Contemporary HIV Treatment and Prevention 2022:

Barriers and Solutions to Expanding PrEP Uptake

This program is supported by ViiV Healthcare.

Program Overview
 Introduction
 Case-Based Discussion
‒ Inequities in PrEP Uptake in Key Populations: Adolescents,
Black and Hispanic/Latinx People, Cisgender Women,
Transgender Women, and PWID
 Solutions for Expanding PrEP Use
 Question and Answer Session
Introduction
 PrEP Guidance: CDC
“All sexually active adults and adolescents should be informed
about PrEP for prevention of HIV acquisition”
Anal or vaginal
sex in past
Sex with men, 6 mo?
women, or both?
Yes No

1 or more sex Had bacterial

HIV+ partner? partners of STI in past
unknown HIV status 6 mo?

Yes No Yes No Yes No

Unknown or MSM: GC, MSW and

Always use
detectable chlamydia, or WSM: GC or
condoms?
HIV-1 RNA? syphilis syphilis
Yes No No Yes Yes No Yes No

Discuss PrEP Discuss PrEP Discuss PrEP Discuss PrEP

Prescribe Prescribe Prescribe Prescribe
Prescribe if Prescribe if Prescribe if Prescribe if
PrEP PrEP PrEP PrEP
requested requested requested requested

CDC. PrEP Guidelines. 2021. Slide credit: clinicaloptions.com

 Preventing HIV Transmission:
The PrEP Gap in the United States
People With An Indication for PrEP (2019)1  ~1.2 million Americans are likely to
benefit from PrEP2
‒ 1 in 4 MSM3: 492,000
~23% ‒ 1 in 5 PWID3: 115,000
On PrEP
‒ 1 in 200 heterosexual adults3: 624,000

Gaps Between PrEP

~77% Awareness, Willingness, and Use4
Without PrEP
American Men’s Internet Survey 2017
(n = 4475 MSM PrEP eligible)
60% 20%
81%
Willing Used
Aware
to use PrEP
1. cdc.gov/hiv/pdf/library/reports/surveillance/cdc-hiv-surveillance-report-vol-26-no-2.pdf.
2. Harris. Morb Mortal Wkly Rep. 2019;68:1117. 3. MMWR Morb Mortal Wkly Rep. 2015;64:1291.
4. Sullivan. J Int AIDS Society. 2020;23:e25461. Slide credit: clinicaloptions.com
 CDC: PrEP Prescribers in the United States (2014-2019)
 Increases in those who prescribed PrEP 10 PrEP Provider Capacity by Region, 2019
from 2014-2019: 8.5

Estimated 100 Persons

8

With PrEP Indication

No. of Prescribers/
‒ All US providers: 0.7% to 4.3% 6
6.2
5.7
4.4
‒ Primary care physicians: 1.8% to 13.6% 4

‒ ID physicians: 14.2% to 34.2% 2

 Number of PrEP providers increased 0

West Northeast Midwest South
from 9621 in 2014 to 65,822 in 2019
 In 2019, the South accounted for:
‒ 2019: Physicians 68%, NPs 21%,
PAs 9% ‒ 52% of new HIV infections

‒ 93% are in urban areas ‒ Largest proportion of people with PrEP

indications (41%)

