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Integrating HIV Prevention
into Primary Care
April 14, 2022
1:00-2:00pm Eastern/ 10:00-11:00am Pacific
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.
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
Objectives
• Review HIV epidemiology
• Understand Sex Positive, Status Neutral approach
• Discuss HIV Prevention Strategies and HIV Testing
• Review HIV transmission
• Discuss PrEP (pre-exposure prophylaxis) and Treatment as
Prevention
• Describe PrEP implementation strategies
6
HIV Epidemiology
• About 1.19 million people with HIV are living in the U.S. as of 2019.
• 1 in 8 (about 13 %) unaware of their infection.
• In 2019, 36,801 new infections occurred.
• Number of new HIV infections decreased overall about 9% from 2015 to 2019.
7
HIV Incidence
CDC.GOV
8
CDC.GOV
9
CDC.GOV
10
CDC.GOV
11
CDC.GOV
12
CDC.GOV
13
CDC.GOV
14
Preventing HIV Transmission:
The PrEP Gap in the United States
15
• 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]
People With an Indication for PrEP (2018)[1]
≈18% on
PrEP*
≈82%
Without PrEP
Gap Between PrEP
Awareness, Willingness, and Use[3]
American Men’s Internet Survey
(n = 4475 PrEP eligible MSM; 2017)
81%
Aware
60%
Willing
to Use
20%
Used
PrEP
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.
Slide credit: clinicaloptions.com
*PrEP coverage in 2016 and 2017 was 9% and 13%, respectively.
New PrEP Starts
in the United States (2014-2017):
Prescription Database
16
• 14% of persons with indications for PrEP started PrEP (158,183/1,144,550)
• Blacks and Hispanics account for 69% of new HIV infections, but their use of PrEP was relatively low
during this period
Black
White
Hispanic/Latinx
Asian, Other, Uncoded
New PrEP Starts (2014-2017) New HIV Infections (2017)
Nguyen. IAS 2019. Abstr TUPEC405. Slide credit: clinicaloptions.com
16
HIV Prevention Strategies
• Risk reduction counseling
• Sexual health counseling
• Condoms and lubricant
• Sterile syringes and “works”
• STI testing and treatment
• PEP (post-exposure prophylaxis)
• HIV testing
• PrEP (pre-exposure prophylaxis)
• Treatment as Prevention (U=U)
17
Sex Positive, Status Neutral Approach
18
Sex Positive, Status Neutral Goals
• Determine who needs STI and HIV testing.
• Identify those who test negative and are at risk for HIV and refer to
PrEP.
• Identify who is living with HIV and link them to care.
19
Population-Based Approach
• Actively reaches people who may benefit from the health service or
intervention.
• Increases access to the service or intervention to more people.
• Can lead to addressing health inequities.
20
Population-Based Approach (cont.)
• Using sexual orientation and gender
identity (SOGI) information, sexual risk
assessments, positive STI results,
substance use screening to reach out to
potential at-risk individuals.
• Targeting messaging to at-risk
populations.
• Making access to services readily
available where people are at.
21
21
Sex Positive, Status Neutral Goals
• Be comfortable talking about sex.
• Check any judgment at the door.
• Make no assumptions.
• Create welcoming environment.
22
• Promote healthy sex lives.
• Invite open and comfortable dialogue about sex.
• No matter who you are, who or how many
you have sex with, and what kind of sex you
like.
• Straight, bi, gay, pansexual; cis, trans, or non-
binary gender; living with or without HIV.
• Empower with knowledge and choice.
• Protect through prevention, screening, and
treatment.
Sexual Risk Assessment
Sex Positive, Status Neutral Goals
23
Risk Reduction Counseling
• Sexual Transmission
• Barrier methods (e.g. condom use)
• Sexual partners
• PEP
• PrEP
• Treatment as Prevention
• Drug Use
• Clean needles/works
• Syringe services programs
• Medications for substance use disorders
• PEP
• PrEP
24
HIV Tests
• Routine HIV Test
• 4th generation Ab/Ag testing
• Blood test (results in 1-2 weeks)
• Sensitivity >99.7%, Specificity 100%
• Rapid Tests
• Alere Determine™ HIV1/2 (4th generation)
• Blood test (results in 15 minutes)
• Sensitivity 100%, specificity 99.8%
• Positive results require confirmation
• Picks up infections earlier (by 1-2 weeks)
25
27
HIV Testing
• CDC and USPSTF recommend routine HIV testing for 13 (15)-64 year olds.
