Chair, Donna E. Sweet, MD, AAHIVS, MACP, prepared useful Practice Aids pertaining to HIV for this CME/MOC/NCPD/CPE activity titled “The HIV Prevention–Certified Provider Program: A Training and Certificate Program Designed to Improve Competencies and Expand the HIV Prevention Workforce.” For the full presentation, downloadable Practice Aids, monograph, and complete CME/MOC/NCPD/CPE information, and to apply for credit, please visit us at https://bit.ly/34T9Mfk. CME/MOC/NCPD/CPE credit will be available until November 11, 2022.

1. Clinical Snapshot: Pre-Exposure
Prophylaxis to Prevent HIV Infection
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www.healthhiv.org
USPSTF Clinical Summary: Pre-Exposure Prophylaxis for the Prevention of HIV Infection1
Persons at high risk of HIV acquisition
Population
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
Full abbreviations, accreditation, and disclosure information available at
PeerView.com/VQJ40
www.healthhiv.org
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
Full abbreviations, accreditation, and disclosure information available at
PeerView.com/VQJ40
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. 3. Truvada (emtricitabine and tenofovir disoproxil fumarate) Prescribing Information. https://www.gilead.com/~/media/Files/pdfs/medicines/hiv/truvada/truvada_pi.pdf.
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. 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.
www.healthhiv.org
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
Full abbreviations, accreditation, and disclosure information available at
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1. https://www.cdc.gov/vitalsigns/hivprep/index.html. 2. Truvada (emtricitabine and tenofovir disoproxil fumarate) Prescribing Information. http://www.gilead.com/~/media/Files/pdfs/medicines/hiv/
truvada/truvada_pi.pdf. 3. Descovy (emtricitabine and tenofovir alafenamide) Prescribing Information. https://www.gilead.com/~/media/Files/pdfs/medicines/hiv/descovy/descovy_pi.pdf.
www.healthhiv.org
•
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 PrEP1
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www.healthhiv.org
HIV Status Algorithm
HIV immunoassay blood test
(rapid test if available)
Signs/symptoms of acute
HIV infection anytime in
prior 4 weeks
Yes
Preferred Options
Send blood for HIV
antibody/antigen assaya
Send blood for
HIV-1 viral load assay
Retest antibody
in 1 month;
Defer PrEP decision
No
Positive
VL 10,000 copies/mL
VL 10,000 copies/mL
VL level of detection
No signs/symptoms on day
of blood draw
VL level of detection with
signs/symptoms on day
of blood draw
Retest in 1 month
Defer PrEP decision
Retest VL
Defer PrEP decision
HIV-
Eligible for PrEP
HIV+
Not eligible for PrEP
HIV status unclear
Defer PrEP decision
Negative
Positive
Negative Indeterminate
HIV+
HIV+
HIV-
HIV-
HIV-
Option 3
Consider HIV+
(pending confirmatory testing)

6. Patient Assessment:
Before and After Initiating PrEP1
Full abbreviations, accreditation, and disclosure information available at
PeerView.com/VQJ40
a
Use only HIV antigen/antibody tests that are approved by FDA for diagnostic purposes.
b
Nucleic Acid Amplification Test (NAAT) to screen for gonorrhea and chlamydia based on anatomic site of exposure; blood test for syphilis.
1. https://www.cdc.gov/hiv/clinicians/prevention/prep.html.
www.healthhiv.org
CDC: Additional Support and Ongoing Assessments
Required for Patients on PrEP
Provide the following services
At 3 months
after PrEP initiation
At 3 months
after the first
3-month follow-up
Every 6 months
after the first
3-month follow-up
• Test for HIV
• Measure serum creatinine and estimate creatinine clearance
• Provide medication adherence and behavioral risk reduction support
• Additionally, for
– MSM: screen for bacterial STIsb
– Women with reproductive potential: test for pregnancy; and
– PWID: assess access to sterile needles/syringes and to drug
treatment services
• Test for HIV
• Provide medication adherence and behavioral risk reduction support
• Additionally, for
– MSM: screen for bacterial STIsb
– Women with reproductive potential: test for pregnancy; and
– PWID: assess access to sterile needles/syringes and to drug
treatment services
• Measure serum creatinine and estimate creatinine clearance
• For all sexually active patients: screen for bacterial STIsb

7. Information for Patients: Effectiveness of
Prevention Strategies to Reduce the Risk
of Acquiring or Transmitting HIV1
Full abbreviations, accreditation, and disclosure information available at
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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.
1. https://www.cdc.gov/hiv/risk/estimates/preventionstrategies.html.
www.healthhiv.org
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%