HIV Prevention Webinar:
Combating PrEP Implementation Challenges
Monday, December 12th 2022
1:00-2:00pm Eastern / 10:00-11:00am Pacific
1

Continuing Education Credits
In support of improving patient care,
Community Health Center, Inc. / Weitzman
Institute is jointly accredited by the
Accreditation Council for Continuing Medical
Education (ACCME), the Accreditation Council
for Pharmacy Education (ACPE), and the
American Nurses Credentialing Center
(ANCC), to provide continuing education for
the healthcare team.
A comprehensive certificate will be sent after
the end of the series, Summer 2022.
2

Disclosure
• With respect to the following presentation, there has been no relevant (direct or indirect) financial relationship
between the party listed above (or spouse/partner) and any for-profit company in the past 12 months which
would be considered a conflict of interest.
• The views expressed in this presentation are those of the presenters and may not reflect official policy of
Community Health Center, Inc. and its Weitzman Institute.
• We are obligated to disclose any products which are off-label, unlabeled, experimental, and/or under
investigation (not FDA approved) and any limitations on the information hat we present, such as data that are
preliminary or that represent ongoing research, interim analyses, and/or unsupported opinion.
• This project is supported by the Health Resources and Services Administration (HRSA) of the U.S. Department of
Health and Human Services (HHS) as part of an award totaling $137,500 with 0% financed with non-
governmental sources. The contents are those of the author(s) and do not necessarily represent the official
views of, nor an endorsement, by HRSA, HHS, or the U.S. Government. For more information, please visit
HRSA.gov.
3

At the Weitzman Institute, we value a
culture of equity, inclusiveness,
diversity, and mutually respectful
dialogue. We want to ensure that all
feel welcome. If there is anything said
in our program that makes you feel
uncomfortable, please let us know via
email at nca@chc1.com
4

National Training and Technical Assistance Partnership
Clinical Workforce Development
Provides free training and technical assistance to health centers across the
nation through national webinars, learning collaboratives, activity
sessions, trainings, research, publications, etc.
5

Speakers
• Marwan Haddad, MD, MPH, AAHIVS
–Medical Director, Center for Key Populations, Community
Health Center, Inc.,
• Jeannie McIntosh, APRN, FNP-C, AAHIVS
–Family Nurse Practitioner, Center for Key Populations,
Community Health Center, Inc.
6

Background
• April 14, 2022: Integrating HIV Prevention into Primary Care
– Slides and Recording: www.chc1.com/nca
• This webinar discussed best practices for integrating HIV prevention
(e.g. HIV testing, PrEP and linkage to care) into primary care within the
context of enhancing clinical workforce development.
7

Objectives
• Review case-based scenarios illustrating common challenges to
integrating HIV PrEP in primary care
– Decision making on how to start PrEP and which regimen to use
– Barriers to PrEP medication access
• Discuss strategies to overcome these challenges in the case-based
scenarios in order to strengthen your PrEP program
8

New HIV Diagnoses
in the United States
9
≈18% on
PrEP*
≈82%
Without PrEP
Volume 33 | HIV Surveillance | Reports | Resource Library | HIV/AIDS | CDC
• New Diagnoses in 2020:
30,635
• 72% among MSM
• 69% among Black
and Hispanic

PrEP in the United States, 2020
10
• Approximately 1.2 million persons
in the United States are likely to
benefit from PrEP[1]
• 1 in 4 sexually active MSM:
814,000[2]
• 1 in 5 PWIDs: 73,000[2]
• 1 in 200 heterosexual adults:
258,000[2]
• Though Blacks and Hispanics
account for 69% of new HIV
infections, their use of PrEP is
relatively low.
2. Volume 27 Number 3 | HIV Surveillance | Reports | Resource Library | HIV/AIDS | CDC
10 1. Harris. MMWR Morb Mortal Wkly Rep. 2019;68:1117. 2. Smith. Ann Epidemiol. 2018;28:.e9. 3. Sullivan. J Int AIDS Society. 2020;23:e25461.

