Prevention of cervical cancer through screening
Form 2. Project summary
The cervical cancer is third leading cause of all mortality among all cancer and the first most common cancer among women in Mongolia. Annually, around 300 new cases of cervical cancer are detected in the country and the most of them are diagnosed at stage of the disease with low survival rates. However in Mongolia, nationwide programs on cervical cancer prevention and control do not exist and the majority of women have never been screened. Therefore there is urgent need to establish the nationwide cervical cancer prevention and control program in Mongolia. Considering the guideline published by JHPIEGO and WHO, the single visit approach (VIA+cryotherapy) will be the best approach of choice among all other methods of screening for low-resources setting.
The overall objective of the project is to assess the acceptability and feasibility of implementing a cervical cancer prevention program based on a "Single visit" approach using VIA/Cryotherapy, through the implementation of several demonstration projects in Ulaanbaatar and rural provinces of Mongolia.
The overall strategy of this project will be followed by the WHO standard protocol to create awareness in the communities about cervical cancer prevention (through Information, Education and Communication (IEC), recruit clients, provide screening using acetic acid, treat those who are eligible using cryotherapy and refer those who are not eligible for further evaluation and treatment .
The project will take place in one district hospital in Ulaanbaatar city and two rural provincial hospitals (the district hospital and rural provincial hospitals which will perform VIA and cryotherapy but also manage women non-eligible for immediate cryotherapy) and two or three other lower-level health units (soum's hospitals) in the catchments area of the referral hospital where VIA and cryotherapy or VIA alone will be implemented. The target population will be all women aged 30-50 years old, and resident in the catchment area.
The initial phase of the project will take two years. This phase will have a pilot phase which will be evaluated after three months of implementation of activities. Necessary adjustments and improvements in the clinical procedures, data collection instruments and mass mobilization will be informed by the experience gathered over this period. This process improvement exercise will continue through the project.
Form 3. Description of the project
3.1 Rationale and objective of the study
Cancer of the cervix uteri is the second most common cancer among women worldwide, with about 500,000 new patients diagnosed and 250,000 deaths every year. More than 70% of all cancer deaths occur in low- and middle-income countries where resources available for prevention, diagnosis and treatment of cancer are limited or nonexistent.1 If not detected early, cervical cancer is a fatal disease and, as such, prevention of cancer through detection of precancerous lesions is the main strategy of significantly reducing the morbidity and mortality associated with it. Late stage disease is associated with low survival rates after surgery or radiotherapy. These treatment modalities may in fact be lacking altogether or too expensive and inaccessible to many women.
Effective screening programs in the developed world have markedly led to the reduction in cervical cancer morbidity and mortality.2 The traditional screening method based on cytology is expensive, requires highly trained human resources, and laboratory equipment. In developing countries, because of the high cost of setting up screening programs based on cytology, these facilities have only been set up in a few referral facilities which are inaccessible to majority of the women. In addition, these programs require a lot of resources and skilled personnel which are largely lacking in most developing countries. Other bottlenecks in screening programs based on cytology relates to the need for referral to distant health facilities that can provide the diagnosis and treatment service, and the long waiting time before cytology results come out. Information about cervical cancer screening is also scanty and subject to a lot misinterpretation and thus affects the utilization of the few available screening services.3
Visual Inspection with acetic Acid (VIA) is an alternative screening method that has been studied over the years to establish its sensitivity and specificity. Several studies indicate that VIA is more sensitive than conventional cytology though less specific.4 For a screening test, it is an attractive alternative given the other advantages it has over the conventional cytology for low resource settings. It is cheap, non-invasive, can be performed by almost any trained personnel, doesn't require a laboratory or technicians and thus can be done in a low level health facility like a health centre. More importantly, the VIA provides instant results and those eligible for treatment can instantly be offered treatment of the precancerous lesions, using cryotherapy, on the same day and in the same facility, stemming the problem of failing to honor referral.5-8 Clients who are ineligible for immediate treatment are referred appropriately. This approach negates the fore mentioned problems associated with the conventional cytology based screening, or testing for the human papilloma virus (HPV). For this reason we are calling this approach the "Single Visit Approach". At the very least, in a single visit, the woman knows what needs to happen next. It could be treatment or it could be referral. Some people have also called it "Screen and Treat".
The biggest perceived drawback of this approach is the likelihood of over treating the false positive cases that would otherwise not need treatment. The false positives result from the moderate specificity of this method. Over treatment exposes more women to the side effects of the treatment and an additional cost to the prevention program as a whole.9-10
The literature shows that, much as the specificity is less than that of cytology, it is reasonably high in the range of 70-80%10 and given the additional advantages of cost and its simplicity, it stands out as an attractive alternative. Different demonstration (feasibility) study conducted in Urban Africa11, Thailand and Ghana12 concluded that a single-visit approach using VIA and cryotherapy proved to be safe, acceptable, and feasible for the cervical cancer prevention. Cluster randomized controlled trial in south India13 also indicates that women accept screening with VIA by nurses and a moderate level of compliance with screening and treatment can be reached through appropriate service delivery systems including health education activities, personal invitations, clinics in proximity to the target women, and testing and treatment in the same session. Studies published to date comparing cost-effectiveness of alternative screening and treatment strategies using a model to estimate cancer incidence, life expectancy, and life time costs seem to suggest that VIA/Cryotherapy is among the most cost effective strategies (among Visual inspection, Pap tests and HPV) even when the consequences of "over-treatment" are taken into consideration, yet safe.14,15
Cryotherapy as a method of treatment for precancerous lesions is favorable compared to other treatment modalities such as Loop Electrosurgical Excision Procedure (LEEP), Loop Excision of the Transformation Zone (LETZ) and cone biopsy in terms of effectiveness. Furthermore, it has additional advantages such as being cheap, does not require complicated equipment, does not require electricity, can be done by less specialized personnel and thus can be implemented in Primary Health Care (PHC) setting.16 The safety of both VIA and cryotherapy are documented.5,9
Mongolia has rapidly increasing rates of NCDIs, including cardiovascular disease, diabetes and cancers. Mongolia's mortality and morbidity rates from cardiovascular disease and cancers greatly exceed those of Western countries and now represent the major cause of death and disability, particularly in younger age groups (i.e., 35 to 55 years of age).17 The cervical cancer is third leading cause of all mortality among all cancer and the first most common cancer among women in Mongolia. Annually, around 300 new cases of cervical cancer are detected in the country and the most of them are diagnosed at stage of the disease with low survival rates.17 A recent population based study conducted in Ulaanbaatar city identified that HPV prevalence in Ulaanbaatar was higher (35%) than that detected by similar HPV testing protocols in other populations in Asia or elsewhere and would suggest an important, yet unquantified, cervical cancer burden.18
However in Mongolia nationwide programs on cervical cancer prevention and control do not exist and the majority of women have never been screened. Therefore there is urgent need to establish the nationwide cervical cancer prevention and control program in Mongolia. VIA/Cryotherapy have not been widely implemented at a primary health care level in a resource poor setting to critically look at operational issues that might affect its implementation on a larger scale and its ability to reduce cervical cancer incidence at an epidemiological level in the country.
