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Decision-Making Guide for the Provision
of PrEP Services in Title X-Funded Family
Planning Service Sites
HHS Oce of Population Aairs
Decision-Making Guide for the Provision of PrEP Services | i
Suggested Citation
Malcolm, N., Marx, K., Hart, J., Rollison, J., Erickson, C., Hall, C., Johnson, D. & Moskosky, S. (2019). Decision-Making
Guide for the Provision of PrEP Services in Title X-Funded Family Planning Service Sites. Rockville, MD: U.S. Department
of Health and Human Services, Oce of Population Aairs.
Acknowledgements
This resource was prepared by Atlas Research under OPA contract number HHSP233201500126I/HHSP23337003T
and supported with funds from the Secretary Minority AIDS Initiative Fund (SMAIF). Atlas Research staff who
prepared the guide include Nikita Malcolm (Project Manager), Kelsey Marx (Analyst), Jamie Hart (Project Director),
Julia Rollison (Senior Advisor), and Clarke Erickson (Senior Analyst), with support from U.S. Department of Health and
Human Services Office of Population Affairs staff Cynda Hall (Public Health Advisor), David Johnson (Operations and
Management Officer), and Susan Moskosky (Deputy Director).
The following Atlas Research sta also contributed to the development of the guide: Melanie Ogleton (Senior Advisor),
Alaysia Phillips (Senior Analyst), and April Joy Damian (Senior Analyst). Megan Weibye (Senior Graphic Designer)
provided publication support.
Publication of this resource would not have been possible without the contributions of the Title X service sites who
piloted the guide at their sites, as well as the experts at the following Federal agencies and non-Federal organizations
who provided external review and feedback: Centers for Disease Control and Prevention Division of HIV/AIDS
Prevention, Health Resources and Services Administration Bureau of Primary Health Care & HIV/AIDS Bureau, Oce
of HIV/AIDS Infectious Disease Policy, American College of Obstetricians and Gynecologists, Emory University Rollins
School of Public Health, Georgetown University O’Neill Institute, HIPS, Family Planning National Training Center,
MidAtlantic AIDS Education & Training Center, National Alliance of State and Territorial AIDS Directors, National Clinical
Training Center for Family Planning, Philadelphia Department of Public Health, Planned Parenthood Federation of
America, Planned Parenthood of Illinois, Planned Parenthood of New York City, SisterLove, Inc., University of California
San Francisco, and Whitman-Walker Health.
Disclaimer
References to non-HHS sites on the Internet are provided as a service to readers and do not constitute or imply
endorsement of these organizations or their programs by the Oce of Population Aairs, the Oce of the Assistant
Secretary for Health or the U.S. Department of Health and Human Services. The Oce of Population Aairs is not
responsible for the content of these sites. URL addresses listed were current as of the date of publication. Use of trade
names and commercial sources is for identication only and does not imply endorsement by the U.S. Department of
Health and Human Services.
Decision-Making Guide for the Provision of PrEP Services | ii
Updated 2/1/2019
Contents
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Decision-Making Guide for the Provision of PrEP Services . . . . . . . . . . . . . . . . . . . . . . . . 2
Development of the Decision-Making Guide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
How to Use This Guide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
PrEP Programs and Partnerships . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Service Capacity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Sta Readiness . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Cost Assessment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Decision-Making Checklist for the Provision of PrEP Services in Title X Sites . . . . . . . . . . . . 15
Conclusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Resources List . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
References. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Decision-Making Guide for the Provision of PrEP Services | 1
Introduction
U.S. Oce of Population Aairs and the Title X Family Planning Program
As the only federal program dedicated solely to providing family planning and related preventive health services, the
Title X program serves approximately four million individuals each year. Title X service delivery is based on Providing
Quality Family Planning Services: Recommendations of the Centers for Disease Control and Prevention (CDC) and the U.S.
Oce of Population Aairs (OPA) and includes a range of services related to preventing or achieving pregnancy, such
as contraceptive services, pregnancy testing and counseling, assistance to achieve pregnancy, basic infertility services,
and other preconception health services. Title X also funds activities to train family planning clinic personnel, conduct
research and evaluation to improve service delivery within Title X and the broader reproductive health care eld, and
develop and disseminate information to communities.
Title X-funded agencies are also required to provide sexually transmitted disease (STD) services, including HIV/
AIDS prevention education and testing. Pre-exposure prophylaxis (PrEP) has emerged as an eective HIV prevention
strategy for individuals who are most at risk, and the inclusion of PrEP in the HIV prevention services provided at Title
X sites is becoming an increasingly important method for protecting individuals of all ages from acquiring HIV. The
purpose of this resource guide is to help Title X-funded family planning service sites make evidence-informed
decisions about their role in assuring access to PrEP services in their communities.
Why PrEP?
PrEP has been advanced as a critical prevention strategy for people at substantial risk for HIV infection. The
medication, a once-a-day pill (brand name Truvada), has been demonstrated to reduce the risk of HIV infection up to
92 percent, when taken as directed.
1
According to CDC, approximately 180,000 sexually active U.S. women
of reproductive age (18 – 49 years) are potential candidates for PrEP.
2
However, awareness and uptake of PrEP among women at risk for
HIV has been limited. Between 2012 and 2015, PrEP uptake in the U.S.
increased signicantly among men, while the number of women starting
PrEP remained steady.
