Concurrent Session 09: Implementation of Cervical Cancer ... · Associate Director, Office of Global Public Health. Director, ... Addis Ababa: “Efforts to address barriers to cervical

Concurrent Session 09: Implementation of Cervical Cancer

Screening in Low-Resource Settings

Consortium of Universities for Global Health

6th Annual Meeting

March 16, 2018

Laura Rozek, Ph.D.

Associate Professor of Environmental Health, Nutrition and Global Public HealthAssociate Director, Office of Global Public Health

Director, Global Cancer Initiative

University of Michigan School of Public Health

The cancer burden is greatest in low and middleincome countries

http://canceratlas.cancer.org/taking-action/cancer-registries/

Proportion (%) of the regional population covered by high quality cancer registration and high quality complete vital registration of

death low levels in many global areas

Globocan: http://globocan.iarc.fr

Unacceptably high global mortality from cervical cancer burden in LMICs

Speakers Gloria Sanchez, Facultad de Medicina Universidad de Antioquia,

Colombia: Evaluation of quality of healthcare delivery to prevent cervical cancer in low-resource settings

Mesrach Ayalew Kebede, St. Pauls Hospital Millennium Medical College, Addis Ababa: Efforts to address barriers to cervical cancer screening in Ethiopia

Rafael Meza, University of Michigan School of Public Health: HPV self-sampling for cervical cancer screening in indigenous and rural communities in Guatemala

Evaluation of quality of healthcare delivery to prevent cervical cancer

in low-resource settings

Implementation of Cervical Cancer Screening in Low Resource SettingsGloria I. Sanchez MSc, PhD6th Annual CUGH ConferenceNew York, NY, March 16, 2018

Regional disparities of cervical cancer mortality in LACs

Almonte M, Murillo R, Snchez GI, Jernimo J, Salmern J, Ferreccio C, Lazcano-Ponce E, Herrero R. Salud Publica Mex. 2010 Nov-Dec;52(6):544-59.

Introduction

Clinically, or self-collected HPV test is more accurate and detects high-grade cervical disease earlier than cytology

However, many HPV positive women will clear infection soon and donot need immediate treatment

Adequate follow-up of HPV positive women in unorganized settings oflow-middle income countries is challenging

Optimal referral avoids overtreatment and overuse of health careservices

Focus in women with higher risk of disease

Introduction

Evidence of implementation of HPV testing mainly in studies within organized screening settings (Dillner L et al, Int J Cancer 2011).

Scaling-up HPV-based screening in unorganized settings, Low-middle income countries.

Pragmatic trials: High-quality evidence, outcomes relevant to patients and decisions makers, real-life clinical practices.

Colombia: Guidelines for screening with hrHPV testing but not programmatic use of it yet

Opportunity to evaluate the quality of health services for follow-up of screen positive women

Aim To compare under routine clinical conditions of a

opportunistic screening setting the effectiveness to detect CIN2+ and efficiency to reduce CIN2+ and health care utilization of immediate colposcopy (IC), conventional cytology at 6/12 months (RC) and hrHPV testing (HPV) after 2 years follow-up of women with ASC-US cytology

ENROLMENTVISIT

STUDYPOPULATION

20-69 years old women, first time ASC-US cytology, residents of the MetropolitanArea of Medellin, attended routine screening services, of three Healthcare

Management Organizations (HMOs) of Medellin, Colombia

Recruitment by phone invitation (until 3 months after ASC-US Pap)

Eligibility criteria, informed consent, pelvic examination, questionnairessample collection (blood, cervical specimens in STM and cytology)

Randomization

Repeat cytology at 6 and 12 months

Immediate routine colposcopy HC2-HPV triage

2 yearsFOLLOW-UP

Phone calls at 6 and 18 m

Visit to primary site at 12 m

Refer to Colposcopy in any cytology ASCUS

Routine management by health care management and provider organizations

EXIT VISIT (24 months)

All women tested by HC2-HPV/Pap smear. if any positive referred to research colposcopy (One or two biopsies from observed lesions and one at random , If no lesions two random biopsies)

