Project RSP+ Webinar - December 11, 2014. Presentation explores the pipeline of new HIV prevention technologies in the research and development phase. This project is an initiative of the AIDS Foundation of Chicago.
Exploring the Pipeline: Lubes, Rings, Films, Fibers, and Shots 4 HIV PreventionJim Pickett
This is a training on the research and development pipeline for new HIV prevention technologies - including PrEP, microbicides, and new male and female condoms. It was conducted by AIDS Foundation of Chicago's Jim Pickett on Thursday, October 9, 2014 in Chicago, Illinois. These slides have been revised and updated from the same training conducted in Bloomington, IL on Sept 29.
This is a training on the research and development pipeline for new HIV prevention technologies - including PrEP, microbicides, and new male and female condoms. It was conducted by AIDS Foundation of Chicago's Jim Pickett in partnership with the Illinois Public Health Association, on Monday, September 29, 2014 in Bloomington, Illinois.
The Rectal Revolution is Here - January 29, 2015 - New Orleans, LAJim Pickett
IRMA's Jim Pickett provided an update on rectal microbicide research and advocacy at the "Building Healthy Communities by Breaking Down Barriers - 2015 CBO Orientation", presented by Louisiana Department of Health and Hospitals. Presentation was made on Jan 29, 2015.
January 29, 2015 – New Orleans
PrEP Training Slides - Austin CBC, CORE Center, AFCJim Pickett
These slides were used for the HIV workforce PrEP training conducted by AIDS Foundation of Chicago on June 23, 2015 at Austin CBC in collaboration with the CORE Center.
PrEP Training - Springfield, IL - May 14, 2015Jim Pickett
This PrEP training was delivered by Jim Pickett to people working in HIV in Springfield, IL on May 14, 2015. This training was conducted in collaboration with AIDS Foundation of Chicago, Illinois Department of Public Health, and the Midwest AIDS Training and Education Center.
Project RSP Training on PrEP - September 11, 2015Jim Pickett
This training was conducted by AIDS Foundation of Chicago for members of Chicago's HIV workforce - in partnership with the Chicago Department of Public Health. It took place on Friday, September 11, 2015. Presenters included the CORE Center's Dr. Sybil Hosek, Jim Pickett of AFC, and Gabe Bahena, a PrEP consumer. .
Project RSP Training on PrEP - November 13, 2015Jim Pickett
This training was conducted by AIDS Foundation of Chicago for members of Chicago's HIV workforce - in partnership with the Chicago Department of Public Health. It took place on Friday, November 13, 2015. Presenters included the CORE Center's Dr. Sybil Hosek, Jim Pickett of AFC, and two PrEP consumers - Gabe Bahena and Curtis Lewis.
Exploring the Pipeline: Lubes, Rings, Films, Fibers, and Shots 4 HIV PreventionJim Pickett
This is a training on the research and development pipeline for new HIV prevention technologies - including PrEP, microbicides, and new male and female condoms. It was conducted by AIDS Foundation of Chicago's Jim Pickett on Thursday, October 9, 2014 in Chicago, Illinois. These slides have been revised and updated from the same training conducted in Bloomington, IL on Sept 29.
This is a training on the research and development pipeline for new HIV prevention technologies - including PrEP, microbicides, and new male and female condoms. It was conducted by AIDS Foundation of Chicago's Jim Pickett in partnership with the Illinois Public Health Association, on Monday, September 29, 2014 in Bloomington, Illinois.
The Rectal Revolution is Here - January 29, 2015 - New Orleans, LAJim Pickett
IRMA's Jim Pickett provided an update on rectal microbicide research and advocacy at the "Building Healthy Communities by Breaking Down Barriers - 2015 CBO Orientation", presented by Louisiana Department of Health and Hospitals. Presentation was made on Jan 29, 2015.
January 29, 2015 – New Orleans
PrEP Training Slides - Austin CBC, CORE Center, AFCJim Pickett
These slides were used for the HIV workforce PrEP training conducted by AIDS Foundation of Chicago on June 23, 2015 at Austin CBC in collaboration with the CORE Center.