– Recommendation for those at higher risk testing at least once a year.
• Routine, opt-out, voluntary testing
• Part of consent to routine medical care
• Opportunity to ask questions
• Option to decline
• Separate written/oral consent not required
• Prevention counseling not required in conjunction with testing.
• Status Neutral Approach
– People with HIV who are aware of status can get HIV treatment
• Promote individual health
• Prevent transmission
– People who don’t have HIV and are at-risk can make decisions about their health, including
PrEP.
28
Who Should We Be Testing?
• All patients 13-64 years of age, at least once
– USPSTF recommends starting at age 15
• Any patient suspected of acute HIV infection
• Patients seeking STD treatment and attending STD clinics
• Pregnant women
• Patients with TB
• Patients with HBV/HCV
29 CDC MMWR Sept 26, 2006
Who Should We Be Testing? (cont.)
• Patients starting new sexual relationships
• Occupationally exposed individuals
• Patients with ongoing risk, at least annually
• People who inject drugs and their sex partners
• Persons who exchange sex for money or drugs
• Sex partners of persons with HIV
• MSM or heterosexual persons who themselves or their partners
have had more than one sexual partner since their last HIV test
29 CDC MMWR Sept 26, 2006
Planned Care Dashboard and Clinical Expectation:
Universal HIV Screening
30
Bodily Fluids
and HIV Transmission Risk
Infectious* Potentially Infectious Not Infectious!
Blood Cerebrospinal fluid Feces
Tissue Synovial fluid Nasal secretions
Semen Pleural fluid Saliva
Vaginal Secretions Peritoneal fluid Sputum
Breast Milk Pericardial fluid Sweat
Amniotic fluid Tears
Urine
Vomitus
! Unless visibly bloody
*Increased risk with visible blood on device; needle directly from
vein/artery; hollow-bore needle; deep injury; source patient with terminal
illness; high viral load.
• Comes into contact with:
• mucous membranes
• damaged tissue
• Typically through:
• Vaginal/anal sex
• Needles
• Occupational exposure
• Injection drug use
• Mother to child
• Pregnancy and delivery
• Breastfeeding
31
32
Mucous Membrane (occupational):
9 per 10,000 Exposures
Condom Use Protection
• HIV: 100% use with usual rates of breakage and slippage
protects 80 to 85% (uncertainty range: 76 to 93%)
• Estimates mainly based on heterosexual couples.
• Very few studies in MSM or with anal sex– showed similar
rates.
• Gonorrhea: similar degree of protection.
• Syphilis: protection in the range of about 50 to 66%..
• Chlamydia/Trichomonis: rates vary from 85 to 26%.
• HSV-2: estimates vary++. 75% use decreases risk by 50%.
• HPV: consistent use protects women about 73% from men.
33
33
Pre-Exposure Prophylaxis (PrEP)
An individual without HIV takes antiretroviral
medication(s) before potential HIV exposure.
34
FDA-Recommended PrEP Regimens
• Fixed-dose TDF/FTC (Truvada) for MSM, transgender women, heterosexually active
men and women, and IDU who meet PrEP prescribing criteria.
• Fixed-dose TAF/FTC (Descovy) for MSM and transgender women.
• Both dosed as a single pill once daily
• Injectable cabotegravir (Apretude) for adults and adolescents at least 35 kg.
• Monthly injection for 2 months then every other month.
35
PrEP Works in MSM, Heterosexual Men and Women,
and People Who Inject Drugs but Adherence Is Critical
Study Efficacy Overall,
%
Blood Samples With TFV
Detected, %
Efficacy By Blood
Detection of TFV, %
iPrEx[1] 44 51 92
iPrEx OLE[2] 49 71 NR
Partners
PrEP[3]
67 (TDF)
75 (TDF/FTC)
81
86 (TDF)
90 (TDF/FTC)
TDF2[4] 62 80 85
Thai IDU[5] 49 67 74
Fem-PrEP[6] No efficacy < 30 NR
VOICE[7] No efficacy < 30 NR
1. Grant RM, et al. N Engl J Med. 2010;363:2587-2599. 2. Grant RM, et al. Lancet Infect Dis. 2014; 14:820-829. 3. Baeten JM, et al. N Engl J Med. 2012;367:399-410. 4. Thigpen MC,
et al. N Engl J Med. 2012;367:423-434. 5. Choopanya K, et al. Lancet. 2013;381:2083-2090. 6. Van Damme L, et al. N Engl J Med. 2012;367:411-422. 7. Marrazzo J, et al. CROI 2013.