FDA-Recommended PrEP Regimens
• Fixed-dose TDF/FTC (Truvada or generic) for MSM, transgender women, heterosexually active men
and women, and people who inject drugs.
• Single pill once daily
• On-Demand 2-1-1 (MSM only)
• Fixed-dose TAF/FTC (Descovy) for sexual prevention in men and transgender women.
• Single pill once daily
• Injectable cabotegravir (Apretude) for adults and adolescents at least 35 kg.
• Monthly injection for 2 months then every other month.
11

12
CDC PrEP
Guidelines
2021

13
CDC PrEP
Guidelines
2021

PrEP Implementation Challenges:
Case-Based Scenarios
14

Case #1: Russell
15
23 year old Black
cis-gender gay
male comes in
asking for STI
screening.
Worried, since 2
1/2 days ago, he
had unprotected
oral and anal sex
(insertive and
receptive) with a
man he did not
know very well.
He had not had
any sexual
encounters for
about a month
prior to that.
He has no
pharyngeal or
anogenital
symptoms but is
concerned he may
have a STI.
He did have
urethral
gonorrhea about 7
months ago (he
does not recall
having anal or
pharyngeal swabs
done at the time).
He has never had
syphilis as far as
he knew.
On exam: pharynx
normal; no lesions
seen in anogenital
area; no discharge
seen in underwear
or from urethra;
testicles normal.

Case #1: Poll Question #1
What do you recommend be done for him in addition to obtaining STI/HIV
testing at this visit?
a. Do a rapid HIV test and if negative with no recent acute HIV
symptoms, start him on PrEP immediately.
b. No need to do anything else at this time. Bring him back in one
week for results. If HIV test negative, discuss PrEP with him then.
c. Do a rapid HIV test and if negative with no recent acute HIV
symptoms, start him on post-exposure prophylaxis (PEP)
immediately.
16

Recommendations
for Use of
Non-Occupational
PEP (nPEP)
AETC National Resource Center, www.aidsetc.org
17

nPEP Recommended Regimens
18

PrEP after nPEP
• Persons who are at ongoing risk of HIV
should be offered PrEP immediately
after 28 days of nPEP.
• A gap between nPEP and PrEP is NOT
necessary
– No proof that taking nPEP delays
seroconversion
– nPEP is highly effective
• Test for HIV, ideally with 4th
generation HIV test at end of nPEP.
• nPEP in context of PrEP when HIV
exposure occurs
– If person adherent to PrEP, no need
for nPEP.
– If person non-adherent to PrEP, 28-
day nPEP may be indicated.
• Continue PrEP after 28 day nPEP
if ongoing risk and HIV test is
negative.
19

The rapid HIV test is
negative and he
agrees to go on nPEP
for 28 days.
3-site gonorrhea and
chlamydia tests
(pharynx, urethra,
rectum) all negative;
syphilis negative. HIV
RNA negative.
At end of 28 days,
HIV test is negative.
He had one sexual
encounter in the last
month and engaged
in oral and anal sex
without condom
use. He said the
partner was on PrEP.
He says he tends to
have sex once a
month on average.
He really does not
like to use condoms,
they cause him to
lose his erection and
he has decreased
sensation when he is
receiving anal sex.
Case #1: Continued
20

Case #1: Poll Question #2
What do you recommend be done for him now that he has finished
nPEP?
a. Advise that he use condoms and to be liberal with lubrication, offer
prescribing a PDE-5 to help with erections but since he is having sex only
once a month, he is not a great candidate for PrEP.
b. Advise that he is a candidate for PrEP and that since he continues to have
unprotected sex with his partners regularly, he should take TDF/FTC daily.
c. Advise that he is a candidate for PrEP and since he is having sex on
average once a month, he could take daily oral PrEP, he could opt for
On-Demand PrEP (2-1-1), or he could use injectable PrEP.
d. Advise since he is not good at using condoms, he would likely not be
good at taking pills and that you recommend he start injectable PrEP.
21