3
Additionally, while HIV disproportionately aects
African-American and Hispanic/Latina women, PrEP initiation among
women of color has been signicantly lower than among white women.
4
CDC recommends PrEP counseling for individuals at substantial risk
for HIV.
7
Women at substantial risk for HIV are dened as those who are
sexually active, not in a monogamous partnership with a recently tested
HIV-negative partner, and at least one of the following:
• In an ongoing sexual relationship with an HIV-positive partner
• Recent bacterial sexually transmitted infection (syphilis and/or
gonorrhea)
• History of inconsistent or no condom use with partners of unknown
HIV status known to be at substantial risk for HIV
• Engage in exchange sex, injection drug use, or live in a high-
prevalence area or network
Barriers to PrEP uptake among
women in the U.S. include:
5,6
Limited knowledge
about PrEP for HIV
prevention
Stigma associated with
HIV
Reluctance to discuss
risk behaviors with
providers to avoid
judgment
Cost of PrEP
Decision-Making Guide for the Provision of PrEP Services | 2
23% 20% 68%
Title X family planning sites are a primary source of care for many women and served approximately 3.5 million
women in 2017.
8
Family planning providers have extensive experience providing sexual and reproductive health
counseling, education, and services and are exceptionally qualied to provide HIV prevention services to women while
incorporating clients’ health goals into individual health care decisions.
9
Studies also show that women consider family
planning sites a preferred source for information about PrEP and access to PrEP services.
10
Title X sites have a key
opportunity to address gaps in PrEP awareness and access among women by integrating PrEP services into existing
HIV prevention services, which often include HIV and STD prevention education, testing and referral, risk reduction
counseling, and behavioral interventions, such as condom use promotion and post-exposure prophylaxis (PEP).
68%23%
Almost one-quarter of all
people living with HIV in the
U.S. are women.
20%
Women accounted for
approximately 20% of new HIV
infections in the U.S. in 2016;
77% of the women were African
American or Hispanic/Latina.
68%
Of the approximately 258,000
heterosexually active U.S.
adults who are eligible for
PrEP, 68% are women.
Decision-Making Guide for the Provision of PrEP Services
Development of the Decision-Making Guide
To address the disparities in PrEP prescribing and uptake among women, OPA developed the Decision-Making Guide
for the Provision of PrEP Services in Title X-Funded Family Planning Service Sites to assist in organizational decision-
making for leadership at Title X service sites who are considering beginning to oer PrEP services, considering
oering a higher level of PrEP services, or unsure about oering PrEP services. While this guide was initially
intended to inform decision-making within Title X-funded agencies, the following considerations may also be
applicable for other settings where family planning services are oered. Users of this guide are encouraged to revisit
the Decision-Making Guide periodically to account for changes in organizational capacity and need for PrEP services
within their service areas.
The Decision-Making Guide was informed by the best-available research and real-world experience in a 4-step process:
• Thoroughly analyzed peer-reviewed literature on PrEP implementation, barriers and facilitators to PrEP adoption,
and challenges for PrEP implementation within the family planning context.
• Conducted key informant interviews with family planning clinic administrators across the U.S.—both in urban and
rural service areas—to assess the level of PrEP service provision, capacity, and resources for oering PrEP services
and the challenges and benets of PrEP implementation.
• Convened a Technical Expert Panel to review and provide critical external feedback on the Decision-Making Guide.
• Implemented a pilot project to test the usefulness and applicability of the Decision-Making Guide among Title X
services sites across the U.S.
Decision-Making Guide for the Provision of PrEP Services | 3
How to Use This Guide
Key Decision-Making Factors
The guide enables Title X sites to consider the key factors for
PrEP provision and allows exibility for sites to make decisions
based on their unique contexts. Each section of the guide is
based on the four key decision-making factors—PrEP Programs
and Partnerships, Service Capacity, Sta Readiness, and
Cost Assessment—and features an interactive worksheet to
document notes and action items. After reviewing each section
of the guide, Title X sites should review the Decision-Making
Checklist, an organizational assessment tool included in this
guide for Title X sites to assess the appropriate level of PrEP
service provision for their site. Title X sites are encouraged to
make PrEP service provision decisions that t their specic
context, capacity, and needs.
Tiers of PrEP Service Provision
The Decision-Making Checklist suggests three tiers of PrEP service provision:
PrEP Counseling, Risk
Assessment, and Referral
Services
PrEP Counseling, Risk
Assessment, Prescription
Services and Referrals for
Follow-up Services
Full Range of PrEP
Services On Site
• PrEP Counseling, Risk Assessment, and Referral Services: Oering referral services for PrEP includes providing
counseling to clients and conducting an initial assessment of clients’ risk for HIV. Referral services may range from
maintaining a resource list of PrEP providers in the area to oering a “warm-hando” to a local PrEP provider. Title
X sites oering PrEP referral services are a key link to services and ensure eligible clients know how and where to
access additional PrEP-related care.
• PrEP Counseling, Risk Assessment, Prescription Services, and Referrals for Follow-Up Services: In this service
model, a Title X site may start a client on PrEP by providing counseling to clients, assessing clients’ risk for HIV,
conducting baseline laboratory tests, and writing the prescription for the medication. The Title X provider then
refers the client out for follow-up services, such as to a primary care provider.
• Full Range of PrEP Services On Site: The nal service level is oering the full range of PrEP services on site, to
include counseling, risk assessment, and baseline laboratory tests for PrEP as well as writing prescriptions and
conducting follow-up visits on site. At both the second and third tiers, Title X sites should be prepared to also oer
osite referrals, based on client preferences for accessing services.