Abstract 26LB.
36
Oral PrEP Reduces Incidence of HIV in
MSM, Even With Incomplete Adherence
• iPreX OLE: open-label extension of iPrEX trial
of daily TDF/FTC oral PrEP in MSM and
transgender women (N = 1603)
• 100% adherence was not required to attain
full benefit
from PrEP
• Benefit of 4-6 tablets/wk similar to 7
tablets/wk
• 2-3 tablets/wk also associated with
significant risk reduction
• Higher levels of sexual risk taking at baseline
were associated with greater adherence to
PrEP
1. Grant R, et al. IAC 2014. Abstract TUAC0105LB. 2. Grant R, et al. Lancet Infect Dis. 2014;14:820-829.
HIV Incidence and Drug Concentrations
5
4
3
2
1
0
1500
1250
1000
700
500
350
LLOQ
0
Off PrEP
On PrEP
TFV-DP in fmol/punch
7
Tablets/
Wk
4-6 Tablets/Wk
< 2
Tablets/
Wk
2-3
Tablets/
Wk
HIV
Incidence
per
100
Person-Yrs
Follow-up
Risk Reduction
95% Cl
26%
44%
-31 to 77%
12%
84%
21 to 99%
21%
100%
12%
100%
86 to 100% (combined)
37
2-1-1 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
• ANRS Ipergay, ANRS Prevenir, AMPrEP
• Not FDA approved
38
38
39
• Discuss HIV PrEP with
every sexually active
adolescent and adult.
• Identify those who are at
risk for HIV and offer
PrEP.
• Prescribe PrEP if eligible
or if requested.
40
41
42
PrEP Monitoring
• Monitoring (F/TDF, F/TAF)
• HIV test every 3 months
• STI screening every 3 months for MSM/transwomen and every 6
months for all others
• Renal function every 6 months for 50+ and GFR<90, once a year for
all others.
• If on F/TAF, lipids once a year
• Monitoring (Cabotegravir)
• HIV test every 2 months
• STI screening every 4 months for MSM/transwomen and every 6
months for all others
43
What is Treatment As Prevention?
44
https://www.cdc.gov/hiv/risk/art/index.html
44
Prevention Access Campaign: 2016
https://www.preventionaccess.org/
45
https://www.cdc.gov/hiv/risk/art/index.html
Risk by Transmission Category
46
Scientific Evidence
47
When does TasP become effective?
48
Implementation
• Identification
• Individual panel management
• Provider education, training, and support
• Flag target populations at patient visits, e.g. through dashboards
• Age groups for HIV screening, STI screening (chlamydia <25 women)
• Sexual orientation/Gender identity (SOGI) information
• Sexual risk assessments
• Positive STIs
• Positive substance use screening
• Population management
• Through EMRs (e.g. dashboards identifying targeted populations), outreach can
be done as well
49
Planned Care Dashboard:
HIV and STI Screening
• Universal HIV screening
• Routine annual STI Screening for specific groups:
• Women 13-24 (chlamydia)
• MSM/Transgender individuals (3-site testing chlamydia/gonorrhea, syphilis)
Center for Key Populations: Reimagining Primary Care
50
6 Essential Sexual Health Questions:
To Determine STD Screening/Treatment
• Have you ever had any type of sex ?
• Oral, Vaginal, Anal?
• When was the last time?
• Are partners men, women, transmen, transwomen? How many (1 or more than 1)?
• Do you use condoms/on PrEP? Always, sometimes, never?
• Any symptoms?
• Were you exposed to any STDs that you know?
51
Center for Key Populations: Reimagining Primary Care
Sexual Risk Assessment:
EHR Template
52
Integration of PrEP
• PrEP training and protocols for providers including sex positive
approaches
• Identify PrEP champions
• ECHO support, mentorships
• Task shifting/sharing in clinical teams
• PrEP navigator for support; nurse visits; medical assistant screenings
• Use of EMRs, dashboards, data pulls
• System of linkage to PrEP and to HIV care
• Create playbooks; communicate with all involved staff; use internal
and external resources.
53
53
Questions?