Routine management

Both negative Any ASC-US Positive Negative

Routine colposcopy

CIN2 CIN1

Follow-up with Pap smear

6/12m

Routine screening

Treatment

Study Design

Total ASC-US referred

7,866

Assessed for eligibility

4,509

Ineligible for invitation (3,357): Age not 20 to 69 years: 856 Residence outside the study area: 513 ASC-US cytology more than 3 m old: 1,988

Randomized2,661

Excluded (1,845): No meeting inclusion criteria: 1,134 (407

reported, previous abnormal cytology, 271 had a clinical, condition, 172 had colposcopy appointment , 123 were pregnant and 161 other reasons)

Declined to participate: 702 Deferred: 12

Immediate colposcopy (IC)882

Repeat cytology at 6/12 m (RC)890

hrHPV triage (HPV)889

100% to routine colposcopy Routine colposcopy if routine cytology ASC-US Routine colposcopy if hrHPV+

had at least one ASC-US cytology (n=125)

NILM only (n=410) without retrieved records (n= 350)

unknown result (n=4) hrHPV+ rate (361/887): 41%

At least one ASC-US cytology (n=217)

NILM only (n=485) without retrieved records (n=178) unknown result (n=10) ASC-US rate (217/702): 31%

FOLLOW-UP

Median (IR) time: 23 (22-25) months

ALLOCATION

had 1 colposcopy 772/882 (88%) had 1 histology 492/772 (64%)

889890882ANALYZEDITT analysis

ENROLLMENT Jan 2011-2014

had 1 colposcopy (372/890): 42% had 1 histology 271/372): 73%

had 1 colposcopy (462/889):52% had 1 histology: (313/462): 68%

At least one ASC-US cytology (n=128)

NILM only (n= 455) without retrieved records (n=291) unknown result (n= 8)

Consort

Data Collection for community-based Diagnoses

1,726 pathology reports 898 biopsies, 697 other specimens and 131 both 1.320 of follow-up and 406 of exit visit

2,301 slides corresponding to 1,017 (59%) reports reviewed by 2 expert pathologists

Only 646 cervical biopsies with unique specimens were included in the final analysis

Cumulative detection of Reviewed CIN2+ in different Health Management Organizations

Logrank test P= 0.26

Logrank test P= 0.12

HPV (n=889)

IC (n=882)

RC (n=890)

ASC-US (n=217)

NLIM (n=485)

hrHPV+ (n=361)

hrHPV- (n=526)

A B

C

Use of Colposcoy by arm and triage test resultdurin 24 months of women with ASCUS cytology

Comparison of total Use of Colposcoy by armand triage test result

Arm / Test # Womenby test result

# Womenattending

Colposcopy%

RC Arm (N= 890)ASCUS 217 183 84,33*ASCUS 485 199 41,03**W/o cytology 188 70 37,23

HPV arm (N=889)Positive 361 334 92,52*Negative 526 127 24,14**W/o Test 2 0

*Chi-squared test P = 0,0019 ASCUS vs. HPV positive**Chi-squared test P < 0,0001 ASCUS vs. HPV Negative

Interpretations of community and Experts histology diagnosis of cervical biopsies

Bhapkar test p-value < 0.001 , Unweighted Kappa= 0.320, 95% confidence interval: 0.275-to 0.365N= 646 diagnostic reports with diagnosis obtained in unique cervical specimens

Negative CIN1 CIN2 CIN3 Cancer TotalNegative 206 20 27 1 0 254Row% 81 8 11 0 0 100CIN1 72 91 104 36 1 304Row% 24 30 34 12 0 100CIN2 5 6 22 38 1 72Row% 7 8 31 53 1 100CIN3 0 0 2 14 0 16Row% 0 0 13 88 0 100Cancer 0 0 0 0 0 0Row% --- --- --- --- --- ---Total 283 117 155 89 2 646

Community Experts

Tabla original

CommunityExperts

NegativeCIN1CIN2CIN3CancerTotalNegativeCIN1CIN2CIN3Cancer

Negative20620271025420620271

Row%81811001007291104361

CIN172911043613045622381

Row%243034120100214

CIN256223817200000

Row%7831531100

CIN300214016

Row%0013880100

Cancer000000

Row%------------------

Total283117155892646

Bhapkar test p-value < 0.001

Agreement

Para 3 categoras: 0, 1 y 2+

By record (n=646)02

AgreementKappa indexAgreementKappa

%(95% CI)k(95% CI)agreeliagrelsagrekliklsk

Global58(54-62)0.39(0.34-0.44)57.8947454.0517361.644410.39035040.34235140.4383493

