Implementation of HPV testing in limited resource settings

Mauricio Maza MD MPH

Executive Director Basic Health International

I have no commercial relationship with any corporate entity that produces or sells products related to HPV

Basic Health International (BHI)

Our Vision: To live in a World where no woman dies of cervical

cancer, a preventable disease

Mission: To eliminate cervical cancer globally

VIETNAM

HONDURAS

DOMINICAN REPUBLIC

GUATEMALA

MALAWI

NICARAGUA

HAITI RWANDA PERU INDIA

THESE ARE COUNTRIES WE HAVE CONSULTED / WORKED ON /SHARED EXPERIENCES

WE ARE CONSTANTLY TRYING TO LEARN ABOUT PROGRAMS

EVERY COUNTRY IS DIFFERENT

BRAZIL CHINA

VACCINATION +

SCREEN AND TREAT STRATEGY PRIMARY HPV

Challenges encountered with current technologies

o Robustness of instrumentation and its ability to withstand temperatures and elements and lack of limited resource settings laboratory settings

o Limitations of Electricity and water

o Costs of instrumentation

Challenges encountered with current LMIC adapted technologies

o Limitations of Electricity consistency, back up battery or generator

o Challenge to repair or swap out if instrument issues arise. Ease of obtaining parts. o How will the instrument be swapped out? Local

presence of instrumentation.

o Intensive manual work required

o Aprox 4 hours to run batches

Challenges encountered with current LMIC adapted technologies

o Costs of instrumentation

o Additional costs of Medium

o Tests designed for POC or batching but no option for both

Challenges to foresee when introducing technologies

Custom challenges

When products where inspected in customs storage, they were at room temperature, not on temperature required for product

Custom challenges

What went wrong?

Gel pack for

cooling!!!

Labels with storages temperatures were covered by transportation stickers

Custom challenges

Problem corrected Insurance Company of Courier

covered costs

Consumable challenges

A program that was suppose to be conducted in 6 months was

conducted in 1 month

Challenges to foresee when introducing technologies

Consumable challenges

What went wrong?

Considerations for LMIC adapted technologies

o Level of expertise required for laboratory and availability of these technicians and test must allow room for error

o Specimen storage requirements

o Product storage and handling requirements (space required for storage and temperature requirements)

Background

• CAPE PROJECT (Cervical Cancer Prevention in El Salvador)

• Project is 3 phases which will screen 30,000 women between 2012 y 2015 Phase 1:

- October 2012 - March 2013

- 2,000 women, 4 municipalities / main health clinics

Phase 2: - September 2013 - May 2014

- 8,000 women, 4 municipalities, expand to additional health houses or community clinics

Phase 3: - July 2014 – December 2015

- 20,000 women, 1/5 of country

Cancer Reduction

Red

uct

ion

in L

ifet

ime

Ris

k o

f C

C (

%)

(5-year)

(5-year)

(2-year)

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

careHPVScreen and Treat

careHPVColposcopy

Management

Pap

40% Coverage

20% Coverage

80% Coverage

60% Coverage

PRELIMINARY RESULTS – DO NOT CITE OR DISTRIBUTE

Cost-Effectiveness Results

Life

exp

ecta

ncy

(ye

ars,

dis

cou

nte

d)

Lifetime Cost ($, discounted)

Pap (2-year)

28.642

28.644

28.646

28.648

28.650

28.652

28.654

28.656

0 20 40 60 80 100 120 140

careHPV Colposcopy Management (5-year)

careHPV Screen and Treat (5-year) $600 per year of life saved

PRELIMINARY RESULTS – DO NOT CITE OR DISTRIBUTE

Screening with careHPV is less costly than Pap smear screening.

Routine screening with careHPV (every 5 years) is more effective and less costly compared to Pap testing (every 2 years).

careHPV Screen and Treat is more effective and less costly than careHPV with Colposcopy Management, and is a very cost-effective intervention in El Salvador.

