Closing the Gap Between Identification and Treatment of Cervical Abnormalities in Lima, Perú Through Integraton of Pocket Colposcopy, Telemedicine and Visual Counseling
Phase: NA
Conditions: Cervical Cancer, HPV Infection, HIV Infections
Sponsor: Duke University

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Closing the gap between identification and treatment of cervical abnormalities in 
Lima, Perú through integraton of pocket colposcopy, telemedicine and visual 
counseling 
 
Document Date: 10/10/2023 
 
NCT05340322 
 

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Randomized Controlled Trial for the evaluation of pocket colposcopes and visual 
counseling for improvement in follow-up and treatment of HPV positive women in 
Peru: HOPE treatment trial. 
 
I. 
BACKGROUND 
Globally each year, there are approximately 570,000 new cases of invasive cervical 
cancer (CC) and 300,000 cervical cancer-related deaths. More than 90% of those deaths 
occur in low- and middle-income countries (LMICs)1. The discovery of the human 
papilloma virus (HPV) as the etiological factor for CC has opened up several opportunities 
for prevention, screening, and therapy2. Currently, there are HPV vaccines available 
(Gardasil, Gardasil 9, and Cervarix) which are prophylactic in nature and derived from 
adjuvanted L1-based virus-like particles of HPV, and these have proven to be very safe 
and efficacious in preventing cervical cancer3. However, vaccine coverage is still limited, 
especially in those countries with the higher burden of disease4. Cytology-based detection 
programs have failed to reduce the incidence of CC in most countries since they are 
complex to implement adequately, and the cytological method, the Papanicolaou (PAP), 
has limited sensitivity and low reproducibility. New screening strategies have appeared, 
especially for LMICs. Visual inspection with acetic acid (VIA) for example, uses 5% acetic 
acid applied to the cervix. With this procedure, the abnormal epithelium (dysplastic) turns 
white and can be detected with the naked eye. However, the sensitivity of VIA is similar 
to a Pap smear and varies among evaluators5,6. Most CC cases are caused by persistent 
infection with high-risk human papillomavirus (hr-HPV) and disease progression from 
HPV infection to micro-invasive cervical cancer is typically slow (over a decade or 
more)7,8,9. Another alternative for the screening recommended by the World Health 
Organization (WHO) is the detection of hr-HPV DNA starting at age 30 and regularly 
afterwards ever three to five years1,10,11. Studies have shown that molecular HPV tests 
are more effective than VIA and PAP.12,13 Some countries, such as Australia, with well-
established high-quality Pap smear programs have changed their programs to molecular 
HPV testing.  
There have been significant global efforts to ramp up screening rates to facilitate early 
identification of cervical cancer and its precursors. However, screening is not enough. 
The traditional approach for following up screen-positive woman includes a visit to a 
referral setting to undergo a confirmatory test which typically needs to be performed by 

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an expert gynecologist, who will visualize the cervix directly (VIA), or, if available, with a 
colposcope, which is an expensive low-power microscope. If an abnormality is found, it 
is biopsied and submitted for pathology. A positive diagnosis is available weeks later and 
requires yet another visit for treatment. Unfortunately, in LMICs, there are often not 
enough expert gynecologists, colposcopes, or treatment equipment, and a woman may 
come for the first visit, but may not necessarily understand the importance of returning for 
results or completing the treatment cascade. In these cases, the opportunity of saving her 
from cervical cancer is lost. 
Recognizing these barriers, WHO has endorsed recommendations for a simple screen-
and-treat strategy, acknowledging that increased access to treatment with simpler 
protocols may result in overtreatment.  In May 2018, WHO Director-General, Dr. Tedros 
Ghebreyesus, announced a call to action to eliminate cervical cancer globally14. However, 
unless we can ensure we have the means for accurate screening, affordable treatment, 
technology that does not require an expert gynecologist, and education for women that 
engages them in the process so that they understand the importance of completing the 
treatment cascade, we will not succeed in the goal of elimination. 
In this study, we propose the implementation of a new low-cost technology, the Pocket 
Colposcope, as a tool to improve the diagnostic capabilities for cervical cancer screening 
and treatment of non-expert health providers in Peru, coupled with improved counseling 
to enhance the women’s experience during the examination and to increase adherence 
to the completion of care. 
 