Zhu. J Acquir Immune Defic Syndr. 2021;88:282. Slide credit: clinicaloptions.com

PrEP Uptake in Adolescents
 PrEP is Underused in Adolescents and Young Adults
 In 2019, people aged 24 yr or HIV Diagnoses Among Adolescents
younger accounted for1: 13-19 Yr of Age, 20192
By Exposure Category By Race/Ethnicity
‒ 14% of PrEP users
‒ 21% of new HIV diagnoses
 Of 7648 new HIV diagnoses
among adults and adolescents
in the US in 20192:
‒ 22% occurred among
adolescents aged 13-19 yr
MSM PWID Black Hispanic/Latinx
Heterosexual Perinatal
‒ 85% occurred in males, White Multiple
Other
12% in cisgender women
1. aidsvu.org/resources/deeper-look-prep/. 2. CDC. HIV Surveillance Report, 2019. Slide credit: clinicaloptions.com
 Provider Barriers to Provision of PrEP for Adolescents
 Providers not aware of PrEP or of  Consent laws vary across states
indication for youth
‒ All 50 states and District of
 Discomfort performing sexual Columbia allow minors to
history consent to STI services
 Discomfort prescribing HIV ‒ 18 states allow providers to
medication inform parents that a minor
is receiving STI services
 Concerns that patients receiving
PrEP may engage in riskier ‒ Parental insurance coverage
behaviors may not guarantee
confidentiality for minors
Yusuf. JAMA Pediatr. 2020;174:1102. guttmacher.org/state-policy/explore/minors-access-sti-services Slide credit: clinicaloptions.com
 Systematic Review and Meta-Analysis:
Adherence to PrEP in Adolescents and Young Adults
 Studies published through May 2020 (29 studies; N = 8679 participants)
‒ Included studies reporting proportion of PrEP-adherent participants
‒ Weighted average age: 24 yr
 Overall adherence: 64% (95% CI: 57%-71%) across studies
 Adherence lower in young cisgender women (46%) vs young MSM (65%)
and vs serodiscordant heterosexual couples (98%)
 No differences observed by age, country, or strategies to promote
adherence

Allison. J Adolesc Health. 2022;70:28. Slide credit: clinicaloptions.com

 Barriers to Adherence in Adolescents and Young Adults
 Young people report lower levels of medication adherence1
 Barriers to adherence2,3
‒ Adverse events
‒ Dissatisfaction with medical team
‒ Forgetting, inconvenience
‒ Depression
‒ Social stigma
‒ Lack of support
‒ Substance use
1. Velloza. AIDS. 2021;35:463. 2. Hightow-Weidman. JMIR Res Protoc. 2018;7:e10365.
3. Okafor.  Acquir Immune Defic Syndr. 2020;85:23. Slide credit: clinicaloptions.com
 Interventions to Support
PrEP Adherence in Adolescents
 Systematic review of interventions for  Multiple technology approaches to
adolescents found that the following increase PrEP uptake and adherence
improve medication adherence1: among adolescents are under
evaluation, including the use of2:
‒ Enhanced and peer-based counseling
‒ Mobile apps
‒ Computer- and phone-based counseling
‒ Text messages ‒ Electronic PrEP care systems

‒ Adolescent-friendly clinics ‒ Social networking

‒ Same-day pill starts ‒ Gamification

‒ Extended pill supply
‒ Provision of medication outside of
medical settings
1. Velloza. AIDS. 2021;35:463. 2. Hightow-Weidman. JMIR Res Protoc. 2018;7:e10365. Slide credit: clinicaloptions.com
PrEP Inequities By Race
 Low PrEP Uptake in Black and Hispanic People
Compared With White People
 Black and Hispanic people accounted for 70% of new HIV diagnoses but only 18% of people
prescribed PrEP in the US in 2019

Prescribed PrEP (n) New HIV Diagnoses (n)

11,698 731

37,703
42,999
Black
White 9,574
15,409
Hispanic
Asian

186,318
9,055

cdc.gov/hiv/library/reports/surveillance-data-tables/vol-1-no-7/index.html Slide credit: clinicaloptions.com

 Structural Barriers to PrEP Adoption
 Growth of PrEP uptake is slower
among racial and ethnic minority
communities
‒ Attributed to homophobia and
racism in healthcare and to
wider racism and socioeconomic
inequality
Jaiswal. AIDS Behav. 2021;25:3057.
 Physical barriers: eg, proximity,
transportation
 Social determinants: (mis)trust
between patients and providers
affecting communication and
decision-making
Slide credit: clinicaloptions.com
 Kaiser Permanente (2012-2019):
PrEP Continuum of Care and New HIV Infections
 Cohort study (n = 13,906 linked to PrEP care) Black vs White were significantly:

Less likely to be
‒ Male (95%), White/Hispanic/Asian/Black 16 prescribed PrEP
(49%/22%/15%/7%) (HR: 0.74)
14 Less likely to
13,906
 Discontinued PrEP at least once: 52%, of start PrEP

Number (in thousands)

12
whom 60% restarted (HR: 0.87)
12,251
10 More likely to
 HIV incidence rates per 100 patient-yr: 12,030 discontinue PrEP
8 (HR: 1.36)
‒ Linked but not prescribed PrEP (0.87) 5750
6
‒ Discontinued without restarting (1.28)
4
‒ Started and persisted with PrEP (0)
2

0
Linked to PrEP PrEP PrEP
PrEP Care Prescription Initiation Persistence

Hojilla. JAMA Netw Open. 2021;4:e2122692. Slide credit: clinicaloptions.com

 Ele[MEN]t Study: PrEP Persistence and
Discontinuation in Young Black MSM
 Prospective, observational cohort study to
evaluate PrEP use in metro Atlanta (n = 298) PrEP Persistence
1
‒ Black MSM without HIV (aged 16-29 yr)
with ≥1 sexual partner in past 3 mo

Proportion Without Discontinuation

0.8 Final PrEP
 HIV incidence in those who started vs discontinuation
never started PrEP: 3.15 vs 8.09 per 100 PY 0.6
(IRR 0.39; P = .03)
 Persistent PrEP coverage was suboptimal 0.4

‒ First and final PrEP discontinuation: 69% and 40% First PrEP
0.2 discontinuation
‒ Factors associated with discontinuation included
younger age, cannabis use, STI, and fewer sex
partners 0
0 90 180 270 360 450 540 630 720
‒ At final visit, 31% reported currently taking PrEP Days After PrEP Initiation

Serota. Clin Infect Dis. 2020;71:574. Slide credit: clinicaloptions.com

 Creating Change: Education of Patients and Providers
Is Key Addressing Inequities in PrEP Uptake
Community-based education to raise awareness, combat implicit and
✓ unconscious bias, and instill trust in the healthcare system

More Black healthcare professionals as trusted community sources of

✓ knowledge

✓ Address unfounded beliefs about risk compensation that feeds

reluctance to PrEP

Positive messaging to patients via social networks and social media to

✓ improve knowledge and attitudes and reduce stigma

Support prevention messages for HIV and STIs through monitoring and
✓ testing
Mayer. Adv Ther. 2020;37:1778. Slide credit: clinicaloptions.com
PrEP Uptake in Cisgender Women
 Prevalence of PrEP Use in Cisgender Women in the US
 Daily FTC/TDF and LA CAB are very effective in preventing HIV transmission in
women when adherence is high
 Pharmacy/claims data suggest  CDC data show that, of women
PrEP uptake among women has But... who could benefit from PrEP, only
steadily increased since 2012 10% were prescribed PrEP in 20191
PrEP Use Rates in Women, 2012-2017
By Age By Region
250
18-24 180
West
PrEP Use Per 100,000

200 25-34 160

140 Midwest
35-44
150 120 Northeast
45-54
100 South
100
55+
80
60
50 40
20
0
2012 2013 2014 2015 2016 2017 0
2012 2013 2014 2015 2016 2017

1. www.cdc.gov/hiv/group/gender/women/prep-coverage.html. 2. Guest. IAC 2020. Abstr OAC0804. Slide credit: clinicaloptions.com