The purpose of this proposal is therefore to rigorously assess the acceptability and feasibility of implementing VIA and cryotherapy ("single visit approach") in Mongolia to a wider population through effective monitoring and evaluation. The project will use existing infrastructure, facilities, and staff. This will in essence be introducing VIA into existing reproductive health services at a district general hospital in Ulaanbaatar city and at a rural provincial hospital or lower level health facility.
3.1.2 Objectives
The overall objective of the project is to assess the acceptability and feasibility of implementing a cervical cancer prevention program based on a "Single visit" approach using VIA/Cryotherapy, through the implementation of several demonstration projects in Ulaanbaatar and rural provinces of Mongolia. The specific objectives of the demonstration project are:
- To create awareness about cervical cancer, its effects and availability of prevention services.
- To assess acceptability of cervical cancer screening using VIA and treatment of precancerous lesions using cryotherapy at all levels (the women, their community, Health Care Workers, policy makers, program managers).
- To assess the feasibility and efficiency (in terms of running costs, personnel, training and equipment) for the "single visit" approach in the prevention of cervical cancer.
3.2 Design and methodology
3.2.1 Interventions to be implemented
The overall strategy of this project will be to create awareness in the communities about cervical cancer prevention (through Information, Education and Communication (IEC), recruit clients, provide screening using acetic acid, treat those who are eligible using cryotherapy and refer those who are not eligible for further evaluation and treatment . Additionally, continuous monitoring and evaluation of the project will be carried out in order to generate evidence about the acceptability and feasibility of such a project in a district and or a primary health care setting. See flow chart on single visit, A1.
3.2.2 Selection of project sites
The project will take place in one district hospital in Ulaanbaatar city and two rural provincial hospitals (the district hospital and rural provincial hospitals which will perform VIA and cryotherapy but also manage women non-eligible for immediate cryotherapy) and two or three other lower-level health units (soum's hospitals) in the catchments area of the referral hospital where VIA and cryotherapy or VIA alone will be implemented. The hospital and its "feeder units" will provide service to a given geographic region. Support and cooperation of the Ministries of Health and the district health management teams will be ensured. Other considerations in choosing a participating health facility will be: size of population being served by the health unit, distance and accessibility to nearest higher level health facility and available personnel.
3.2.3 Target population
Our target population will be all women aged 30-50 years old, and resident in the catchment area. Clients will be recruited into the project on particular days of the week by the assigned staff. This will be irrespective of whether they are self referred (those responding to outreach initiatives), referred by other health workers, or those who come for other reproductive health check up or child health care services, as long as it is a clinic day.
Clients will have to meet the selection criteria listed below, and they will also be required to consent to participate in the project. Thereafter they will be offered screening using VIA and those eligible for treatment will be treated with cryotherapy. Those who are tested positive but ineligible for immediate cryotherapy will be referred for further evaluation at a referral facility or if the facility has a specialist, such a client will have to be reassessed by the specialist and managed accordingly.
Selection Criteria for clients
The project will cover all women residing in the locality defined by the project (catchment area), aged between 30 and 50 years who consent to participate in the project.
Exclusion Criteria for VIA procedures
The following categories of women will be excluded from the VIA procedure: severe ill health, pregnancy beyond 20 weeks, and until 12 weeks post partum, overt growth/fungating mass on the cervix, previous treatment for cancerous lesions, known allergy to acetic acid, and history of total hysterectomy.
Exclusion from the cryotherapy procedure
The following categories of women will be excluded from the cryotherapy procedure: a history of prior treatment of the cervix for pre-cancer, suspicion of cancer, known pregnancy and until 12 weeks post partum.
Recruitment
Clients will come spontaneously to the service or as a consequence of the awareness campaign (described below paragraph 3.2.4/vii). Those who meet the selection criteria will be recruited in the project and the following interventions will be done at first visit:
- counseling and information about cervical cancer prevention
- VIA
- information about the next steps according to VIA results.
3.2.4 Preparatory activities
- Stakeholders meeting
- Sell the protocol to health care providers and other key local stakeholders and get their commitment to the implementation of the cervical cancer screening project
- Discuss the organization of services (dedicated screening by setting aside time, space/room, and staff.
- Describe the composition and functions of the project "team" and staff expectations;
- Draw a practical plan of how the project will be implemented given the prevailing local circumstances.
- Referral system to be used in the project.
- Situational Analysis
- Existing policy on cancer prevention
- Existence of cervical cancer screening services or a national cancer program
- Importance of the Cervical Cancer in this area of work and community perspectives on this issue
- Size of the eligible population targeted (Using census data i.e., women aged 30-50 years)
- Available and accessible health units and their status (services provided)
- Number, experience and qualifications of available staff, and their willingness to participate in the project
- Equipment per health unit, and room for counseling, examination and treatment.
- Other cervical cancer screening services in the neighboring health facilities.
- Providers and community perspectives about cancer and its prevention.
- iii. Training
- How to perform and interpret VIA/Cryotherapy procedures
- Test data collection tools.
- Local-specific implementation plans
- Orientation to and use of standardized training materials in preparation for the country specific training.