IC54(48-61)0.35(0.27-0.42)54.2986447.7134760.736930.34699550.26915040.4248406

RC59(53-66)0.41(0.33-0.49)59.3301452.5603665.763140.41089670.32680840.4949849

ASC-US55(45-65)0.38(0.26-0.50)55.4347845.2637165.170190.3806240.26020090.501047

HPV60(54-66)0.41(0.33-0.50)60.1851953.5339366.48050.41363640.3275810.4996917

hrHPV+57(49-64)0.39(0.29-0.48)57.0552149.3799964.405550.38540260.28710980.4836954

By case (n=565)



Global58(54-62)0.40(0.35-0.45)58.4070854.2995462.401080.40143450.35003860.4528303

IC53(46-60)0.33(0.25-0.41)52.7363245.8479359.522070.33401930.25350620.4145323

RC61(49-71)0.44(0.30-0.58)60.8108149.4195271.135080.44114580.30150640.5807853

ASC-US63(56-69)0.45(0.36-0.54)62.702755.5421369.346470.45160460.36042690.5427823

HPV60(53-67)0.43(0.33-0.52)60.335253.0238767.212240.42532220.33088720.5197571

hrHPV+56(48-65)0.38(0.27-0.49)56.2547.598164.537690.37858690.26663290.4905409

Reproducibility between Community and Expert Pathologists histological Diagnosis

N= 646 diagnostic reports with diagnosis obtained in unique specimens. IC = immediate colposcopy, RC= repeat cytology, HPV: Human Papillomavirus. *Unweighted Kappa estimated using 3 categories (Negative, CIN1 and CIN2+).ASC-US: Atypical Squamous Cells of Undetermined Significance

% (95% CI) k (95% CI)Global 58 (54-62) 0,39 (0,34-0,44)IC arm 54 (48-61) 0,35 (0,27-0,42)RC arm 59 (53-66) 0,41 (0,33-0,49)

ASC-US 55 (45-65) 0,38 (0,26-0,50)HPV 60 (54-66) 0,41 (0,33-0,50)

hrHPV+ arm 57 (49-64) 0,39 (0,29-0,48)

Agreement Kappa index*

Tabla original

LocalReviewed

NegativeCIN1CIN2CIN3CancerTotalNegativeCIN1CIN2CIN3Cancer

Negative20620271025420620271

Row%81811001007291104361

CIN172911043613045622381

Row%243034120100214

CIN256223817200000

Row%7831531100

CIN300214016

Row%0013880100

Cancer000000

Row%------------------

Total283117155892646

Bhapkar test p-value < 0.001

Agreement

Para 3 categoras: 0, 1 y 2+

By record (n=646)02

AgreementKappa index*AgreementKappa


Global58(54-62)0.39(0.34-0.44)57.8947454.0517361.644410.39035040.34235140.4383493

IC arm54(48-61)0.35(0.27-0.42)54.2986447.7134760.736930.34699550.26915040.4248406

RC arm59(53-66)0.41(0.33-0.49)59.3301452.5603665.763140.41089670.32680840.4949849

ASC-US55(45-65)0.38(0.26-0.50)55.4347845.2637165.170190.3806240.26020090.501047

HPV60(54-66)0.41(0.33-0.50)60.1851953.5339366.48050.41363640.3275810.4996917

hrHPV+ arm57(49-64)0.39(0.29-0.48)57.0552149.3799964.405550.38540260.28710980.4836954

By case (n=565)



Global58(54-62)0.40(0.35-0.45)58.4070854.2995462.401080.40143450.35003860.4528303

IC53(46-60)0.33(0.25-0.41)52.7363245.8479359.522070.33401930.25350620.4145323

RC61(49-71)0.44(0.30-0.58)60.8108149.4195271.135080.44114580.30150640.5807853

ASC-US63(56-69)0.45(0.36-0.54)62.702755.5421369.346470.45160460.36042690.5427823

HPV60(53-67)0.43(0.33-0.52)60.335253.0238767.212240.42532220.33088720.5197571

hrHPV+56(48-65)0.38(0.27-0.49)56.2547.598164.537690.37858690.26663290.4905409

Cumulative detection of CIN2+ by Community and Expert Pathologists diagnosis by period and arm

