Skip to main content

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

Subchapters

22.0 Introduction and Overview

22.1 Promotion of PrEP/PEP Through Community Education and Awareness Activities

22.2 Promoting Adoption of PrEP/PEP by Clinical Service Providers

22.3 PrEP/PEP Client Support Services

22.4 PrEP/PEP Clinical Services 

22.5 Minimum Requirements for PrEP and PEP Documentation

22.6 Quality Assurance Requirements for PrEP/oPEP/nPEP 

22.7 Resources

22.0 Introduction and Overview

This chapter provides guidelines for the delivery of safe, consistent, and high-quality PrEP and PEPPEP 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 PEPPEP clinical and client support services. Texas DSHS supports the adoption and use of biomedical interventions for HIV prevention, such as PrEP, PEPPEP, 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, Ending the HIV Epidemic: A Plan for America, Achieving Together: A Community Plan to End the HIV Epidemic in Texas, and the 2017-2021 Texas HIV Plan.

These POPS are intended to supplement existing clinical guidelines for PrEP: 2021 Clinical Practice Guidelines and nPEP: 2016 Guidelines for Antiretroviral Post-Exposure Prophylaxis.

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 them. For more information about Combination Prevention, please visit the resources section at the end of this chapter.
     
  • Post-Exposure Prophylaxis (PEP) is a biomedical intervention that consists of taking antiretroviral therapy within 72 hours of a possible exposure in order to prevent HIV acquisition. Exposure may be occupational (oPEP) through a needle stick or exposure to bodily fluids as a part of one’s employment or non-occupational (nPEP) through sex or needle-sharing. DSHS does not currently fund oPEP services. For more information on PEP visit the resources section at the end of this chapter.
     
  • Pre-Exposure Prophylaxis (PrEP) is a biomedical intervention that consists of taking regular antiretroviral therapy 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

Contractors funded by Texas DSHS for this scope of work are required to implement each of the following three (3) program components:

  • Program Component #1: Promotion of PrEP/PEP 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/PEP by local clinical service providers, including outreach, education, and recruitment
     
  • Program Component #3: Delivery of PrEP/PEP clinical and client support services

Agencies who are new to implementing PrEP/PEP services should consider these components in their program planning. Note that contractors funded by DSHS are not required to directly provide PEP, but at minimum must provide immediate linkage to a local clinical service provider. See Section 22.2.1 for more information.

Overall, PrEP and PEP 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.

22.0.3 Priority Populations

PrEP programs should be focused on or designed to primarily benefit the priority populations for their HSDA. Through analysis of state epidemiological data, DSHS has identified priority populations for PrEP programs that are being implemented in the state of Texas. See 2020-2024 Eligible Priority Populations for a table of appropriate priority populations.

22.1 Promotion of PrEP through Community Education and Awareness

Activities under program component #1 aim to increase awareness, understanding, acceptability, intent to access PrEP and PEP 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 that   contractors can use to engage priority population(s). Contractors can contact their HIV Prevention consultant for technical assistance regarding outreach, education, and recruitment for PrEP/PEP. For further information on recruitment and outreach you can also refer to POPS chapter 1.3.

Outreach

  • New media engagement (e.g., apps, social networking sites)
  • Traditional/print media placement
  • Street/venue-based outreach
  • Community partnerships and mobilization

Education

  • 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

Recruitment

  • New media engagement (e.g., apps, social networking sites)
  • Employ peer navigators and influencers
  • Social Networking Strategies (SNS)
  • Community partnerships and mobilization

22.1.1 Requirements for Implementation

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

Outreach

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

Education

  • Conduct activities in person and through digital media platforms (e.g., apps, social networking sites).
  • Tailor activities to focused population(s).
  • Ensure messaging is culturally-responsive and medically accurate. See Section 22.2.3 for more information.

Recruitment

  • Conduct activities in person and through digital media platforms (e.g., apps, social networking sites).
  • Tailor activities to focused population(s).
  • Conduct screening for PrEP/PEP candidacy, using a community-informed or evidence-based tool or protocol.
  • Initiate clinical and client support services for potential PrEP/PEP candidates. See Section 22.3 for more information.