 Barriers to PrEP Uptake in Cisgender Women
 Low awareness/lack of information
 Low perceived risk for HIV
 Competing priorities
 Need for daily adherence if taking oral PrEP
 Perceived complexity of PrEP monitoring and follow-up
 Preference for barrier protection against STIs and unwanted pregnancy
 Concerns about adverse events, drug interactions, disclosure and stigma,
financial challenges, potential increase in risk behavior
 Distrust of the medical system
Baldwin. Arch Sex Behav. 2021;50:1713. Goparaju. J AIDS Clin Res. 2015;6:1.
Hirschhorn. J Acquir Immune Defic Syndr. 2020;84:497. Pasipanodya. BMC Womens Health. 2021;21:220. Slide credit: clinicaloptions.com
 Implementation of PrEP Within
Family Planning Clinics in Atlanta
 Implementation study to improve HIV risk assessment and PrEP counseling in
4 safety net FP clinics in Atlanta, Georgia
 Providers and staff underwent PrEP education and training
 500 women underwent exit interviews following a FP clinic visit
‒ 19% had heard of PrEP prior to the visit
‒ 55% reported the provider discussed how to prevent HIV
‒ Of those, 74% reported the provider discussed PrEP

‒ 29% determined to be at risk for HIV by provider

‒ Of those, 66% said their provider discussed PrEP, 29% interested in PrEP, 18% received
referral for off-site PrEP, 76% would have been willing to take PrEP if offered by that clinic
Sales. J Acquir Immune Defic Syndr. 2019;81:414. Slide credit: clinicaloptions.com
 PrEP in Pregnancy and Breastfeeding
 Pregnancy associated with increased  FTC/TDF widely used in persons with
risk of HIV acquisition1 HIV, including pregnant women3-6
 However, concerns about the safety of ‒ No link to teratogenicity in Antiretroviral
PrEP in pregnancy and effects on Pregnancy Registry7
fertility have been noted as barriers to ‒ Data from lactation studies in women
PrEP uptake among cisgender women2 with HIV suggest limited drug exposure3-6

 TDF-based PrEP not associated with

differences in pregnancy or perinatal
outcomes in 5 completed studies1
 FTC/TDF daily recommended for
PrEP in pregnancy and
1. Davey. J Int AIDS Soc. 2020;23:e25426. 2. Pasipanodya. BMC Womens Health. 2021;21:220.
breastfeeding 3,8

3. CDC. PrEP Guidelines. 2021. 4. Stalter. Expert Opin Drug Saf. 2021;20:1367. 5. Silberry. AIDS. 2012;26:1151.
6. Gibb. PLoS Med. 2012;9:e1001217. 7. Antiretroviral Pregnancy Registry. 2021. 8. DHHS. Perinatal Guidelines. Slide credit: clinicaloptions.com
PrEP Uptake in Transgender Women
 Barriers to PrEP Uptake in Transgender Women
 TGW are disproportionately Barriers to PrEP Uptake in Transgender Women3
affected by HIV1 Individual Factors Interpersonal and Structural Factors
Community Factors
‒ Estimated HIV prevalence 14%
 Cost concerns  Romantic partner  Employment
in TGW and 44% in Black TGW  Mental health influence  Transportation
concerns  Patient–provider  Housing
 Uptake of PrEP in Black and Latinx  Substance use communication security
 PrEP adverse  Stigma
transgender women is reported to events  Negative
be as low as 17% of those who  FHT community
would benefit2 interaction opinions
 Negative
experiences in
healthcare settings

1. Becasen. Am J Public Health. 2019;109:e1. 2. Poteat. J Acquir Immune Defic Syndr. 2019;82:131.
3. Ogunbayo. AIDS Behav. 2021;25:2301. Slide credit: clinicaloptions.com
 High PrEP Adherence Among TGW and Transfeminine
Individuals in a Real-World Healthcare Setting in NYC
 Observational study of 100 TGW/TFI persons T2 T3
receiving PrEP at a community-based health Urine TFV
center Concentration in
PrEP Patients* N % N %
 Adherence assessed at 3 visits using
self-report surveys, patient interviews, and Total sample 64 -- 55 --
TFV urine assay  TFV detected 55 86 42 76
 TFV >1000 ng/mL 50 78 40 73
 >80% reported ≥90% adherence at each visit  TFV not detected 9 14 13 24
 High concordance between self-reported Patient interview:
adherence and urine assay self-reported last pill† 
 Took pill within 59 -- 49 --
‒ Providers can trust patient self-reports past 48 hr
 TFV detected 54 92 40 82
 Need for strategies that support sustained  TFV >1000 ng/mL 49 83 39 80
PrEP use and better understanding of drivers  TFV
*Patients
not detected 5 8 9 18
included if they had a valid urine sample and self-reported recent PrEP
of PrEP discontinuation use at their study visit, defined as last pill within 7 days of sample collection.
†
Derived from self-reported last pill data on data of sample collection.