1.1 Cervical Cancer in Peru 
Peru is a Latin American country with a population of 32 million, of which approximately 
11 million are women 15 years and older. In Peru, one woman dies every five hours from 
cervical cancer. Annually, it is estimated that at least 4,100 women are diagnosed with 
cervical cancer, 50% of which die due to late diagnosis15. According to international 
sources, cervical cancer ranks as the second most frequent cancer among Peruvian 
women. This data is based on the cancer registry, which mainly collects data from Lima, 
Peru, the capital city. Unpublished data from the Ministry of Health (MOH) shows that 
outside of Lima, cervical is the most frequent and fatal cancer in women. It is estimated 

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that 6.6% of women in the general population have HPV16/HPV18 and at least 66% of 
invasive cancers are attributed to these forms of HPV.  
In 2011, HPV vaccination efforts for young girls between the ages of nine to eleven began. 
However, only in 2016 did coverage increase substantially.  
Most of the screening for cervical cancer in Peru has been done historically by cytology 
(Pap smears) at health centers free of charge.  In a study that we conducted in 20 cities 
in Peru, including upwards of 6,000 women between the ages of 18 and 29, we found 
that only 30.9% had ever had a PAP, with even lower rates in the rainforest and 
mountainous regions16. These data are consistent with other reports of only 53.9% of 
women between 25 and 59 years of age who report having had a PAP in the last three 
years15. There are also data on the gaps in the delivery of results and the follow-up of 
positive cases: only 25% of women with PAP abnormalities would receive adequate and 
timely management17. This same study showed that the PAP had a sensitivity of just 
42.5% to detect Carcinoma, which embodied another serious problem: the low sensitivity 
of PAP which could be explained by the multiple steps in the processing of samples for 
this test that can fail. Another study in Peru showed that fear and embarrassment of being 
“examined and exposed”, along with lack of knowledge were the main barriers identified 
for not getting Pap smears18. 
 
1.2 HOPE: A new model for cervical cancer screening in Peru 
With funding from Grand Challenges Canada in 2015, we started the implementation and 
evaluation of the viability and performance of a new model for the detection of CC in Peru. 
HOPE included participation of women of the community as agents of change (the HOPE 
Ladies), the use of self-sampling with molecular hr-HPV-testing (CareHPV®), and the use 
of technology to ensure results reached women (SMS, internet) and that treatment was 
provided. This was a proof-of-concept grant with a duration of eighteen months. There 
were more than 2,000 tests distributed free-of-charge and at least two-thirds of the 
women had never had a PAP screening. Self-sampling was very well accepted. Most 
women (74.2%) were satisfied or very satisfied with the program. The majority (68%) 
preferred self-sampling over physician-sample collection at the health center. Almost all 
(96.9%) said they would choose to participate in the same program again and 99% said 

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that they would recommend the program to a friend19. HPV Positive women were referred 
for treatment to the health center, and the main limitation was the lack of a health center 
equipped and with personnel trained to offer treatment. For the study, we were able to 
implement treatment for cervical cancer at the Ventanilla local network by training a 
colposcopist and by donating a colposcope and equipment for cryotherapy. 
 
1.3 New guidelines for cervical cancer screening in Peru and the National Plan 
for Cervical Cancer 2017-2021 
After national and international consultations in 2016, the new “Guidelines for Prevention 
and Management of Cervical Cancer” were released by the MOH20. These guidelines 
summarized international experiences and the local findings with HOPE, and they 
incorporated screening with VIA and HPV molecular testing, self-sampling between other 
things. In 2017, the MOH published the National Plan for Prevention and Control of 
Cervical Cancer in Peru 2017-2021. The plan included an assessment of the current 
situation, the needs and gaps, and a plan for procurement of HPV tests, colposcopes, 
cryotherapy equipment, additional equipment for surgical procedures, training of 
professionals, and implementation of an information system for around $30 million over 
the course of the five year period. With funding from the Binational Plan: Peru-Ecuador in 
early 2018, the implementation of HPV self-testing started in the north of Peru on the 
border between the two countries. More than 8,000 women were screened, and screen-
positive women were treated.  
Unfortunately, the MOH now is focusing only on training of health professionals to perform 
VIA screening.   
1.4 HOPE Peru: Women helping women fight cervical cancer 
Based on the success of HOPE, we applied for additional funding to continue improving 
this model. In hopes of securing sustainability, we proposed the creation of the first 
Peruvian public health social enterprise aiming to improve access to healthcare 
technologies for communities with the involvement of women from the communities. 
HOPE’s first project seeks to market the HPV self-testing (CareHPV®), to gain 
commitment, and to promote a culture of cervical cancer prevention. The tests will be sold 
to high-income women to create a sustainable platform to offer free testing to women with 