Summary of Key Findings from Phase 2

PRELIMINARY RESULTS – DO NOT CITE OR DISTRIBUTE

NOW WE HAVE RESULTS NOW WE HAVE OUR OWN EVIDENCE

NOW WE CAN JUSTIFY CHANGE

Preliminary Results

Women screened (from 20,000 target)

17,908

89.5%

HPV Positive Results 2,214 12.4%

Underwent VT (from 2,214) 1,975 89.2%

Received cryotherapy (from 1,975) 1,678 85.0%

Referred to colposcopy (from 1,975) 297 15.0%

Received tx colposcopy (from 297) 98 33.0%

Total HPV + with Tx at 6 months (from 2,214) 1,776 80.2%

> 100,000 Tests

Information System Trainings

Visual Triage Trainings

Educational / Training sessions

ZONA OCCIDENTAL

Micro-redes de salud = 13

SANTA ANA

UCSF Chalchuapa SA UCSF Sabanetas el Paste UCSF El coco UCSF Chalchuapa SA Las Lajas UCSF Chalchuapa SA Las Lomas UCSF Chalchuapa SA Galeano UCSF Chalchuapa SA Las Cruces UCSF Chalchuapa SA Las Flores UCSF Chalchuapa SA La Magdalena 1 UCSF Chalchuapa SA La Magdalena 2 UCSF Chalchuapa SA San José UCSF Chalchuapa SA San Sebastian UCSF Chalchuapa SA Zacamíl UCSF El Porvenir UCSF El Porvenir SA Amate Blanco UCSF El Porvenir SA El Cerrón UCSF El Porvenir SA San Juan Chiquito UCSF San Sebastian Salitrillo UCSF San Sebastian Salitrillo Santa Rosa

UCSF El Congo UCSF Planes de la Laguna UCSF Coatepeque UCSF Coatepeque Las Piletas UCSF Coatepeque Sa Conacaste UCSF San Jacinto UCSF El Tinteral

El Congo Chalchuapa Candelaria de la Frontera

UCSF Candelaria de la Frontera UCSF La Parada Aldea Bolaños UCSF San Antonio Pajonal UCSF Santiago de la Frontera UCSF Santiago la Frontera SA Las Piletas UCSF Santiago la Frontera SA Santa Cruz

Metapán

UCSF Metapan UCSF San Jerónimo (Metapán) UCSF Jose Ingenio (Metapán) UCSF San Juan Las Minas (Metapán) UCSF Belen Guijat (Matapán) UCSF Masahuat SA La Joya UCSF Santa Rosa Guachipilin UCSF Santa Rosa Guachipilin SA El Despoblado

Santa Ana

UCSF Casa del Niño UCSF Dr. Tomás Pineda Martinez UCSF El Palmar UCSF Natividad UCSF San Miguelito Santa Ana UCSF San Rafael (Santa Ana) UCSF Santa Barbara UCSF Santa Lucia (Santa Ana) UCSF Texistepeque UCSF Guarnecia UCSF San Miguel Texis

ZONA ORIENTAL

Micro-redes de salud = 20

SAN MIGUEL

UCSF Ciudad Barrios UCSF Ciudad Barrios El Porvenir UCSF Ciudad Barrios El Porvenir SM UCSF Guanaste UCSF Ciudad Barrios San Matías UCSF Ciudad Barrios Llano El Angel UCSF Ciudad Barrios San Cristobal UCSF San Luis De La Reina UCSF San Luis De La Reina SM San Antonio UCSF San Luis De La Reina EL Ostucal UCSF Carolina UCSF Carolina SM La Ceibita UCSF Carolina SM Rosa Nacaspilo UCSF San Gerardo UCSF San Gerardo SM La Laguna UCSF San Gerardo SM San Jerónimo UCSF Sesori UCSF Sesori SM Managuara UCSF Sesori SM El Tablon UCSF Sesori SM San Sebastián UCSF San Antonio SM UCSF San Antonio SM San Marcos UCSF San Simón MO El Corrizal UCSF San Simón MO Las Quebradas UCSF Chapeltique, SM, La Trinidad

