Assembling your team

Your team should include at least one of each of the parties listed here. Not everyone will have to be involved in every step of planning, but it will be helpful to identify them as an advisor early in the process.

Core Team

Lead Clinician

• Ideally someone who currently sees PrEP patients and understands confidentiality workflows in this population
• Clinic template organizer/creator
• Lead PrEP provider at least one half day a week, or 2 appointments a day if blocking off patient clots in current schedule
• Serves as a resource for remainder of PrEP provider pool as it expands
• Coordinates workflow for lab ordering and result follow-up

Project Manager

• Can be a lead PrEP Navigator, medical assistant, nurse
• Responsible for meeting coordination, timeline and logistical follow-up
• Responsible for patient outreach and follow-up between clinic visits

Provider Pool

• In addition to Lead Clinician above, identify 2-3 additional providers who will provide direct patient care

Advisors

Scheduling

• Understands how appointments are booked and has access to any guided questionnaires for patients who call to schedule an appointment
• Will create scheduling workflows for phone calls, referrals and web-based scheduling

Web Development Team

• Creates your website that hosts patient and provider FAQ
• Creates direct patient scheduling (if possible)

Informatics Analyst/Builder

• Responsible for any electronic health record (HER) build such as creating a confidential visit type and/or department, internal referral, managing patient appointment reminders and scheduling, results routing, etc.

Representative

• A representative from any grant funding sources you intend to use
• Ensures you are aligning with any grant-funded metrics

Billing

• Advises on how patients will be billed for confidential visits (not using parent insurance, possibly using PrEP assistance program) and standard insurance

Compliance

• Advises on how you can verify patient identity prior to visit to ensure they are following institutional guidelines

Centering health equity

Understanding and addressing the barriers to accessing PrEP for HIV prevention among young people ages 13-24 is essential for increasing equitable access to care.¹³

These barriers can be broadly categorized as societal,¹⁴ community¹⁵, clinical, and individual factors¹⁶, each posing unique challenges for youth, with particular considerations for youth of color.¹⁷

BARRIERS TO CARE (Figure 2)

Societal barriers encompass cultural norms, stigmatization, and social attitudes that impact young individuals’ willingness to seek PrEP services.^18,19 Stigma and discrimination related to HIV and sexual health can deter youth, including youth of color, from seeking PrEP, exacerbated by racial bias and lack of awareness about HIV prevention within minority communities.^20-22 Cultural beliefs and language barriers further hinder access to accurate information.²³

Community-level barriers include limited access to healthcare facilities offering PrEP services, lack of tailored youth-centered programs, and social norms that discourage discussions about sexual health and HIV prevention, affecting youth, including youth of color and LGBTQIA+ youth in specific communities. ^24,25

Clinical factors related to issues within the healthcare system²⁶, such as economic disparities, confidentiality concerns, limited provider knowledge about PrEP²⁷, healthcare disparities, and underrepresentation of providers from minority backgrounds, collectively affect young people’s engagement with PrEP services.²⁸

Lastly, individual barriers involve personal challenges and attitudes, including fear and anxiety about seeking PrEP, underestimating risk perception,²² self-stigma, historical distrust of medical institutions^29,30, economic inequity,³¹ and immigration status concerns^32,33, all of which can hinder access to PrEP services, particularly for youth of color and LGBTQIA+ youth. ^34,35

PrEP Awareness

Young people need to be aware of PrEP to seek your services. The tools below can help your organization in planning outreach efforts to increase awareness of PrEP, as well as ensuring a welcoming environment where youth will want to seek PrEP and sexual healthcare.

Equity-focused approach to engaging youth

By considering these commonly identified barriers to care and addressing the guiding questions in the worksheet, your organization can develop a well-informed and equity-focused approach to engage and support youth, particularly youth of color and LGBTIA+ youth, in accessing PrEP and healthcare services. This comprehensive approach may help reduce barriers and promote positive sexual health outcomes for all young individuals.

Equity-focused approach to engaging youth: worksheet

Mapping exercise

Mapping out where adolescents and young adults in your community are learning about PrEP will help you understand where you can target your patient outreach. See the table below to get started.

Mapping Exercise

Linking to PrEP

Once patients are aware of PrEP, the next step is linking to access it. Understanding how patients are first contacting your organization is essential to understand the patient’s first impressions and perceived ease of access. Whenever possible, we recommend that organizations cater to different patient preferences by providing several different ways to be contacted. We encourage organizations to think broadly about patient’s preferred ways to contact a provider – and create patient – friendly contact methods (for example through text messaging).