While reviewing this guide, Title X sites should consider their current level of PrEP service provision, if any, and
the resources required to provide a level of service that assures access to PrEP services in their communities.
For example, many Title X sites oer PrEP counseling and education services. For those sites, this guide may be a useful
tool for considering how to oer add-on services, such as referrals for PrEP or onsite PrEP services.
Decision-Making Guide for the Provision of PrEP Services | 4
??????
Ask while reading this section: Do the existing local PrEP programs suciently meet the need of
our family planning clients and the needs of the community?
?
PrEP Programs and Partnerships
Understanding the existing PrEP programs and organizational partners in a Title X site’s service area is integral to
understanding the local need for PrEP service provision.
Ask while reading this section: Do the existing local PrEP programs suciently meet the need of
our family planning clients and the needs of the community?
Existing PrEP Programs in the Service Area
Assessing the existing PrEP programs in the service area can help a Title X site understand whether
there is a local need for PrEP service provision. In some areas, comprehensive PrEP service programs
may already be in place. Neighboring family planning clinics, health centers, state or local health
departments, and other community organizations may oer PrEP medication and other related services,
including assessment of HIV risk, HIV and PrEP education services, HIV and STD testing, nancial counseling
for PrEP, or PrEP adherence counseling and risk reduction support. In areas where the existing PrEP service
provision programs suciently meet the local need for PrEP, Title X sites may leverage partnerships to
ensure PrEP services are available and accessible for all potential clients via referral services.
An assessment of the local existing PrEP programs
may highlight a service gap and an opportunity
for a Title X site to ll that gap in the community.
Local health centers may not oer PrEP medication,
or the services may not be tailored to the needs
of Title X clients. For example, in areas where PrEP
services are available in HIV-related treatment centers
or health centers tailored to LGBTQ clients, a service
gap may still exist for clients who prefer accessing
HIV prevention services within a family planning site
where reproductive health services are integrated
and clients are more comfortable discussing
sexual risk behaviors in a familiar setting.
11
In areas
where there are limited or no existing PrEP service
programs, Title X sites may be ideal PrEP providers for
their clients.
PleasePrEPMe.org and PrEPLocator.org are
two searchable location-based PrEP provider
directories for identifying local PrEP programs.
Current and Potential Organizational Partnerships
Partnerships with outside organizations present valuable opportunities for collaboration, whether
your site decides to oer PrEP services on site or via referral. Community partners, including local
public health departments, community-based organizations, and other key stakeholder agencies, may oer
PrEP services or serve as referral partners, help link high-risk clients to services at the Title X site, provide
PrEP service training to Title X providers, or oer nancial resources to support the clinic’s PrEP activities.
PrEP decision-making in Title X sites includes an evaluation of current and potential partners and their roles
in maximizing the impact of local HIV prevention eorts.
Decision-Making Guide for the Provision of PrEP Services | 5
Applying PrEP Programs and Partnerships at My Title X Site
PrEP-ING FOR PrEP NOTES
ü Identify the local PrEP providers in your
service area by visiting PleasePrEPMe.
org and PrEPLocator.org.
ü Ask the following questions at your site:
• Do the local PrEP providers in the
area meet the needs of our family
planning clients? Are the programs in
an accessible location for our clients?
• Are the local PrEP providers
accepting new clients? Are the
programs friendly to all new clients,
including women or uninsured
clients?
• Does our Title X site have
partnerships with the local PrEP
providers? For example, do any of
the local health centers in our health
system oer PrEP services?
ü Reach out to local PrEP providers in
your area to nd an organization who is
willing to “mentor” your site as you plan
for PrEP services.
ü List your current and potential partners
who may provide assistance for your
PrEP program by linking high-risk
clients or oering nancial resources, for
example.
Use the Decision-Making Checklist at
the end of this Guide to assess your site’s
readiness for PrEP and nd your suggested
level of PrEP service.
SITE SPOTLIGHT
A Title X site partnered with the HIV Clinical Services Unit in
their county health department to oer PrEP via electronic
referrals. After providing PrEP counseling and risk assessment,
the Title X clinician used the shared electronic medical record
to communicate referral information with the HIV specialist.
The service model enhanced coordination between clinics
and streamlined care for clients.
Decision-Making Guide for the Provision of PrEP Services | 6
Service Capacity
Title X sites should assess their service capacity for oering PrEP services, including examining the site’s unique
structural and functional qualities that may inuence PrEP service capacity.
Ask while reading this section: Does our Title X site have the service capacity to assess client’s HIV
risk, perfor
m laboratory tests, prescribe PrEP and conduct follow-up visits?
PrEP Services Within a Framework of Comprehensive STD Services
PrEP is a part of comprehensive HIV and STD prevention services, including education, testing and
treatment, and risk reduction counseling. Title X sites can build on the framework of services already
in place to incorporate PrEP services. For example, your site may consider incorporating PrEP education
into your current STD education and testing services or adapting your site’s standard procedures for STD
treatment referrals for referral services for PrEP. Title X sites may also consider building on, or beginning to
oer, patient navigation services to assist with linking patients to nancial resources for PrEP.