UCSF Dr. Roberto A. Carías (Las Presitas) UCSF San Antonio Silva UCSF San Miguel El Tocomatal UCSF San Miguel Martin Zaldívar UCSF Tierra Blanca (Chirilagua) UCSF Chirilagua UCSF San Pedro Chirilagua UCSF Chirilagua El Cuco

Dr. Roberto A. Carías Ciudad Barrios San Miguel UCSF San Miguel UCSF San Miguel Milagro de la Paz UCSF San Miguel El Niño UCSF San Miguel Miraflores UCSF San Miguel SM Las Brisas UCSF San Miguel Espiritu Santo UCSF Yayantique Lu UCSF Yayantique Lu Los Amates UCSF El Pastor

El Zamorán

UCSF San Miguel El Zamorán UCSF San Carlos San Miguel UCSF Uluazapa UCSF Comacarán UCSF Yucuainquin

Chinameca

UCSF Chinameca UCSF Chinameca Las Marias UCSF Chinameca Las Placitas UCSF Chinameca El Jocote Dulce UCSF Sanbuenaventura UCSF Las Charcas (San Buena) UCSF Lolotique UCSF Quelepa UCSF Moncagua UCSF Moncagua Tongolona UCSF Moncagua El Platanar UCSF Chapeltique UCSF Jucuapa

Considerations for LMIC adapted technologies

o Packaging materials (more eco friendly and aware of space limitations)

o Temperature requirements of kits/tests and expiration dating when arriving to destinations.

o Awareness of the types of accessories and disposables that will be needed to run the test. (Cost prohibitive or even access to these types of products).

Considerations for LMIC adapted technologies

o Level of expertise required for laboratory and availability of these technicians and test must allow room for error

o Specimen storage requirements.

o Product storage and handling requirements (space required for storage and temperature requirements)

Distribution and Data

• How will country obtain technical support if there is lack of local presence (direct or via distributor)

• Technical support in local language and via app, phone, email (doable for local setting limitations)

• Patient tracking and data entry to national data banks. Manual systems make it a challenge

• Equipment or systems that can interact with local methods of tracking patients or working within systems where there is zero patient tracking

Target Product Profile

• Test robustness requirement

• Clinical sensitivity and clinical specificity that is close to gold standards offered in the developed world

• Consideration of technology/platform that will be used in the settings in need (Electrical and water requirements and environmental considerations)

• Internal and external quality assurance/quality control and calibration requirements

• Ideally >12 months expiration dating from when it arrives in country

• Data output, access, security, storage and communication (connectivity requirements)

• Regulatory requirements must be met

• Availability to work with partners of patient/medical staff educational material (Know your client)

• Self Sampling as an option for use with product

• Manufacturers should identify methods to get it to a cost of $5.00 per test

Challenges for the Manufacturer

• Having secure funding that will balance the investment risk

• Procurement mechanism, most companies sell via distributors and have limited local presence and distributors (might not have full control on how product is sold)

• For cost effectiveness in manufacturing, large volumes must be procured

• Lack of personal within manufacturers with expertise for issues that arise in the markets where testing should be performed. (Know your client setting)

Global and Regional Health community Role

• Time to act, manufacturers wish things to move faster and health programs move slower • This is changing with the call for Action to Eliminate Cervical

Cancer

• Partners must ensure commitment towards sustainability

Reality in LMIC

• Initial implementation costs might be high, but there is always support from partners on this investment. So many lose if not everything is set in place

• If there is a technology failure, impact patient results

• Understand negative outcome of not focusing on success of programs, when just focusing on sales

• A new market with huge potential for growth

WE CAN OVERCOME CHALLENGES

LEARN FROM OUR EARLY MISTAKES

Share our experience to other LMIC

No one solution

Challenges are very common, regardless the country

IT CAN BE DONE

THE TIME IS NOW

Saving women,

Shaping the future

Thank you