54
Contact Information
55
For information on future webinars, activity
sessions, and learning collaboratives:
please reach out to nca@chc1.com or visit
https://www.chc1.com/nca

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Integrating HIV Prevention into Primary Care

  • 1. Integrating HIV Prevention into Primary Care April 14, 2022 1:00-2:00pm Eastern/ 10:00-11:00am Pacific 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. 1
  • 2. 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
  • 3. 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
  • 4. 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
  • 5. 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
  • 6. Objectives • Review HIV epidemiology • Understand Sex Positive, Status Neutral approach • Discuss HIV Prevention Strategies and HIV Testing • Review HIV transmission • Discuss PrEP (pre-exposure prophylaxis) and Treatment as Prevention • Describe PrEP implementation strategies 6
  • 7. HIV Epidemiology • About 1.19 million people with HIV are living in the U.S. as of 2019. • 1 in 8 (about 13 %) unaware of their infection. • In 2019, 36,801 new infections occurred. • Number of new HIV infections decreased overall about 9% from 2015 to 2019. 7
  • 15. Preventing HIV Transmission: The PrEP Gap in the United States 15 • 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] People With an Indication for PrEP (2018)[1] ≈18% on PrEP* ≈82% Without PrEP Gap Between PrEP Awareness, Willingness, and Use[3] American Men’s Internet Survey (n = 4475 PrEP eligible MSM; 2017) 81% Aware 60% Willing to Use 20% Used PrEP 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. Slide credit: clinicaloptions.com *PrEP coverage in 2016 and 2017 was 9% and 13%, respectively.
  • 16. New PrEP Starts in the United States (2014-2017): Prescription Database 16 • 14% of persons with indications for PrEP started PrEP (158,183/1,144,550) • Blacks and Hispanics account for 69% of new HIV infections, but their use of PrEP was relatively low during this period Black White Hispanic/Latinx Asian, Other, Uncoded New PrEP Starts (2014-2017) New HIV Infections (2017) Nguyen. IAS 2019. Abstr TUPEC405. Slide credit: clinicaloptions.com 16
  • 17. HIV Prevention Strategies • Risk reduction counseling • Sexual health counseling • Condoms and lubricant • Sterile syringes and “works” • STI testing and treatment • PEP (post-exposure prophylaxis) • HIV testing • PrEP (pre-exposure prophylaxis) • Treatment as Prevention (U=U) 17
  • 18. Sex Positive, Status Neutral Approach 18
  • 19. Sex Positive, Status Neutral Goals • Determine who needs STI and HIV testing. • Identify those who test negative and are at risk for HIV and refer to PrEP. • Identify who is living with HIV and link them to care. 19
  • 20. Population-Based Approach • Actively reaches people who may benefit from the health service or intervention. • Increases access to the service or intervention to more people. • Can lead to addressing health inequities. 20
  • 21. Population-Based Approach (cont.) • Using sexual orientation and gender identity (SOGI) information, sexual risk assessments, positive STI results, substance use screening to reach out to potential at-risk individuals. • Targeting messaging to at-risk populations. • Making access to services readily available where people are at. 21 21
  • 22. Sex Positive, Status Neutral Goals • Be comfortable talking about sex. • Check any judgment at the door. • Make no assumptions. • Create welcoming environment. 22
  • 23. • Promote healthy sex lives. • Invite open and comfortable dialogue about sex. • No matter who you are, who or how many you have sex with, and what kind of sex you like. • Straight, bi, gay, pansexual; cis, trans, or non- binary gender; living with or without HIV. • Empower with knowledge and choice. • Protect through prevention, screening, and treatment. Sexual Risk Assessment Sex Positive, Status Neutral Goals 23
  • 24. Risk Reduction Counseling • Sexual Transmission • Barrier methods (e.g. condom use) • Sexual partners • PEP • PrEP • Treatment as Prevention • Drug Use • Clean needles/works • Syringe services programs • Medications for substance use disorders • PEP • PrEP 24
  • 25. HIV Tests • Routine HIV Test • 4th generation Ab/Ag testing • Blood test (results in 1-2 weeks) • Sensitivity >99.7%, Specificity 100% • Rapid Tests • Alere Determine™ HIV1/2 (4th generation) • Blood test (results in 15 minutes) • Sensitivity 100%, specificity 99.8% • Positive results require confirmation • Picks up infections earlier (by 1-2 weeks) 25