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less resources involving training of community women (as the “HOPE Ladies”). The 
project is based on four key pillars: (1) the use of molecular HPV tests for screening, with 
better sensitivity and affordability than PAP tests; (2) the use of self-collected vaginal 
samples, which offers an opportunity to increase screening coverage; (3) community 
women teaching other women about cervical cancer and how to apply the HPV self-test; 
and (4) use of affordable technology and development of an informatics platform to collect 
data for the distribution of molecular HPV screening tests, results, follow-up of women 
screened, and the transmission of reminders through text messages (SMS) for clinic 
visits, along with an internet information platform and hot-line. Additionally, HOPE is 
promoting the concepts of timely detection and saving another life through the purchase 
of a kit, since for each test sold, we will be able to reach a woman who otherwise would 
not likely be tested for cervical cancer. 
The distribution model relies on “HOPE Ladies”, women from marginalized communities 
who disseminate information on HPV door-to-door in their communities, and then provide 
screening kits for convenient and relatively comfortable self-testing for free or at a semi-
subsidized price, depending on the region. The HOPE Ladies receive an incentive for 
every test distributed. This project is in the phase of transition to scale and has received 
funding for Grand Challenges Canada for up to 1 million CAD for the next three years, for 
which it required matching funding. So far, HOPE has received funds from Fogarty NIH, 
the Center for Global Health, the University of Manitoba, Crowdfunding, United for Health 
Innovation (UfHI), Global Coalition Against Cancer, and Qiagen.  
In the social component, women are referred to the MOH health centers. We are 
coordinating with the MOH and regional governments to train health professionals on 
HPV testing and cervical cancer screening according WHO guidelines. HOPE aims to 
scale up progressively across the country over the next three years, but we need to 
address the limitation of an inadequate number of trained professionals and health 
centers with capacities to manage women who have been screened and are HPV 
positive. 
 
1.5 New technologies to improve cervical cancer see-and-treat strategy 
a. Screening: Pocket Colposcope 

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The Point-of-Care Pocket Colposcope was designed as a portable, cost-effective 
alternative to high-end colposcopes used in hospital settings. Rather than requiring high-
resolution cameras and optics as in the high-end colposcopes, the pocket colposcope’s 
design enables insertion with a speculum to take close-up images of the cervix (three 
centimeters rather than thirty centimeters) which provides images of comparable quality 
for a fraction of the cost. Stakeholder interviews and surveys in a variety of countries were 
administered to ensure that the technology was a good fit in a multitude of contexts. By 
bringing the ability to perform colposcopy exams to a primary care setting, we are creating 
an avenue for access to cervical cancer screening for women in LMICs who are most 
vulnerable to this preventable disease. 
The Pocket Colposcope currently has FDA 510k clearance and is actively used around 
the globe. We are in the process of manufacturing the device at a larger scale with 
intentions of obtaining a CE mark for global acceptance. 
b. Treatment: Thermocoagulation  
In the 1990’s Peru was one of the first countries to introduce cryotherapy for treatment of 
pre-cancerous lesions of the uterine cervix; as part of that experience many challenges 
and limitations were found with cryotherapy. It was wrongly assumed that procurement 
and distribution of the gas refrigerant could be easier than having a electricity-powered 
medical device, but the experience in Peru and globally shows that gas is usually 
expensive with limited availability in gas plants located in very few sites in the country, 
and transportation of the gas tanks is challenging. Additionally, cryotherapy units could 
be obstructed during the procedure, and the final temperature in the cryo tip is very 
variable. 
In recent years the global attention turned to thermal-coagulation, an electricity-powered 
device used for 50 years in United Kingdom and some countries in Asia; the cure rates 
of thermal ablation in those settings is around 90%, better than cryotherapy, and 
comparable to LEEP. In addition, the thermal ablation units can be powered with 
rechargeable batteries similar to cell phones, and very light for transportation (1 Kg) and 
they do not need any supplies to work. In May 2019 the WHO approved the new 
guidelines for use of thermal ablation, recommending thermal ablation for the treatment 
of pre-cancerous lesions of the uterine cervix. 