1.47 1.46

2.590.11

1.35

0.22

0.79

0.67 0.341.13

2.36

1.24

0

2

4

6

8

10

12

IC(N=882)

RC(N=890)

HPV(N=889)

2 ye

ar C

umul

ativ

e De

tect

ion

of C

IN2+

by

Com

mun

ity P

atho

logi

sts (

%)

6.92

3.03

6.52

0.23

2.47

0.56

1.13

1.46

0.56

3.51

4.492.59

0

2

4

6

8

10

12

IC(N=882)

RC(N=890)

HPV(N=889)

2 ye

ar C

umul

ativ

e De

tect

ion

of C

IN2+

by

Exp

ert P

atho

logi

sts (

%)

4.6 x 2.0x

2 p value = 0.004

2 p value = < 0.001

2.5x

Expertpathology

result

TotalN

With No LEEP (%)

With LEEP (%)

Negative 971 960 (98.9) 11 (1.1)

CIN1 172 163 (94.8) 9 (5.2)

CIN2 160 111 (69.4) 49 (30.6)

CIN3/AIS 48 18 (37.5) 30 (62.5)

Treatment among women of the ASCUS-COL trial with biopsies given the diagnosis

of expert pathologists

Period on LEEP/LLETZ tissue specimens during the 24 months follow-up of 2.661 women of the ASCUS Trial

PERIODIC arm RC arm HPV arm Total by

periodN % N % N %

Enrollment 14 (28,5) 17 (34,6) 18 (36,7) 49

Follow-up 6 (25,0) 6 (25,0) 12 (50,0) 24

Exit 14 (50,0) 10 (35,7) 4 (14,2) 28

Total by arm 34 33 34 101

FET P= 0.03 Enrollment vs exit of IC vs HPV arm

Enrollment period (first six months for IC and HPV, and first 12 months for RC).

Worst histopathology result of biopsy by local and expert pathologists

Julia C. Gage Juan Felix, Mario Morales, Mauricio Maza, Karla Alfaro, Philip E. Castle, Jane Kim, Rachel Masch, Proma Paul, Miriam Cremer. Accuracy of Histopathology in a Regional Cervical Cancer Screening Program in El Salvador

Conclusions

Under routine conditions of health care services serving women with ASC-US cytology of Medellin, compared with strategies that include colposcopy or repeat cytology, the strategy that included HPV testing:Detected more cases of CIN2+ at enrolmentSignificantly reduced more health care utilization

The strategy of immediate colposcopy presented the highest underdiagnosed of CIN2+

The underdiagnosed pathology had impact on the proper treatment of women with CIN2+

Final considerations

Quality and delivery of services in unorganized screening settings are heterogeneous

Assessment of quality of services for follow-up of screening positives should be a requirement for implementation of new screening technologies

Need for external assessment of Quality of Pathology Education and enforcement for the adequate use of guidelines is also

highlighted

Comparison of immediate colposcopy, repeat conventional cytology and hrHPV testing for the management of ASC-US cytology in routine health services of

Medellin, Colombia:

The ASCUS-COL Trial: A randomized pragmatic trial

Sponsor

Primary research site

Secondary Research sitesUnidad Video Diagnstica De La Mujer S.A.S

Competing interests: The HC2-hrHPV DNA test was donated by QIAGEN.

Gloria I. Sanchez, MSc, PhDPrincipal Investigator

Research TeamMark Stoler, MD Phil Castle, PhD Peter Sasieni, PhD Maribel Almonte, PhD

Rolando Herero, MD, PhD

Maria Cecilia , MD,PhD candidate

Armando Baena , MSc, PhD, current postdoct at IARC

Maria C Agudelo* MD, Armando Baena, PhD* Tatiana Ramirez*, Melisa Castaeda. Infection and Cancer Group School of Medicine, University of Antioquia, Medellin, Colombia.

