Donna E. Sweet, MD, AAHIVS, MACP, prepared useful practice aids pertaining to HIV prevention for this CME/MOC/CNE/CPE activity titled "Creating an HIV Prevention–Certified Provider Workforce: A Training and Certificate Program Designed to Improve the Competencies of Providers in Delivering Comprehensive HIV Prevention." For the full presentation, monograph, complete CME/MOC/CNE/CPE information, and to apply for credit, please visit us at http://bit.ly/33e2CQt. CME/MOC/CNE/CPE credit will be available until November 18, 2020.

1. Clinical Snapshot: Pre-Exposure
Prophylaxis to Prevent HIV Infection
Access the activity, “Creating an HIV Prevention–Certified Provider Workforce: A Training
and Certificate Program Designed to Improve the Competencies of Providers in Delivering
Comprehensive HIV Prevention,” at PeerView.com/BDE40.
PRACTICE AID
USPSTF Clinical Summary: Pre-Exposure Prophylaxis for the Prevention of HIV Infection1
Persons at high risk of HIV acquisitionPopulation
Offer PrEP
Grade: A
• Definition: The USPSTF recommends the service. There is high certainty that the net
benefit is substantial
• Suggestions for practice: Offer or provide this service
Recommendation
Persons at risk of HIV infection include men who have sex with men, persons at risk via
heterosexual contact, and persons who inject drugs. Within these groups, certain risk
factors or behaviors can place persons at high risk of HIV infection.
Men who have sex with men, are sexually active, and have one of the following
characteristics
• A serodiscordant sex partner (ie, in a sexual relationship with a partner living with HIV)
• Inconsistent use of condoms during receptive or insertive anal sex
• An STI with syphilis, gonorrhea, or chlamydia within the past 6 months
Heterosexually active women and men who have one of the following characteristics
• A serodiscordant sex partner (ie, in a sexual relationship with a partner living with HIV)
• Inconsistent use of condoms during sex with a partner whose HIV status is unknown
and who is at high risk (eg, a person who injects drugs or a man who has sex with
men and women)
• An STI with syphilis or gonorrhea within the past 6 months
Persons who inject drugs and have one of the following characteristics
• Shared use of drug injection equipment
• Risk of sexual acquisition of HIV (see above)
Persons who engage in transactional sex, persons who are trafficked for sex work, men who
have sex with men and women, and transgender women and men who are sexually active
can be at high risk of HIV infection and should be considered for PrEP based on the criteria
outlined above.
Risk Assessment
Once-daily oral treatment with combined tenofovir alafenamide/emtricitabine or
tenofovir disoproxil fumarate/emtricitabine are the only formulations of PrEP currently
approved by the US FDA for use in the United States in persons at risk of sexual
acquisition of HIV infection.
Preventive
Medications2,3
The USPSTF has issued recommendations on behavioral counseling to reduce risk of
STIs and on screening for HIV infection.
Relevant USPSTF
Recommendations

2. Clinical Snapshot: Pre-Exposure
Prophylaxis to Prevent HIV Infection
Access the activity, “Creating an HIV Prevention–Certified Provider Workforce: A Training
and Certificate Program Designed to Improve the Competencies of Providers in Delivering
Comprehensive HIV Prevention,” at PeerView.com/BDE40.
PRACTICE AID
Two Ways to Identify Candidates for PrEP4
Passive Prescribing
• Relies on patients self-identifying as being
at risk of HIV infection and asking about
PrEP; however, many at-risk patients do not
recognize their need for PrEP
Active Screening
• Requires that physicians, or staff, take sexual history from
all patients, which can be overwhelming
– Commit to talking to subsets of potentially high-risk
patients, such as MSM or transgender patients
– Sexual orientation and gender identity are not direct
risk factors; a nuanced sexual history is often needed to
understand potential exposures
– A diagnosis of syphilis or other bacterial STI is a marker
of high risk of HIV acquisition
Questions to Ask When Assessing Risk of HIV Infection5-7
Sexual risk
Have you had sex in the past 6 months? If “Yes,” with how many partners?
Do you have sex with men, women, or both men and women?
How often do you use a condom with these partners?
As far as you know, do any of your partners have HIV infection?
Have you been treated for an STI, such as gonorrhea, chlamydia, or syphilis? If “Yes,” do you know which infection
you had?
Have you used methamphetamines, such as crystal or speed?
Injection risk
Have you ever injected drugs that were not prescribed for you? If “Yes,” have you injected in the past 6 months?
Do you use needles or injection equipment after they have been used by someone else?
Patient Identification