Engagement of Clients in PrEP Services
Title X sites should consider the site’s ability to assess client risk for HIV, conduct appropriate
laboratory tests to determine clinical eligibility for PrEP, prescribe PrEP medication or oer referrals,
and provide follow-up services to clients. CDC publishes comprehensive clinical practice guidelines for
the use of PrEP for HIV prevention. The link to the CDC guidelines is included at the end of this guide in the
Resources List.
• Assess client risk for HIV. CDC recommends individuals at
substantial risk of HIV be counseled on PrEP. In clinical decision-
making, Title X sites should consider the HIV and STD prevention
needs of the client population. A site’s STD testing data, including
the number of conrmed HIV cases in recent years, may serve as
an indicator of the need for HIV prevention in the community.
Local HIV and STD data may also be available through state
and local data sources, such as a local health department.
An additional helpful resource is AIDSVu.org, which features
interactive county- and city-level HIV data, dynamic maps, and
local health proles.
Regardless of the HIV-related surveillance data, a site’s client
population may include individuals who are at substantial risk of
HIV and may benet from access to additional prevention services.
It is important that family planning providers understand clients’
individual HIV prevention needs and reproductive intentions,
and counsel clients on risks and benets of PrEP including the
importance of medication adherence.
• Conduct appropriate laboratory tests. Clinicians should also
conduct a series of laboratory tests to determine clinical eligibility
for potential and returning PrEP candidates.
Local HIV data is a useful tool
for making organizational
decisions, gaining buy-in and
informing processes for oering
PrEP services.
Local STD data is also important
for PrEP decision-making and
understanding the local HIV
risk. Recent data suggests
that women with a history
of gonorrhea are 5x as likely
to acquire HIV; Women with
a history of syphilis are 20x
12
as likely to acquire HIV. STD
education and testing are key
opportunities to talk about PrEP!
??
Decision-Making Guide for the Provision of PrEP Services | 7
CDC Guidelines for PrEP-Related Laboratory Testing Capabilities (2017)
Laboratory
Test
Timeframe Additional Information
HIV test Prior to prescribing
PrEP and at least every
three months after
starting PrEP (and,
before relling a PrEP
prescription)
• HIV testing and the documentation of results are required to conrm that
patients do not have HIV infection when they start taking PrEP medication.
• Clinicians should document a negative antibody test result within the week
before initiating (or reinitiating) PrEP medications, ideally with an antigen/
antibody test conducted by a laboratory.
• The required HIV testing can be accomplished by 1) drawing blood (serum) and
sending the specimen to a laboratory for an antigen/antibody test or antibody-
only test or 2) performing a rapid, point-of-care, FDA-approved, nger stick
blood test.
• Rapid tests that use oral uid should not be used to screen for HIV infection
when considering PrEP use because they can be less sensitive than blood tests.
Clinicians should not accept patient-reported testing results or documented
anonymous test results.
Renal function Prior to prescribing PrEP
and at least every six
months after starting
PrEP
• A clinician should determine renal function and test for infection with hepatitis
B virus (HBV) because both decreased renal function and active HBV infection
are potential safety issues for the use of TDF/FTC (or Truvada®) as PrEP.
• For all persons considered for PrEP, a serum creatinine test should be done,
and an estimated creatinine clearance (eCrCl) should be calculated using the
Cockcroft-Gault formula. Any person with an eCrCl of <60 ml/min should not
be prescribed PrEP with TDF/FTC.
Hepatitis
serology
Prior to prescribing PrEP • HBV infection status should be documented by screening serology before TDF/
FTC is prescribed as PrEP. Those patients determined to be susceptible to HBV
infection should be vaccinated.
• Hepatitis C virus (HCV) infection testing is recommended for MSM and all
sexually active persons starting PrEP.
Screening
for sexually
transmitted
infections (STI)
Prior to prescribing PrEP
Every three months
for sexually active
persons with signs and
symptoms of infection
and MSM at high risk for
recurrent bacterial STIs
Every six months
for sexually active
adolescents and adults
even if asymptomatic
• Tests to screen for syphilis are recommended for all adults prescribed PrEP, both
at screening and at semi-annual visits.
• Tests to screen for gonorrhea are recommended for all sexually active adults
prescribed PrEP, both at screening and at semi-annual visits.
• Tests to screen for chlamydia are recommended for all sexually active MSM
prescribed PrEP, both at screening and at semi-annual visits.
• Because chlamydia is very common, especially in young women and does not
strongly correlate with risk of HIV acquisition, regular screening for chlamydia is
not recommended for all sexually active women as a component of PrEP care.
Clinicians should refer to the 2015 STD guidelines for recommendations about
chlamydia testing frequency for women regardless of PrEP use.
Baseline
pregnancy test
Every three months
for women who may
become pregnant
• If a woman is pregnant when starting PrEP or becomes pregnant while on PrEP,
discuss with her the known risks and benets of continuing and discontinuing
PrEP, and the eects of Truvada on a newborn.
• Prescribe PrEP medication or oer referral. After assessing HIV risk, conducting appropriate laboratory
tests, and conrming that clients starting PrEP do not have HIV infection, clinicians can prescribe PrEP
for clients or oer referral for PrEP, depending on the Title X site’s PrEP service model. The medication
currently approved by the FDA for PrEP is a single daily dose of tenofovir disoproxil fumarate (TDF) and
emtricitabine (FTC) (brand name: Truvada). Identifying clinic sta to act as case managers or patient
navigators is especially useful for linking uninsured and underinsured clients to resources for accessing
PrEP. Title X sites should also consider partnering with pharmacies to ensure that clients have access
to the PrEP medication. In some cases, a local pharmacy may regularly stock PrEP medication and
therefore may understand the nancing mechanisms for PrEP. In other cases, Title X sites should consider
developing a working relationship with a local pharmacy to ensure client access to the medication.