David SuescunLaboratory of Pathology Suescun

Carlos BuitragoClinica Soma, Medellin, Colombia

Juan C. OchoaVideodiagnostica de la Mujer, Medellin, Colombia

Marcela Riveros, MDDepartment of Pathology, Hospital Pablo Tobon Uribe, Medellin, Colombia

Guadalupe Posada, MD, Luis Jaime Gomez, MDDinamica IPS, Medellin, Colombia,

*Recipients of Fellowships for doctoral training from COLCIENCIAS

Carolina Lopez MD, Jorge Castao MD, Miguel Roldan. MD, Mauricio BorreroDepartments of Pathology, and Ginecology and Obstetrics, School of Medicine, University of Antioquia, Medellin, Colombia.

EFFORTS TO ADDRESS BARRIERS TO CERVICAL CANCER SCREENING IN ETHIOPIA

Mesrach Ayalew, MPHResearch Investigator and Lecturer

St. Pauls Hospital Millennium Medical College (SPHMMC)Addis Ababa, Ethiopia

28

Outline

Cervical cancer; incidence and mortality rates CC Screening in Ethiopia, SPHMMC Findings from VIA screening- SPHMMC Why self-collected samples?

Pilot in Addis Ababa; Self collected CC screeningData collection device, Results

Challenges and Opportunities Future directions

Findings from a focus group discussion Potential impact

29

The ProblemHigh incidence of cervical cancer

high mortality from cervical cancer


32

Cervical Cancer Incidence and Mortality Rates

0

5

10

15

20

25

30

Incidence Mortality

Per 1

00,0

00 w

omen

EthiopiaGuatemalaUSUKCanada


33

In a large number of countries, the majority of women have never had a pelvic exam. This proportion is largest in Malawi, Ethiopia and Bangladesh, where more than 90% of women report that they have never had a pelvic exam.

PLOS Medicine, 2008

CC screening

34

Single visit approach (VIA), cytology Health facilities, NGO, target groups (30-45), community mobilization (HEW)

>90% of cervical cancer is caused by HPV High-risk HPV types 16 (55.7%), 18 (8.2%), 56 (8.2%), 45 (4.1%), 39 (2.5%), 52 (1.6%), 31 (1.6%), 35 (1.6%), 58 (0.8%),

33 (0.8%), 59 (0.8%) were observed as single multiple infection in south western Ethiopia (A. Bekele et al, 2010)

In rural parts of Ethiopia the most common genotypes of HPV are 16 (24.4%), followed by 52 (11.6%), 56 (10.5%) and 31 (10.5%) (Sami-Ramzi et al, 2014)

35

Screening protocol - SPHMMC

Cervical cancer

screeningSCJ

PAP smear

Negative

Re-test in 5 years

Positive

LEEP cryotherapy

Follow-up after one yearRe-screening

36

191 (12 %) of the women screened for VIA had positive results and 10 (0.6%) women with lesions suspicious for cancer. No information on HPV rates Limited information on follow-up care through VIA screening

VIA screening at SPHMMC

Based on logistic regression models:

women with lower education status, higher parity, and living outside Addis Ababa have higher odds of a positive VIA result ; adjusting for all other variables.

Odds of positive VIA result decrease by 6% for one year increase in age at first intercourse; adjusting for all other variables.

Kebede et al (in progress)

Barriers to screening

37

Lack of knowledge about the need for cervical screening, fatalistic attitudes about cervical cancer

Availability and convenience

Embarrassment or shame about having a pelvic exam, as well as fear of the screening procedure

Previous bad experience

Why study self-collection?

Self-collection has never been tested in Ethiopia, effective in other locations

Screening services may not be available or, when available, are inaccessible, underused, or unreliable. (informal FGD)

Supplements the static approach (VIA) and hence increases the screening coverage

Skepticism about acceptability, stigma

High rates of interest and participation (results from a pilot study), privacy Evidence to inform policy making

Why..Pilot in Addis Ababa Cross sectional design, women sampled from 3 kebeles in Addis Ababa

Women ages 20-60 recruited by health workers

Structured, quantitative interview Understanding of HPV/cervical cancer Health beliefs Limited health history

Interviews conducted in Amharic by nurses

Data Collection Devices

Interview data collected through Qualtrics app

HPV samples collected using HerSwab kits Will be used to test for HPV (14 high risk types: 16, 18, 31,

33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68)

Samples to be tested at SPHMMC

Women will be called to receive results

All women with positive results will be encouraged to attend VIA screening clinic

Preliminary Results 206 women, 206 samples (July 2017); Average age: 39.8 years (range 18