Starbuck. J Acquir Immune Defic Syndr. 2022;9:15.  Slide credit: clinicaloptions.com

PrEP Uptake in PWID
 PrEP Uptake and Recommendations in PWID
 1 in 10 HIV diagnoses are in PWID1 Assessing Indications for PrEP in PWID3
Ever
 In 1 survey study of PWID in SSPs in injected
drugs?
Baltimore, 25% had heard of PrEP and
63% were interested, but <1% were Yes No

taking PrEP2 Injected Prescribe if

past 6 mo? requested
 2021 CDC Guidelines recommend
Yes No
PrEP for PWID in combination with
substance use disorder treatment or Shared injection
syringe services programs3 equipment?

‒ Sexual risk for HIV should also be Yes No

assessed in all PWID Prescribe Prescribe if Prescribe if

PrEP requested requested

1. cdc.gov/vitalsigns/hiv-drug-use/index.html. 2. Sherman. Drug Alcohol Depend. 2019;195:148.

3. cdc.gov/hiv/pdf/risk/prep/cdc-hiv-prep-guidelines-2021.pdf Slide credit: clinicaloptions.com
 Project SHE: Integrating PrEP With Community-Based
Syringe Services for Women Who Inject Drugs
 PrEP demonstration project integrated within SSP in Philadelphia, Pennsylvania
 WWID ≥18 yr of age offered education and 24 wk of daily oral PrEP
‒ N = 136 recruited; n = 95 included in final sample; n = 63 accepted PrEP prescription at Wk 1
‒ Uptake associated with greater SSP use, inconsistent condom use, experience of sexual assault

 42 of 95 (44.2%) women retained at Wk 24

‒ Higher retention with more frequent SSP use at BL

 Adherence high by self-report but discordant with urine testing of TFV

 2 HIV seroconversions occurred during follow-up and 1 pregnancy
 High PrEP acceptability/satisfaction reported with good tolerability

Roth. J Acquir Immune Defic Syndr. 2021;86:e61. Slide credit: clinicaloptions.com

Solutions for Expanding PrEP Use
 Key Barriers to PrEP Uptake and Potential
Approaches to Removing Barriers to PrEP
Key Barriers to PrEP Uptake Potential Approaches to Removing Barriers
Awareness of PrEP  Patient and provider education
 Better communication between providers
HIV risk perception  Patient and provider education
Stigma  Improved cultural humility (via education and advocacy)
 Improved communication and understanding between patient and provider
Provider bias and distrust of  Patient and provider education
healthcare system  Addressing systemic entrenched bias (via education, advocacy, and recruitment of more
Black, Latinx, and LGBTQ healthcare professionals)

Access to medical care  Patient and provider education

 Extending access to PrEP (eg, substance use clinics, ER, pharmacies, corrections)
 Leveraging technology to improve access (eg, telemedicine)
 Addressing competing priorities (eg, food, shelter, safety, other healthcare, childcare)

Lack of access to  Help for patients navigating financial aid options

financial assistance
Adverse events  Patient and provider education

Mayer. Adv Ther. 2020;37:1778. Slide credit: clinicaloptions.com

 Potential Provider Barriers to Prescribing PrEP
 Uncomfortable discussing sexual behavior and HIV risk
 Concerns about real-world effectiveness
 Anticipated unintended consequences (eg, resistance, safety, behavioral disinhibition, STIs)
 Ambiguity about who should prescribe it
‒ Some PCPs are unfamiliar with prescribing ART and PrEP
‒ Some HIV specialists have few high-risk HIV-uninfected patients

