• DSHS HIV/STD Program

    Post Office Box 149347, MC 1873
    Austin, Texas 78714

    Phone: (737) 255-4300

    Email the HIV/STD Program

    Email data requests to HIV/STD Program - This email can be used to request data and statistics on HIV, TB, and STDs in Texas. It cannot be used to get treatment or infection history for individuals, or to request information on programs and services. Please do not include any personal, identifying health information in your email such as HIV status, Date of Birth, Social Security Number, etc.

    For treatment/testing history, please contact your local Health Department.

    For information on HIV testing and services available to Persons Living with HIV and AIDS, please contact your local HIV services organization.

POPS Chapter 22 - Pre-Exposure Prophylaxis (PrEP) and Non-occupational Post-Exposure Prophylaxis (nPEP)


22.0 Introduction and Overview

This chapter provides guidelines for the delivery of safe, consistent, and high-quality PrEP and nPEP services. The guidelines are written to assist clinicians, program managers, prevention specialists, and other staff who are providing or intend to provide PrEP and/or nPEP clinical and client support services. Texas DSHS supports the adoption and use of biomedical interventions for HIV prevention, such as PrEP, nPEP, and Treatment as Prevention (TasP), as part of a larger strategy to end the HIV epidemic in Texas. The guidelines are aligned with the National HIV/AIDS Strategy for the United States (PDF) [HIV.gov], Ending the HIV Epidemic: A Plan for America [HIV.gov], Achieving Together: A Community Plan to End the HIV Epidemic in Texas [Achieving Together], and the 2017-2021 Texas HIV Plan [Texas HIV Syndicate]. These POPS are intended to supplement existing clinical guidelines for PrEP: 2017 Clinical Practice Guidelines (PDF) [CDC] and nPEP: 2016 Guidelines for Antiretroviral Post-Exposure Prophylaxis (PDF) [CDC].

22.0.1 Definitions

  • Combination Prevention promotes the use of one or more tools, or options, to prevent the transmission and acquisition of HIV and other sexually transmitted diseases (STDs), regardless of an individual’s HIV status. Combination Prevention is intended to empower clients to choose the option(s) that work best for their lifestyle. For more information about Combination Prevention, please visit the resources section at the end of this chapter.
  • Non-occupational Post-Exposure Prophylaxis (nPEP) is a biomedical intervention that consists of taking antiretroviral therapy within 72 hours of a possible sexual or needle-sharing exposure in order to prevent HIV acquisition. In order to be effective, nPEP medicines must be started within 72 hours and be taken for 28 consecutive days. nPEP should be treated as a medical emergency. For more information about nPEP, visit the resources section at the end of this chapter.
  • Occupational Post-Exposure Prophylaxis (oPEP) is a biomedical intervention that consists of taking antiretroviral therapy within 72 hours after a needlestick or related exposure taking place within an occupational setting. DSHS does not currently fund oPEP services. For more information about oPEP, visit the resources section at the end of this chapter.
  • Pre-Exposure Prophylaxis (PrEP) is a biomedical intervention that consists of taking antiretroviral therapy daily in order to prevent HIV acquisition before any possible sexual or needle-sharing exposure(s). PrEP is intended for use among individuals with increased vulnerability to HIV and has been shown to reduce the risk of getting HIV from sex by about 99% when taken daily. For more information about PrEP, visit the resources section at the end of this chapter.

22.0.2 Program Components

Agencies funded by Texas DSHS are required to implement each of the three (3) program components listed below. Agencies who are new to implementing PrEP/nPEP services should consider these components in their program planning.

  • Program Component #1: Promotion of PrEP/nPEP through community education and awareness activities, including outreach, education, and recruitment focused on populations most vulnerable to HIV
  • Program Component #2: Promotion of adoption of PrEP/nPEP by local clinical service providers, including outreach, education, and recruitment
  • Program Component #3: Delivery of PrEP/nPEP clinical and client support services

Note that agencies funded by DSHS are not required to directly provide nPEP, but at minimum must provide immediate linkage to a local clinical service provider. See Section 22.2.1 for more information.