65)

16% Muslim, 73% Orthodox, 11% Protestant

11% had a previous Pap/VIA, 4% told they had an abnormal test (40% dont remember)

Of those who did not have a Pap/VIA or did not remember: 53% of the women reported no reason/never thought about it 34% said they did not know or did not think they needed the test

Preliminary Results Majority (81%) of women believe cervical cancer is very or extremely

serious, 78% think cervical cancer is curable with early detection and treatment (14% did not know)

Only 40% of the women preferred to do the test at home prior to the self swab

POST test Majority (80.6%) reported the self-test comfortable and very comfortable,

and 90.3 % said it was easy and very easy to do the swab.

Majority (82%) preferred to test at home after the self-swab

Why study.self collection

FGD (CHW, Women in the community both urban and rural)

Focused on Knowledge about cervical cancer Knowledge source Cervical cancer screening

experience Screening barriers Future self screening Screening motivation Support system and etc.

Urban / Rural Previous experience Availability of VIA Having children/not

having children Younger / older

43

Challenges for CC Screening in Ethiopia

Issues with the processing of samples/tests

Infrastructure, expertise, organization

Challenges with returning results, and follow-up of positive tests

Complicated landscape with many small NGOs

No screening modality will be effective unless these issues are addressed

Opportunities

HEP ;Deeply rooted in communities, providing primary level preventive activities to household members

15 packages

Key players : HEW, Model families, HDA (30 HH), women focused HDA

45

Future directions

46

Identify the individual stakeholders in the community (HDA)

Laboratory support

Large scale promotional activities

Phased approach (Mobile service then move to integrated services)

Conduct both HPV and VIA screening to validate results for community

stakeholders

Maintaining effective links

47

Counseling (HEW, trained HDA) and provision of Her Swab kit (weekly HDA meet ups-Home)

Transport of self collected samples and reports (scheduled once a week) (Laboratory to HC)

Women collect report and get treatment when indicated at the HC

Tracking system for client who do not attend treatment or didnt collect results (HEW-Home visit or HDA network meet ups)

Collection of screening data (HIS) and feedback from clients

Potential Impact Generating evidence to inform local and regional cervical cancer prevention

and control planning

Enabling cervical cancer screening in all Ethiopian women Make HPV self-collection a reality Set up community programs to help facilitate self-swab HPV screening

Empowering women in Ethiopia to take care of their health and understand risk

Further characterize HPV infection types in Addis

49

Thank you

HPV self-sampling for cervical cancer screening in indigenous and rural

communities in Guatemala

Rafael MezaAssociate Professor

Department of EpidemiologyGlobal Public Health

University of Michigan

[email protected]; @meza_rafa

50

mailto:[email protected]

Cervical Cancer Incidence and Mortality Rates

0

5

10

15

20

25

Incidence Mortality

Per 1

00,0

00 w

omen

*

Guatemala

US

UK

Canada

30-35% of annual female cancers at the National Cancerology Hospital (INCAN) in 2013

Source: INCAN cancer registry

* Luciani et al 2013

Chart1

22.35.78.87.5

12.53.132.4

Guatemala

US

UK

Canada

Per 100,000 women*

Sheet1

GuatemalaUSUKCanada

Incidence22.35.78.87.5

Mortality12.53.132.4

To update the chart, enter data into this table. The data is automatically saved in the chart.

Globocan 2012

Cervical Cancer Screening in Guatemala

*

* American Cancer Society 2011


DHS 2014-2015, women ages 15-49 Ever Pap - 49.8 %

Ethnicity Non-indigenous women - 54.2% Indigenous women - 43.5%

Urbanicity Urban 52.8% Rural 46.9%

Access is only part of the equation

Quality

Follow-up

Treatment


HPV self-sampling Pap smears and VIA may not be the

most effective method for preventing cervical cancer in indigenous and rural populations in Guatemala

Is HPV self-collection an acceptable, and perhaps more effective, alternative to universal Pap or VIA screening in this setting?