PrEP Training - Springfield, IL - May 14, 2015Jim Pickett
This PrEP training was delivered by Jim Pickett to people working in HIV in Springfield, IL on May 14, 2015. This training was conducted in collaboration with AIDS Foundation of Chicago, Illinois Department of Public Health, and the Midwest AIDS Training and Education Center.
Project RSP Training on PrEP - September 11, 2015Jim Pickett
This training was conducted by AIDS Foundation of Chicago for members of Chicago's HIV workforce - in partnership with the Chicago Department of Public Health. It took place on Friday, September 11, 2015. Presenters included the CORE Center's Dr. Sybil Hosek, Jim Pickett of AFC, and Gabe Bahena, a PrEP consumer. .
Project RSP Training on PrEP - November 13, 2015Jim Pickett
This training was conducted by AIDS Foundation of Chicago for members of Chicago's HIV workforce - in partnership with the Chicago Department of Public Health. It took place on Friday, November 13, 2015. Presenters included the CORE Center's Dr. Sybil Hosek, Jim Pickett of AFC, and two PrEP consumers - Gabe Bahena and Curtis Lewis.
Project Ready, Set, PrEP! training on PrEP - Updated 9/5/14Jim Pickett
This training on PrEP for HIV prevention was conducted by AIDS Foundation of Chicago (AFC) in collaboration with the Chicago Department of Public Health and MATEC on September 5, 2014. Other partners on this training included John Stroger Hospital and Gilead. These slides comprise a 3.5 hour training designed for people in the HIV workforce AFC and partners conduct at various times in the year.
Project Ready, Set, PrEP! training on PrEP for HIV Prevention - UPDATED NOV 17Jim Pickett
This training on PrEP for HIV prevention was conducted by AIDS Foundation of Chicago (AFC) in collaboration with the Chicago Department of Public Health on November 17. Other partners on this training included University of Chicago. These slides comprise a 3.5 hour training designed for people in the HIV workforce that AFC and partners conduct at various times in the year. They are continually updated.
PrEP training slides - Lisle, April 16, 2015Jim Pickett
These slides are part of a one-day training by Illinois Department of Public Health, Midwest AIDS Training and Education Center, and AIDS Foundation of Chicago (AFC) called "PrEP: What is it and How Am I to Integrate it in My Conversations with Clients?" They were presented by Jim Pickett, Director of Prevention Advocacy and Gay Men's Health at AFC.
Project RSP! training on PrEP for the HIV workforce (March 19, 2015)Jim Pickett
This training on PrEP for HIV prevention was conducted by AIDS Foundation of Chicago (AFC) in collaboration with the Chicago Department of Public Health on March 19, 2015. These slides comprise a 3.5 hour training designed for people in the HIV workforce in Chicago and throughout Illinois that AFC and partners conduct at various times in the year. They are continually updated - this presentation includes recent PrEP data presented at CROI 2015 in late February.
Project RSP! Training on PrEP for HIV PreventionJim Pickett
This is a training on PrEP (pre-exposure prohylaxis) for HIV prevention, designed for people who work in the HIV prevention field. The training is designed by AIDS Foundation of Chicago's Project Ready, Set, PrEP! (RSP!). For more information on PrEP, visit the project's blog at www.myprepexperience.blogspot.com.
Project RSP! Training on PrEP for HIV PreventionJim Pickett
June 11 - UPDATED training on PrEP for HIV prevention from Chicago's Project Ready, Set, PrEP! (RSP!). Visit the Project RSP!'s My PrEP Experience blog at www.myprepexperience.blogspot.com for more informational resources, including the personal stories of individuals who have chosen to use PrEP.
Dr. Kathleen Brady's presentation on PrEP (pre-exposure prophylaxis) for HIV, as given to the Philadelphia HIV Prevention Planning Group (HPG) on March 25, 2015.
Project RSP Training on PrEP - July 31, 2015Jim Pickett
This PrEP training - a collaboration between AIDS Foundation of Chicago and the Chicago Department of Public Health - was provided to members of Chicago's HIV workforce on Friday, July 31, 2015.
Panelists:
Dr. Abiye Kalaiwo is a Public Health Specialist and USAID's Nigeria's technical lead for Key Populations, managing PEPFAR's
single largest Key Populations program. He has over 12 years of experience in HIV and infectious disease programs at the national level.