Decision-Making Guide for the Provision of PrEP Services | 8
• Provide follow-up services: PrEP ecacy is highly dependent on adherence. Title X sites should consider
their ability to provide follow-up services at least every three months to support PrEP adherence, assess
client HIV status, and promote risk reduction. PrEP providers should also be able to advise clients when to
discontinue PrEP use (e.g., lowered risk for HIV infection, continual nonadherence, signs and symptoms of
seroconversion, personal client choice).
7
Activities to promote proper use of PrEP medication include:
» Engaging with client’s primary care provider.
» Scheduling frequent follow-up visits.
» Assigning clinic sta person(s) to act as case manager or patient navigator to actively remind clients
of follow-up.
» Providing condoms at every clinic visit and discussing use of eective contraception.
» Contacting the pharmacy to conrm PrEP medication is regularly stocked and does not need a prior
authorization.
» Referring clients to relevant support groups.
» For serodiscordant couples, recommending treatment for the HIV-infected partner.
» For injection drug users, oering referrals to substance use treatment and needle-exchange
programs.
Process for Oering PrEP Services
Many components of oering PrEP may be integrated into a client’s family planning visit or STD testing visit.
1
Oer PrEP education
and counseling
2
Assess risk of HIV if
client is interested
in PrEP
3
Conduct laboratory
tests and conrm
negative HIV test result
4
Prescribe PrEP or
oer referral to local
provider
5
Provide follow-up
services or oer referral
to local provider
Performance Measures for PrEP Services
Prior to implementing PrEP services, Title X sites should consider adopting performance measures
to assess the success of service implementation. These may include process, quality, or outcome-
related measures. Performance measures may also help sites identify service gaps and opportunities to
move along the PrEP service continuum. For example, a Title X site may nd a high percentage of its at-risk
clients who received PrEP counseling ultimately started PrEP at another health center. This may indicate
an opportunity for the Title X site to establish referral partnerships with local PrEP providers or consider
prescribing PrEP medication on site. The following organizational, clinical, and patient-level indicators are a
sample of measures your site may consider using:
7,13
» Percentage of clients who received PrEP counseling and education services.
» Percentage of clients screened for PrEP services and at signicant risk for HIV who began medication.
» Percentage of PrEP clients who attended scheduled follow-up visits at 3, 6, 9, and 12 months.
» Percentage of PrEP clients reporting proper adherence to medication and duration of PrEP use.
» Percentage of PrEP clients (taking the medication for more than one month) who seroconvert.
» Percentage of PrEP clients choosing to discontinue medication.
Decision-Making Guide for the Provision of PrEP Services | 9
Applying Service Capacity at My Title X Site
PrEP-ING FOR PrEP NOTES
ü Review the local HIV and STD data within
your Title X site and service area to
understand the risk of HIV and need for
PrEP.
ü Identify existing opportunities to
incorporate PrEP services at your Title X
site. For example, consider incorporating
PrEP education into your HIV and STD
education and testing services.
ü Ask the following questions at your site:
Is our Title X site able to:
• Assess clients risk for HIV?
• Conduct appropriate laboratory
tests for potential and returning PrEP
clients?
• Prescribe PrEP medication on site or
oer referrals for PrEP prescriptions to
a local PrEP provider?
• Provide regular follow-up services
for PrEP clients at least every three
months or oer referrals for follow-up
services?
ü Consider the performance measures your
Title X site will use to evaluate your PrEP
program.
Use the Decision-Making Checklist at
the end of this Guide to assess your site’s
readiness for PrEP and nd your suggested
level of PrEP service.
SITE SPOTLIGHT
A Title X site used performance measures to identify gaps
in PrEP awareness and access among its clients. Using
demographic information, the site determined that the
majority of clients oered and prescribed PrEP identied as
male. This prompted sta trainings on PrEP for women and
transgender individuals. It also presented an opportunity for
clinic leadership to identify and assess additional barriers to
PrEP services among clinicians, in the health centers, and in
the community.
Decision-Making Guide for the Provision of PrEP Services | 10
??
Ask while reading this section: Does our site have adequate sta capacity for PrEP service
implementation? How can our site access training resources for PrEP?
Sta Readiness
Sta readiness factors are related to leadership, clinicians and sta within the clinic and involve identifying and
understanding the level of readiness for PrEP service implementation.
Ask while reading this section: Does our site have adequate sta capacity for PrEP service
implementation? How can our site access training resources for PrEP?
Support of Clinic Leadership
Leadership support within Title X sites is vital to successful PrEP service implementation and
sustainability. Engaged and supportive leadership inuences agenda-setting, reinforces priorities, and
promotes readiness for implementation and integration across services.
14,15
Leadership must be committed
to planning and implementation activities for providing services, directing resources (e.g., sta resources,
including training and nancial resources) to PrEP service programs, and overcoming initial barriers
to service implementation. Pointing to other health centers and organizations who have successfully
implemented PrEP programs may be helpful in garnering leadership support.
15
Sta Resources for PrEP Service Provision
Sta capacity. Title X sites must have adequate stang and sucient sta time to implement PrEP
services. Linking PrEP programs to existing HIV prevention services at your Title X site can help providers
and sta who are accustomed to counseling and testing for HIV skillfully oer PrEP as an additional service
for clients.