 Logistical concerns
‒ Time constraints (eg, risk behavior assessment)
‒ Insurance coverage and out-of-pocket costs
‒ Identifying a Clinic Champion
Powell. Curr Infect Dis Rep. 2019;21:28. Yusuf. AMA Pediatr. 2020;174:1102. Rosengren. AIDS Behav. 2021;25:2054. Slide credit: clinicaloptions.com
 Addressing the Gap in PrEP Provider Training
 Secondary analysis of survey to providers in
18 southern US states and District of Columbia
‒ Included 351 providers from 224 clinics
 Comfort with PrEP screening > follow-up > initiation
Generalized Linear Mixed Model of Self-Efficacy in PrEP
All Providers Prescribers
Knowledge About PrEP
 Positively associated with PrEP self-efficacy
‒ Knowledge about PrEP (prescribers),
attitudes toward PrEP (nonprescribers),
self-efficacy in FP, on-site primary care,
Medicaid expansion
Nonprescribers
 Model suggests 3 ways to customize provider
training to increase self-efficacy

Attitudes Toward PrEP

‒ Anchor in FP training, train on insurance
navigation, address attitudes/concerns
Variable

Self-Efficacy in Family Planning

 Target clinics for training without on-site
Able to Prescribe Medication
insurance support or Medicaid expansion

On-site Insurance Assistance

- 0. 0. 0. - 0. 0. 0. - 0. 0. 0.
0.2 0 2 4 0.2 0 2 4 0.2 0 2 4
Ramakrishnan. IDWeek 2021. Slide credit: clinicaloptions.com
 Expanding PrEP Options to Facilitate Adherence and
Persistence: Today and in the Near Future
Present Emerging Future
Once-Daily* Oral Tablets Long-Acting Options

LA CAB

FTC/TDF

FTC/TAF

*Off-label on-demand use of FTC/TDF supported by international guidelines.

hiv.gov/hiv-basics/hiv-prevention/potential-future-options/long-acting-prep Slide credit: clinicaloptions.com
 Immediate PrEP Initiation at NYC Sexual Health Clinics
 Medical record–based cohort study of PrEP candidates >18 yr of age
(n = 1437 cisgender men and women) in NYC sexual health clinics from 2017-20181
‒ Eligible for immediate PrEP if they had a negative rapid HIV test and no reported
kidney disease, HBV infection, or symptoms of acute HIV (BL sample drawn)
 97% of candidates qualified for immediate PrEP
‒ <1% stopped for eGFR <60 mL/min or a positive HIV NAAT result
 Only 3% of candidates had delayed PrEP; of those, only 35% started PrEP
 2021 CDC PrEP Guidelines outline procedures for providing PrEP on the same day
as initial evaluation for select patients2

1. Mikati. CROI 2019. Abstr 962. 2. cdc.gov/hiv/pdf/risk/prep/cdc-hiv-prep-guidelines-2021.pdf Slide credit: clinicaloptions.com

 Providing PrEP by Telehealth
 Progressive decline in PrEP initiation  PrEP screening, initiation, or
observed from Feb 2020 to April 2020 follow-up visits can be conducted by
at start of the COVID-19 pandemic1 phone or web-based consult with
HCPs2
First-Time PrEP Initiators
18,000 ‒ Obtain specimens for HIV, STI,
FTC/TDF
16,000
FTC/TAF
or other PrEP-related laboratory
No. of New Users Per Mo

14,000 Total tests by:

12,000
10,000 ‒ Laboratory visits for specimen
8,000 collection only
6,000
4,000
‒ Order home specimen collection kits
2,000
for specified tests
0
12/19 2/20 4/20 6/20 8/20 10/20 12/20

1. Tao. J Int AIDS Soc. 2021;24:35. Abstract OAC0203. 2. cdc.gov/hiv/pdf/risk/prep/cdc-hiv-prep-guidelines-2021.pdf Slide credit: clinicaloptions.com