- An orientation on the general aspects of cervical cancer and the specific project plans at the local site
- Outreach guide for community workers for mass mobilization
- Client counseling related to cervical cancer, its prevention, treatment options and screening using VIA/Cryotherapy
- Data management
- Achievement of competency in VIA/cryotherapy among those providing the service
- Ethical clearance
- Procurement of supplies and equipment:
- Examination tray with
- Vaginal speculum Cusco's /Grave's.
- Acetic acid 3 - 5%
- Cotton swabs or cotton balls.
- Small bowl to hold acetic acid
- Cryotherapy gun and probe tips. We recommend a "one size fits all" approach to the cryotherapy tip. It keeps things simpler and the vast majority of women can be treated with a probe that has a shallow nipple and a diameter of 19-20 mm.
- Refrigerant gas (nitrous oxide or carbon dioxide) and reliable supplier
- Wrench for attaching the cryotherapy gun to the gas tank.
- Data collection instruments
- Creating Awareness: Information Education and Communication materials
- Check list for IEC activities for community workers
- Check list for counseling
- Leaflets to be distributed to women in community and health centers (information on Cervical cancer, VIA and services)
- Information on post cryotherapy follow-up and management
- That cervical cancer is the most common female cancer in the country
- Women age 30 -50 are more likely to develop cervical cancer than women who are younger or older than those in this age bracket
- Cervical cancer develops slowly
- Screening can detect treatable precancerous lesions before they progress to cancer
- Screening is simple, quick and not painful
- Women age 30 -50 should be screened at least once
- A few women will need treatment after the screening. This is available as a simple outpatient procedure to remove the lesion
- The community should be informed of the centers where and when screening is being offered.
National meeting:
A national level stakeholders' meeting will be held in Ulaanbaatar to prepare for the project. The Ministries of Health (MOH -Reproductive Health Division) in conjunction with the principle investigators will convene this meeting and the invitees will include representatives of National Cancer Control Program, Representatives of Ministry of Health, Members of Parliament, civil society leaders, local donors, local health leaders (e.g., hospital directors), WHO and UN partners such as UNFPA, women's associations, and NGOs. This will be a strategic meeting designed to ensure the concerned parties remain committed to this project in terms of both necessary extra funding and future sustainability. An Advisory Committee will be formed and will be composed of a representative from the MOH, WHO representative, UNFPA representative, area member of parliament, and head of the host health facility. Progress and constraints will be reported to this committee and will also ensure all necessary facilitation for the project is secured. Progress will be reported regularly (twice a year) to this committee. The committee's mandate will last up to the end of the project.
Operational meeting - at local level:
Key local stakeholders will be invited to participate in a meeting/workshop designed to develop, prioritize and collaborate on implementation plans. One outcome of this meeting will be the appointment of a project management committee which will guide the project implementation and through reports to the National Advisory Committee, help in "selling" the project to the local community. This management committee will involve community leaders, heads and managers of participating health units, and health care providers. The main objectives of the meeting will be:
A situation analysis documenting a number of issues that may promote or hinder the normal progress of the project is a good starting point in planning implementation of activities. A stock of available resources will be taken to ensure that readily available resources are made use of instead of creating new ones. Existing gaps and ways of addressing them will be sought. Some of the information needed in this respect is:
Centralized training of project-site supervisors
Each project site will have a project-site supervisor. The project-site supervisors will be trained on the project protocol and VIA and Cryotherapy procedures. A training workshop for the project-site supervisors will be provided by the principle investigators who experienced in VIA/Cryotheraphy and will be held in the OB/GYN Clinic, MCH Center, Ulaanbaatar Mongolia. The following items will be included, in addition to clinical training:
Training of local providers:
Local training will be held at each site with the principle investigators who experienced in VIA/Cryotherapy service and training. Training site(s) will be chosen to maximize the likelihood of trainees being exposed to the full spectrum of disease. Training will include:
Supportive supervision of trainees
Competency based training will be followed by monitoring and evaluation. A continuous process of supervision will be done by the project-site supervisors and the principle investigators as well. This will be strengthened by a six monthly monitoring visit by technical and experienced experts in this field. Where needed refresher training will be provided by the study team including the principle investigators.
The generic proposal will be reviewed through the Research in Human Reproduction review mechanism at World Health Organization.
Additionally, ethical clearance will be sought from the relevant institutions according to local procedures and regulations.
Instruments, reagents, sundries needed in the day to day execution of the activities will be secured in advance. Advantage will be taken of existing facilities such as couches, etc. as per report on the situation analysis.
Basic equipment and supplies that is essential for VIA:
Examination couch /table -preferably with appropriate leg/heel rest.
Report forms, client register
A good white light source
Examination tray with
Basic equipment and supplies for cryotherapy:
Questionnaires (qualitative and quantitative) should be detailed enough to be able to capture a minimal amount of information from the participating sites in order to be able to answer the questions we set out to answer but also not too detailed to interfere with normal work schedule at the clinics. The instruments should be piloted and improved after a 3-month period of piloting. The data collection instruments are attached in annexes B1-B6.
A minimum IEC package on cervical cancer, its prevention and treatment will be adopted across the sites and will be made available at both the health care facility and the general community in the most widely understood languages. Materials developed will be adapted from existing material which has been already tested and used in other African countries (see annex A5-A10). The clinic (client) messages will be more detailed and focused to help potential clients know more about the project. Community messages will be similar but less detailed and mainly for purposes of creating awareness of the availability of screening services Due to sensitivities and concerns that might be encountered in various communities, messages will be packaged in such a way that they are acceptable, non-offensive and appealing to the masses but maintaining the main message.
Minimum IEC package:
This will include a;
Key Messages:
The key messages during the awareness campaign will be clear and simple. They will be designed to motivate women to come for screening and should include the following:
Communication support:
Each project site will need to identify the best format for delivering the messages about the availability and value of screening to its community. The material will be developed in collaboration with IEC team from Ministries of Health. Delivery of messages (medium) will vary such as use of mass media, public meetings, schools, plays, posters, pamphlets, or direct personal contact (to name a few ). To a large extent men influence decisions that affect women health in terms of finances to enable them seek care, permission to leave home etc. Therefore, there will be deliberate effort to involve men in terms of information.