A priori answer: Yes, but we need to demonstrate it

HPV testing and self-collection >90% of cervical cancer is caused by HPV -70% by

types 16 and 18

Sensitivity: >90% for HPV Higher sensitivity than Pap smears (improved w/ positive HPV test) If HPV test is done first, will miss lesions not related to HPV HPV tests have been shown to have higher sensitivity than Pap for CIN II,

III, and cancerous lesions (relative detection rate of 1.3-2)

Specificity: Negative results signify minimal risk of disease in next 10 years

Self-collection as effective and clinician collection

Limitations: cost and infrastructure requirements CareHPV, Hibribio, Genexpert

Why more studies of self-collection? Self-testing works! Widely

acceptable. But,

Few studies among rural/indigenous communities in Latin America context matters

Skepticism about acceptability STD, stigma, privacy

Pilot Summer 2015Santiago Atitlan, Guatemala

Approximately 40,000 residents Primary language: Tzutujil Average daily income: 4 USD Over 80% have at most primary

education

Methods Cross sectional design,

women proportionately sampled from 6 urban and 3 rural neighborhoods

Women ages 18-60 recruited by community health workers

87% of interviews conducted in Tzutujil, 13% in Spanish

Data Collection Devices Interview data collected through

Qualtrics app

HPV samples collected using HerSwabkits

Samples shipped to Guatemala City bi-weekly for testing

Women called 10 days after collection to receive results

All women encouraged to attend local VIA screening clinic

HPV Testing Testing done at independent, non-profit lab

Asociacion de Salud Integral

Tested for 28 types of HPV 13 high risk types (known cervical cancer risk factors): 16, 18,

31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 68 15 low risk types

Expensive

Results: Self-Collection

202 women completed survey 95% of women who began the survey completed the survey (no

major issues answering sensitive questions)

93% of women surveyed wanted to take self-swab test 88% eligible (179 women)

100% of the women who took the test were willing to take it again

91% of women tested called to get their results

Gotschlich et al, JGO 2017

Results: HPV Testing

21% tested positive for HPV17% tested positive for high-risk HPV

Gotschlich et al, JGO 2017

Discussion/Conclusions < 15% of women had previously heard of HPV

The self-swab test was found to be highly acceptable: -78% of women found it comfortable-90% found it easy-100% were willing to use as CC screening method

Over 80% of women said that they preferred to be screened in their home with a self-swab kit over being screened at a doctors office

Multi-Ethnic Longitudinal Study 2016-2017

Does HPV test result affect follow-up rates?

Two communities: Santiago Atitlan and Livingston Izabal

Implemented low-cost test at local lab

Follow women

Livingston Izabal, Guatemala

Approximately 60,000 residentsMix of Garifuna, Ladino and Qeqchi ethnicitiesAverage income: 10 USD50% have completed at least some secondary school

Recruitment

Santiago Atitlan 500 women 10 semi-structured surveys Surveys/interviews in

Spanish and Tzutujil

Livingston Izabal 449 women

40% Indigenous, 30% Garifuna, 30% Ladino

11 semi-structured surveys

Surveys/interviews conducted in Spanish, Garifuna, and Qeqchi

Murchland et al, under review

Results: Self-sampling

Santiago 2015 Santiago 2016 LivingstonWilling to self-collect* 93% 94% 53%

Collected sample 179 497 169Comfortable 78% 81% 87%Easy 90% 85% 87%Would prefer self-sampling over pap**

91% 97% 91%

Willingness to self-collect as regular screening

100% 99% 100%

* Age eligible women; ** among women who collected sample

Murchland et al, under review

Results

Lower willingness to self-collect in Livingtson

Literacy was significantly higher in women willing to self-collect adjusted prevalence ratio, 1.45 [1.07-1.95]

Neither ethnicity, history of screening, nor reproductive history were associated with the willingness to self-collect

Results HPV testing

Hybribio 13 (low-cost test) 19% positive samples for high-risk HPV* No significant differences between the two

communities Women were called to return their results Provided free access to follow-up pap/VIA to all

* Genotyping pending

Discussion

Generating evidence to inform local and regional cervical cancer prevention and control planning

Enabling cervical cancer screening for indigenous/rural women-Make HPV self-collection a reality-Set up community programs to help facilitate self-swab HPV screening

Follow-up and access to treatment remain a challenge independently of screening modality

Challenges for CC Screening in Guatemala

Access for indigenous and rural communities remains limited Issues with the processing of samples/tests

Infrastructure, expertise, organization Need for a low-cost widely available test Challenges with returning results, and follow-up of positive tests