Overall, PrEP and nPEP program services must be:

  1. Client-centered and focused on the individual’s concerns and situation.
  2. Culturally-responsive with respect to race, ethnicity, gender expression, gender identity, sexual orientation, age, language, literacy, relationship status, or other relevant factors.
  3. Include ongoing community input purposefully and systematically to ensure high rates of relevance, impact, effectiveness, and satisfaction among the populations served.

This POPS chapter is structured to provide Program Component-specific requirements and considerations, as well as overarching requirements and considerations for implementing PrEP and nPEP services.

22.0 Introduction and Overview

Program Components

 arrow

Program Component-Specific Requirements and Considerations

22.1 Engagement of
focused populations

22.2 Engagement of local
clinical providers

22.3 Clinical and client
support services

22.4 Documentation
requirements

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Overarching Requirements and Considerations

22.5 Assessments

22.6 Collaboration and
cooperation

22.7 Messaging

22.8 Training and
supervision

 arrow

22.9 Resources

Note that technical assistance is available for all of the activities and services described in this POPS chapter. Please contact your Texas DSHS HIV Prevention Consultant for assistance.

 

22.1 Program Component #1: Promotion of PrEP/nPEP through community education and awareness activities

Activities under this component aim to increase awareness, understanding, acceptability, intent to access PrEP and nPEP and to reduce any existing barriers among populations who are most vulnerable to HIV acquisition. The Program Component #1 Activity Matrix below outlines potential approaches and activities to engaging focused population(s). Programs can contact their HIV Prevention consultant for technical assistance regarding outreach, education, and recruitment for PrEP/nPEP.

Outreach

Education

Recruitment

  • New media engagement (e.g., apps, social networking sites)
  • Traditional/print media placement
  • Street/venue-based outreach
  • Community partnerships and mobilization
  • New media engagement (e.g., apps, social networking sites)
  • Traditional/print media placement
  • Workshops, seminars, and event-based presentations
  • Community events
  • Combination Prevention education and promotion
  • New media engagement (e.g., apps, social networking sites)
  • Employ peer navigators and influencers
  • Social Networking Strategies (SNS) [CDC]
  • Community partnerships and mobilization

 

22.1.1 Requirements for Implementation

Below are the requirements for implementing outreach, education, and promotion efforts related to PrEP and nPEP that are focused on populations most vulnerable to HIV.

Outreach

Education

Recruitment

Conduct activities in person and through digital media platforms (e.g., apps, social networking sites). Tailor activities to focused population(s).

Conduct activities in person and through digital media platforms (e.g., apps, social networking sites). Tailor activities to focused population(s).

Conduct activities in person and through digital media platforms (e.g., apps, social networking sites). Tailor activities to focused population(s).

Structure activities to raise awareness and address barriers to accessing PrEP/nPEP.

Ensure messaging is culturally-responsive and medically accurate. See Section 22.6 for more information.

Conduct screening for PrEP/nPEP candidacy, using a community-informed or evidence-based tool or protocol.

Coordinate with other programs and organizations conducting outreach, education, and recruitment to decrease duplication of efforts in engaging focused population(s).

Initiate clinical and client support services for potential PrEP/nPEP candidates. See Section 22.3 for more information.

 

22.1.2 Screening for Candidacy

Screening for PrEP/nPEP can be defined as a rapid assessment of an individual’s vulnerability to HIV through behavioral and sociostructural factors, in order to determine if biomedical interventions are appropriate or indicated. Programs must streamline their processes and systems for screening in order to identify potential populations vulnerable to HIV and to facilitate seamless entry into PrEP/nPEP clinical and client support services.

As listed in the Clinical Practice Guidelines, consider the following behavioral and sociostructural factors in screening for candidacy, as they can lead to increased vulnerability to HIV.