2-1-1 Oral PrEP On-Demand
• Taking PrEP before and after sex, instead of daily
• 2 pills at least 2-24 hours before sex
• 1 pill 24 hours after first dose
• 1 pill 48 hours after first dose
• If sexually activity continues, take 1 pill every 24 hrs until 48 hrs after last sex
• Only studied in MSM and only with TDF/FTC (Truvada)
• ANRS Ipergay, ANRS Prevenir, AMPrEP
• Not FDA approved but is recommended as an option in CDC Guidelines for MSM.
• For those who experience side effects, they may continue to occur with every use.
• Should not use in a person with chronic Hepatitis B.
22
22

After hearing his options for PrEP, he chooses to
proceed with On-Demand PrEP (2-1-1) with
TDF/FTC.
He knows if the frequency of his sexual encounters
increases to about once a week, it is equivalent to
taking daily PrEP and he should just switch to daily.
He was scared of the injectable PrEP despite it
being superior to TDF/FTC in clinical trials.
• He was worried about side effects.
• Doesn’t love needles.
• Felt concerned about injecting something new in
him that lasted so long in his body.
Case #1: Continued
• Prescribe TDF/FTC 30 pills a month with 2 refills
despite being on 2-1-1 to ensure adequate supply.
• Monitoring:
– Every 3 months:
• Follow-up visit to assess adherence and
provide sexual health counseling
• Labs: HIV Ag/Ab, HIV RNA, 3-site GC/CT,
syphilis
– Every 12 months:
• Check renal function
– Q 6 mos. if ≥50 years or who have an
eCrCl <90 ml/min at PrEP initiation
23

Case #2: Sandra
24
51 year old Hispanic
cis-female with opioid
use disorder, T2DM,
HTN and stage III CKD.
Taking buprenorphine,
which helps with her
opioid cravings and
has resulted in
diminished use.
However, she does
continue to inject
fentanyl a few times
per month and
occasionally shares
needles and works
with acquaintances.
Last month labs
showed A1C 7.8%,
eGFR 47, HIV Ag/Ab
screening negative,
HCV Ab + and viral
load undetectable,
urine gonorrhea and
chlamydia +, T.
pallidum Ab neg.
She came in for
treatment of
gonorrhea and
chlamydia with
nursing visit earlier in
the month.
At today’s
buprenorphine
follow-up visit, upon
reviewing her lab
results, Sandra reports
that recently she has
been engaging in sex
work (oral, vaginal,
anal) in exchange for
shelter, drugs and
money.

Case #2: Poll Question #1
In addition to counseling on safe injection, what would you recommend at
today’s visit?
a. Do rapid HIV test, and if negative, offer Descovy for PrEP given her
GFR is <60.
b. Offer repeat STI screening, including 3-site gonorrhea/chlamydia
testing
c. Do rapid HIV test, and if negative, offer Truvada every other day
according to renal dosing based on her current GFR.
d. Do rapid HIV test, draw blood for HIV RNA viral load, and if
negative, offer injectable Apretude for PrEP.
e. Both b and d
25

PrEP use among Cis-Women
• From 2012 to 2021 18% of new HIV infections in the US occurred in women.
During this same time period only 8% of all PrEP users were female.
• Stigma, barriers to access, lack of awareness and low self-perceived risk have been
identified as reasons for low PrEP uptake in women.
1. “HIV and Women: PrEP Coverage.” CDC. https://www.cdc.gov/hiv/group/gender/women/prep-coverage.html.
2. “AIDSVu Releases New Data Showing Significant Inequities in PrEP Use Among Black and Hispanic Americans.” AIDSVu. July 2022. https://aidsvu.org/prep-use-race-ethnicity-launch-22/
2. Goparaju L, Praschan NC, Warren-Jeanpiere L, Experton LS, Young MA, Kassaye S. Stigma, Partners, Providers and Costs: Potential Barriers to PrEP Uptake among US Women. J AIDS Clin Res. 2017 Sep;8(9):730. doi: 10.4172/2155-6113.1000730. Epub 2017 Sep 25. PMID: 29201531; PMCID: PMC5708581.
4. Cernasev A, Walker C, Armstrong D, Golden J. Changing the PrEP Narrative: A Call to Action to Increase PrEP Uptake among Women. Women. 2021; 1(2):120-127. https://doi.org/10.3390/women1020011
26

