maintain protective levels. For more information on prescribing PrEP, please see the U.S. Public Health Service’s Clinical Practice Guideline pdf icon[PDF – 2 MB].
HIV and STD testing are essential components of the PrEP care system. Before prescribing PrEP, the clinician must rule out an HIV infection, including an assessment of recent potential exposure and signs and symptoms of acute HIV. If there has been a potential HIV exposure within the last 72 hours, post-exposure prophylaxis should be considered prior to initiating PrEP.
While on PrEP, a person is advised to also get periodic HIV and STD testing. HIV testing should be done every 3 months. If the person acquires HIV while taking PrEP, they must immediately be provided a full antiretroviral therapy (ART) regimen to prevent drug resistance.
PrEP provides protection from HIV, not from bacterial STD. STD screening is recommended at least every 6 months for persons who are sexually active while taking PrEP. STD screening should be done every 3 months for men and women with signs and symptoms of a bacterial STD or for MSM or others with a high risk of STD, defined as persons with multiple sex partners or those with prior STD diagnosis. Diagnosed STD should be treated immediately. This will further reduce the risk of HIV acquisition and prevent the spread of STD in the community.
For more detail on HIV and STD testing, see the U.S. Public Health Service’s Clinical Practice Guideline pdf icon[PDF – 2 MB].
PrEP should be taken every day. PrEP users should be educated on the importance of adherence. They may need help creating a PrEP adherence plan —including a backup plan for missed doses. Clinics can collaborate with CBOs to provide adherence support to patients who need it. Section 10 of U.S. Public Health Service’s Clinical Practice Guideline pdf icon[PDF – 2 MB] contains more detail on counseling patients on adherence. The Partnership for Health-Medication Adherence intervention is designed to improve adherence among persons with HIV, but can also be used to improve adherence to PrEP.
Education and Assistance
Patients starting PrEP should be counseled on:
- What PrEP medication is and how it works;
- The importance of adherence;
- Potential side effects and their management;
- Safer sex and sterile injection practices; and
- When to contact their provider.
PrEP is part of a system of care that includes regular medical visits; adherence coaching; discussion of safer sex practices; as well as screening for HIV, STDs, and medication side effects. Although Truvada® for PrEP is covered by Medicaid in most states and most commercial insurance companies, some patients may have high co-pays for the medication. PrEP users may need education and assistance in each of these areas. Clinic benefits managers, social workers, as well as CBOs, may be able to support a healthcare organization’s clients with payment assistance education and navigation.
Additional Testing and Follow-Up
Providers should discuss treatment options with patients following their test results. The following tests are performed before PrEP is initiated, and then periodically to monitor side effects.
Initial baseline testing, prior to starting PrEP, includes:
- Chlamydia, gonorrhea, and syphilis;
- Kidney function;
- Pregnancy and pregnancy intent; and
- Hepatitis B and C virus.
Follow-up testing includes:
- HIV, every 3 months;
- STD, every 3 to 6 months;
- Kidney function, every 6 months;
- Pregnancy and assess pregnancy intent every 3 months; and
- For PrEP users who have chronic hepatitis B infection, HBV DNA test every 6 to 12 months while prescribed PrEP.
See the U.S. Public Health Service’s Clinical Practice Guideline pdf icon[PDF – 2 MB] for more information on routine monitoring to assess the side effects of PrEP.
National Clinician Consultation Center for PrEP
The University of California, San Francisco’s National Clinician Consultation Centerexternal icon provides direct guidance on all aspects of PrEP management. This service includes guidance on assessing indications for PrEP, prescribing practices, PrEP-related laboratory protocols, and assistance with adherence issues.
- The PrEP Warmline: (855) 448-7737 or (855) HIV-PrEP, Monday – Friday, 9 a.m.- 8 p.m. EST.
Healthcare organizations seeking to increase their capacity around PrEP can also utilize CDC’s Capacity Building Assistance (CBA) Tracking System (CTS), a web-based application that allows CDC-funded organizations to request CBA services. A user ID and password are required to access the application.
There is no CDC-supported classroom training currently available for PrEP. However, this HIV prevention strategy has multiple related eLearning components addressing a variety of subjects including but not limited to:
- HIV PrEP: Engaging Patients in U.S. Clinics
- HIV PrEP: PrEP and Pregnancy
- HIV PrEP: Prescribing PrEP
To access eLearning modules, including classroom training prerequisite courses:
- Log-in to CDC TRAINexternal icon and access the HIV CBA Training Plan (step-by-step instructionspdf iconexternal icon are available).
- Select the module you wish to take.
- Launch the module or save the module for later.
If you have questions or need additional assistance, please contact DHAPCBB@cdc.gov.
Technical assistance for PrEP implementation is available.
To request technical assistance:
- CDC’s directly funded health department and CBO partners may request technical assistance by submitting a request in the CBA Tracking System.
- Organizations not directly funded by CDC may contact their local health department for assistance in submitting a request.
If you have questions or need additional assistance, please contact DHAPCBB@cdc.gov.