3.3 SCREENING AND TREATMENT ACTIVITIES
Upon coming to the clinic, clients will be given general information on cervical cancer, its effects, prevention through screening, treatment and possible outcomes. Eligible clients for VIA/Cryotherapy will be specifically counseled using standard guidelines and consent sought before any procedures are done. (See Annex A1)
3.3.1 General information
Health education and counseling of clients attending the clinic will include the following components in an easy and simplified manner:
- Information concerning cancer of the cervix will be provided using visual aides
- Factors associated with cervical cancer
- Effects of cancer of the cervix
- Prevention and treatment options
- About the project (Aims of the project and why they need to participate)
- Procedures involved VIA and Cryotherapy,
- Possible adverse effects and complications
3.3.2 Counseling and consent
Clients who will come for cervical screening and meet the eligibility criteria will be given counseling about the procedures to be performed. Counseling will be done for both VIA and cryotherapy prior to these procedures being done. This is to avoid interrupting the continuity of the two procedures if the client qualifies for both. However, clients wishing to get more information or expresses the need to discuss the findings and recommendations with their spouse or other people will be encouraged to do so. Another appointment may be offered. Written informed consent will be obtained prior to cryotherapy. Participants will be given a chance to read through or have the consent read to them and project staff will make all necessary clarifications before the client signs the form (See annex A2 for consent form). Those who decline the offer of the procedures will be advised to return for screening any time they change their mind. In order to understand better the reason of their refusal, a short questionnaire (open questions) will be administered anonymously (see annex B0).
3.3.3 Screening
Screening using VIA will be done as described in Annex A3 and the results recorded on the client's form, (See annex B1).
A summary of the envisaged overall client management will proceed as depicted in the flow chart. (See Annex A1-Flow chart)
Those who are VIA negative will be advised to seek re-screening in 5 yrs.
Those with suspicious cancer lesions will be referred to a referral health facility for further evaluation.
Those who are VIA positive will be assessed for cryotherapy eligibility and will have the procedure done or appropriate recommendation made (see section 3.3.4).
Women noted to have signs of STIs will be managed according to recommended STI management guidelines in that facility and consistent with country-specific protocol.
A data sheet with the relevant client's particulars will be completed (see annex B1).
4.4 Interpretation and reporting of VIA test results
A uniform and standard system of grading the VIA findings will be used in all sites. This is to ensure consistency of reporting so that the results from different sites can be comparable. We recommend the following standard reporting format as found in "A practical Manual for Screening for Cervical Neoplasia" by Sankaranarayanan and Wesley[18].
- VIA Negative:
- No acetowhite lesions observed
- Polyps protruding from the cervix with bluish white acetowhite areas
- Nabothian follicles appearing acetowhite
- Dot like areas in the endocervix taking up acetic acid
- Shiny, pinkish-white, bluish-white, faint, patchy or doubtful lesions with ill defined margins, blending with the rest of the cervix
- Acetowhite lesions far away or distant from the squamocolumnar junction ( satellite lesions)
- Faint, line-like or ill defined acetowhitening at the squamocolumnar junction
- Streak-like acetowhitening in the columnar epithelium
- VIA Positive
- There are acetowhite lesion with the following characteristics:
- distinct,
- well-defined,
- dense (opaque, dull- or oyster-white) acetowhite areas
- regular or irregular margins,
- close to or abutting the squamocolumnar junction,
- close to the external os if the squamocolumnar junction is not visible
- appears slightly raised off the epithelium
- Strikingly dense acetowhite areas in the columnar epithelium
- The entire cervix becomes densely white after the application of acetic acid
- Suspicious for Cancer
- There is a clinically visible ulcero-proliferative growth on the cervix that turns densely white after application of acetic acid and bleeds on contact.
- Overt fungating cervical mass, that is friable and bleeds to contact.
VIA screening is reported as negative in any of the following cases:
The VIA test is reported as positive in any of the following situations:
The test outcome is scored as suspicious for cancer when:
3.3.5 Treatment with cryotherapy
For those eligible for treatment using cryotherapy (See Annex A4 for details of the procedure) will be offered and performed either at the same visit or as soon as treatment can be arranged
- Those with lesions suspicious for cancer on VIA or found unsuitable for cryotherapy (according to eligibility criteria) will be referred for further evaluation and appropriate management.
- Up to 20 weeks of gestation, pregnant women can receive cryotherapy. Beyond 20 weeks, they will be referred to tertiary hospital if lesions are large, or advise to come back for screening twelve weeks post partum.
- Those with cervicitis will be offered a course of antibiotics (consistent with STI standards) and can be provided cryotherapy at the same visit or as soon as cryotherapy can be arranged. (NOTE--Cervicitis will be defined as the presence of mucopurulent discharge, and cervical spotting on contact). Condom use will be particularly recommended in these clients.
- Double freeze cryotherapy will be done according to the standard procedure. (See annex -A4).
- Post-cryotherapy, a supply of pads to deal with the watery discharge will also be provided.
After the cryotherapy procedure, the patient will receive post cryotherapy counseling and instructions (See annex -A4).
3.3.6 Referral
The following categories of clients will be referred to a next level health facility for further tests and/or treatment, (For referral form see annex B3):
- ? Cervix with fungating, friable lesion suspicious for cancer.
- ? Those with aceto-white lesions suspicious of cervical cancer
- ? Those who are VIA positive but are ineligible for immediate cryotherapy because;
- o The lesion occupies more than 75% of the surface area of the cervix
- o The cryotherapy probe does not cover the lesion or leave a space of no more than 2 mm
- o The lesion extends more than 2 mm into the cervical canal
- o The lesion extends onto the vaginal wall.
- ? Those who will test VIA positive 12 months after treatment using cryotherapy
An agreement with the referral facility must be made such that information concerning the treatment and outcome are provided to the facility that originally referred the patient. (Country specific adaptation depending on their referral procedures will be allowed).
3.4 FOLLOW-UP VISITS AND PROCEDURES
Follow up will be passive in that the clients who received cryotherapy will be encouraged and expected to return to the clinics themselves. Clients will be given appointment cards to remind them about the next appointment.
Two kinds of follow-up are planned after procedure:
- Return due to any perceived complication at any time, such as fever within a few days of the procedure, severe abdominal pain, excessive bleeding with clots etc. The details of this visit will be filled in form B4 (See Annex B4). A patient diary (see screening card annexed) will be provided after initial visit, if VIA is positive, and patients will be encouraged to come back with screening card, each time they come to the clinic, for review by health care provider .