Connecting

Connecting to PrEP care can be highly variable depending on your organization’s overall patient enrollment strategy. Below are some key factors to consider in ensuring that youth who may contact your program are able to access care.

Patients may connect via the web, either an online form or email, a phone call or some other form of communication.

For a new patient with a first appointment identify the following things:

• Estimated response time from staff
• Estimated wait time for appointment
• Scheduling staff guided questionnaires

Then think about:

• Identifying opportunities for optimizing responsive/wait times
• Ensuring all scheduling staff are trained

Finally, consider modifying intake/guided questionnaires to screen for PEP eligibility and refer for same-day care.

HOW PATIENTS MAY CONNECT WITH A PrEP PROGRAM (Figure 4)

Confidentiality

A key concern that comes up with most clinical settings is the concern for adolescent confidentiality, and we have included guidance for how to evaluate your intake system and electronic health record to ensure these processes are ready for adolescent PrEP patients. For simplicity, we encourage you to think about your existing workflows with providing confidential reproductive care to other adolescent patients, as opposed to trying to reinvent the wheel for PrEP.

• Review your state’s confidentiality laws around PrEP access
• Minor Consent and Confidentiality Laws for PrEP and HIV Treatment
• Review your clinic’s readiness for providing confidential PrEP care

ADDRESSING CONFIDENTIALITY FOR PREeP CARE WITH ADOLESCENTS (Figure 5)

Telehealth Care

Here are some tips for telehealth care with adolescents and young adults:

1. Give yourself more time for the appointment – recommend at least 30 minutes. Longer for the first visit to allow for delays with connection, appointment reminders, etc.
2. Small talk before big talk – establish rapport first. This is especially important with virtual care where building trust initially can be more challenging. Here are a few ideas from more to less personal.
   • Mention something personal: acknowledge something neat about their shirt, haircut, style – youth are often experimenting with their image and expression and looking for validation
   • Ask about something less personal: how school is going, what they like doing for fun
   • Ask about something that’s very neutral, like the weather – something neutral and quick
3. Remember that for those taking oral PrEP, a daily medication is a big deal for them – this is likely their first time.
4. Schedule follow-up before end of visit instead of having them call back to speak with your scheduling team. If they have to call back, they are much less likely to schedule a follow up appointment. There’s a greater chance they will be lost to follow-up
5. Stick to frequent follow-up at first, every 2-4 weeks initially. Then you can transition to less frequent visits once they have started PrEP, navigated common adherence challenges, and PrEP care becomes more routine

PrEP CARE IS A DEPARTURE FROM ADOLESCENT CARE (Figure 6)

Check out these additional resources for implementing PrEP telehealth services:

• NASTAD TelePrEP Online Learning Series: resources on state telehealth laws, telePrEP delivery models, home-testing and lab contracts, program promotion, and use of the 340B program.
• Washington University TelePrEP Hub: resources on program planning, billing, technology, telehealth PrEP navigation, and successful telePrEP programs.

Starting PrEP

When starting PrEP it’s important to consider whether this is the first time a patient will be regularly taking medication. Many have also not had laboratories done on a regular basis, and might have more questions about logistical challenges or fear of needles/phlebotomy. They are also new to understanding how medications and labs are covered by insurance. Cultivating an environment of empowerment as opposed to medicalizing and potentially pathologizing is essential.

Prescribing PrEP medications

Once you have laid the groundwork, starting PrEP is straightforward. The most crucial components are

1. A recent and accurate HIV test and

2. An adherence and follow up plan to ensure they will actually take PrEP medication.

Drawing labs same day is ideal, but not always possible depending on clinical circumstances or lab proximity. Plan for the earliest possible follow up once labs are complete.

It’s very important to know the type of HIV test that is being used, as there is a variable ‘window period’ or delayed time to positivity for each of these.

Home-based testing is helpful in overcoming transportation barriers and providing an avenue for extragenital STI testing. Extragenital swabs are often rejected by local laboratories such as LabCorp and Quest. Of note, there are no home-based testing programs that office HIV viral load tests currently (which is helpful if you are considering acute or early HIV when starting oral PrEP, and required for injectable PrEP follow up).

Some patients might also be hesitant about drawing their blood at home, so focusing on the minimally invasive nature is helpful – it’s similar to a finger prick for checking blood sugar. Your team can also offer an observed first home-based lab draw where you can coach the patient through the process. See the table below for information on home-based testing resources.

