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Effective Interventions

PrEP and Healthcare Organizations

Healthcare Organizations

Delivery of PrEP 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.

Healthcare organizations can provide PrEP services to patients directly. The clinical practice guidelines 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.

Additional Information

Healthcare organizations can provide the following key services in support of PrEP:

  • Assessment of indications for PrEP;
  • Prescription for Truvada® ;
  • HIV/STI 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 six month
  • Have condomless anal or vaginal sex
  • Had a bacterial sexually transmitted infection (STI) in last 6 months

PrEP can be used by:

  • Gay, bisexual, and other men who have sex with men
  • Women or men in heterosexual relationships
  • Transgender persons
  • Persons who inject drugs

PrEP should be used if 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 clinical providers’ supplement contains tools clinicians may use to determine if men who have sex with men or persons who inject drugs are at high-risk for HIV acquisition and likely candidates for PrEP.

Prescription for Truvada®:

Truvada® is currently the only medication FDA approved 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 will need to take PrEP daily to maintain protective levels. For more information on prescribing PrEP, please see the clinical practice guidelines.

HIV/STI Testing:

HIV and STI 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 exposures and signs and symptoms of acute HIV. If there has been
a potential exposure to HIV within the last 72 hours, post-exposure prophylaxis should be considered prior to initiating PrEP.

While on PrEP, a person should also get periodic HIV and STI 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 regimen to prevent the development of drug resistance.

PrEP provides protection from HIV, not from bacterial STIs. STI screening is recommended at least every 6 months for persons who are sexually active and taking PrEP. STI screening should be done every 3 months for men and women with signs and symptoms of a bacterial STI or for MSM or others with a high risk of STI, defined as persons with multiple sex partners or those with prior STI diagnosis. Diagnosed STIs should be treated immediately. This will further reduce the risk of HIV acquisition and prevent the spread of STIs in the community. For more detail on HIV and STI testing see the clinical practice guidelines.

Adherence Support:

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 back-up plan for missed doses. Clinics can collaborate with community-based organizations
to provide adherence support to patients who need it. Section 10 of the clinical providers’ supplement contains more detail on counseling patients on adherence. Every Dose Every Day is a toolkit designed to improve adherence among persons living
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, STIs, 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 community-based organizations may be able to support a healthcare organization’s clients with payment assistance education and navigation.

Additional Testing and Follow-Up:

The following tests are performed before PrEP is initiated, and then periodically to monitor side effects. Providers should discuss treatment options with patients following their test results.

Initial baseline testing, prior to starting PrEP, includes:

  • STI testing for chlamydia, gonorrhea, and syphilis;
  • HIV test;
  • Kidney function test;
  • Pregnancy test and assess pregnancy intent for women; and
  • Hepatitis B and C virus tests.

Follow-up testing includes:

  • HIV test every 3 months,
  • STI tests every 3 to 6 months,
  • Kidney function test every 6 months,
  • Pregnancy test and assess pregnancy intent every 3 months in women, and
  • For PrEP users who have chronic hepatitis B infection, HBV DNA test every 6 to 12 months while prescribed PrEP.

See the clinical practice guidelines for more information on routine monitoring to assess the side effects of PrEP.

National Clinician Consultation Center for PrEP

The Clinician Consultation Center 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

CBA Request Information System (CRIS) is a web-based application that allows CDCfunded and other organizations to request CBA services. It also serves as a tool to monitor, track, and follow-up on CBA Requests. A user ID and password are required to access this CDC-sponsored web application.

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