- Follow up at one-year post cryotherapy (See annex B5). At this time they will be re-screened using VIA and managed appropriately. Those who are VIA positive will be referred for further evaluation. Those who are VIA negative will be advised to seek re-screening after 3 years.
3.5 MONITORING AND EVALUATION
In order to demonstrate the feasibility and acceptability of using VIA screening and treatment through cryotherapy in low resource settings, the project activities will require proper documentation.
In annexes B1-B6, we have included samples of forms that will be used to collect data. Socio-demographic data, VIA/Cryotherapy findings and other important events that might occur during follow up period will be captured. Data collected will be used for program improvement and end of project performance assessment using key indicators generated from the data. While health personnel are likely to regard this documentation as a waste of time, the principle investigators and project-site supervisers will need to emphasize the need for diligent and accurate documentation to be able to capture what the project has been able to do and what it has failed to achieve.
In annex C2, the log frame for the project, showing the key goals, broad activities, indicators and means of verification and assumptions used is presented. This will guide and give overall direction to the project, focusing on the key objectives it set out to achieve. This is to be used as a management tool to guide the project as a whole in trying to achieve the set objectives.
Given the importance of documentation in this project, a set of data collection instruments will be used even when an existing information system is in place. This is because we want to capture all the information with the necessary detail needed for demonstration of feasibility and acceptability, which the existing information systems don't collect routinely.
Information on acceptability will be generated from two sources:
- Focus group discussions will be conducted with all health care providers participating in the project to get their feed back on the process. This will be done 6 months after the project in place.
- Acceptability of the interventions will be assessed through questions directed to clients in forms B1 and B2.
The main indicators to be used to monitor the acceptability of VIA and cryotherapy will be the coverage of the screening and the percentage of women VIA positive with an indication of cryotherapy that goes to cryotherapy.
3.6 WORK PLAN
The project work plan, specifying key activities, timelines and indicators is attached (See annex C1). This will guide the day to day execution of the various project activities over the project life span. Project-site supervisors may opt to add a column of the responsible person(s) for each of the activities.
The initial phase of the project will take two years. This phase will have a pilot phase which will be evaluated after three months of implementation of activities. Necessary adjustments and improvements in the clinical procedures, data collection instruments and mass mobilization will be informed by the experience gathered over this period. This process improvement exercise will continue through the project. The principle investigators will use interim results from the data and physical on-job facilitation to continually improve the quality of the work being done by the project staff. In order to do this, proper and accurate documentation of activities and procedures must be carried out. The personnel in the clinic in addition to carrying out the procedures, will record all the necessary details and procedure findings in the data capturing forms. These raw data will then be taken periodically (Weekly) to the principle investigators's station for checking and entry into a computer and interim analysis. Periodic feedback to the project-site supervisors on any issues to do with data quality will be done by the principle investigators. The project-site supervisors will then use this information to address any issues in the field that may require a corrective action.
Land mark activities and dates are provided in the attached draft Work Plan (See annex C1). A set of progress and performance indicators and how they will be used are shown in the work plan.
3.7 DATA MANAGEMENT
The quality of data collected in this project is critical as it will lay the basis for judging the overall performance of the project. Data will be collected and recorded by trained study team with ability to accurately make observations..
3.7.1 Data collection tools
Health care providers will collect the information on the women recruited into the programme after counseling for both VIA and cryotherapy prior to these procedures being done. In case of a refusal, a short questionnaire (see form B0) will be administered anonymously, in order to understand better the reason of their refusal
- VIA Results Record, Annex B1
- Cryotherapy treatment form, Annex B2
- Referral form, Annex B3
- Adverse effects/complications form, Annex B4
- Follow up after one year form, Annex B5.
- Focus group discussion guide
This form will collect information on socio-demographic characteristics of the client and the VIA procedure findings
Cryotherapy treatment observations and other treatment given will be recorded on this form.
Details and reasons for referral of clients referred for further evaluation will be recorded on this form.
Reasons for coming back to clinic resulting from the procedures will be captured using this form. Observations such as pain, fever, excessive discharge, severe abdominal pain, excessive vaginal bleeding and their management will be recorded.
This form will capture both clinical and repeat VIA findings after one year from the time the client was last tested.
Focus group discussion guide will be developed by the principle investigators (see annex 5 p.12-19). This will focus on health care workers feedback on the project implementation.
3.7.2 Data flow
Completed data collection forms will be forwarded to the principle investigators at the MCH Center on a regular basis, preferably weekly. The forms will be checked for accuracy, completeness and data will be entered into a computer using appropriate data entry software by a data entry clerk. Each client, clinic and health official working on the project will have a unique identifier. Data will be backed up on a weekly basis.The project-site supervisor in each site will be responsible for sending the completed and checked data forms to the principle investigators. The principle investigators will maintain the data base by checking for errors, completeness and consistency.
3.7.3 Data analysis
The data analysis will be done using R software and by a skilled person. Results (indicators) for publications will only be derived from a clean data set. Other analyses (detailed) of data will be discussed during the scientific meeting 18 months after inception. Annex C2, logframe, describes the indicators that will be pulled out of the analysis of the different variables. Example of analysis and use of information is presented in Annex 5 page 59-70.
3.7.4 Data Quality
In order to ensure quality control and comparability of findings and procedures across the project sites, the following procedures will be used:
- Standard training manual and procedures for the nurses/midwives, and medical officers who will perform the VIA test, and cryotherapy will be adhered to. On the job competency testing will be done, and all training will be competency-based, with testing of all trainees at the end of the training.
- Minimum guidelines on the content of the IEC package will guide development of the country specific materials, with due consideration of existing materials from WHO and PATH (Annex 6-10).
- Assess progress of field work (logistics, performance of the field workers and referral) at end of the first 3 months.
- Comply with expiration date of acetic acid 3-5% and discard when expired.
- Similar light source (White light/halogen torch) as this affects visualization of the aceto-white lesions.
- Standard questionnaires and data entry screens will be used in all sites
- Crosschecking for completeness and accuracy of questionnaire and entered data will be routinely done
- Sites will use similar work plans and hence the same progress and quality control indicators. This will allow for comparison between sites.