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II. 
AIMS 
The continuum of care is one of the main challenges to ensure effective actions against 
cervical cancer. We are proposing to leverage what we are doing within the project “HOPE 
Peru: Women helping women fight cervical cancer” and improving treatment at the health 
center for those women found to be HPV(+). Our goal is to demonstrate that the 
combination of HPV self-sampling with the participation of community women, the Pocket 
colposcope and the thermocoagulator will yield a high proportion of HPV positive women 
who complete treatment and follow-up care.  
Main Aim  
To perform a demonstration trial on the feasibility of HPV self-sampling as a way to 
mobilize women to get to the next level of care and the feasibility of a “see and treat” 
strategy in a community health setting and the effectiveness of the Pocket colposcope 
and the thermocoagulator to improve the rates of treatment and follow up care to women 
who have a positive HPV results.  
Specific Aims 
Aim # 1: To assess the proportion of HPV positive women who go to a health center for 
treatment, are examined with the Pocket Colposcope and if required, received 
Thermocoagulation. 
Aim # 2: To assess the proportion of HPV positive women that receive treatment and  a 
6 month follow up visit.   
Aim #3: To evaluate feasibility, acceptability, and ease of use of the Pocket colposcope  
Aim #4: To assess the costs, cost-effectiveness, and population health impact of using 
the pocket Colposcope, and thermocoagulator for cervical cancer treatment. 
 
III. 
LOGIC MODEL AND FRAMEWORK 
Currently, the MOH does not have a follow-up system to track and secure a successful 
progression of women with a positive screen test to the subsequent steps in the cervical 
cascade of care. This study will provide the MOH with direct insight into how cervical 
cancer treatment is offered in standard practice and what can be improved to facilitate 
the progression along the cascade with the introduction of new technology and 
counseling. 

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The cascade of care (also known as the “continuum of care”) is a concept used to 
describe the patient’s pathway within the process of receiving care for a disease23. The 
most successful example of its application is within HIV care, and has also been used for 
TB, hepatitis C infection, other STIs, and more recently, non-communicable diseases 
such as diabetes. It is increasingly considered a valuable tool for scientific and public 
health evaluations and interventions; however, it has not been consistently applied to 
other conditions that might benefit from its use. As we have seen, unless we ensure that 
every woman at high-risk for cervical cancer, and every woman found to be HPV (+) 
receives the care she needs, investments in screening are largely lost.  
Framework 
a. “The Continuum of Care” construct 
The construct of the continuum of care derives from the models used in the 1980s and 
1990s to understand systems of care within STI and TB. However, only in 2014 did it 
become more popular in public health research and program evaluation due to its 
effectiveness in identification of gaps within HIV care and in proposing global goals for 
controlling the HIV epidemic. Its usefulness mainly lies on the visual representation of the 
model as a bar graph where eat bar represents the proportion of persons completing each 
step along the continuum of care of a disease (prevention, diagnosis, linkage to treatment, 
adherence to treatment or retention, and successful treatment). This bar graph thus helps 
to identify the losses occurring at each step of the continuum of care23. The use of 
continuum models that reflect longitudinal rather than cross-sectional data may be 
particularly important for understanding chronic conditions.  
The specificities of the continuum, such as the starting point, the endpoint, the steps being 
considered, or the denominators used for each step, are not clearly defined, and usually 
vary according to the disease or condition being studied. 
In this study, the construct of the continuum of care will be applied for the evaluation of 
losses within the process of linkage to treatment after a woman receives a positive results 
from HPV screening until she receives her treatment and has her six month follow-up 
visit. We will also include the addition of the time required for transitions from one step to 
the next, and we will track cases to analyze causes of loss within the care cascade, as 
done in other settings24. 

