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Effective Interventions

Pre-Exposure Prophylaxis (PrEP)

PrEP Care System: Delivery Models for Assessment and Monitoring

CDC recommends PrEP as an HIV prevention strategy. The PrEP care system is the system of PrEP delivery for HIV-negative persons who are at risk of HIV infection. The PrEP care system includes engaging persons at risk of HIV infection; assessment of indications for PrEP use; laboratory and testing services; risk-reduction support; provision of clinical services; and adherence support.1 The PrEP care system can be simplified into three phases along the prevention continuum for PrEP. These phases are screening, PrEP initiation, and follow-up. Health departments, community-based organizations, and healthcare organizations can form partnerships to support PrEP delivery within this system to prevent HIV infection in high-risk populations.

Providing Care within the PrEP Care System

The PrEP care system encompasses three phases in the delivery of PrEP: screening, PrEP initiation, and follow-up.

timeline-graphic
I. Screening

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. Engagement 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 PrEP services and to 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. Initial clinical evaluation occurs before prescribing PrEP and includes a brief history -- including signs or symptoms of acute HIV or STI, 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 STIs, 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 PrEP 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 PrEP guidelines provide 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 program (https://start.truvada.com/paying-for-truvada) 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 “resources” page has links to additional resources on paying for and financing PrEP. 

III. Follow-up

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 sexually transmitted infections (STIs), acute HIV infection, and side effects
    • Conduct HIV risk behavior assessment
    • Screen for STIs in sexually active adults and adolescents with signs or symptoms of an STI and in men who have sex with men at high risk, defined as those with a recent bacterial STI 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 STIs in sexually active adults and adolescents who do not meet the criteria for more frequent screening
    • Assess kidney function
Delivery Models

Health departments, community-based organizations, and healthcare organizations each play a role in the PrEP care system.  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 clinic-based model will need skilled personnel, adequate equipment, and access to lab services. This type of model requires a broad spectrum of resources available under one roof to address each phase of the PrEP care system: pre-clinical screening including engagement, clinical screening utilizing laboratory values, PrEP initiation, and follow-up.

clinicbasedmodel

Who is involved: Healthcare organizations would manage most or all aspects of the PrEP care system under the clinic-based model, but community-based organizations might provide in-house counseling and health departments may assist with lab services, such as HIV and STI testing.

Advantages: This model is easiest for clients as all of 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, community-based organizations, and healthcare organizations work together to provide services within the PrEP care system. 

new-collaborative-model

Who is involved: Health departments, community-based organizations, 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, community-based organizations, 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, community-based organizations 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.

In conclusion
The PrEP webpages on Effective Interventions provide guidance to health departments, community-based organizations, and healthcare organizations on strategies and recommendations to support and maintain a successful PrEP care system that will reach and engage populations in need, provide PrEP services, and support retention in PrEP care.

References:
1. US Public Health Service. “Preexposure prophylaxis for the prevention of HIV infection in the United States – 2017 update” published March 2018. https://www.cdc.gov/hiv/pdf/risk/prep/cdc-hiv-prep-guidelines-2017.pdf.

 

 

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