- On job facilitative supervision. The principle investigators will continually assess performance of field workers using cervicographs, on-patient interpretation of findings and other indicators such as test positive rate per worker over time.
- The principle investigator will be the master trainer and to maintain the skill to be able to supervise others, he will have to remain actively involved with VIA screening and treatment exercises.
REFERENCES
- "Cancer control" knowledge in to practice. WHO guide for effective programing. Published by World Health Organization 2007. http://www.who.int/cancer/ modules/Prevention%20Module.pdf
- Miller A, Cervical Cancer screening programmes: Managerial guidelines. 1992, WHO: Geneva.
- Bingham A, B.A., Coffey P, Winkler J, Bradley JDzuba I, Agurto I, Factors affecting utilization of cervical cancer prevention services in low resource settings. Salud Publica de Mexico, 2003. 45(Suplemento 3).
- University of Harare/JHPIEGO Cervical Cancer Study Group. Visual inspection with acetic acid for cervical cancer screening: test qualities in a primary-care setting. Lancet, 1999. 353(9156): p. 857 - 859.
- RTCOG/JHPIEGO Cervical Cancer Prevention Project. Safety, Acceptability, and Feasibility of a Single-visit Approach to Cervical Cancer Prevention in Rural Thailand: A Demonstration Project. 2003, JHPIEGO: Baltimore.
- Olatunbosun O, Outcome of Cryotherapy for Cervical Intraepithelial Neoplasia in a developing country. International Journal of Gynecology and Obstetrics, 1992. 38: p. 305-310.
- Thailand Cervicare Group. A Qualitative Evaluation of the Acceptability and Feasibility of a Single Visit Approach to Cervical Cancer Prevention; Roi Et Province, Thailand. 2004, JHPIEGO: Baltimore.
- Adadevoh S, A.-A.A., Saleh A, Awuah B, Blumenthal P, Vanderpuye V, A Qualitative Evaluation of the Acceptability and Feasibility of a Single Visit Approach to Cervical Cancer Prevention in Ghana. 2004, JHPIEGO: Baltimore.
- Sellors J, L.K., Kidula K' Muhombe K' Tsu V, Herdman C, Screening and management of precancerous lesions to prevent cercal cancer in low resource settings. Asian Pacific Journal of Cancer Prevention, 2003. 4.
- Ferreccio Catterina, C.J., Visual inspection of the uterine cervix with Acetic acid (VIA). A critical Review and Selected Articles. 2003, Washington: PAHO.
- Paul D. Blumenthal, Lynne G, Sylvia D et al and Ghana Cervicare Group Cervical cancer prevention: safety, acceptability, and feasibility of a single-visit approach in Accra, Ghana American Journal of Obstetrics and Gynecology, 2007; 407: e1-e9
- Harshad S, Khunying K L, Marya P et al. Cervical cancer screening using visual inspection with acetic acid: operational experiences from Ghana and Thailand. Reproductive Health Matters. 2008;16:67-77
- Rengaswamy S, Rajamanickam R, Silvina A, Rajapandian T, Pulikattil O E, Cιdric M, Richard M, Donald M P, Jacob Ch. Determinants of participation of women in a cervical cancer visual screening trial in rural south India. Cancer Detection and Prevention. 2003; 27: 457-465)
- Population Reference Bureau, Preventing Cervical Cancer World Wide. 2004, Alliance for Cervical Cancer Prevention (PATH): Seattle. p. 11-12.
- Sue Goldie. Policy analysis of Cervical cancer Screening Strategies in Low-Resource setting. Journal of the American Medical Association, 2001. 285(24): p. 3107-15.
- Chirenje ZM, R.S., Akino V, Mlingo M. A randomised trial of Loop Electrosurgical Excision procedure (LEEP) versus cryotherapy in the treatment of cervical cancer intraepithelial neoplasia. J. of Obs and Gyn, 2001.
- Ministry of Health. Health indicators 2008. Ministry of Health. Ulaanbaatar. 2009
- Bolormaa D, Gary M. C, Salvatore et al. Human Papillomavirus Infection in Ulaanbaatar, Mongolia: A Population-Based Study. Cancer Epidemiol Biomarkers Prev 2008;17(7):1731-8
Form 4a. Ethical considerations
Potential risks and benefits to the study participants
Potential risks
VIA
Application of acetic acid may cause some sting-like discomfort but is usually mild. There is no known risk associated to VIA.
Cryotheraphy
Incase the participant treated with cryotheraphy, the normal consequences of the cryotheraphy such as: vaginal discharge, lower abdominal pain, and fever (though very rare) would be reasons to early return to the clinic for follow-up.
Benefits to the participants
Early changes will be instantly treated. Those with established cancer will be referred for appropriate care. If the participant has any other infection seen at the time of being examined, it will be treated appropriately at no cost.
Informed consent and confidentiality
A written consent form will be obtained from each participant. Information gathered from the participant will be kept with utmost confidentiality. Only the concerned researchers will have access to this information. The participant's name will only be used for contact purposes, but not for any other purposes. The participant will be identified using a number and this together with the participant's details will be entered into a computer for analysis and program monitoring. No publication or any other communication from the researchers to other researchers will bear the participant's name or identification number.
Form 4b. Gender issues
1. Describe how the research addresses a demonstrated public health need and a need expressed by women or men.
The cervical cancer is third leading cause of all mortality among all cancer and the first most common cancer among women in Mongolia. Annually, around 300 new cases of cervical cancer are detected in the country and the most of them are diagnosed at stage of the disease with low survival rates. But in Mongolia nationwide programs on cervical cancer prevention and control do not exist, and the majority of women have never been screened. Therefore this project will address this urgent need to establish the nationwide cervical cancer prevention and control program in Mongolia.
2. How will the research reduce (or not increase) inequities in health and health care and inequities between women and men?
This project seeks to identify women who may have changes on their cervices indicative of early cancer. The women will be given instant treatment for these changes to prevent them from developing cancer later.
3. Describe plans for disseminating results and sharing knowledge with research subjects and the non-scientific community.