PrEP for People who Inject Drugs (PWID)
CDC, 2021
• Only about 1-3% of PWID are estimated to be taking PrEP.
• Provider bias and concerns about adherence are cited as two of the reasons for low PrEP
uptake in this population.
• Bangkok Tenofovir Study (2013): Daily tenofovir DF found to reduce HIV transmission by 49%
in PWID.
• Subsequent analysis showed at least 74% efficacy when TDF observed to be taken
consistently and detectable in blood, highlighting the importance of adherence.
1. HIV and Injection Drug use. CDC. Last updated April 2021. https://www.cdc.gov/hiv/basics/hiv-transmission/injection-drug-use.html
2. Pleuhs B, Mistler CB, Quinn KG, Dickson-Gomez J, Walsh JL, Petroll AE, John SA. Evidence of Potential Discriminatory HIV Pre-Exposure Prophylaxis (PrEP) Prescribing Practices for People Who Inject Drugs Among a Small Percentage of Providers in the U.S. J Prim Care Community Health. 2022 Jan-
Dec;13:21501319211063999. doi: 10.1177/21501319211063999. PMID: 35068243; PMCID: PMC8796077.
3. Choopanya, K. et al. “Antiretroviral prophylaxis for HIV infection in injecting drug users in Bangkok, Thailand (the Bangkok Tenofovir Study): a randomised, double-blind, placebo-controlled phase 3 trial.” Lancet. 2013; 381: 2083–90
27

• TRUVADA (Emtricitabine / Tenofovir TDF):
- TDF carries some risk for nephrotoxicity, particularly with long-term use
- Generally safe to use as PrEP in individuals without any underlying CKD risk factors
- Not recommended for PrEP if CrCl <60 mL/minute
• DESCOVY (Emtricitabine / Tenofovir AF):
- TAF is present in lower serum levels compared to TDF, resulting in decreased risk of nephrotoxicity
- Can be used for PrEP in individuals with CKD who have CrCl ≥ 30 mL/minute
- DISCOVER trial evaluating efficacy of Descovy as PrEP did NOT include individuals assigned female
at birth (AFAB)
- Not FDA- approved for use as PrEP in AFAB patients engaging in receptive vaginal intercourse
• ***APRETUDE (Cabotegravir LAI)***:
- No dose adjustment needed if CrCl ≥ 15 mL/minute
- Increased monitoring for adverse effects recommended if CrCl 15-30 mL/minute
- Limited data in ESRD/dialysis
PrEP and Chronic Kidney Disease (CKD)
Mayer KH, Molina JM, Thompson MA, Anderson PL, Mounzer KC, De Wet JJ, DeJesus E, Jessen H, Grant RM, Ruane PJ, Wong P, Ebrahimi R, Zhong L, Mathias A, Callebaut C, Collins SE, Das M, McCallister S, Brainard DM, Brinson C, Clarke A, Coll P, Post FA, Hare CB. Emtricitabine and tenofovir alafenamide vs
emtricitabine and tenofovir disoproxil fumarate for HIV pre-exposure prophylaxis (DISCOVER): primary results from a randomised, double-blind, multicentre, active-controlled, phase 3, non-inferiority trial. Lancet. 2020 Jul 25;396(10246):239-254. doi: 10.1016/S0140-6736(20)31065-5. PMID: 32711800; PMCID:
PMC9665936.
28

Case #2 Continued
• Injection schedule:
– 600 mg IM once monthly x two months, then every
other month after that
– May be administered 7 days before or after the due
date.
• Lab monitoring:
– HIV Ag/Ab at baseline
– HIV Ag/Ab + HIV RNA at 1 month, then every 2
months
– Bacterial STI screenings every 4-6 months depending
upon risk
• Additional considerations:
– Cabotegravir “tail” after discontinuation – risk for ART
resistance if HIV infection occurs
– It is not yet known exactly when Apretude reaches
therapeutic levels in anogenital mucosa
29
Sandra decides to start on Apretude (cabotegravir) long-
acting injectable PrEP.
She likes the idea of not having to add another pill to her
med regimen. Additionally, she is already coming into
the clinic regularly for buprenorphine MOUD visits so she
feels she can adhere to the injection schedule.
Sandra elects not to complete a month-long oral lead-in
course and instead decides to start the injection right
away.