HOME TESTING PROGRAMS (Table 2)

Molecular Labs, Take Me Home, My Lab Box

For many patients starting oral PrEP, this will be the first time they are taking a daily medication, so it can be helpful to meet with them again once labs are complete to answer any questions they have about starting. Virtual visits are helpful given the minimal disruption in patient scheduling and transportation barriers; however, these require additional coordination to complete labs after the visit. For patients who are on injectable PrEP, consider virtual visits supplemented with injection drop-in visits. This approach allows for greater scheduling flexibility for timing the injections that do not rely on the clinic availability of your provider.

We have included resources below to support prescribers, as well as answer common questions related to clinical care of adolescents.

• Quickstart guide (oral PrEP)
• Oral PrEP provider card
• Injectable PrEP provider card
• Clinical Topics for HIV PrEP Use in Adolescents, CDC

Paying for PrEP

Whenever possible, it is best to use the patient’s existing insurance. Labs, medication, and visits should all be covered but this might vary in practice. Some states also allow individuals insured as dependents to request that medical services be kept confidential by their insurer; in California, adolescents can complete this request at myhealthmyinfo.org.

For patients who cannot use their existing insurance because of confidentiality concerns, please follow your existing workflows for confidential reproductive health services (for example, a young patient who would like to start contraception medication). In California, a confidential reproductive assistance program (Family PACT) covers clinic visits and some labs but unfortunately PrEP medication is not covered, so programs have to leverage other statewide assistance programs. We suggest that you become familiar with your local resources. A great resource is local Adolescent Medicine providers or pediatricians at your closest academic medical center.

Below are additional resources on paying for PrEP.

• NASTAD: State-by-State PrEP Assistance Programs
• CDC guide to paying for PrEP
• Ready, Set, PrEP for uninsured patients
• PrEP Navigation Manual
• Protecting Confidentiality for Individuals Insured as Dependents

Adherence Support

PrEP works if it’s taken as prescribed. Adherence is especially challenging with adolescents and young adults – both with PrEP as well as other chronic medication use. Troubleshooting adherence challenges is a key part of each encounter.

It’s imperative to highlight that many adolescent and young adult patients have not taken medication regularly before. Focus on the importance of adherence throughout the visit as well as through robust follow up. Engage your patient with teach back (asking the patient to repeat back their understanding) and interactive questions (“What do you think could happen if you forget to take your medication for a week?” “What would you do if you run out of pills before your next appointment?”) to ensure they clearly understand. We recommend coupling this interactive approach with strategies to promote daily adherence. These can include automated reminders, mobile applications, and leveraging their existing routines (such as putting the PrEP pill bottle next to their toothbrush so they see it every time they bush their teeth).

Strategies to support adherence in this population include:

• Daily pill reminders

Round Health

MediSafe

Phone alarm

TimeCap

• Motivational interviewing

AMA training presentation

Fundamentals of Motivational Interviewing for HIV training, offered through the CDC Capacity Building Assistance program

• Easy access to providers

Prefer text or messaging-based – ideally through electronic health record or other HIPAA secure platform

• Plan for frequent communication and follow-up visits

Weekly messaging at first

Early intervention for missed responses and missed appointments

• PrEPmate: a secure, 2-way text-messaging platform endorsed by CDC as an evidence-based intervention for PrEP care. Randomized clinical trials in young men who have sex with men demonstrated increased rates of adherence to PrEP and retention in care with PrEPmate.¹²
• PrEP Adherence Toolkit: a compendium of evidence-based interventions to support adherence to PrEP.

Retention in Care

The final component of the care continuum is supporting patients’ continued engagement in care. We know that a patient’s PrEP needs will vary over time, but continuing a close relationship is imperative. This can include intermittent outreach even if they have decided to take a break from PrEP.

PrEP ADHERENCE OVER TIME IN A DEMONSTRATION STUDY WITH ADOLESCENT MSM AGES 15-17 YEARS, AS MEASURED BY SERUM DRUG LEVELS. (Figure 7)

Monthly visits were scheduled until Week 12, then visit frequency was reduced to 3 months.

• Develop a strategy to track which patients are regularly responding to messages and attending clinic appointments. These can include automated reports about completed, missed and canceled appointments.
• Develop a plan for quickly identifying and responding to patients that could benefit from additional engagement. This can include a workflow to follow up on missed/cancelled appointments, as well as a way for providers to flag patients who will likely benefit from specialized adherence and retention support.