3. Clinical Snapshot: Pre-Exposure
Prophylaxis to Prevent HIV Infection
Access the activity, “Creating an HIV Prevention–Certified Provider Workforce: A Training
and Certificate Program Designed to Improve the Competencies of Providers in Delivering
Comprehensive HIV Prevention,” at PeerView.com/BDE40.
PRACTICE AID
HIV: human immunodeficiency virus; PrEP: pre-exposure prophylaxis; PWID: persons who inject drugs; STI: sexually transmitted infection; USPSTF: US Preventive Services Task Force.
1. US Preventive Services Task Force et al. JAMA. 2019;321:2203-2213. 2. Descovy (emtricitabine and tenofovir alafenamide) Prescribing Information. https://www.gilead.com/~/media/Files/pdfs/
medicines/hiv/descovy/descovy_pi.pdf. Accessed October 18, 2019. 3. Truvada (emtricitabine and tenofovir disoproxil fumarate) Prescribing Information. https://www.gilead.com/~/media/Files/pdfs/
medicines/hiv/truvada/truvada_pi.pdf. Accessed October 18, 2019. 4. Stewart J, Stekler JD. J Fam Pract. 2019;68:254-261. 5. www.cdc.gov/hiv/pdf/risk/prep/cdc-hiv-prep-guidelines-2017.pdf.
Accessed October 14, 2019. 6. Smith DK et al. J Addict Med. 2015;9:226-232. 7. Smith DK al. J Acquir Immune Defic Syndr. 2012;60:421-427.
Recommended Indications for PrEP5
Men Who Have
Sex With Men
Heterosexual
Women and Men
People Who
Inject Drugs
• Adult or adolescent male patient
weighing at least 35 kg (77 lbs)
– Without acute or established
HIV infection
– Any male sex partners in past
6 months (if also has sex with
women; see next box)
– Not in a monogamous
partnership with a recently
tested, HIV-negative man
• Adult or adolescent person
weighing at least 35 kg (77 lbs)
– Without acute or established
HIV infection
– Any sex with opposite sex
partners in past 6 months
– Not in a monogamous
partnership with a recently
tested, HIV-negative partner
• Adult or adolescent person
weighing at least 35 kg (77 lbs)
– Without acute or established
HIV infection
– Any injection of drugs not
prescribed by a clinician in past
6 months
And at least one of the following
• Any anal sex without condoms
(receptive or insertive) in past 6
months
• A bacterial STI (syphilis, gonorrhea,
or chlamydia) diagnosed or reported
in past 6 months
And at least one of the following
• Is a man who has sex with both
women and men (also evaluate
by criteria in previous boxes)
• Infrequently uses condoms during
sex with one or more partners of
unknown HIV status who are
known to be at substantial risk
of HIV infection (PWID or bisexual
male partner)
• Is in an ongoing sexual relationship
with an HIV-positive partner
• A bacterial STI (syphilis, gonorrhea
in women or men) diagnosed or
reported in past 6 months
And at least one of the following
• Any sharing of injection or drug
preparation equipment in past
6 months
• Risk of sexual acquisition
(also evaluate by criteria in
previous boxes)

4. Flow Chart: Any Prescribing
Healthcare Provider Can
Provide PrEP Care1-3
Access the activity, “Creating an HIV Prevention–Certified Provider Workforce: A Training
and Certificate Program Designed to Improve the Competencies of Providers in Delivering
Comprehensive HIV Prevention,” at PeerView.com/BDE40.
PRACTICE AID
HIV: human immunodeficiency virus; PrEP: pre-exposure prophylaxis.
1. https://www.cdc.gov/vitalsigns/hivprep/index.html. Accessed October 14, 2019. 2. Truvada (emtricitabine and tenofovir disoproxil fumarate) Prescribing Information. http://www.gilead.com/~/
media/Files/pdfs/medicines/hiv/truvada/truvada_pi.pdf. Accessed October 14, 2019. 3. Descovy (emtricitabine and tenofovir alafenamide) Prescribing Information. https://www.gilead.com/~/media/
Files/pdfs/medicines/hiv/descovy/descovy_pi.pdf. Accessed October 14, 2019.
• If HIV positive, provide or refer
patient for HIV treatment and other
services to maintain health and
prevent further spread of HIV
• If HIV negative, ask about sex and
drug use behaviors
– If HIV risk is low, discuss
prevention methods
– If HIV risk is high, discuss risk
behaviors, PrEP, and use of other
prevention methods
• If tests show reason not to
prescribe PrEP (eg, abnormal
kidney function), discuss other
prevention methods
• If tests show patient still benefits
from taking PrEP, go to next step
• Prescribe PrEP, and instruct patient
to take one pill every day
• Currently tenofovir alafenamide/
emtricitabine or tenofovir
disoproxil fumarate/emtricitabine
are only medications approved by
the FDA for PrEP
• Most public and private insurance
programs cover PrEP, and patients
can get help with their copayments
• Drug assistance programs can help
patients without insurance pay
for PrEP
• Schedule appointments every 3
months for follow-up, including HIV
testing and prescription refills
HELP
ORDER
PRESCRIBE
FOLLOW UP
TEST