Case #3: Jordan
30
Jordan is a 16 year old
white cis-male with no
significant past
medical history.
Over the past year he
has engaged in
receptive oral and anal
sex with multiple male
partners. Additionally,
he has been treated
for syphilis and rectal
chlamydia this year.
At a recent visit at the
school-based health
clinic his nurse
practitioner asks if he
would be interested in
learning more about
PrEP.
Jordan informs his NP
that he heard of
Truvada and would
really like to take it.
However, his parents
don’t approve of his
sexuality. He worries
that he could be kicked
out of the house if
they found out he was
taking it.

• Adolescents and young adults (AYA, 13-24 years old) account for about one fifth of new HIV
infections.
• This age group also has the poorest outcomes in every step of the HIV care continuum (including
awareness of diagnosis, linkage to care, and retention to care) so it is critical to target PrEP outreach
toward AYA.
• In 2018 the FDA extended approval of daily Truvada as PrEP to include adolescents weighing at least
35 kg (77 lb).
• Descovy and Apretude are now also approved for use in adolescents weighing ≥ 35 kg.
• 2017 Adolescent Trials Network (ATN) 113 Study:
– Adherence decreased significantly when follow-up visit frequency declined from Q4wk visits to
Q12wk visits later in trial.
– May consider more frequent follow-up or case management outreach in this age group to help
support adherence
PrEP for Adolescents
1. “Adolescents and Young Adults with HIV.” NIH HIV Clinical Guidelines. Last updated June 2021. https://clinicalinfo.hiv.gov/en/guidelines/hiv-clinical-guidelines-adult-and-adolescent-arv/adolescents-and-young-adults.
2. Hosek, S. et al. “Safety and Feasibility of Antiretroviral Preexposure Prophylaxis for Adolescent Men Who Have Sex With Men Aged 15 to 17 Years in the United States.” JAMA Pediatrics. November 2017. Volume 171, Number 11
31

Parental Consent Laws
• Only a few states have explicit laws allowing
minors access to PrEP without parental
consent. However, in many other jurisdictions
it may be considered part of other STI or HIV
services.
• To prescribe PrEP without the parent or
guardian’s consent in the state of CT, the
provider must document the reasons for the
determination to provide PrEP without
parental consent, signed by the minor, in the
minor’s clinical record.
32 “State Laws that Enable a Minor to Provide Informed Consent to Receive HIV and STD Services.” CDC. 2022. https://www.cdc.gov/hiv/policies/law/states/minors.html.

Considerations for
Preventing Incidental Disclosure
• Verify whether or not a detailed explanation of benefits (EOB) for labs /
rx will be sent to insurance policy holder
• Labs through DPH STI clinic or sliding scale fee schedule
• Medication through 340B, GoodRx or a pharmacy discount program
• Consider stocking generic Truvada at clinic
• List patient’s personal phone number as preferred contact and list PrEP
program office as mailing address
• PrEP access through school-based health centers (SBHCs)
33

Jordan decides to start on daily Truvada for
PrEP.
He is able to get a monthly supply for $17
through 340B and completes routine lab
work through DPH STI clinic.
He keeps it in his locker at school and sets an
alarm to take it at lunchtime each day.
Jordan checks in with SBHC nurse
practitioner on a monthly basis.
Case #3: Continued
At these visits the NP:
• Assesses adherence
• Counsels on use of barrier method and
potential nPEP need if there is a
treatment interruption
• Orders syphilis and three-site
gonorrhea/chlamydia screenings every
three months (or more often if
concern for potential exposure)
34

Case #4: Elena
35
27 y/o trans woman who
has sex with men.
Originally from Ecuador.
Uninsured and
undocumented. Accesses
primary care at an FQHC
on an affordable sliding
scale fee schedule.
In a monogamous long-
term relationship with a
cis-male partner who has
HIV and does not
consistently take his ART
medication. Desires to
start on PrEP.
Elena has no underlying
health conditions but
worries about Truvada
because “I hear it is safer
for your bones and
kidneys.”