Program evaluation

A key consideration throughout the PrEP care continuum is ensuring that your program meets its intended goals, and that you have insight into what is going well, as well as areas where you can improve. Towards this end, you should develop a plan for ongoing evaluation and quality improvement efforts. Below are guiding questions and tools to facilitate this process.

Guiding Questions

• What is your quality assurance plan and planned frequency for evaluation?
• How will you assess how well you are reaching your target population and identifying blind spots?
• How will you assess patient and provider satisfaction?

Program evaluation tools

Developing a Logic Model for your program will assist in guiding the evaluation efforts that you undertake. The figure below outlines the logic model approach.

WHAT ARE INPUTS, OUTPUTS, OUTCOMES AND IMPACT? THE LOGIC MODEL APPROACH (Figure 8)

The table below provides an example of a logic model specific to a telePrEP program for youth.

LOGIC MODEL EXAMPLE (Table 3)

Data collection activities may include quantitative and qualitative data.

• Quantitative data can often be accessed from your organization’s EHR, for example, number of patients attending medical visits, and demographic data describing your patient population.
• Qualitative data can include patient experience surveys and interviews. American Academy of Family Practice has a resource on patient satisfaction surveys.

Toolkit Contributors

Geoffrey Hart-Cooper MD

Geoff is the Medical Director of Stanford’s Virtual PrEP Program for Adolescents and Young Adults and a primary care pediatrician. He completed an applied epidemiology fellowship in the Divisions of HIV and STD Prevention at the Centers for Disease Control, and has focused on adolescent and young adult sexual health since. During his pediatric residency at the University of California San Francisco, he developed PrEP provider trainings and conducted a national adolescent provider survey regarding PrEP knowledge, attitudes and practices. As an HIV prevention specialist at the San Francisco Department of Public Health Capacity Building Assistance Program, he has worked with various health departments and organizations to develop and implement PrEP telehealth programs. His expertise focuses on leveraging telemedicine to improve PrEP care for adolescents and young adults.

Sabrina Cluesman MSW LCSW

Sabrina is a PhD Candidate at NYU’s Silver School of Social Work. Sabrina’s research agenda aims to advance the science of HIV prevention with youth and emerging adults. Her dissertation research, funded by NIDA, focuses on the experiences of gender minority youth and emerging adults 13-24 years of age who identify as transgender and gender-expansive, and explores questions related to the connections between gender minority stress and substance use behaviors and how these may impact preexposure prophylaxis (PrEP) outcomes. Prior to joining NYU, Sabrina spent 18 years in direct clinical practice, including 12+ years working for JASMYN, an LGBT youth non-profit, in Jacksonville, FL, where she co-created extensive case management and clinical services for the agency, including their Sexual Health Clinic.

Jessica Bloome MD MPH

Jessica is an Assistant Professor of Medicine at the University of California, San Francisco, and Deputy Director of the Capacity Building Assistance program for HIV prevention at the San Francisco Department of Health. She provides technical assistance to health departments in implementing evidence-based approaches to PrEP and other HIV prevention tools, and leads a retention and re-engagement program at the San Francisco General Hospital Ward 86 clinic.

Amy Lee MPhil

Amy is the Distance Learning Specialist at the San Francisco Department of Public Health Center for Learning & Innovation. Previously based at UC Berkeley, she taught a wide spectrum of courses across the humanities, social sciences, and STEM fields, including literature, composition, ethnic studies, and capstone seminars for engineers. She’s also taught at the California College of the Arts and Mount Tamalpais College (formerly the Prison University Project) at San Quentin State Prison. As a community-engaged scholar, she developed curricula in partnership with community groups to address challenges faced by communities of color.

Acknowledgements

The authors would like to thank the members of the Capacity Building Assistance Provider Network (CPN), Jeffrey Birnbaum MD (SUNY Downstate Medical Center), Miguel Bujanda (REACH LA), Jennifer Carlson MD (Stanford University), and Kristefer Stojanowksi PhD (getSFcba, Emory University) for their input and  feedback on early versions of this toolkit.

getSFcba, the CBA program of the San Francisco Department of Public Health, is funded by the US Centers for Disease Control and Prevention (CDC) under Funding Opportunity Announcement 19-1904 and the creation of this toolkit was supported by Cooperative Agreement Number 5U65PS004411-02 REVISED.

The views expressed herein represent those of the authors and do not necessarily reflect the official policies of the Department of Health and Human Services or the San Francisco Department of Public Health, nor does the mention of trade names, commercial practices, or organizations imply endorsement by the U.S. Government or the City and County of San Francisco.

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