Dr. Jason Reed offers more than 12 years of experience in public health surveillance and medical epidemiology, specifically in HIV surveillance systems, prevention programming, and implementation research at state, national and international levels.
Speakers discuss PrEP counseling, special situations, and other topics covered in training modules three and four. During this webinar, expert speakers review key highlights from modules three and four, and respond to questions from participants.
Part one: https://www.slideshare.net/jsi/prep-elearning-discussion-i
Project RSP! training on PrEP - updated November 2013Jim Pickett
This is a training for the HIV workforce on PrEP, and is a part of Chicago's Project Ready, Set, PrEP! (RSP!) Project RSP! is an education and awareness initiative of the AIDS Foundation of Chicago. Visit us at www.myprepexperience.blogspot.com.
Project RSP! Training on PrEP - Oct 2013Jim Pickett
This training was conducted for members of the HIV workforce in Chicago on October 21, 2013 at the Chicago Department of Public Health's Mile Square location.
Project RSP! Training on PrEP - Peoria, IL - August 18, 2015Jim Pickett
This AIDS Foundation of Chicago training on PrEP for the HIV workforce took place in Peoria, IL on August 18, 2015. The training was conducted in collaboration with the Illinois Public Health Association and Central Illinois FRIENDS of PWA, Inc.
Marvin Thompson's, advocate, presentation at the Sex in the City II: Men, Sex, Love and HIV conference, held in Chicago on September 25, 2014. Sponsored by AIDS Foundation of Chicago and other partners.
Beyond PrEP: Intersectionality, Resilience & the Health of Black MSMJim Pickett
David Malebranche's, University of Pennsylvania, presentation at the Sex in the City II: Men, Sex, Love and HIV conference, held in Chicago on September 25, 2014. Sponsored by AIDS Foundation of Chicago and other partners.
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This training on PrEP for HIV prevention was conducted by AIDS Foundation of Chicago (AFC) in collaboration with the Chicago Department of Public Health and MATEC on September 5, 2014. Other partners on this training included John Stroger Hospital and Gilead. These slides comprise a 3.5 hour training designed for people in the HIV workforce AFC and partners conduct at various times in the year.
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This training on PrEP for HIV prevention was conducted by AIDS Foundation of Chicago (AFC) in collaboration with the Chicago Department of Public Health on November 17. Other partners on this training included University of Chicago. These slides comprise a 3.5 hour training designed for people in the HIV workforce that AFC and partners conduct at various times in the year. They are continually updated.
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This training on PrEP for HIV prevention was conducted by AIDS Foundation of Chicago (AFC) in collaboration with the Chicago Department of Public Health on March 19, 2015. These slides comprise a 3.5 hour training designed for people in the HIV workforce in Chicago and throughout Illinois that AFC and partners conduct at various times in the year. They are continually updated - this presentation includes recent PrEP data presented at CROI 2015 in late February.
Project RSP! Training on PrEP for HIV PreventionJim Pickett
This is a training on PrEP (pre-exposure prohylaxis) for HIV prevention, designed for people who work in the HIV prevention field. The training is designed by AIDS Foundation of Chicago's Project Ready, Set, PrEP! (RSP!). For more information on PrEP, visit the project's blog at www.myprepexperience.blogspot.com.
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Panelists:
Dr. Abiye Kalaiwo is a Public Health Specialist and USAID's Nigeria's technical lead for Key Populations, managing PEPFAR's
single largest Key Populations program. He has over 12 years of experience in HIV and infectious disease programs at the national level.
Dr. Jason Reed offers more than 12 years of experience in public health surveillance and medical epidemiology, specifically in HIV surveillance systems, prevention programming, and implementation research at state, national and international levels.
Speakers discuss PrEP counseling, special situations, and other topics covered in training modules three and four. During this webinar, expert speakers review key highlights from modules three and four, and respond to questions from participants.
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Mapping Pathways Knowledge Exchange Workshop - San Francisco - July 2013Jim Pickett
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These lecture slides, by Dr Sidra Arshad, offer a quick overview of the physiological basis of a normal electrocardiogram.