Case #4: Poll Question #1
What are Elena’s options for PrEP?
a. Daily Truvada
b. On-Demand Truvada (2-1-1)
c. Daily Descovy
d. Injectable Apretude
e. All of the above
f. All of the above except On-Demand Truvada
36

Ready, Set, PrEP
• Federal program that provides free Truvada and Descovy to people living with the US who have
a prescription from a healthcare provider.
• No income cap.
• Social security number not required on application.
• Application can be faxed or completed online. Once accepted member receives member ID, BIN
and Group Number that needs to be provided to pharmacy.
PARTICIPATING PHARMACIES
37

Drug Manufacturers
Patient Assistance Programs
• Truvada and Descovy
• Copay Coupon Card for commercially insured
patients with high copay
• Patient Support Program for patients without
prescription drug coverage
• Apretude
• Savings Program for commercially insured
patients
• up to $7,500 in assistance with out-of-
pocket costs per year
• Patient Assistance Program (PAP)
• Free medication for patients with very
limited (or no) prescription drug coverage
• Household income ≤ 500% federal poverty
level
https://www.gileadadvancingaccess.com/
38

Discounted Generic
Emtricitabine/Tenofovir DF
• 30-day supply for less than $30 per month
• A good option for patients who want to pick up the rx immediately and
do not mind paying out-of-pocket
• Options:
 340B – at eligible clinics serving low-income communities
 Pharmacy discount programs
 GoodRx https://www.goodrx.com/truvada
39

Elena opts to get Descovy through Gilead
Advancing Access.
She continues to take it daily over the course
of two years.
Over time Elena’s partner becomes engaged
in care and very adherent to ART. Once his
HIV viral load has been persistently
suppressed over the course of six months
she decides to discontinue PrEP.
Case #4: Continued
Monitoring:
– Every 3 months:
• Follow-up visit to assess adherence and provide
safe sex counseling
• Labs: HIV Ag/Ab, HIV RNA, 3-site GC/CT, syphilis
– Every 12 months:
• Check renal function (Q 6 mos. if ≥50 years or
who have an eCrCl <90 ml/min at PrEP initiation)
• Check lipid panel
• Assess for weight gain
40 Kasadha, B. “What does undetectable = untransmittable (U=U) mean?” NAM AidsMap. July 2019. https://www.aidsmap.com/about-hiv/faq/what-does-undetectable-untransmittable-uu-mean.

Summary Slide
• Consider nPEP for those with recent exposure prior to prescribing PrEP.
• Tailoring PrEP regimen to patient eligibility and preference.
• Target PrEP outreach to populations with disproportionately low uptake
of PrEP (cis-women, PWID, Black and Hispanic MSM, transgender
women).
• Familiarize yourself with available resources to extend access to PrEP
(e.g. medications, labs, visits).
• Scaling up PrEP access and treatment nationwide is integral to ending
the HIV epidemic.
41

• Free 6-month learning experience from January to June 2023 designed to
provide strategies for implementation of best practices to provide evidence-
based, compassionate and respectful HIV prevention, including:
– Education on a population-based approach to HIV prevention
– Protocols, tools, and workflows for HIV prevention (e.g. sexual risk
assessment, SOGI collection, HIV testing, STI treatment)
– Support and guidance in developing PrEP programs at various stages of
implementation (e.g. regimens and eligibility, context in which PrEP is
being provided, what to include in outreach events, etc.)
• This opportunity is only available to health centers beginning to implement
their HIV Prevention program or looking to make significant improvements
• For more information, please reach out to Meaghan Angers
(angersm@chc1.com) or visit https://regpack.com/reg/nttap
42
HIV Prevention Learning Collaborative

Questions?
43

Contact Information
44
For information on future webinars, activity
sessions, and learning collaboratives:
please reach out to nca@chc1.com or visit
https://www.chc1.com/nca