16
Title X sites may also consider various service models and types of sta who may be involved,
including clinicians, counselors, health educators, patient navigators, nancial counselors, and pharmacists,
as a way to reduce clinician burden and costs.
16
For example, ancillary sta can serve as PrEP patient
navigators by assisting with initial PrEP counseling, lab work, nancial paperwork, or other non-provider
specic tasks.
Sta buy-in. Like other clinical services, clinician and sta support
for PrEP services is a key factor for service provision. Knowledgeable
providers and sta with favorable attitudes are integral to a clinic’s
successful service implementation. For example, try gauging
provider and sta attitudes toward PrEP by asking whether they
believe HIV prevention and PrEP education are essential parts
of a family planning visit.
17
Sta training and standardized PrEP
screening tools to identify PrEP candidates may also help mitigate
implementation challenges.
7
Sta training. Title X sites should consider sta training needs
for PrEP service provision. Clinical sta should be aware of the
importance of PrEP for HIV prevention, indications for PrEP use,
prescribing considerations (e.g., when to initiate treatment,
awareness of toxicity concerns), and culturally appropriate ways to
approach risk reduction counseling. All non-clinical sta should also
receive training on PrEP, with a tailored approach to individual job
functions. For example, billing sta should be provided information
Do you have a PrEP champion at
your site?
A PrEP champion, who is
passionate and committed to
the cause, may be a powerful
advocate who engages other
clinic sta around service
provision and helps articulate
the benets of setting up a PrEP
program.
Decision-Making Guide for the Provision of PrEP Services | 11
on the nancial considerations on PrEP, and front-desk sta should be aware that PrEP is oered in the clinic
and trained on culturally competent ways of interacting with potential and returning PrEP clients.
Training topics may include:
» Identication of clients who may
benet from PrEP.
» Culturally sensitive HIV risk
reduction and PrEP counseling.
» Initial and follow-up visit protocols
for clients using PrEP to monitor
for adherence and side eects.
» Common comorbidities and other
prescribing considerations.
» Billing procedures and any internal
policies regarding referrals or
prescription.
The AIDS Education and Training Center Program, funded
by the Health Resources and Services Administration (HRSA),
provides clinical consultation and technical assistance to
integrate HIV care along the continuum, including PrEP
services. This training resource, along with several other
helpful tools, may be found in the Resources List.
Clinicians at your Title X site who are
knowledgeable about PrEP services may
be a resource for in-house trainings.
Additionally, local PrEP providers in your area, state or local health departments, and other community
organizations and partners may be willing to oer in-person PrEP trainings at your site. Several online
training resources also exist for PrEP service implementation, such as webinars, pamphlets, and fact sheets.
Review the Resources List to nd links to helpful training resources.
Medical Assistants or
Nursing Assistants may:
•
•
•
Provide PrEP education and
counseling
Assist with lab screenings
for new and returning PrEP
clients
Oer risk reduction
counseling and resources
Patient Navigators or
Health Educators may:
•
•
•
Provide PrEP education and
counseling
Assist PrEP clients in
identifying a local
pharmacy to ll a
prescription
Link clients to nancial
resources to cover the costs
of PrEP
Clinical Pharmacists may:
•
•
•
•
Conduct laboratory
screenings for new and
returning PrEP clients
Prescribe PrEP medication
Provide follow-up services
for PrEP clients
Oer in-house PrEP
trainings
Various clinicians and sta may play an important role in your Title X site’s PrEP program.
Decision-Making Guide for the Provision of PrEP Services | 12
Applying Sta Readiness at My Title X Site
PrEP-ING FOR PrEP NOTES
ü Talk to clinic leadership about interest in
oering PrEP services.
ü Identify a PrEP champion to engage
leadership, clinicians and sta around PrEP
services.
ü Consider innovative service delivery models
that involve various sta.
ü Ask the following questions at your site:
- Who are the clinicians at my site who
would be involved in implementing PrEP
services? What training would they need?
- Who are the sta at my site who would be
involved in implementing PrEP services?
What training would they need?
ü Identify training opportunities for clinicians
and sta to learn about PrEP service delivery.
Potential resources for training include:
- In-house trainings, if there is a clinician
who can provide training.
- State and local health departments.
- Existing PrEP providers in your area.
- Online training resources, including the
Family Planning National Training Center
and National Clinical Training Center for
Family Planning.
Use the Decision-Making Checklist at the end of this
Guide to assess your site’s readiness for PrEP and nd
your suggested level of PrEP service.
SITE SPOTLIGHT
A Title X site implemented PrEP on site by involving
family physicians and clinical pharmacists in service
implementation. Clients interested in PrEP establish
care with a family physician, who sends an electronic
referral to the clinical pharmacists. The pharmacists
determine the appropriateness of PrEP for the client,
conduct labs, help with nancial assistance navigation,
provide the drug, and complete 3-month follow-up
visits with clients.
Decision-Making Guide for the Provision of PrEP Services | 13
??
Cost Assessment
PrEP is a cost-eective HIV prevention strategy at the population level, especially when directed toward the
populations at highest risk and in areas with high HIV prevalence.
18-22
Nonetheless, the costs of PrEP services for the
client and the site are important for Title X sites to consider.