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IV. 
METHODOLOGY 
4.1 Study Design 
This is a demonstration/implementation trial. 
     4.2 Study Setting 
The study will be conducted in the Cajamarca region of Peru. The department of 
Cajamarca is located in the Andean region, at a distance of 856 km from the city of Lima, 
the capital of Peru. It has 13 provinces and 127 districts, and its provinces are: 
Cajabamba, Cajamarca, Celendín, Contumazá, Cutervo, Chota, Hualgayoc, Jaén, San 
Ignacio, San Miguel, San Marcos, San Pablo, and Santa Cruz. It has an area of 33,317 
km2. This surface represents 2.6% of the national territory. We aim to work on one of the 
provinces, which will be chosen in coordination with the Directorate of Health of 
Cajamarca.  
4.3 Study population and sample size 
Our main aim is to increase the proportion of women HPV(+) who complete treatment. 
From previous data collected in the region of Callao, we have found that only around 30% 
of women found to have an abnormal high-grade PAP completed treatment in 2014, we 
will explore if there is data available in Cajamarca to calculate comparative historical 
information regarding rates of treatment of women with positive screening tests.  
Power Calculations: With an overall testing population of 10,000 women, assuming 10% 
HPV positivity, there will be approximately 1,000 HPV positive women. Assuming an 
uptake rate of 80%, the effective sample size will be 800 HPV(+) women for follow.  This 
will provide us with a precision of 3.5% or better for the estimation of the proportions to 
be estimated in the two primary outcomes27.   We are planning to include 10 to 12 health 
centers in the region, with around 60-80 women HPV(+) to be seen and followed in each 
center.   
 
 
 
4.4 Selection criteria for women 
Women between the ages of 30-49 will be offered the HPV self-sampling at the semi-
subsidized price. This is the screening age recommended in Peru in the National 

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Guidelines20. The exclusion criteria for the testing will be women with history of 
hysterectomy or pregnant.  
4.5 Data collection  
Part of the data will be collected directly on the HOPE informatics platform: system in 𝛽𝛽 
version currently in use for the collection of data of logistics of the HPV test distribution, 
processing, and results.  As part of the project we will develop fields for the follow-up of 
each woman so we will be able to collect the specific data on times. The data for follow-
up will be collected directly from the medical records. 
For the surveys and qualitative data collection, data will be collected and analyzed 
accordingly. 
Costing data will be collected as part of the baseline data collection and during the 
implementation.  At the end a costing evaluation and cost-effectiveness analysis will be 
performed 
4.6 Study design 
 
 
10,000 women with HPV self-testing, HPV+ women will be assigned geographically 
to the centers for management. 
 
 
 

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V. 
STUDY PROCEDURES 
5.1 Initial Activities 
5.1.1 Seek ethical approval of the protocol by Cayetano Heredia University  
5.1.2 Initial and working meetings  
We will perform a stakeholder assessment at the national and regional level to guide the 
future meetings and activities within the project. The meetings will be held with the key 
authorities of the most relevant institutions related with public health and cervical cancer 
at the national level and with the Regional Authorities of Health in Cajamarca. We will 
have an initial visit to Cajamarca to define the area where the study will be implemented. 
It will be important to start sharing the scope of the study and to collect suggestions and 
contributions. Then meetings will be scheduled throughout the study to report on progress 
and achievements as the implementation of the intervention evolves to prepare for scaling 
up and sustainability of the model.   
5.1.3 Start the approval process for the entrance of the Pocket colposcope in Peru 
for research purposes (DIGEMID-INS) 
5.1.4 Interview and hire personnel for the study. 
 
5.2 Preparatory activities 
5.2.1 Collection of baseline data 
We will be collecting baseline data of the health centers and surrounding areas in 
Cajamarca to plan the future activities. We will collect information about (a) cervical 
screening in Cajamarca (numbers, providers, supplies, costs, rates of treatment etc.); (b) 
processes related to cervical cancer screening at health establishments. 
5.2.2 Procurement of Thermocoagulators and other supplies 
5.2.3 Pocket Colposcope 
The Pocket Colposcope currently has 510k clearance and the Center for Global Women’s 
Health Technologies is working with local manufacturing companies in the US to prepare 
an appropriate shipment. 
5.2.4 Software improvement for the Pocket Colposcope 

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A software for image acquisition and telemedicine capabilities will be implemented. We 
plan to collect inputs and outputs and to use artificial intelligence to map the relationships 
between the inputs that lead to health disparities. 
5.2.5 Adaptation/Enhancement of the HOPE platform 
We will assure that the indicators pertinent to the project will be captured. We will also 
develop a module for follow up of the cases.  
5.2.6 Development of training manuals, videos and other materials for providers 
who will use the pocket colposcope and the thermocoagulator. These materials should 
be easily accessible for providers in low-resource clinics. 
 