Contractors should develop mechanisms by which outreach, education and recruitment activities are tracked for reporting to DSHS. Documentation may take the form of event sign-in sheets; outreach logs; annual or semi-annual survey of outreach, education or recruitment activities; community partner meetings; program material review panels (PMRP) etc.

22.1.2 Community Assessment

Contractors must establish systems and mechanisms for systematically gathering input from consumers and community stakeholders to improve strategies and activities related to PrEP and PEP. It is vital to engage members of priority 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, contractors must establish and maintain a Community Advisory Board (CAB) to assist with programmatic decision-making. Contractors can opt to establish a CAB specifically for PrEP/PEP activities, or integrate PrEP and PEP activities into existing CABs at their organization.

22.1.3 Values of Collaboration and Cooperation

Contractors must create or expand existing partnerships with community partners and stakeholders to increase access to PrEP and PEP. A robust referral network is necessary for Program Components 1-3. The list below contains examples of organizations that contractors can partner with in order to meet the needs of their community.

  • 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

22.2 Promoting Adoption of PrEP/PEP by Clinical Service Providers

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

Outreach

  • 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/PEP “champions”

Education

  • 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/PEP “champions”

Recruitment

  • Maintain and disseminate local PrEP/PEP directory
  • Connect nascent clinical service providers to clinical service providers with experience prescribing and providing PrEP/PEP
  • 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/PEP “champions”

22.2.1 Requirements for Implementation

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

Outreach

  • 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/PEP availability in the community and identify barriers to prescribing.
  • Coordinate with other programs and organizations conducting clinical education to decrease duplication of efforts in conducting outreach.

Education

  • Conduct activities in person and through digital media platforms (e.g., social networking sites).
  • Tailor content to address barriers to prescribing PrEP/PEP, as identified through the availability assessment.
  • Ensure messaging is culturally-responsive and medically accurate. See Section 22.2.3 for more information.

Recruitment

  • Conduct activities in person and through digital media platforms (e.g., social networking sites).
  • Conduct follow-up activities to assess adoption of PrEP/PEP by clinical service providers engaged in outreach and education.

Contractors should develop mechanisms by which outreach, education and recruitment activities are tracked for reporting to DSHS. Documentation may take the form of event sign-in sheets; outreach logs; annual or semi-annual survey of outreach, education or recruitment activities; community partner meetings; program material review panels (PMRP) etc.

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

22.2.2 Ongoing Provider Assessment

For Program Component 2, contractors 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 PEP. 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.

22.2.3 Culturally-Responsive and Medically-Accurate Messaging and Materials

Contractors must ensure that their educational and promotional materials for priority population(s) and clinical service providers are accurate and consistent with the 2021 PrEP Clinical Practice Guidelines and the 2016 Guidelines for Antiretroviral Post-Exposure Prophylaxis. 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 priority population(s), the contractor 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 as prescribed. For oral PrEP this means taking medication daily; for injectable PrEP this means keeping to the bi-monthly schedule of follow-up dosing with clinician.

Clients must test negative for HIV-1 within one (1) week of being prescribed PrEP.

Clients must be tested for HIV and STDs regularly according to the clinical guidelines, including extragenital testing.

PEP

Clients must be evaluated for and prescribed PEP within 72 hours of a potential non-occupational exposure.

PEP consists of taking antiretroviral medicines for 28 consecutive days. Clients must receive HIV testing at the time of evaluation for PEP and after the regimen has been completed.

Clients receiving PEP should also be screened and treated for other related conditions, such as trauma, STDs, pregnancy, and hepatitis B and hepatitis C.

Clients who report behaviors that lead to ongoing exposure or who have received PEP more than once in the past 12 months should be considered for PrEP.

Combination Prevention

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

22.3 PrEP/PEP Client Support Services

Activities under program component #3 aim to facilitate uptake and maintenance of PrEP and PEP therapy and to reduce any existing barriers among populations who are most vulnerable to HIV acquisition. This section outlines activities that encompass client support services such as navigation and referral services. Section 22.4 outlines activities that encompass clinical services for PrEP and PEP.

22.3.1 Operational Assessment

Prior to implementation of any PrEP or PEP activities, programs must perform an operational assessment to determine how the program components 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.