Learning objectives:
1. Define an electrocardiogram (ECG) and electrocardiography
2. Describe how dipoles generated by the heart produce the waveforms of the ECG
3. Describe the components of a normal electrocardiogram of a typical bipolar lead (limb II)
4. Differentiate between intervals and segments
5. Enlist some common indications for obtaining an ECG
6. Describe the flow of current around the heart during the cardiac cycle
7. Discuss the placement and polarity of the leads of electrocardiograph
8. Describe the normal electrocardiograms recorded from the limb leads and explain the physiological basis of the different records that are obtained
9. Define mean electrical vector (axis) of the heart and give the normal range
10. Define the mean QRS vector
11. Describe the axes of leads (hexagonal reference system)
12. Comprehend the vectorial analysis of the normal ECG
13. Determine the mean electrical axis of the ventricular QRS and appreciate the mean axis deviation
14. Explain the concepts of current of injury, J point, and their significance
Study Resources:
1. Chapter 11, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 9, Human Physiology - From Cells to Systems, Lauralee Sherwood, 9th edition
3. Chapter 29, Ganong’s Review of Medical Physiology, 26th edition
4. Electrocardiogram, StatPearls - https://www.ncbi.nlm.nih.gov/books/NBK549803/
5. ECG in Medical Practice by ABM Abdullah, 4th edition
6. Chapter 3, Cardiology Explained, https://www.ncbi.nlm.nih.gov/books/NBK2214/
7. ECG Basics, http://www.nataliescasebook.com/tag/e-c-g-basics
Ozempic: Preoperative Management of Patients on GLP-1 Receptor Agonists Saeid Safari
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Rasamanikya is a excellent preparation in the field of Rasashastra, it is used in various Kushtha Roga, Shwasa, Vicharchika, Bhagandara, Vatarakta, and Phiranga Roga. In this article Preparation& Comparative analytical profile for both Formulationon i.e Rasamanikya prepared by Kushmanda swarasa & Churnodhaka Shodita Haratala. The study aims to provide insights into the comparative efficacy and analytical aspects of these formulations for enhanced therapeutic outcomes.
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- Video recording of this lecture in English language: https://youtu.be/kqbnxVAZs-0
- Video recording of this lecture in Arabic language: https://youtu.be/SINlygW1Mpc
- Link to download the book free: https://nephrotube.blogspot.com/p/nephrotube-nephrology-books.html
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Title: Sense of Smell
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the primary categories of smells and the concept of odor blindness.
Explain the structure and location of the olfactory membrane and mucosa, including the types and roles of cells involved in olfaction.
Describe the pathway and mechanisms of olfactory signal transmission from the olfactory receptors to the brain.
Illustrate the biochemical cascade triggered by odorant binding to olfactory receptors, including the role of G-proteins and second messengers in generating an action potential.
Identify different types of olfactory disorders such as anosmia, hyposmia, hyperosmia, and dysosmia, including their potential causes.
Key Topics:
Olfactory Genes:
3% of the human genome accounts for olfactory genes.
400 genes for odorant receptors.
Olfactory Membrane:
Located in the superior part of the nasal cavity.
Medially: Folds downward along the superior septum.
Laterally: Folds over the superior turbinate and upper surface of the middle turbinate.
Total surface area: 5-10 square centimeters.
Olfactory Mucosa:
Olfactory Cells: Bipolar nerve cells derived from the CNS (100 million), with 4-25 olfactory cilia per cell.
Sustentacular Cells: Produce mucus and maintain ionic and molecular environment.
Basal Cells: Replace worn-out olfactory cells with an average lifespan of 1-2 months.
Bowman’s Gland: Secretes mucus.
Stimulation of Olfactory Cells:
Odorant dissolves in mucus and attaches to receptors on olfactory cilia.
Involves a cascade effect through G-proteins and second messengers, leading to depolarization and action potential generation in the olfactory nerve.
Quality of a Good Odorant:
Small (3-20 Carbon atoms), volatile, water-soluble, and lipid-soluble.
Facilitated by odorant-binding proteins in mucus.
Membrane Potential and Action Potential:
Resting membrane potential: -55mV.
Action potential frequency in the olfactory nerve increases with odorant strength.
Adaptation Towards the Sense of Smell:
Rapid adaptation within the first second, with further slow adaptation.
Psychological adaptation greater than receptor adaptation, involving feedback inhibition from the central nervous system.