5.3 Implementation of the local laboratory in Cajamarca for the processing of 
the HPV tests. 
The staff of the DIRESA laboratory will be trained in the processing of HPV tests. We will 
provide the necessary equipment, implement a quality control system, and set up a 
connection to the HOPE digital platform.  
 
5.4 Designation of health centers to participate in the trial and training of health 
providers at Health Centers (intervention and control) 
Providers will need to be trained about the study protocol, the national guidelines 
for cervical cancer, the use of the thermocoagulator, visual counseling, and pocket, and 
the deployment of equipment.  
 
5.5 Identification and recruitment of women leaders (HOPE Ladies) 
Through key informants, data will be collected on groups and activities of women in the 
community that will allow us to identify potential female “leaders”. The field coordinator 
will meet in different places (mothers clubs, wawawasi, health center, municipality, etc.) 
with these women and they will be introduced to the HOPE model and invited to 
participate. The leaders will receive training specifically on cervical cancer, HPV testing, 
importance of treatment and for those HOPE ladies in the intervention areas they will 
learn about the visual counseling. As per the HOPE model, the HOPE Ladies will receive 
a small incentive (around $1) for each HPV test process from a woman they contacted. 

14 
 
We hope to recruit between 2-4 HOPE Ladies per catchment area of a health center with 
approximately 24-48 women leaders in total among the 10-12 health centers. We will 
assess knowledge and address myths about cervical cancer, and we will build strategies 
to improve the coverage in the community. We will use the materials, contents, and 
methodology that we have already developed, piloted, and used to train and coach the 
HOPE Ladies.  
 
5.6 Initiation of the trial, distribution of collection kits to HOPE Ladies, collection 
of data, and visits to health centers by local monitors 
 
5.7 Data collection and analysis 
For the demonstration trial we will collect process information about the distribution of 
HPV tests and basic information from women who participate in the  HPV self-sampling 
as age, history of previous paps. For the HPV (+) women coming to the centers we will 
collect data on dates, procedures and results of procedures performed (pocket 
colposcopy, thermocoagulation, other procedures as leep/hysterectomy).  To maintain 
the confidentiality of the information, we will use codes and keep protected health 
information separate from the rest of the study data. At the end of the study, personal 
identifiers will be destroyed. The data will be stored in a specially developed database. 
The information from the source documents will be reviewed and encrypted. We will use 
descriptive analysis of the data (process and outcomes) and comparisons with historical 
information if available and appropriate.  
 
5.9 Process and Impact Measures 
Activity  
KPI Metric  
How to measure metric  
Conduct a baseline KAP 
survey of a sample of 
providers regarding HPV 
tests and cervical cancer 
management  
Survey performed  
Report of survey results  
Conduct a baseline 
assessment of health centers 
Assessment performed 
Report of assessment  

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in the Andean Region where 
we will be working  
Implementation of local 
laboratory with capabilities to 
process HPV testing  
1 laboratory 
implemented for HPV 
testing 
Visit Report  
Identification of rural health 
clinics in Andean region of 
Peru and provision of 
appropriate equipment 
(pocket colposcope, 
thermocoagulators) 
# of health clinics (10-
12) 
# of innovations 
deployed 
#thermocoagulators 
deployed (#10-12) 
# pocket colposcopes 
deployed (10-12) 
Visit reports 
Send staff to train HOPE 
Ladies in the rural regions 
chosen  
 # HOPE Ladies trained 
and registered 
HOPE informatics platform 
Preparation of tools for the 
use of pocket colposcope 
and thermocoagulator 
manual of use of pocket 
colposcope and 
thermocoagulator 
finished in Spanish. 
Video tutorial for the use 
of pocket colposcope 
 
 
 