5. Patient Assessment:
Before and After Initiating PrEP
Access the activity, “Creating an HIV Prevention–Certified Provider Workforce: A Training
and Certificate Program Designed to Improve the Competencies of Providers in Delivering
Comprehensive HIV Prevention,” at PeerView.com/BDE40.
PRACTICE AID
Signs/symptoms of acute HIV
infection anytime in prior
4 weeks
Retest antibody
in 1 month; defer
PrEP decision
HIV-
Eligible for PrEP
HIV+
Not eligible for
PrEP
HIV status unclear
Defer PrEP decision
No
Option 1 Option 3
Link to care
and treatment
Consider HIV +
(pending confirmatory testing)
Yes
HIV+
VL 3,000
copies/mL
VL 3,000
copies/mL
HIV-
VL level of detection
No signs/symptoms on day of
blood draw
VL level of detection
Signs/symptoms on day of
blood draw
Retest in 1 month
Defer PrEP decision
Send blood for
HIV-1 VL assay
HIV immunoassay blood test
Negative Indeterminate
HIV+
Option 2 (preferred)
HIV-
Send blood for
HIV antibody/
antigen assaya
Positive
Negative
Positive?
HIV Status Algorithm1
Retest VL
Defer PrEP decision

6. Patient Assessment:
Before and After Initiating PrEP
Access the activity, “Creating an HIV Prevention–Certified Provider Workforce: A Training
and Certificate Program Designed to Improve the Competencies of Providers in Delivering
Comprehensive HIV Prevention,” at PeerView.com/BDE40.
PRACTICE AID
a
Use only HIV/antigen tests that are approved by FDA for diagnostic purposes.
HIV: human immunodeficiency virus; PrEP: pre-exposure prophylaxis; STI: sexually transmitted infections; VL: viral load.
1. https://www.cdc.gov/stophivtogether/library/prescribe-hiv-prevention/brochures/cdc-lsht-php-brochure-prep-faq.pdf. Accessed October 14, 2019.
2. www.cdc.gov/hiv/pdf/risk/prep/cdc-hiv-prep-guidelines-2017.pdf. Accessed October 14, 2019.
• Assess adherence
• Provide risk-reduction counseling
• Offer condoms
• Manage side effects
At every visit
• HIV testing (fingerstick or other blood test)
STI symptom screen and testing
For male patients
• Nucleic Acid Amplification Test (NAAT) to screen for
gonorrhea and chlamydia, based on exposure site
• Test for syphilis
For female patients
• Nucleic Acid Amplification Test (NAAT) to screen for
gonorrhea, based on exposure site
• Test for syphilis
• Serum creatinine and calculated creatinine clearance
• Pregnancy testing
• Every 3 months
and
• Whenever there are symptoms of acute infection
Symptom screen
• At every visit
Testing
• Every 3 months for sexually active persons
with symptoms
• Every 3 months for asymptomatic MSM at high
risk for recurrent STIs (eg, those with recent STIs or
multiple sex partners)
• Every 6 months for sexually active persons, even
if asymptomatic
• Whenever symptoms are reported
• At 3 months after initiation, and then every 6 months
• Every 3 months
CDC Guidelines: Monitoring While on PrEP2
Prevention and Medication Support
Laboratory Testing
Frequency
Frequency

7. Information for Patients:
Effectiveness of Prevention
Strategies to Reduce the Risk of
Acquiring or Transmitting HIV1
Access the activity, “Creating an HIV Prevention–Certified Provider Workforce: A Training
and Certificate Program Designed to Improve the Competencies of Providers in Delivering
Comprehensive HIV Prevention,” at PeerView.com/BDE40.
PRACTICE AID
a
Optimal use of oral daily PrEP is defined as taking PrEP daily. In studies, optimal or daily PrEP use has been determined by levels of TFV-DP detected in dried blood spots equivalent to seven pills/week.
Consistent use is defined as taking PrEP at least four pills/week and has been measured in studies by levels of TFV-DP detected in dried blood spots or other objective adherence measures, consistent
with at least four pills/week.
HIV: human immunodeficiency virus; TFV-DP: tenofovir-diphosphate.
1. https://www.cdc.gov/hiv/risk/estimates/preventionstrategies.html. Accessed October 14, 2019.
Oral Daily Pre-Exposure Prophylaxis (PrEP) for HIV-Negative Persons
Population Effectiveness Estimate
“Optimal or Consistent Use” (Taking PrEP daily or at least 4 times per week)a
Men who have sex with men (MSM) ~99%
Heterosexual men and women ~99%
Persons who inject drugs (PWIDs) 74% to 84%
Antiretroviral Therapy (ART) for HIV-Positive Persons to Prevent Sexual Transmission
Population Effectiveness Estimate
“Optimal Use” (Taking ART daily as prescribed and achieving and maintaining viral suppression)
Heterosexual men and women 100%
Men who have sex with men (MSM) 100%
Circumcision of Adult Males
Population Effectiveness Estimate
MSM, insertive anal sex Inconclusive
MSM, receptive anal sex Inconclusive
Heterosexual men 50%
Heterosexual women Inconclusive
Male Condom Use
Population Effectiveness Estimate
“Optimal Use” (Used consistently and correctly during every sex act)
MSM or heterosexual men and women N/A
“Consistent Use” (Always used during sex per self-report)
Heterosexual men and women 80%
MSM, receptive anal sex 72% to 91%
MSM, insertive anal sex 63%