The study's results will be presented and disseminated to pivotal health police makers, planners and health/medical practitioners responsible for reproductive health and cancer service in order to influence the development of more suitable policies, plans, programs and modifications of the cancer and cervical cancer services. The results will be published in national and international journals.
4. What is the sex composition of the research team? Describe whether the research topic warrants female or male researchers specifically.
Due to the fact that most health workers and researchers in a health system are female, the research team consists of mainly female doctors/researchers. However, there is no gender discrimination in any part of the administration and no effect of researcher's gender on this study.
Form 5. Budget
Personnel cost
2 scientific staff x 50$/month x 24 months = 2,400$
2 consultants x 50$/month x 12 months=1,000$
3 project-site supervisors x 30$/month x 12 months = 1,080$
Subtotal 4,480$
Supplies
Basic equipment and supplies that is essential for VIA (Examination gloves, Vaginal speculum, acetic acid, cotton swabs or cotton balls, small bowl to hold acetic acid): 9 sites x 300$=2,700$
Basic equipment and supplies for cryotherapy:
Cryotherapy gun and probe tips: One cryotheraphy gun and probe tips per each site:
7 cryotheraphy guns and probe tips (1 district hospital, 2 rural provincial hospitals, 4 primary health care units) x 3,500$= 24,500$
Refrigerant gas (nitrous oxide or carbon dioxide) and reliable supplier: 9 sites x 100$= 900$
Subtotal 28,100$
Transportation of study team
2 researchers x 2 provinces x 2 times/year x 500$= 4000$
Subtotal 4,000$
Other costs
National meeting and Operational meeting - at local level: 500$
Centralized training of project-site supervisors: 500$
Training of project in-country team: 500$
Information Education and Communication materials: 1,000$
Printing data collection instruments, consent forms etc: 1,000$
Pilot study, in-depth interview with providers and clients: ~500$ (subject cost, tape recorder, cassette, batteries etc)
Costs associated with planning, stationary, communication etc: ~500$
Subtotal 4,500 $
Form 6. Other support for the proposed research
- Is this research currently being supported directly by any other body?
If yes, give the name(s) of the Organization(s), nature, amount, and duration of support being provided - (b) Is this application currently being considered elsewhere?
If yes, by which Organization(s) and by what date a decision is expected?
NO.
NO.
Form 8. Curricula vitae of the principal investigator(s) and co-investigator(s)*
- 1. Surname and first name(s): Munkhbayar Choijiljav
- 2. Degrees (subjects, university or school, year awarded):
- 3. Posts held (type of post, institution/authority, dates):
- 4. Memberships in professional societies:
- 5. Recent publications (last five years, with titles and bibliographical references) and papers in press (use extra pages if needed):
Place of birth: Arkhangai province, Mongolia
Date of birth: 17.01.1969
Nationality: Mongolian
Sex: Male
1993- 1995 Master of Science, Mongolian Health Science University, Ulaanbaatar
1993- 1995 Obstetric Gynecologist, Mongolian Health Science University, Ulaanbaatar
1986- 1993 Medical doctor (Medical faculty of Mongolian Health Science University,
Ulaanbaatar)
Since 2007 - Obstetrician Gynecologist, State Research Center on MCH
2001-2007 - OB/GYN, Provincial Hospital Arkhangai
1998-2001 - researcher, MSU
1995-1998 - OB/GYN, Maternity Hospital #1
Member of Mongolian Obstetric Gynecologist's Association
Member of Mongolian Family Welfare Association
Ch.Munkhbayar et al. "Implications of the cytological screening for detection of precancerous growths in the cervix uteri". Mongolian Journal of Obstetrics/Gynecology and Pediatrics 2008;1(03):160-165
Ch.Munkhbayar et al. "A comparison study on cervical cancer detection and treatment". Abstracts of Scientific Conference, Ulaanbaatar 2009;42-45
A2: CONSENT FORM
Consent to participate in the screening and treatment program for precancerous lesions of the cervix
Client's name
Client's identification number ..
Background information
In Mongolia, cancer of the cervix is major killer of women and yet it is a preventable disease. Early detection of changes that lead to the development of cervical cancer ensures successful prevention by halting progression to a later stage that is less untreatable. This project seeks to identify women who may have changes on their cervices indicative of early cancer. The women will be given instant treatment for these changes to prevent them from developing cancer later.
Data collected from the questionnaires will be used to asses the possibility to implement the procedure in other health centers all over your country
Procedures
According to the counseling you have just received, a health care worker will examine you and insert an instrument in the vagina in order to have a look at the cervix. She will look at the cervix using a torch flash light. She will then apply a solution known as acetic acid to your cervix to allow her clearly see if the cervix has any changes on it. However if your cervix has an abnormal growth that looks like cancer, you will be referred for further assessment and treatment because the treatment procedure that we have will not benefit you now. After applying acetic acid, the health official will wait for about 1 minute to allow for the changes to become clearer. The medical person will then note his/her observations and write them on a piece of paper.
This procedure, called VIA for visual inspection with acetic acid, is safe and an adopted practice in several centers in different countries.
If the cervix is found to be normal, that will be the end of the examination. You will need to seek another screening test after five years. If the cervix is found to be abnormal, you will be offered treatment with cryotherapy. This method uses very cold gas to freeze and destroy the abnormal cells. During VIA procedure you may feel a sensation of cold and mild cramping. You will then be required to come back for review after 12 months to the same clinic where you had the screening test. In the meantime if any problems occur, we encourage you to come back as soon as possible to your health centre. You will be given a diary on which you will write down your own observation, please bring it with you whenever you come to the clinic.
If you want to discuss the results with your family or spouse before you decide to accept treatment, please feel free to do so and you will be given an appointment to return to the clinic.
Benefits
Early changes will be instantly treated. Those with established cancer will be referred for appropriate care. If you have any other infection seen at the time of being examined, it will be treated appropriately at no cost.
Risks
VIA
Application of acetic acid may cause some sting-like discomfort but is usually mild. There is no known risk associated to VIA.
Cryotherapy
In case you are treated with cryotherapy, the normal consequences of the cryotherapy such as: vaginal discharge, lower abdominal pain, and fever (though very rare) would be reasons to early return to the clinic for follow-up.