22.3.2 Requirements for Client Support Services

Below are the requirements for implementing client support services for PrEP and PEP for priority population(s). Programs should:

  • Accept referrals from internal and external sources through formal intake process.
  • Review the process for accessing PrEP or PEP with individuals receiving services, to include rights, roles and responsibilities.
  • Provide education on PrEP and PEP basics. Ensure messaging is culturally-responsive and medically accurate (See Section 22.2.3).
  • 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.
  • 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/PEP services.

PEP

If a contractor has opted to provide PEP services under this scope of work the following are required client support services.

  • If PEP is indicated or if further assessment by a clinical provider is needed after a possible exposure, immediately link the individual to appropriate care.
  • For individuals who are currently taking or have previously taken PEP, streamline entry into PrEP services.
  • Programs that provide PEP clinical services must be able to support and track individuals as they complete their regimen and complete follow-up testing.

22.3.3 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 PEP therapy safely and effectively. Programs must streamline their processes and systems in order to facilitate entry into PrEP and PEP 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 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 PrEP or PEP candidates to appropriate care. Consider whether or not external clinical service providers are able to accept under/uninsured individuals, determine clinical eligibility for PrEP/PEP therapy, provide baseline and follow-up testing, prescribe the appropriate regimen, and provide client support and navigation services.

22.4 PrEP/PEP Clinical Services

This section outlines activities that encompass clinical services for PrEP and PEP:

22.4.1 Requirements for Clinical Services

Below are the requirements for implementing clinical services for this scope of work with a focus on providing services for priority population(s). Programs should:

  • Provide PrEP and PEP services in accordance with the most current clinical guidelines:
  • Conduct required initial and follow-up laboratory testing, including extragenital testing for STDs. Provide treatment for STDs, as indicated.
  • Texas DSHS has indicated locally relevant priority populations for programs based on their region and HIV Service Delivery Area (HSDA). See 2020-2021 Eligible Priority Populations.
  • Locally relevant eligibility guidelines should expand upon CDC practice guidelines and be informed by research that shows express need and epidemiological data that supports expanding PrEP eligibility to certain locally relevant populations.
  • 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.

22.4.2 Screening for Candidacy

Screening a candidate for PrEP/PEP can be defined as a rapid assessment of an individual’s vulnerability to HIV through behavioral and socio-structural 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/PEP clinical and client support services.

The CDC clinical practice guidelines recommend that PrEP should be offered to sexually active adults and adolescents at substantial risk of HIV acquisition. Consider the following behavioral and socio-structural factors in screening for candidacy, as they can lead to increased likelihood of acquiring HIV.

  • Inconsistent or no condom use with recent sexual partner(s);
  • Sex with partners who have an unknown HIV status or are living with a detectable level of HIV;
  • Sexually transmitted disease (STD) diagnosis within the last 6 months;
  • History of having sex while under the influence of alcohol or drugs;
  • History or current practice of sharing injection equipment; and/or
  • Sharing injection equipment with partner(s) who have an unknown HIV status or are living with HIV.

If a client has indicated they had a potential exposure to HIV within the past 72 hours, contractors should have protocols in place to screen these clients for PEP eligibility and refer these individuals to PEP providers in accordance with CDC guidelines.

Individuals may request PrEP out of concern about acquiring HIV but might not feel able to report sexual or injection behaviors that can lead to HIV acquisition to their clinical providers. This may be out of a fear of stigma or judgment within medical settings. For this reason, CDC clinical guidelines recommend that if an individual requests PrEP, they should be offered it, even when screening does not reveal any heightened vulnerability to HIV.

An individual is considered “eligible for PrEP” when screening shows they do not currently have HIV, have an increased likelihood of acquiring HIV, and they are willing to take PrEP.

Further Considerations

Screening can be performed by any staff member, from front-desk staff to prevention specialists 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 PEP.

Screening is not limited to in-person interactions; phone conversations or online screenings are acceptable ways to screen clients. 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/PEP.