Ask while reading this section: Is our Title X site able to access resources to assess and manage
PrEP service costs for the site and clients?
Considering Costs to the Client
Coverage for client costs is an important consideration for Title X sites oering PrEP services.
Financial counseling and other client resources for accessing low- or no-cost PrEP medication may help
minimize barriers to care and increase patient adherence to the medication. Private insurance companies
often cover PrEP medication, clinic visits, and lab work; some plans may require co-payments or other
cost-sharing mechanisms. Publicly funded programs, such as Medicaid, Medicare, and state and local
government programs, may also oer nancial assistance to cover expenses associated with PrEP. There
are several resources available to help Title X sites evaluate the cost of PrEP services and potential coverage
scenarios for clients found in the Resources List at the end of this guide.
Prescription assistance programs can help reduce the cost of
PrEP for clients. The Gilead Advancing Access Program assists
clients without insurance or prescription drug coverage to oset
PrEP medication costs. For eligible commercially insured individuals,
Gilead oers a co-pay assistance program to oset out-of-pocket
costs up to $7,200 annually. Clients enrolled in government health
care programs, such as Medicaid, Medicare (except those without
prescription coverage), or other federal and state prescription drug
programs, are not eligible for the co-pay program. For uninsured
individuals, the Gilead Medication Assistance Program provides free medication for those who qualify
based on nancial need. The Patient Advocate Foundation’s Co-Pay Relief Program assists clients with
private insurance living below 400% of the Federal Poverty Level (FPL) with out-of-pocket co-pays for PrEP
medication up to $7,500 per year. Title X sites may nd it useful to identify sta who can assist clients with
accessing the available nancial resources for PrEP.
State and local
prescription assistance
programs can help reduce
the cost of PrEP for clients, such
as the Washington State PrEP
Assistance Program, the New York
Department of Health PrEP-AP, and
the Illinois PrEP Assistance Program.
Considering Costs to the Site
Costs to the site may include sta time for training and service delivery, as well as medication and
lab services not covered by the client. Innovative service delivery models and free training resources
may help oset costs to the site. The 340B Drug Pricing Program may assist with discounted medication
and related medical supplies. Certain qualifying safety-net providers, including FQHCs and specialized
clinics, such as STD clinics and Title X-funded family planning clinics, are eligible to participate and receive
discounts on eligible outpatient medications, and subsequently provide medications to eligible clients,
regardless of payer status. National Alliance of State and Territorial AIDS Directors (NASTAD) also oers
a Billing Coding Guide for HIV Prevention: PrEP, Screening, and Linkage Services, which describes
various scenarios for PrEP provision and the corresponding CPT and ICD-10 diagnosis codes for ling a
claim with the client’s insurance company or government payer. This resource and others may be found in
the Resources List at the end of this guide.
Decision-Making Guide for the Provision of PrEP Services | 14
Applying Cost Assessment at My Title X Site
PrEP-ING FOR PrEP NOTES
ü Assess the cost of PrEP services for
your Title X site and clients. Available
resources are listed at the end of this
guide in the Resources List.
ü Talk to billing sta, or others at your
Title X site familiar with funding,
about existing grants or nancing
programs for PrEP.
ü Identify state and local PrEP
nancing mechanisms for your site.
Identify state and local prescription
assistance programs for your clients.
ü Ask the following questions at your
site:
- Who at our site can assist clients
with accessing available nancial
resources for PrEP? What training
would sta need to help clients
apply for nancial assistance or
enroll in insurance programs?
- What resources does our site
need to provide to clients to help
them access nancial resources
for PrEP?
Use the Decision-Making Checklist at
the end of this Guide to assess your site’s
readiness for PrEP and nd your suggested
level of PrEP service.
SITE SPOTLIGHT
A Title X site placed strong emphasis on the availability of
nancial counselors within their onsite PrEP service model. The
robust nancial counseling program to assist and counsel clients
through options for covering the medication was described as
integral to their PrEP service implementation.
Decision-Making Guide for the Provision of PrEP Services | 15
Decision-Making Checklist for the Provision of PrEP Services
in Title X Sites
The Decision-Making Checklist is an organizational assessment tool to determine your Title X site's position as it relates
to the key decision-making factors covered in this guide: PrEP Programs and Partnerships; Service Capacity; Sta
Readiness; and Cost Assessment. Now that you have read the Decision-Making Guide, complete the Decision-
Making Checklist to assess your site's readiness for PrEP services. Review each criteria in the checklist and
select the appropriate readiness level (Low, Medium, or High) for your site. Total the number of checkmarks for
each readiness level and use the tips below to nd the suggested level of PrEP service provision for your site.
Criteria Low Medium High Additional Considerations
PrEP Programs and Partnerships
Need for PrEP services unmet by existing
local PrEP programs
Service Capacity
Ability to oer full range of PrEP services
on site (i.e., counseling, risk assessment,
laboratory tests, prescription and follow-up
visits)
Sta Readiness
Leadership and sta buy-in for in-house PrEP
implementation
Sta capacity to provide PrEP services
Cost Assessment
Access to resources to assess and manage
PrEP service costs for the site and clients
Total
n/a
PrEP Counseling, Risk
Assessment, and Referral
Services
PrEP Counseling, Risk
Assessment, Prescription
Services and Referrals for
Follow-up Services
Full Range of PrEP
Services On Site
Title X sites are encouraged to make PrEP service provision decisions that t the specic needs of the site.