  • 26. 27
  • 27. HIV Testing • CDC and USPSTF recommend routine HIV testing for 13 (15)-64 year olds. – Recommendation for those at higher risk testing at least once a year. • Routine, opt-out, voluntary testing • Part of consent to routine medical care • Opportunity to ask questions • Option to decline • Separate written/oral consent not required • Prevention counseling not required in conjunction with testing. • Status Neutral Approach – People with HIV who are aware of status can get HIV treatment • Promote individual health • Prevent transmission – People who don’t have HIV and are at-risk can make decisions about their health, including PrEP. 28
  • 28. Who Should We Be Testing? • All patients 13-64 years of age, at least once – USPSTF recommends starting at age 15 • Any patient suspected of acute HIV infection • Patients seeking STD treatment and attending STD clinics • Pregnant women • Patients with TB • Patients with HBV/HCV 29 CDC MMWR Sept 26, 2006
  • 29. Who Should We Be Testing? (cont.) • Patients starting new sexual relationships • Occupationally exposed individuals • Patients with ongoing risk, at least annually • People who inject drugs and their sex partners • Persons who exchange sex for money or drugs • Sex partners of persons with HIV • MSM or heterosexual persons who themselves or their partners have had more than one sexual partner since their last HIV test 29 CDC MMWR Sept 26, 2006
  • 30. Planned Care Dashboard and Clinical Expectation: Universal HIV Screening 30
  • 31. Bodily Fluids and HIV Transmission Risk Infectious* Potentially Infectious Not Infectious! Blood Cerebrospinal fluid Feces Tissue Synovial fluid Nasal secretions Semen Pleural fluid Saliva Vaginal Secretions Peritoneal fluid Sputum Breast Milk Pericardial fluid Sweat Amniotic fluid Tears Urine Vomitus ! Unless visibly bloody *Increased risk with visible blood on device; needle directly from vein/artery; hollow-bore needle; deep injury; source patient with terminal illness; high viral load. • Comes into contact with: • mucous membranes • damaged tissue • Typically through: • Vaginal/anal sex • Needles • Occupational exposure • Injection drug use • Mother to child • Pregnancy and delivery • Breastfeeding 31
  • 32. 32 Mucous Membrane (occupational): 9 per 10,000 Exposures
  • 33. Condom Use Protection • HIV: 100% use with usual rates of breakage and slippage protects 80 to 85% (uncertainty range: 76 to 93%) • Estimates mainly based on heterosexual couples. • Very few studies in MSM or with anal sex– showed similar rates. • Gonorrhea: similar degree of protection. • Syphilis: protection in the range of about 50 to 66%.. • Chlamydia/Trichomonis: rates vary from 85 to 26%. • HSV-2: estimates vary++. 75% use decreases risk by 50%. • HPV: consistent use protects women about 73% from men. 33 33
  • 34. Pre-Exposure Prophylaxis (PrEP) An individual without HIV takes antiretroviral medication(s) before potential HIV exposure. 34
  • 35. FDA-Recommended PrEP Regimens • Fixed-dose TDF/FTC (Truvada) for MSM, transgender women, heterosexually active men and women, and IDU who meet PrEP prescribing criteria. • Fixed-dose TAF/FTC (Descovy) for MSM and transgender women. • Both dosed as a single pill once daily • Injectable cabotegravir (Apretude) for adults and adolescents at least 35 kg. • Monthly injection for 2 months then every other month. 35
  • 36. PrEP Works in MSM, Heterosexual Men and Women, and People Who Inject Drugs but Adherence Is Critical Study Efficacy Overall, % Blood Samples With TFV Detected, % Efficacy By Blood Detection of TFV, % iPrEx[1] 44 51 92 iPrEx OLE[2] 49 71 NR Partners PrEP[3] 67 (TDF) 75 (TDF/FTC) 81 86 (TDF) 90 (TDF/FTC) TDF2[4] 62 80 85 Thai IDU[5] 49 67 74 Fem-PrEP[6] No efficacy < 30 NR VOICE[7] No efficacy < 30 NR 1. Grant RM, et al. N Engl J Med. 2010;363:2587-2599. 2. Grant RM, et al. Lancet Infect Dis. 2014; 14:820-829. 3. Baeten JM, et al. N Engl J Med. 2012;367:399-410. 4. Thigpen MC, et al. N Engl J Med. 2012;367:423-434. 5. Choopanya K, et al. Lancet. 2013;381:2083-2090. 6. Van Damme L, et al. N Engl J Med. 2012;367:411-422. 7. Marrazzo J, et al. CROI 2013. Abstract 26LB. 36