22.4.3 Determining Clinical Eligibility

Clinical eligibility is determined after review of an individual’s laboratory results to ensure client can physically tolerate PrEP and it is an appropriate medication for them. Clinical service providers are the ultimate authority to verify that a client is clinically eligible to take PrEP or PEP medications for HIV prevention. Eligibility is outlined by the US Public Health Service in 2021 Clinical Practice Guidelines for PrEP and the 2016 Guidelines for Antiretroviral Post-Exposure Prophylaxis. Local eligibility criteria may expand upon CDC guidelines, including locally relevant priority populations based on your program’s HSDA (2020-2024 Eligible Priority Populations).

22.4.4 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 PEP. 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

Behavioral interventions can be tailored to individuals receiving PrEP services, in order to enhance maintenance, adherence, and engagement in combination prevention.

The decision to remain on PrEP is one that each individual client makes based on their own changing circumstances. Clients may decide to end PrEP for a variety of reasons such as: change in sexual/romantic behaviors; cost of the medication; change in financial situation; side effects; etc. Program clinical and navigation staff should be equipped to discuss client’s decision to continue or end PrEP and be able to help client navigate systemic barriers to PrEP care.

22.4.5 Telemedicine and TelePrEP

Texas House Bill (HB) 4 (87th Legislative Session 2021) states that where there is delivery of an in-person service, there must also be an option of that service via telecommunications or using information technology. This applies to providers who seek payment through Medicare or other third-party payers such as private insurance. Telemedicine for PrEP (or Tele-PrEP) is a relatively recent expansion of telehealth visits and includes replacing some or all in-person visits for the provisions of PrEP.

The 2021 CDC PrEP clinical guidelines include a brief section for how providers can adapt their practices to include PrEP including the following adaptations:

  • Conduct PrEP screening, initiation, or follow-up visits by phone or web-based consult with clinicians
     
  • Obtain specimens for HIV, STD, or other PrEP-related laboratory tests by:
    • Laboratory visits for specimen collection only
    • Order home specimen collection kits for specified tests.
      • Specimen kits are mailed to the patient’s home and contain supplies to collect blood from a fingerstick or other appropriate method (e.g. self-collected swabs and urine).
      • The kit is then mailed back to the lab with test results returned to the clinician who acts on results accordingly.
    • For HIV testing, only if a patient has no possible access to a lab (in-person or by mail), clinicians can provide an oral swab-based self-test that the patient can conduct and report the result to the clinician (e.g., photo of the test result). Because of the low sensitivity of oral Ab tests in detection of acute HIV infection, this should only be used for PrEP patients as a last resort.
       
  • When HIV-negative status is confirmed, provide a prescription for a 90-day supply of PrEP medication (rather than a 30-day supply with two refills) to minimize trips to the pharmacy and to facilitate PrEP adherence. (p. 40)

Telemedicine medical services should be delivered by a physician licensed in Texas or by a health professional who acts under the delegation and supervisions of a health professional licensed in Texas. See Title 3, Subtitle A, Chapter 11, §111.001(4) of the Texas Occupations Code (TOC) for a fuller definition of what constitutes telemedicine medical services. Practitioner and patient relationship should be established in accordance with the rules under the Texas Occupations Code (TOC) Section 111.006 and is subject to the same standards of care for an in-person setting.

  • Telemedicine services should have audio and video capability and can encompass different modalities such as:
     
  • Real time synchronous or store and forward telemedicine
     
  • Mobile health care services delivered by use of a laptop or desktop computer, smart phone, or tablet
     
  • Any HIPAA-approved telemedicine platform is strongly recommended. A sample list of HIPAA compliant platforms can be found at:
    • Texas Medical Association vendor options
    • HHS vendor options

22.4.6 Client Health Information Security

The following guidelines regarding the security of client health information must be followed when providing telemedicine and telehealth services:

  • The physical environments of the client and the distant site provider must ensure that the client’s Protected Health Information (PHI) remains confidential.
     
  • Providers of telehealth or telemedicine medical services must maintain the confidentiality of PHI as required by Federal Register 42, Code of Federal Regulations (CFR) Part 2, 45 CFR Parts 160 and 164, Chapters 111 and 159 of the Texas Occupations Code, and other applicable federal and state law.
     
  • Providers of telehealth or telemedicine services must comply with the requirements for authorized disclosure of PHI relating to clients in an ambulatory health setting.
     