Primary Sensations of Smell:
Camphoraceous, Musky, Floral, Pepperminty, Ethereal, Pungent, Putrid.
Odor Detection Threshold:
Examples: Hydrogen sulfide (0.0005 ppm), Methyl-mercaptan (0.002 ppm).
Some toxic substances are odorless at lethal concentrations.
Characteristics of Smell:
Odor blindness for single substances due to lack of appropriate receptor protein.
Behavioral and emotional influences of smell.
Transmission of Olfactory Signals:
From olfactory cells to glomeruli in the olfactory bulb, involving lateral inhibition.
Primitive, less old, and new olfactory systems with different path
Muktapishti is a traditional Ayurvedic preparation made from Shoditha Mukta (Purified Pearl), is believed to help regulate thyroid function and reduce symptoms of hyperthyroidism due to its cooling and balancing properties. Clinical evidence on its efficacy remains limited, necessitating further research to validate its therapeutic benefits.
Recomendações da OMS sobre cuidados maternos e neonatais para uma experiência pós-natal positiva.
Em consonância com os ODS – Objetivos do Desenvolvimento Sustentável e a Estratégia Global para a Saúde das Mulheres, Crianças e Adolescentes, e aplicando uma abordagem baseada nos direitos humanos, os esforços de cuidados pós-natais devem expandir-se para além da cobertura e da simples sobrevivência, de modo a incluir cuidados de qualidade.
Estas diretrizes visam melhorar a qualidade dos cuidados pós-natais essenciais e de rotina prestados às mulheres e aos recém-nascidos, com o objetivo final de melhorar a saúde e o bem-estar materno e neonatal.
Uma “experiência pós-natal positiva” é um resultado importante para todas as mulheres que dão à luz e para os seus recém-nascidos, estabelecendo as bases para a melhoria da saúde e do bem-estar a curto e longo prazo. Uma experiência pós-natal positiva é definida como aquela em que as mulheres, pessoas que gestam, os recém-nascidos, os casais, os pais, os cuidadores e as famílias recebem informação consistente, garantia e apoio de profissionais de saúde motivados; e onde um sistema de saúde flexível e com recursos reconheça as necessidades das mulheres e dos bebês e respeite o seu contexto cultural.
Estas diretrizes consolidadas apresentam algumas recomendações novas e já bem fundamentadas sobre cuidados pós-natais de rotina para mulheres e neonatos que recebem cuidados no pós-parto em unidades de saúde ou na comunidade, independentemente dos recursos disponíveis.
É fornecido um conjunto abrangente de recomendações para cuidados durante o período puerperal, com ênfase nos cuidados essenciais que todas as mulheres e recém-nascidos devem receber, e com a devida atenção à qualidade dos cuidados; isto é, a entrega e a experiência do cuidado recebido. Estas diretrizes atualizam e ampliam as recomendações da OMS de 2014 sobre cuidados pós-natais da mãe e do recém-nascido e complementam as atuais diretrizes da OMS sobre a gestão de complicações pós-natais.
O estabelecimento da amamentação e o manejo das principais intercorrências é contemplada.
Recomendamos muito.
Vamos discutir essas recomendações no nosso curso de pós-graduação em Aleitamento no Instituto Ciclos.
Esta publicação só está disponível em inglês até o momento.
Prof. Marcus Renato de Carvalho
www.agostodourado.com
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Dec 11, '14 WEBINAR - Lubes, Rings, Films, Fibers, and Shots 4 HIV Prevention
1. Welcome
Lubes, Rings, Films, Fibers, and Shots 4 HIV Prevention
December 11, 2014 webinar
Exploring the Pipeline
2. Use the question feature to ask questions
during the webinar
• All attendees are in listen-only
mode
• Everyone can ask questions
at any time using the
questions feature or by
emailing
ssemelka@aidschicago.org.
• During Q & A breaks, the
moderators will read
questions that have been
submitted
3. Can’t hear the audio?
• Use your telephone!
