Prep toolkit ebrief2 v05 final

Steps to PrEP

Pre-exposure prophylaxis (PrEP) is a powerful tool that can help prevent the transmission of human immunodeficiency virus (HIV), but establishing a PrEP program in your clinic requires education and effort. Staff must be educated on the effectiveness of tenofovir/emtricitabine (TDF/FTC) for HIV prevention and must also understand how to prescribe it. Staff must also be able to support on-treatment care and help patients navigate payment-assistance programs to help offset medication cost. So before establishing a PrEP program, consider these questions:  Are you and your staff sufficiently educated on PrEP?  Are your staff members trained in cultural competence, especially with regard to taking sexual histories of patients?  Do you have access to the laboratory tests required to confirm whether a patient can begin taking once-daily TDF/FTC?  Can your clinic/organization provide on-treatment care for individuals taking PrEP?  Have you identified staff members who can help patients navigate the paperwork associated with PrEP-related payment-assistance programs?

Step 1: Get Educated on PrEP When used as directed by the United States (US) Public Health Service guidelines, PrEP reduces the risk of sexually transmitted HIV by more than 90%. Because of its effectiveness, the Centers for Disease Control and Prevention (CDC) recommends PrEP for individuals who have a substantial risk of contracting HIV, including men who have sex with men (MSM), heterosexual men and women in serodiscordant relationships, and people who inject drugs (PWID). It is also important to know that:  Adherence is key to effectiveness  For HIV protection in receptive vaginal intercourse, time from PrEP initiation to maximum drug concentration is 20 days; for receptive anal intercourse, time to maximum drug concentration is 7 days  Any side effects associated with PrEP medications are usually mild and temporary  Daily oral TDF/FTC does NOT protect against sexually transmitted infections (STIs), prevent pregnancy, or cure HIV  In studies of real-world settings, PrEP does not appear to lead people to engage in riskier sexual behaviors (ie, sexual risk compensation)

Step 2: Identify Individuals Who Are Candidates for PrEP Candidates for PrEP are identified through behavioral and laboratory screening. A thorough sexual history is used to identify individuals who are candidates for PrEP because of high-risk sexual behavior, and laboratory tests are used to confirm that candidates meet several biological criteria before initiating PrEP. An individual should not be issued a prescription for the medications used in PrEP without a complete initial evaluation.

Behavioral Assessment If you are interested in implementing a PrEP program, it is imperative that staff be trained to conduct culturally competent sexual histories. The US Public Health Service has developed sexual history screening assessments specific to heterosexual men and women, MSM, and transgender women (www.cdc.gov/hiv/pdf/guidelines/PrEPguidelines2014.pdf). Patients must meet a combination of sexual risk indicators to be identified as candidates for PrEP. A separate assessment is used to evaluate the risk behaviors of PWID with questions that focus on whether the individual shares injection equipment or engages in unsafe injection practices.

Laboratory Tests If an individual is identified as a candidate for PrEP based on the behavioral assessment, several biological criteria must be met before prescribing medication. Any clinic/organization offering PrEP services should be prepared to offer the following:  HIV test  Creatine clearance test  Hepatitis B virus (HBV) test  Pregnancy test Candidates must test negative for HIV before starting TDF/FTC. A rapid HIV test can give a falsenegative result if it is conducted in the “window period,” that is, after infection has occurred but before detectable antibodies are present. Thus, before starting PrEP, HIV-negative status should be confirmed with a fourth-generation blood test that detects both HIV antibodies and an HIV antigen. Candidates must also have a creatinine clearance of at least 60 min/mL, as the medications used in PrEP may reversibly affect kidney function. If candidates tests positive for HBV, PrEP may still be recommended, but they should also be referred to an infectious disease specialist. A positive pregnancy test does not preclude a woman from initiating PrEP, but the potential risks and benefits of using TDF/FTC for HIV prevention during pregnancy should be discussed.

Step 3: Maintain Patients in PrEP Programs When a patient is considering taking the medications used in PrEP, it is important to think beyond the prescription. Individuals who have been identified as candidates for PrEP and who are interested in starting a daily medication regimen should be connected to PrEP programs that are able to support on-treatment care such as quarterly HIV tests, ongoing risk assessments, and adherence support.

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After receiving a 90-day prescription for TDF/FTC, patients should return every 3 months for follow-up visits for HIV testing, pregnancy testing, side-effect monitoring, adherence monitoring/support, and risk-reduction counseling.

Of note, although current US Public Health Service PrEP guidelines recommend STI testing every 3 to 6 months, data presented in the summer of 2016 from a real-world cohort of MSM in San Francisco suggest that testing for STIs every 3 months is optimal for detection in MSM, as quarterly screening increased the detection of gonorrhea, chlamydia, and syphilis. The need to continue PrEP as HIV prevention should be discussed with patients at least once every year.

The paperwork associated with patient reimbursement for PrEP can seem daunting. Designating one person in your clinic to handle all reimbursement forms can help streamline the process.

More information on paying for PrEP is covered in the next and final e-brief in this series, “Accessing PrEP.”

References US Public Health Service. PrEP for the prevention of HIV infection in the United States, 2014. www.cdc.gov/hiv/pdf/guidelines/PrEPguidelines2014.pdf. Accessed November 3, 2016.

Cohen S, Vittinghoff E, Philip SS, et al. Quarterly STI screening optimizes STI detection among PrEP users in demo project. CROI 2016; February 22-25, 2016; Boston, MA. Abstract 870.

Conniff J, Evensen A. Preexposure prophylaxis (PrEP) for HIV prevention: the primary care perspective. J Am Board Fam Med. 2016;29(1):143151.

Liu A, Cohen S, Follansbee S, et al. Early experiences implementing pre-exposure prophylaxis (PrEP) for HIV prevention in San Fransisco. PLoS Med. 2014;11(30):e1001613.

This activity was developed by Med-IQ in collaboration with HealthHIV, Pozitively Healthy, and the National Coalition for LGBT Health.

The information provided through this activity is for continuing education purposes only and is not meant to substitute for the independent medical judgment of a physician relative to diagnostic and treatment options of a specific patient’s medical condition.

Supported by an educational grant from Gilead Sciences, Inc. © 2016 Med-IQ. All rights reserved.

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