  • History of inconsistent or no condom use with sexual partner(s);
  • Sex and/or injecting partner(s) living with HIV;
  • Sexually transmitted disease (STD) diagnosis within the last 12 months;
  • History of having sex while under the influence of alcohol or drugs; or
  • History or current practice of sharing injection equipment.

Further Considerations

  • Screening can be performed by any staff member, from front-desk staff to prevention specialist to clinicians.
  • Screening generally occurs before an individual is assessed by a clinical service provider and predicates a clinical determination of eligibility for PrEP or nPEP.
  • Screening is not limited to in-person interactions (e.g., phone or online screenings are acceptable). Programs must have policies, practices, and safeguards to protect confidentiality and maintain security of digital communications.
  • Screening can be done in tandem with HIV/STD testing, in order to streamline lab processing and reporting for new PrEP prescriptions.
  • Programs can obtain authorization(s) to release protected health information (PHI) such as lab results with external clinical service providers to expedite and streamline referrals to HIV care services or PrEP/nPEP.
  • For individuals who do not report increased vulnerability to HIV through screening but still request to be linked to PrEP and to see a clinical service provider, they should be assessed case-by-case with the understanding that clinical service providers have the ultimate authority for determining PrEP eligibility.

 

22.2 Program Component #2:  Promoting Adoption of PrEP/nPEP by Clinical Service Providers 

Activities under this component aim to increase understanding, acceptability, and adoption of PrEP and nPEP among local clinical service providers. The Program Component #2 Activity Matrix below outlines potential approaches to engaging clinical service providers. Programs can contact their HIV Prevention consultant for technical assistance regarding outreach, education, and recruitment for clinical service providers.

Outreach

Education

Recruitment

  • Partner with local academic and professional organizations
  • Digital media engagement (e.g., social networking sites)
  • Traditional/ print media placement
  • Public health and academic detailing
  • Cold calls
  • Community partnerships and mobilization
  • Identify local clinical service providers who can serve as PrEP/nPEP “champions”
  • Public health and academic detailing
  • Partner with stakeholders to create or promote continuing education opportunities
  • Facilitate individual or group seminars, webinars, and in-services
  • Establish fora for peer learning and case conferencing
  • Design and implement pre- and post-tests
  • Identify local clinical service providers who can serve as PrEP/nPEP “champions”
  • Maintain and disseminate local PrEP/nPEP directory
  • Connect nascent clinical service providers to clinical service providers with experience prescribing and providing PrEP/nPEP
  • Establish formal agreements for providing/accepting referrals
  • Conduct follow-up activities
  • Community partnerships and mobilization
  • Identify local clinical service providers who can serve as PrEP/nPEP “champions”

 

22.2.1 Requirements for Implementation

Below are the requirements for implementing outreach, education, and recruitment efforts related to PrEP and nPEP adoption by local clinical service providers.

Outreach

Education

Recruitment

Conduct activities in person and through digital media platforms (e.g., social networking sites).

Conduct activities in person and through digital media platforms (e.g., social networking sites).

Conduct activities in person and through digital media platforms (e.g., social networking sites).

Coordinate with other programs and organizations conducting clinical education to assess PrEP/nPEP availability in the community and identify barriers to prescribing.

Tailor content to address barriers to prescribing PrEP/nPEP, as identified through the availability assessment.

Conduct follow-up activities to assess adoption of PrEP/nPEP by clinical service providers engaged in outreach and education.

Coordinate with other programs and organizations conducting clinical education to decrease duplication of efforts in conducting outreach.

Ensure messaging is culturally-responsive and medically accurate. See Section 22.6 for more information. 

 

22.3 Program Component #3:  PrEP/nPEP Clinical and Client Support Services

Activities under this component aim to facilitate uptake and maintenance of PrEP and nPEP therapy and to reduce any existing barriers among populations who are most vulnerable to HIV acquisition.

 

22.3.1 Requirements for Implementation

Below are the requirements for implementing clinical and client support services for PrEP and nPEP for focused population(s).

Clinical

Client Support

Provide PrEP and nPEP services in accordance with the most current clinical guidelines:

Accept referrals from internal and external sources through formal intake process.