Reports 
Tools ready 
 
Send staff to train health 
providers in the use of pocket 
colposcope and 
thermocoagulators  
# of health providers 
trained on the use of 
pocket colposcope  
# of health providers 
using pocket colposcope 
# of providers using 
thermocoagulator 
Reports 
Provide 10,000 HPV self-
sampling kits for HOPE 
ladies to distribute 
# of HPV tests 
distributed to HOPE 
ladies  
# of HPV tests correctly 
returned 
# of HPV tests 
processed 
# of HPV tests positive 
# of women who receive 
HPV positive results 
HOPE informatics platform 

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Facilitate women HPV (+) to 
get treatment at Health 
centers  
% of HPV (+) women 
coming to the health 
center for treatment  
Monitors/hope ladies 
HOPE informatics platform 
Health centers giving 
treatment and F/U to HPV (+) 
women  
-% of HPV (+) women 
completing treatment  
 
-% of HPV (+) women 
completing F/U at 6m  
 
 
Monitors/ review health centers 
records (check list) 
HOPE informatics platform  
Conduct a post-study 
evaluation (qualitative, 
quantitative)  
of providers to evaluate 
acceptability and ease of use 
(pocket colposcope)  
# of providers who 
indicate they would use 
the 
Pocket/thermocoagulator 
regularly for cervical 
cancer 
diagnosis/treatment or 
found it useful 
Report of results 
Measuring Efficiency  
-Average time to come 
for treatment  
-Average time to 
complete treatment  
Monitors/ review health centers 
records (check list) 
HOPE informatics platform 
Cost-effectiveness  
Complete cost of care 
cascade  
Patient level cost 
Monthly budget 
Cash on hand 
Co-funder contribution 
Personel  
Report  
*PC + TC = Pocket Colposcopy + Thermocoagulator 
 
VI. 
ETHICAL CONSIDERATIONS 
The study will be presented for IRB approval by Cayetano Heredia University and Duke 
University.  
 
 
 
 
 
 

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VII. 
TIMELINE  
 
 
 
Timeline
M1
M2
M3
M4
M5
M6
M7
M8
M9 M10 M11 M12 M1
M2
M3
M4
M5
M6
M7
M8
M9 M10 M11 M12
AGO SEP
OCT NOV DEC JAN FEB
MAR APR MAY JUN JULY AGO SEP OCT NOV DEC JAN FEB MAR APR MAY JUN JULY
Prepare all the docs for IRB, and obtain approvals


Send docs for RCT and Obtain approval from National Institute of Health for the use of Pocket 
colposcope in trial and facilitate shipment to Peru



Initial coordinations with Regional government/approvals 


Hiring/training team 

Identify and visit 10-12 health centers in Andean Region to be included in the trial 



Conduct baseline data collection in each center (2 days observation workflows, costing) 
Interview personnel about barriers for cervical cancer screening, potential solutions etc

 Procurement of additional supplies/materials/equipment missing at health centers for see/and 
treat


Integration of mhealth software platform with HOPE platform



Procurement of thermocoagulators 


Shipment of  pocket colposcopes to Peru (needed to start the training)

Prepare/Print educational materials for IVA, Pocket colposcope, thermocoagulator,



Training and implementation of health centers: Controls IVA/thermocoagulator   Intervention 
Pocket colposcope/thermocoagulation/ethical issues consents etc. 


Procurement of  HPV equipment

Procurement of HPV tests  (10,000 total , but we have to buy it in batches)


Identification and training of women from the community (HOPE Ladies) who will promote and 
distribute HPV testing



Periodic meetings/communications with authorities MOH (including report of final findings) 






















HOPE Ladies start promotion and distribution of HPV self-sampling

Implemented centers working

10,000 women had a HPV self-sampling performed - 2400 HPV positive women 
Collect data on costing in centers










Complete data collection of  women HPV positive













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Data analysis of trial and final report 


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

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






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
Economic analysis performed 

Dissemination meeting with stakeholders, local research teams, providers, national authorities  
to present results 


Obtain local registration from DIGEMID in Peru for Pocket colposcope (preparing for scale-up) 


Preparation of Manuscript with trial results 


 Presentation of results in international congress


Year 2
Year 1

18 
 
VIII. 
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