8. CDC Guidance
Follow-Up and Monitoring
Follow-Up
Evaluate for All Persons
Receiving PrEP for HIV
Visit Checklist
At least every
3 months
• HIV testing (4th generation p24
Ag/Ab test)
• Clinical visit and medication
adherence assessment and
counseling
• Side-effect assessment
• Behavioral risk reduction review
and support
• 90-day supply (TDF/FTC or
TAF/FTC)
• Pregnancy testing
• Answer any new questions
❑HIV test
❑Assess for acute infection
❑Check for side effects
❑Pregnancy testing
❑Prescribe 90-day supply of
medication
At least every
6 months
• Assess renal function by serum
creatinine (estimated CrCl)
• Test for bacterial STIs (three sites
for chlamydia and gonorrhea;
syphilis); every 3 months in MSM
❑HIV test
❑STI tests
❑Pregnancy testing
❑Renal function
❑90-day prescription
Every
9 months
• Test for bacterial STIs (three sites
for chlamydia and gonorrhea;
syphilis); every 3 months in MSM
❑HIV test
❑Pregnancy test
❑90-day prescription
At least every
12 months
• Evaluate need to continue PrEP
❑HIV test
❑STI tests
❑Pregnancy testing
❑Renal function
❑90-day prescription
❑Assess the need to continue PrEP
Many experts recommend more frequent follow-up (ie, monthly) of patients on PrEP
(ie, TDF/FTC or TAF/FTC) to assess adherence and monitor for STIs, including HIV.

9. Pre-Exposure Prophylaxis (PrEP)
Myths and Urban Legends
• PrEP will protect me from HIV and other STDs.
• PrEP will lower my gender-affirming hormone levels and interfere with my gender expression.
• Studies in Africa have shown that PrEP doesn’t work for heterosexual cis-gender women.
• Studies have shown that PrEP does not work for transgender women.
• PrEP causes serious liver and kidney disease.
• As long as I take at least half of my PrEP tablets, I will be protected from HIV.
• My doctor told me that I can take my first tablet of PrEP this morning and be protected from HIV this
evening.
• Since U=U is true for PLWH taking ART, and PrEP is 97% effective in preventing HIV acquisition,
there’s no reason to use condoms anymore.
• The increasing use of PrEP is directly responsible for the increasing numbers of STIs in the US.
• Taking PrEP will not only protect me from HIV, but it will also prevent pregnancy.
• If I start taking PrEP, I can never stop taking it, because if I acquire HIV it will be resistant to all
antiretroviral medications.
• Taking PrEP makes men and women more sexually promiscuous.
• For cis-gender women like me, the best way to prevent HIV acquisition is to use PrEP gel inserted into
my vagina before and after I have sex with a man.
• If the PrEP tablets cause me to have side effects like nausea, I can always insert the tablet into my
rectum (or vagina) before I have sex to protect me from acquiring HIV infection.
• The cost of PrEP is very high and I do not have medical insurance, so there is no way for me to
access PrEP.
• The FDA recently approved a new type of PrEP which not only prevents HIV acquisition more than the
old PrEP, but it will not harm my kidneys or bones.
• The new PrEP medication approved by the FDA does not work in cis-gender women, which is why the
FDA rejected it for cis-gender women who have vaginal sex.
• HIV resistance to PrEP is increasing rapidly because many persons taking PrEP are not adherent with
their medications.
• There is a new way to take PrEP developed in France which is now FDA-approved in the US. It is
called “as-needed” PrEP and is taken a couple of hours before sex and immediately after sex.
• If I only have sex once or twice a month, my risk of acquiring HIV is too low to need PrEP.
Key
PrEP: Pre-exposure prophylaxis
U=U: Undetectable=Untransmittable
PLWH: People living with HIV
ART: Antiretroviral therapy
STI: Sexually transmitted infection