Conduct required initial and follow-up laboratory testing, including extragenital testing for STDs. Provide treatment for STDs, as indicated.

Review the process for accessing PrEP or nPEP with individuals receiving services, to include rights, roles and responsibilities.
Provide education on PrEP and nPEP basics. Ensure messaging is culturally-responsive and medically accurate. See Section 22.6 for more information.

Offer, provide, and document the following navigation services:

  • Scheduling initial medical appointment; 
  • Transportation and/or accompaniment;
  • Readiness assessment; 
  • Benefits and insurance navigation;
  • Adherence counseling and support;

Appointment reminders and follow-up communication.

Assess, document, and provide referrals for social and support needs (e.g., housing, employment, behavioral health).
Support individuals with obtaining treatment medications. Staff must be well-versed in insurance benefits and be able to liaise with insurance providers to expedite prior authorizations and address any gaps in coverage. Staff must assist individuals with accessing pharmacy benefits through public insurance and/or patient assistance programs.
Provide scheduling of medical appointments for initial PrEP assessments with your internal clinical service provider.
Provide client support and navigation services to individuals who may decide to seek care with an external clinical service provider.
If nPEP is indicated or if further assessment by a clinical provider is needed after a possible exposure, immediately link the individual to appropriate care.
Conduct follow-up communications to remind individuals accessing PrEP of upcoming lab appointments, medical appointments, and pharmacy refills. Track appointments, correspondence, and engagement in client support services for all individuals recruited or referred to PrEP/nPEP services.
For individuals who are currently taking or have previously taken nPEP, streamline entry into PrEP services.
Programs that provide nPEP clinical services must be able to support and track individuals as they complete their regimen and complete follow-up testing.

 

22.3.2 Client Support and Navigation

Client support and navigation services are intended to wrap around clinical services to increase the likelihood that individuals use PrEP or nPEP therapy safely and effectively. Programs must streamline their processes and systems in order to facilitate entry into PrEP and nPEP program(s) from both internal and external referral sources.

Further Considerations

  • Assist with enrollment into public insurance plans during open enrollment periods or refer individuals to organizations who are able to assist with enrollment.
  • The provision of “same-day PrEP” can help address attrition for individuals receiving services, and can reduce barriers to initiating PrEP therapy. Reducing the number of required, in-person visits can also reduce barriers.
  • Staff who conduct provide support and navigation activities should be able to provide real-time scheduling of medical appointments for initial PrEP assessments with internal clinical service providers. If staff are unable to directly make appointments, they should minimally have direct access to staff that are able to secure appointments.
  • Communications with individuals receiving services should not be limited to phone or mail; emails or text messages through secure means, are encouraged. Programs must have policies, practices, and safeguards to protect confidentiality and maintain security of digital communications.
  • Ensure that your program understands the limitations of external clinical service providers before linking nPEP candidates to appropriate care. Consider whether or not external clinical service providers are able to accept under/uninsured individuals, determine clinical eligibility for nPEP therapy, provide baseline and follow-up testing, prescribe the appropriate regimen, and provide client support and navigation services.

22.3.3 Determining Clinical Eligibility

Clinical service providers are the ultimate authority to verify that a client is clinically eligible to take PrEP or nPEP medications for HIV Prevention. Eligibility is outlined by the US Public Health Service in 2017 Clinical Practice Guidelines for PrEP (PDF) [CDC] and the 2016 Guidelines for Antiretroviral Post-Exposure Prophylaxis (PDF) [CDC].

22.3.4 Ongoing Engagement in Clinical Services

Programs must engage clients in ongoing clinical services, to support maintenance and adherence, as part of safe and effective use of PrEP and nPEP. If you witness sentinel events such as reactive HIV test results for individuals taking PrEP or other anomalies, please consult your supervising clinical service provider for further guidance and notify your DSHS HIV Prevention consultant.