  • 37. Oral PrEP Reduces Incidence of HIV in MSM, Even With Incomplete Adherence • iPreX OLE: open-label extension of iPrEX trial of daily TDF/FTC oral PrEP in MSM and transgender women (N = 1603) • 100% adherence was not required to attain full benefit from PrEP • Benefit of 4-6 tablets/wk similar to 7 tablets/wk • 2-3 tablets/wk also associated with significant risk reduction • Higher levels of sexual risk taking at baseline were associated with greater adherence to PrEP 1. Grant R, et al. IAC 2014. Abstract TUAC0105LB. 2. Grant R, et al. Lancet Infect Dis. 2014;14:820-829. HIV Incidence and Drug Concentrations 5 4 3 2 1 0 1500 1250 1000 700 500 350 LLOQ 0 Off PrEP On PrEP TFV-DP in fmol/punch 7 Tablets/ Wk 4-6 Tablets/Wk < 2 Tablets/ Wk 2-3 Tablets/ Wk HIV Incidence per 100 Person-Yrs Follow-up Risk Reduction 95% Cl 26% 44% -31 to 77% 12% 84% 21 to 99% 21% 100% 12% 100% 86 to 100% (combined) 37
  • 38. 2-1-1 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 • ANRS Ipergay, ANRS Prevenir, AMPrEP • Not FDA approved 38 38
  • 39. 39
  • 40. • Discuss HIV PrEP with every sexually active adolescent and adult. • Identify those who are at risk for HIV and offer PrEP. • Prescribe PrEP if eligible or if requested. 40
  • 41. 41
  • 42. 42
  • 43. PrEP Monitoring • Monitoring (F/TDF, F/TAF) • HIV test every 3 months • STI screening every 3 months for MSM/transwomen and every 6 months for all others • Renal function every 6 months for 50+ and GFR<90, once a year for all others. • If on F/TAF, lipids once a year • Monitoring (Cabotegravir) • HIV test every 2 months • STI screening every 4 months for MSM/transwomen and every 6 months for all others 43
  • 44. What is Treatment As Prevention? 44 https://www.cdc.gov/hiv/risk/art/index.html 44
  • 45. Prevention Access Campaign: 2016 https://www.preventionaccess.org/ 45
  • 48. When does TasP become effective? 48
  • 49. Implementation • Identification • Individual panel management • Provider education, training, and support • Flag target populations at patient visits, e.g. through dashboards • Age groups for HIV screening, STI screening (chlamydia <25 women) • Sexual orientation/Gender identity (SOGI) information • Sexual risk assessments • Positive STIs • Positive substance use screening • Population management • Through EMRs (e.g. dashboards identifying targeted populations), outreach can be done as well 49
  • 50. Planned Care Dashboard: HIV and STI Screening • Universal HIV screening • Routine annual STI Screening for specific groups: • Women 13-24 (chlamydia) • MSM/Transgender individuals (3-site testing chlamydia/gonorrhea, syphilis) Center for Key Populations: Reimagining Primary Care 50
  • 51. 6 Essential Sexual Health Questions: To Determine STD Screening/Treatment • Have you ever had any type of sex ? • Oral, Vaginal, Anal? • When was the last time? • Are partners men, women, transmen, transwomen? How many (1 or more than 1)? • Do you use condoms/on PrEP? Always, sometimes, never? • Any symptoms? • Were you exposed to any STDs that you know? 51
  • 52. Center for Key Populations: Reimagining Primary Care Sexual Risk Assessment: EHR Template 52
  • 53. Integration of PrEP • PrEP training and protocols for providers including sex positive approaches • Identify PrEP champions • ECHO support, mentorships • Task shifting/sharing in clinical teams • PrEP navigator for support; nurse visits; medical assistant screenings • Use of EMRs, dashboards, data pulls • System of linkage to PrEP and to HIV care • Create playbooks; communicate with all involved staff; use internal and external resources. 53 53
  • 55. Contact Information 55 For information on future webinars, activity sessions, and learning collaboratives: please reach out to nca@chc1.com or visit https://www.chc1.com/nca

Notas del editor

  1. Amanda
  2. Bianca
  3. Bianca
  4. Bianca
  5. MSM, men who have sex with men; PrEP, pre-exposure prophylaxis; PWID, people who inject drugs.
  6. Incorporating into routine testing More testing for those at higher risk Sexual history Condoms Identify those who would benefit and be eligible for PrEP
  7. FTC, emtricitabine; NR, not reported; PrEP, pre-exposure prophylaxis; TDF, tenofovir disoproxil fumarate; TFV, tenofovir. Oral PrEP works, but adherence is critical. For IPrEx, when you analyze efficacy with the detection of tenofovir in the person’s blood, it showed that if you took tenofovir as instructed, the efficacy of PrEP was 92%.
  8. Updated photo 2022
  9. MH
  10. Bianca