• Click on the “audio” tab
• Dial the telephone number,
access code, and PIN you
see on your computer
5. Housekeeping & questions
• Use the “questions” feature to ask
questions OR
• Email ssemelka@aidschicago.org
• Can’t hear? Click the “audio” tab and
dial the number and code
• Download the slides at
www.myprepexperience.org
6. Housekeeping & questions
• Use the “questions” feature to ask
questions OR
• Email ssemelka@aidschicago.org
• Can’t hear? Click the “audio” tab and
dial the number and code
• Download the slides at
www.myprepexperience.org
8. ARV-Based Prevention Pipeline (March 2014)
PRE-CLINICAL PHASE I PHASE II PHASE III PHASE IV
Pop Council
IPM
IPCP NIAID
Pop Council
R
IPM HPTN/ACTG CONRAD IPM Gilead
CONRAD
Albert Einstein
GSK CONRAD
IPM
CONRAD
Janssen
TaiMed
Pop Council
IPM
IPM
IPM
IPM
PBS
IPM
R
IPM
R
Pop Council
RTI
Pop Council
Mintaka
ImQuest
ImQuest
DELIVERY SYSTEM
Oral pills
Vaginal gel
Vaginal film
Vaginal tablet
Vaginal ring
Long acting
injectable
Thin film
polymer
Phosphate Nano-fiber
buffered saline
PBS
R
Rectal gel
IPM
IPM
IPM
IPM
TFV/
FTC
TDF/
FTC
MIV
150
TMC
278
MVA
DAR Darunavir
GRF
TFV
TDF
DAP
IQP IQP-0528
5P12 5P12-RANTES
744
Tenofovir
Tenofovir disoproxil
fumarate
MIV 150
Maraviroc MAb
GSK 744
Tenofovir disoproxil
fumarate/emtricitabine
Dapivirine
Ripilvirine
Monoclonal antibody
Tenofovir/
emtricitabine
Griffithsin
DS003 DS003 (BMS793)
No drug tested
currently
TFV Tenofovir
prodrug
ACTIVE DRUG
RAL Raltegravir
CDC
CONRAD
Adapted from AVAC Report 2013: Research & Reality. www.avac.org/report2013
33. PREP WARM LINE
33
Recently launched!
PrEPline, 855-448-7737
The CCC Pre-Exposure Prophylaxis Service
11 a.m. – 6 p.m. EST
http://nccc.ucsf.edu/2014/09/29/introducing-the-ccc-prepline/
34. HANDY BROCHURE!
34
Designed to help individuals talk to
their doctors about PrEP
Before, during, after visit
Questions to ask
Web resources
tinyurl.com/talkPrEPtoDr
35. ACCESSING PREP— INSURANCE
FDA approval of
Truvada enables
private ins to cover
Truvada
on
Medicaid
formulary
Ins companies
covering, so far
ADAP
does not
cover
PrEP
35
37. Gilead
support
programs
Medication
Assistance
Program
500% FPL
Co-pay
program
$300/mo.
37
NEWLY IMPROVED – OCTOBER 15, 2014
38. PREP UTILIZATION
38
A total of 2,319 unique individuals who started
TVD for PrEP between 01 Jan 2012 and 30 Sep
2013 were included in the analysis.
• 48.8% of PrEP users were women.
• Mean age was 38.2 ± 12.2 years
• Males were significantly older (39.5 ±
12.0) than females (36.8 ± 12.3).
p<0.0001
• 12.3% of individuals were under 25 years old.
• The proportion of males under 25 was
8.0% (95% CI 6.5 – 9.5) significantly lower
than that of women 16.8% (95% CI 14.6 –
19.0). p<0.0001
Overall distribution of TVD for PrEP
prescriptions by prescriber specialty:
• Family Practice (18%)
• Internal Medicine (16%)
• Infectious Diseases (11%)
• Nurse Practitioners (9%)
• Physician Assistants (9%)
WY
CO
ND
SD MI
OK AR
Uninfected individuals receiving TVD for PrEP were:
DE
– 1.8 times more likely to be female (95% CI 1.6 – 1.9)
– 1.4 times more likely to be younger than 25 years old (95% CI
1.3 – 1.7)
MA
– 3.6 times more likely to be treated by a non-ID physician (95%
CI 3.2 – 4.1).