Further Considerations

  • Ensure that your program understands the limitations of external clinical service providers before linking PrEP candidates to appropriate care. Consider whether or not external clinical service providers are able to accept under/uninsured individuals, determine clinical eligibility for PrEP therapy, provide baseline and follow-up testing, prescribe the appropriate regimen, and provide client support and navigation services.
  • Behavioral interventions can be tailored to individuals receiving PrEP services, in order to enhance maintenance, adherence, and engagement in combination prevention.

 

22.4 Minimum Requirements for PrEP and nPEP Documentation

Records must include information on both clinical and client support service provision:

  • HIV test result and date, including evidence of testing for acute HIV infection (when indicated);
  • Screening for potential exposure(s) to HIV in the last 72 hours;
  • STI test results and dates: syphilis, GC/CT genital and extragenital testing, if applicable;
  • Serum creatinine test and hepatitis B test results and dates;
  • Documentation of navigation/client support service(s) offer and provision, including:
    • Scheduling an initial medical appointment,
    • Transportation and/or accompaniment,
    • Benefits and insurance navigation,
    • Adherence counseling and support,
    • Appointment reminders and follow-up communications;
  • Signed consent for client to receive HIV testing and clinical services;
  • Self-reported or lab-verified medication adherence during follow-up appointments,
  • Signed authorization to release confidential information form for referring individuals to external clinical service providers;
  • Reasons for discontinuing PrEP use, based on client self-report or clinical contraindication, if available. 

 

22.5 Operational, Community, and Provider Assessments

22.5.1 Operational Assessment

Prior to implementation of any PrEP or nPEP activities, programs must perform an operational assessment to determine how Program Components 1-3 will be implemented and integrated into their organization’s existing workflow and infrastructure. Programs must implement clinical and client support activities using patient flows and staff roles that best serve clients and best fit their organizational structure and staffing.

22.5.2 Ongoing Community Assessment

For Program Components 1 and 3, programs must establish systems and mechanisms for systematically gathering input from consumers and community stakeholders to improve strategies and activities related to PrEP and nPEP. It is vital to engage members of focused population(s) in program design and monitoring and evaluation in order to enhance the quality of services, to grow the program, and to respond to the needs of the community. At minimum, programs must:

  • Establish and maintain a Community Advisory Board (CAB) to assist with programmatic decision-making. Programs can opt to establish a CAB specifically for PrEP/nPEP activities, or to integrate PrEP and nPEP activities into existing CABs at their organization.

22.5.3 Ongoing Provider Assessment

For Program Component 2, programs must establish systems and mechanisms for gathering input from clinical service providers and other community stakeholders to improve strategies and activities related to PrEP and nPEP. It is vital to engage local clinical service providers in program design and monitoring and evaluation in order to enhance the quality of provider engagement, to grow the program, and to respond to the needs of the local providers.

 

22.6 Values of Collaboration and Cooperation

Programs must create or expand existing partnerships with community partners and stakeholders to increase access to PrEP and nPEP. A robust referral network is necessary for Program Components 1-3. See list below for examples of organization types to partner with:

Community-Based Organizations Lesbian, Gay, Bisexual, and Transgender (LGBT) organizations and affinity groups
Regional/Local Health Departments
Local professional organizations and affiliations
STD clinics and Disease Investigation Services (DIS) programs
Pharmacies and pharmaceutical companies
Urgent Care Centers and Emergency Departments
Community Health Centers/ Federally Qualified Health Centers (FQHCs)
Hospitals and Hospital Systems
HIV Care Services providers
Private clinical service providers, including individual and group practice settings
Non-traditional partners, such as local businesses and schools and universities


Programs must develop patient care protocols, policies, and procedures, and must be willing to share these with other stakeholders and providers. Programs must also develop written policies and procedures for making and accepting internal and external referrals for clinical and client support services.

For Program Component 2 specifically, programs must coordinate their outreach and education to clinical providers with other providers of PrEP and nPEP services and with other organizations conducting clinical
education on these interventions.