Complicated landscape with many small NGOs, plus a few large ones and the government providing care

No screening modality will be effective unless these issues are addressed

Status of CC Prevention in Guatemala

National Cervical Cancer Prevention Plan - 2014 CareHPV Guatemala Scale-Up trial

MSPAS, Instancia por la Salud, PATH ~80K HPV tests in four urban districts

HPV -> VIA -> Thermocoagulation MSPAS will continue, but no major plans for expansion yet

HPV vaccination Starting Challenge of implementation

Other settings

Southern Thailand (preliminary data) Buddhist and Muslim women

High acceptability: >95%

Even higher among Muslim women, who have lower screening rates (ever pap 92% vs 73%)

100% preference over papCollaboration with Laura Rozek, Hutcha Sriplung (PSU)

Acknowledgments Anna Gottschlich Audrey Murchland and Kristin Bevilacqua Carlos Mendoza & Alvaro Rivera, INCAP Michael Dean, NCI Gina Ogilvie, UBC Research Team:

Edwin Grajeda Andres Pineda Andree Sandoval Christian Alvarez Regina Garca / Amanda Agustn

Community Health Workers Our participants and their communities UM Office of Global Public Health, MCubed, CIHR CUGH, Laura Rozek, panelists

Concurrent Session 09: Implementation of Cervical Cancer Screening in Low-Resource SettingsSlide Number 2Proportion (%) of the regional population covered by high quality cancer registration and high quality complete vital registration of death low levels in many global areasUnacceptably high global mortality from cervical cancer burden in LMICsSpeakersEvaluation of quality of healthcare delivery to prevent cervical cancer in low-resource settingsRegional disparities of cervical cancer mortality in LACsIntroductionIntroductionAimStudy DesignConsortData Collection for community-based DiagnosesCumulative detection of Reviewed CIN2+ in different Health Management Organizations Use of Colposcoy by arm and triage test result durin 24 months of women with ASCUS cytologyComparison of total Use of Colposcoy by arm and triage test resultInterpretations of community and Experts histology diagnosis of cervical biopsiesReproducibility between Community and Expert Pathologists histological Diagnosis Cumulative detection of CIN2+ by Community and Expert Pathologists diagnosis by period and arm Treatment among women of the ASCUS-COL trial with biopsies given the diagnosis of expert pathologistsPeriod on LEEP/LLETZ tissue specimens during the 24 months follow-up of 2.661 women of the ASCUS TrialWorst histopathology result of biopsy by local and expert pathologists ConclusionsFinal considerationsComparison of immediate colposcopy, repeat conventional cytology and hrHPV testing for the management of ASC-US cytology in routine health services of Medellin, Colombia:Slide Number 26EFFORTS TO ADDRESS BARRIERS TO CERVICAL CANCER SCREENING IN ETHIOPIAOutline Slide Number 30The ProblemSlide Number 32Slide Number 33CC screening Slide Number 35VIA screening at SPHMMCBarriers to screening Why study self-collection?Why..Pilot in Addis AbabaData Collection DevicesPreliminary ResultsPreliminary ResultsWhy study.self collection Challenges for CC Screening in EthiopiaOpportunities Future directions Maintaining effective links Potential ImpactSlide Number 49HPV self-sampling for cervical cancer screening in indigenous and rural communities in GuatemalaSlide Number 51Slide Number 52Cervical Cancer Screening in GuatemalaCervical Cancer Screening in GuatemalaCervical Cancer Screening in GuatemalaHPV self-sampling HPV testing and self-collectionWhy more studies of self-collection?Pilot Summer 2015MethodsData Collection DevicesHPV TestingResults: Self-CollectionResults: HPV TestingDiscussion/ConclusionsMulti-Ethnic Longitudinal Study 2016-2017Livingston Izabal, GuatemalaSlide Number 68RecruitmentResults: Self-samplingResultsResultsDiscussionChallenges for CC Screening in GuatemalaStatus of CC Prevention in GuatemalaOther settingsAcknowledgments Slide Number 78Slide Number 79

Documents

Concurrent Session 09: Implementation of Cervical Cancer ... · Associate Director, Office of Global Public Health. Director, ... Addis Ababa: “Efforts to address barriers to cervical