WA
OR
CA
NV
ID
UT
AZ
MT
NM
NE
KS
WI
MN
IA
MO
IL IN OH
KY
ME
NH
VT
RI
NY
CT
NJ
PA NY
C,
LI
A
K
TX
LA
AL GA
SC
NC
WV
MD
MS
TN
VA
FL
Midwest
16%
Northeast
25%
South
32%
West
27%
Prescribers of TVD for PrEP are located in 49 of the 50 U.S. states
Overall Midwest Northeast South West
Unique PrEP users n (%) 2,319* 373 (16%) 570 (25%) 729 (32%) 604 (27%)
Mean age in years (SD) 38 (12) 37 (12) 37 (12) 40 (12) 38 (12)
Younger <25 y/o 12.3% 16.4% 12.3% 9.7% 12.4%
Female 48.8% 53.6% 51.4% 51.4% 39.2%
Medicaid 9.9% 15.3% 15.3% 6.6% 5.1%
42. STAGES OF CLINICAL TRIALS
42
Graphic courtesy International Partnership for Microbicides
43. PERSPECTIVE
43
Of 10,000 compounds that get
tested in the lab, 5 make it to
human trials and 1 makes it to
market.
44. THE PREVENTION PACKAGE
44
Condoms – male and female
Condom-compatible lubricant
Information/education
Counseling/risk reduction
HIV testing
STI testing/treatment
HEP A and B vaccinations
45. A PRODUCT APPLIED TOPICALLY IN THE VAGINA OR THE
RECTUM THAT CAN OFFER PROTECTION AGAINST HIV AND,
IDEALLY, OTHER STIs
IDEALLY WOULD HAVE A CONTRACEPTIVE VERSION, AND
ANOTHER TO ALLOW FOR PREGNANCY – ARV/NON-ARV
FORMULATED AS A GEL/LUBRICANT, FILM, FIBER, VAGINAL
RING
A RECTAL MICROBICIDE MIGHT BE DELIVERED VIA
GEL/LUBRICANT, DOUCHE/ENEMA, OR …
MICROBICIDES ARE STILL IN DEVELOPMENT
THEY ARE NOT AVAILABLE YET!
45
MICROBICIDES
47. An act of unprotected anal
intercourse is 10 to 20 times more
likely to result in HIV transmission
compared to an act of
unprotected vaginal intercourse.
50. MTN 017
RECTAL GEL
A Phase 2 Randomized Sequence
Open Label Expanded Safety and
Acceptability Study of Oral
Emtricitabine/Tenofovir Disoproxil
Fumarate Tablet and Rectally-Applied
Tenofovir Reduced-Glycerin 1% Gel
51. N = 192
RECTAL GEL
[Sept ’13 – June ‘16 ]
Participants
Gay/MSM,
transgender
women
Study sites
• US (4)
• Thailand (2)
• RSA (1)
• Peru (1)
52. 017 IN BRIEF
Study regimens include:
RECTAL GEL
• Rectal tenofovir gel used daily
• Rectal tenofovir gel used before and after sex
• Truvada tablets taken daily
Each participant will follow all of the study regimens for
eight weeks, with a weeklong break between regimens
when no product will be used
• The order in which participants follow study regimens will be based on
random assignment
All participants receive standard HIV prevention package
53. Product
Sequence
N Period 1
(8 weeks)
Product Break
(1 week)
017 STUDY DESIGN
Period 2
(8 weeks)
Product
Break
(1 week)
Period 3
(8 weeks)
1 31 Daily Truvada
Daily rectal gel
Rectal gel before and
after sex
2 31 Rectal gel before and
after sex Daily Truvada Daily rectal gel
3 31
Daily rectal gel
Rectal gel before and
after sex Daily Truvada
4 31
Daily rectal gel Daily Truvada
Rectal gel before and
after sex
5 31
Daily Truvada
Rectal gel before and
after sex Daily rectal gel
6 31 Rectal gel before and
after sex Daily Rectal gel Daily Truvada
Slide courtesy of Dr. Ross D. Cranston, 017 Principal Investigator
RECTAL GEL
54. 017 ADHERENCE
PK monitoring, “real time” PK
RECTAL GEL
Layered approach to monitoring
•SMS (text messages)
• Product returns
• CASI (computer assisted self interview)
60. RECTAL GELS
Combination HIV Antiretroviral Rectal
Microbicide Program (CHARM)
Phase I
Maraviroc gel
Microbicide Trials Network
Phase I – in development
Dapivirine gel
64. South Africa -
2 sites in
KwaZulu-Natal
Phase IIB - 889
HIV- women,
18 – 40
Enrolled May
2007 – Jan.