  • All client health information generated or utilized during a telehealth or telemedicine medical service must be stored securely by the distant site provider in a client health record or electronic health record.
     
  • When the distant site provider stores the patient health information in an electronic health record (EHR), the provider must use software that complies with Health Insurance Portability and Accountability Act (HIPAA) confidentiality and data encryption requirements, as well as with the United States Department of Health and Human Services (DHHS) rules implementing HIPAA.
     
  • A Business Associate Agreement (BAA) is required to ensure safety of PHI when using electronic communications and telehealth platforms; DHHS delineates the information that is required in a BAA and offers a sample downloadable BAA. Please note the sample is an example only and would need to be reviewed by the provider’s legal counsel.

For a sample list of HIPAA compliant platforms see, Texas Medical Association’s (TMA) Vendor List. HIPAA compliant platforms are noted on the document.

22.5 Minimum Requirements for PrEP and PEP Documentation

Program component #3 involves the provision of clinical and client support services and will involve maintaining records, similar to how programs maintain records on HIV testing. Records must include the information on both clinical and client support service provision:

  • Signed consent for client to receive HIV testing and clinical services;
     
  • Signed authorization to release confidential information form for referring individuals to external clinical service providers;
     
  • Screening for potential exposure(s) to HIV in the last 72 hours;
     
  • If there is a potential exposure within 72 hours client record should indicate some level of engagement concerning PEP including but not limited to referral to PEP provider, referral to internal PEP, or client declination of PEP.
     
  • HIV test result and date, including evidence of testing for acute HIV infection (when indicated);
     
  • STD test results and dates: syphilis, GC/CT genital and extragenital testing, if applicable;
     
  • Serum creatinine test and hepatitis B test results (for oral PrEP) 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;
       
  • Self-reported or lab-verified medication adherence during follow-up appointments;
     
  • Documented reasons for discontinuing PrEP use, based on client self-report or clinical contraindication, if available.

22.5.1 Retention and Destruction of Client Records

The agency will have a system in place that complies with current confidentiality laws to protect client or patient records and documents maintained in connection with HIV/STD prevention activities. See sections 2.3 and 2.4 for further information on retention and destruction of client records..

22.6 Quality Assurance Requirements for PrEP/PEP

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.

22.6.1 Staff Training and Observations

Staff who support activities for Program Components 1-3 and are funded under this scope of work must complete DSHS required trainings for all HIV prevention contractors. A current list of training requirements for DSHS contractors can be found on the DSHS HIV/STD training website requirements.

The following is a list of the current training requirements. Keep in mind that requirements can change and those changes will be posted on the website before these POPS are updated

FTN Five-Part series
Training Training should be completed:
HIV Navigation in Texas (HNT) 12 months from employment date
Gender and Sexual Diversity Training 12 months from employment date
Social Determinants of Health 12 months from employment date
Trauma Informed Care (TIC) 12 months from employment date
Health Equity Training 12 months from employment date
FTN Update:
Training Training should be completed
HIPAA Privacy Training for Contractors and Volunteers 6 months from employment date
Foundations of Testing and Navigation (FTN) 3 months from employment date
Hepatitis C (HCV) Training 12 months from employment date
STD 101: What You Need to Know 12 months from employment date
Security and Confidentiality Training Annually during duration of employment

A note about Foundations of Testing and Navigation (FTN):

  • FTN Five-Part series: Is required for new DSHS funded staff who provide client support services such as navigation, education and outreach.
  • FTN Update: FTN Update course is an option for client support staff who were previously trained under Foundations of Counseling and Testing (FCT) or Protocol-Based Counseling (PBC). Clinical providers (MDs, NPs etc.) and management who do not provide direct services to clients can opt for the FTN Update course to satisfy this requirement.

Observations of DSHS-funded personnel must be conducted according to the following schedule:

Length of time the staff member has been conducting PrEP/PEP activities: Prevention staff must be monitored at least:
Community outreach, education and recruitment 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

22.6.2 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 PEP, and for conducting follow-up. The plan must also include strategies for improvement and remediation, based on clinical service provider feedback.

22.6.3 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.

22.7 Resources

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

HIV/STD Program

HIV/STD Program

Program Operating Procedures and Standards (POPS)