 

22.7 Culturally-Responsive and Medically-Accurate Messaging and Materials

Programs must ensure that their educational and promotional materials for focused population(s) and clinical service providers are accurate and consistent with the 2017 PrEP Clinical Practice Guidelines (PDF) [CDC] and the 2016 Guidelines for Antiretroviral Post-Exposure Prophylaxis (PDF) [CDC]. Texas DSHS materials and materials from federal governmental agencies (e.g., CDC, HRSA, NIH) may be used without prior approval. All other program materials must be approved by a Program Materials Review Panel (PMRP) at the local or state level.

For focused population(s), the program must ensure that their materials and messages are culturally-responsive; this includes taking health literacy, language access, and reading levels into consideration. Program materials intended for clinical audiences should be reviewed by a licensed clinician or subject matter expert, to assure accuracy.

Key Messages

Programs are required, at minimum, to address the following key messages in their educational activities:

PrEP

  • PrEP is most effective when taken daily, as prescribed.
  • Clients must test negative for HIV-1 within one (1) week of being prescribed PrEP.
  • Clients must be tested for HIV at least every three (3) months and tested for STIs regularly, including extragenital testing.

nPEP

  • Clients must be evaluated for and prescribed nPEP as soon as possible (within 72 hours) of a potential non-occupational exposure.
  • nPEP consists of taking antiretroviral medicines for 28 consecutive days. Clients must receive HIV testing at the time of evaluation for nPEP and after the regimen has been completed.
  • Clients receiving nPEP should also be screened and treated for other related conditions, such as trauma, STIs, pregnancy, and hepatitis B and hepatitis C.
  • Clients who report behaviors that lead to ongoing exposure or who have received nPEP more than once in the past 12 months should be considered for PrEP. 

Combination Prevention

  • PrEP and nPEP work in combination with other options to prevent HIV transmission and acquisition. 

 

22.8 Training, Supervision, and Quality Management

Programs must maintain policies and procedures to address quality assurance and training requirements. Written, step-by-step instructions for conducting activities for Program Components 1-3 should be made available to all prevention personnel.

Staff who support activities for Program Components 1-3 must complete the required trainings within one (1) year of providing services. Observations of DSHS-funded prevention personnel must be conducted according to the following schedule:

Length of time the staff member has been conducting PrEP/nPEP activities:

Prevention staff must be observed at least:

PrEP/nPEP education activities for focused populations(s)

Clinical education activities

Client support services

6 months or less Twice a month Monthly Twice a month
7 to 12 months Monthly Quarterly Monthly
1 to 2 years Quarterly Quarterly Quarterly
2 years or more Every 6 months Every 6 months Every 6 months


22.8.1 Quality Management of Provider Engagement

Programs must develop a plan for assessing quality of provider engagement activities and evaluating effectiveness. The plan must include strategies for assessing differences in clinical service provider knowledge, attitudes, and practices as they pertain to PrEP and nPEP, and for conducting follow-up. The plan must also include strategies for improvement and remediation, based on clinical service provider feedback.

22.8.2 Quality Management of Clinical and Client Support Services

Programs must develop a plan for assessing quality of clinical and client support services and evaluating effectiveness. The plan must include strategies for assessing and monitoring outcomes for individuals receiving services, such as case conferences and regular review of charts. The plan must also include strategies for improvement and remediation, based on community feedback.

 

22.9 Resources

Listed below are clinical and nonclinical resources for programs conducting PrEP and nPEP activities:


 

Subchapters

22.0 Introduction and Overview

22.1 Program Component #1: Promotion of PrEP/nPEP through community education and awareness activities

22.2 Program Component #2: Promoting Adoption of PrEP/nPEP by Clinical Service Providers

22.3 Program Component #3: PrEP/nPEP Clinical and Client Support Services

22.4 Minimum Requirements for PrEP and nPEP Documentation

22.5 Operational, Community, and Provider Assessments

22.6 Values of Collaboration and Cooperation

22.7 Culturally-Responsive and Medically-Accurate Messaging and Materials

22.8 Training, Supervision, and Quality Management

22.9 Resources

Last updated May 15, 2020