2009
Vaginally
formulated
tenofovir gel
Results July
20, 2010 –
AIDS 2010
65.
66.
67.
68.
69. CAPRISA 008
Implementation study
underway
HIV-negative CAPRISA 004
participants
Effectiveness/sustainability
in rural and urban clinics
Oct ‘12 – Mar ’15
VOICE [MTN]
Phase 2B, randomized, double-blind,
placebo-controlled, 5-arm
trial
5029 women in trial – Uganda,
S. Africa, Zimbabwe
Studied daily use of following :
Vaginal tenofovir 1% gel
Oral tenofovir
Oral Truvada
Results announced March 2013
69
VAGINAL GELS
71. VOICE
C, D
Why women didn’t take study product
Asked participants, partners, community members
• Lack of social support
• Hearing that other women were not using
product
• Ambivalence about not knowing if placebo or
active drug
• Concerns about side effects, lack of side effects
• Stigma of using drug used by PLWHIV
72. VAGINAL GELS
Phase III trial of tenofovir gel
BAT24 dosing – hope to confirm
CAPRISA 004
2600 women, age 18-30, South Africa,
10 sites
Oct 2011 ~ late 2014
Results 2015
79. VAGINAL RINGS
Monthly vaginal ring with Dapivirine
The Ring Study/IPM 023
• Phase III
• 1650 women
• South Africa, Rwanda
• Apr 2012 ~ mid 2015
ASPIRE/MTN 027
• Phase III
• 3500 women
• Malawi, SA, Uganda, Zambia,
Zimbabwe
• July 2012 ~ end 2014
Slide courtesy AVAC
TWO TRIALS
83. International Partnership for Microbicides
Early preclinical
Maraviroc/tenofovir film
Dapivirine/maraviroc film
Phase I
Dapivirine film
83
VAGINAL FILMS
85. Weave maraviroc into water-soluble nano fibers
200 times thinner than strand of human hair
After insertion into vagina, fibers can dissolve
and release an effective dose in about 6 min
Intercourse could further disperse drug
throughout the vagina
85
VAGINAL NANOFIBERS
UNIVERSITY OF WASHINGTON
POPULATION COUNCIL
87. Alternative Dosing to Augment
Pre-Exposure Prophylaxis Pill Taking
540 HIV-negative volunteers, randomized to 3 arms
Gay men, transgender women, cisgender women
Bangkok, Cape Town, New York City
Began late 2011, ongoing
87
INTERMITTENT PREP
88. 88
INTERMITTENT PREP
Intervention Préventive de l'Exposition aux Risques avec et pour les
hommes Gays
Action to Prevent Risk Exposure By and For Gay Men
Randomized, placebo controlled, pilot study to assess adherence and
feasibility.
France Jan ‘12, Quebec July ’13
Gay men, Canada (50) and France (300) – haven’t used condoms for
anal w/at least 2 partners in past 6 mos
Controversial study design
AIDS 2014 – good adherence (CASI, pill counts, plasma, hair)
89. 89
INTERMITTENT PREP
Regimen = Two Truvada 2 to 24 hours before sex, one tablet
within 24 hours after sex, and another tablet within 48 hours
after sex.
91. 91
ORAL MARAVIROC
Phase II safety and tolerability study – June ‘12 – July ‘15
600 HIV-negative individuals – women and gay men
All U.S. sites
Comparing 4 regimens
• Maraviroc
• Maraviroc + Emtricitabine (FTC)
• Maraviroc + Tenofovir (TDF)
• Truvada (TDF +FTC)
107. ACCESS Grand Boulevard
Aidsmap
AVAC – Global Advocacy for HIV Prevention
CORE Center
FACTS
HIV Prevention Trials Network
HIV & Microbicides Resource Tracking
Working Group
Howard Brown Health Center
International Partnership for Microbicides
Jessica Terlikowski/AFC
Microbicide Trials Network
Population Council
Treatment Action Group
University of Chicago
107
ACKNOWLEDGMENTS
Thank you