After completing the checklist for your Title X site, if you:
• Answered mostly lowsà Consider oering PrEP services via referrals to a partnering service provider and
begin planning and implementation activities for referral services.
• Answered mostly mediumsà Consider oering PrEP counseling, risk assessment, and prescription services
on site with osite referrals for follow-up services and begin planning and implementation activities for service
provision.
• Answered mostly highsà Consider oering the full range of PrEP services onsite and begin planning and
implementation activities for service provision.
Decision-Making Guide for the Provision of PrEP Services | 16
Conclusion
As leaders in sexual and reproductive health care, Title X sites play a key role in assuring access to PrEP services in
their communities and are in a prime position to address the disparities in PrEP awareness and access among women.
Given PrEP’s eectiveness as an HIV prevention tool, many Title X sites have already begun to integrate PrEP services
into their existing HIV prevention strategies. This Decision-Making Guide is a key resource for those Title X sites
contemplating the appropriate level of PrEP services to oer in their sites to consider the key decision-making factors:
• PrEP Programs and Partnerships: Do the existing PrEP programs suciently meet the need of the site’s family
planning clients, and the larger community?
• Service Capacity: Does the site have the service capacity to assess HIV risk, perform laboratory tests, prescribe
PrEP, and conduct follow-up visits?
• Sta Readiness: Does the site have adequate sta capacity for PrEP service implementation? How can the site
access training resources for PrEP?
• Cost Assessment: Is the site able to access resources to assess and manage PrEP service costs for the site and
clients?
Throughout the Decision-Making Guide, Title X sites are prompted to consider their current level of organizational
readiness across the four key decision-making factors to decide on the appropriate level of PrEP service provision:
oer PrEP counseling, education, and referral services; oer PrEP counseling, education, and PrEP prescription services
with referrals for follow-up services; and oer the full range of PrEP services on site. Suggested resources, tools, and
solutions to increase the site’s capacity to oer PrEP services are oered throughout the Decision-Making Guide, and
additional resources are included in the Resources List on the following page.
DECISION
TIME
Ready to
Decide on
PrEP!
Now that you have read the Decision-Making Guide, complete the Decision-
Making Checklist (found on page 15) to assess your site’s readiness for PrEP
service in each of the four key areas and nd the suggested level of PrEP service
for the site! Title X sites are encouraged to make PrEP service provision decisions
that t the specic needs of their sites.
When your site is ready to begin planning and implementing your PrEP
program, remember to visit the Family Planning National Training Center
website, the National Clinical Training Center for Family Planning website,
and the Family Planning Provider PrEP Toolkit for additional PrEP training and
implementation resources!
Decision-Making Guide for the Provision of PrEP Services | 17
Resources List
The following resources may help inform decision-making and implementation of PrEP services in Title X-funded
agencies.
Clinical Guidelines for PrEP
• Preexposure Prophylaxis for the Prevention of HIV
Infection in the United States - 2017 Update Clinical
Practice Guideline: U.S. Public Health Service and
Centers for Disease Control and Prevention
• Preexposure Prophylaxis for the Prevention of HIV
Infection in the United States – 2017 Update Clinical
Providers’ Supplement: U.S. Public Health Service and
Centers for Disease Control and Prevention
Implementation and Training Resources
• Family Planning Provider PrEP Toolkit: San Francisco
Department of Health Center for Public Health
and Innovation in coordination with University
of California San Francisco’s Hub of Positive and
Reproductive Sexual Health (HIVE)
• AIDS Education and Training Centers
The AIDS Education and Training Centers, the training
arm of the Ryan White HIV/AIDS Program, is a national
network of HIV experts who provide locally based,
tailored education, clinical consultation and technical
assistance along the HIV care continuum.
• Clinician Consultation Center PrEPline
The CCC PrEPline provides free, expert consultations
an all aspects of PrEP management to clinicians across
the country. Monday - Friday 9am - 8pm EST at (855)
448-7737 or (855) HIV-PREP
• San Francisco Department of Public Health Capacity
Building Assistance
The San Francisco Department of Public Health
provides free, customized, peer-to-peer Capacity
Building Assistance in high-impact HIV prevention to
health departments.
• Minors' Consent Laws for HIV and STI Services
In 2018, the Food and Drug Administration (FDA)
approved PrEP use among adolescents who weigh at
least 35 kg (77 lb). This CDC resource summarizes state
statutes and regulations regarding HIV prevention for
minors.
PrEP Financing Resources
• Paying for PrEP Fact Sheet: Centers for Disease Control
and Prevention
General overview of how the costs associated with
PrEP care may be covered.
• Getting PrEPped Flow Chart: Project Inform
Flowchart to help consumers and patient navigators
understand how to access services and cover medical
costs for PrEP
• Gilead Advancing Access® Program: Gilead Sciences
Additional information about the Advancing Access®
Program, including the enrollment process.
• Billing Coding Guide for HIV Prevention: PrEP,
Screening and Linkage Services: NASTAD
Example scenarios for PrEP provision and the
corresponding CPT and ICD-10 diagnosis codes for
ling a claim with the client’s insurance company or
government payer.
• PrEPCost.org: NASTAD
PrEPcost.org is an online health plan nder for PrEP.
PrEPcost.org can assist navigators by searching
across plans in the Marketplace and evaluating PrEP
coverage to nd the best options available. This
resource will be relaunched in early November 2018.
Decision-Making Guide for the Provision of PrEP Services | 18
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