Rights
You are under no obligation to continue participating in the project if you wish to discontinue your participation for whatever reason. Leaving the project does not attract any repercussions such as denial of treatment at the clinic, or any other form of discrimination. In case you want to seek clarification or lodge any complaint about the project or procedure done, you should feel free to call the following people to register your issue;
- Dr Munkhbayar Tel 99020031
- Dr Bayalag Tel 99088562
Confidentiality
Information gathered from you will be kept with utmost confidentiality. Only the concerned researchers will have access to this information. Your name will only be used for contact purposes, but not for any other purposes. You will be identified using a number and this together with your details will be entered into a computer for analysis and program monitoring. No publication or any other communication from the researchers to other researchers will bear your name or identification number.
Interviewer declaration
I hereby declare that I have fully and clearly explained the information contained in this document to the participant. I also offered her an opportunity to ask questions which I answered fully.
The participant agreed to take part in the study.
Name and signature of participant or Thumbprint / Date
Name and signature of witness / Date
If the participant refused to take part in the study, record reason(s) given
A3: THE VIA PROCEDURE GUIDELINES
Basic equipment and Supplies Needed
- Examination couch or table
- Initial Visit Record Form (Appendix B3)
- Good white light source (e.g. halogen torch)
- Examination tray:
Latex examination gloves (clean)
Vaginal speculum (Cuscos /Graves)
3 - 5% acetic acid
Cotton balls
Sponge holding forceps
Small bowl to hold acetic acid.
Getting Ready
- Check that the speculum, gloves and other supplies are ready
- Tell the client what is going to be done and encourage her to ask questions
- Check that the client has emptied her bladder
- Ask her to undress so that a vaginal exam can be performed
- Help her onto the examination table
- Position and drape her for examination
- Wash hands with soap and water
- Put on the gloves
- Arrange instruments ready for use.
VIA Procedure
- With the patient in dorsal modified lithotomy position, inspect the external genitalia
- Insert the vaginal speculum
- Adjust the speculum and light source so that the entire cervix can be seen. Leave the speculum in situ
- Inspect the cervix (for growths, distortion, ulcers, inflammation, etc)
- Use a clean vaginal swab to remove any discharge, blood or mucous. A moistened swab is recommended if the vagina or cervix appear dry.
- Define your landmarks (the external os, the squamocolumnar junction, and the transformation zone)
- Liberally apply the acetic acid solution to the cervix (using cotton swab, or cotton ball) to the cervix
- WAIT 1 FULL MINUTE for the acetic acid to be absorbed and the acetowhite reaction to appear
- Report your VIA findings
- Gently remove the speculum from the vagina
- Write and draw your findings on the data sheet
- Explain your findings to the patient and give the relevant advice.
A4: THE CRYOTHERAPY PROCEDURE GUIDELINES
Basic equipment needed
- The VIA equipment and supplies
- Cryotherapy gun and probe tips
- Refrigerant gas (Nitrous oxide or Carbon dioxide)
- Wrench/spanner for attaching the cryotherapy unit to the gas tank
- Sanitary pads
- 70 -90% ethyl or isopropyl alcohol for wiping the cryotip and sleeve
- If using the British type CO2 connector, a supply of washers
Eligibility criteria for cryotherapy
- The lesion is located on the ectocervix without extension to the vagina and /or the endocervix
- The lesion is visible in its entire extent and does not extend more than 2 -3 mm into the canal
- The lesion can be adequately covered by the largest available cryotherapy probe (2.5cm) and extends less than 2mm beyond the probe
- There is no evidence of invasive cancer
- The Endocervical canal is normal and there is no evidence of glandular dysplasia
- The woman is not pregnant
- If she has recently delivered she is at least 12 weeks post partum
- There is no evidence of pelvic inflammatory disease
- The woman has given consent for the treatment.
Cryotherapy Procedure
- Do the VIA procedure and identify the lesion
- Confirm that the client is eligible for cryotherapy
- Fit the cryotip to the cryo-unit
- Place the cryoprobe so that it covers the whole lesion
- Freeze for 3 minutes and thaw for 5 minutes
- Repeat the freeze- thaw cycle
- Do not attempt to remove the cryoprobe from the cervix until complete thawing has occurred
- Examine the cervix for any bleeding
- Do not pack the vagina
- Give the patient a sanitary pad.
- Process and maintain the cryotherapy unit consistent with manufacturers instructions
- GIVE POST CRYOTHERAPY COUNSELLING
Cryotherapy Follow up care includes
- Analgesics to relieve cramping
- No sexual intercourse for 4 weeks
- No douching or using tampons for 4 weeks (Nothing in the Vagina)
- Provide a supply condomsif patient is doubtful about ability to be abstinent
- Report back to the clinic if they have any of the following:
- Fever more than 2 days
- Foul smelling orpus colored discharge
- Severe lower abdominal pain
- Heavy bleeding (unrelated to menses)
- Inform the client that they may experience
- Cramping
- Profuse watery discharge (emphasize this is usually clear or light yellow and non offensive)
- Spotting or mild bleeding
- Perspectives on the project
- Do you think offering test and treat services at these clinics have any effect (positively or negatively) on other services provided at these clinics?
- 2) Perspectives on VIA & Cryotherapy training
- Comment on how adequately you feel training prepared you to provide VIA? Would you suggest any changes to future training sessions?
- How long after training did it take you to feel confident in your VIA assessments? How many procedures did it take for you to feel confident providing VIA?
- Comment on how adequately you feel training prepared you to provide cryotherapy? How many procedures did it take you to feel confident providing cryotherapy?
- To what extent did training prepare you for the way things actually work in the clinics where you are/were posted for the project?
- 3) Perspectives on provider's role
- How do you feel about your role in making clinical management decisions based on the VIA test result?
- How do you feel about your role in treating those women who have a VIA positive test result?
- 4) Perspectives on supervision
- How much do you feel you need supervision?
- How often should supervisory visits take place? How frequently would such visits be useful?
- Comment on how adequate you felt supervision was by the project clinical supervisors in terms of helping you with any logistics, supplies or scheduling problems, or increasing your confidence in performing VIA and cryotherapy procedures
- 5) Perspectives on the role of nurses in cxca prevention
- a) What do you think of nurses taking on supervision responsibilities for cervical cancer prevention activities?
- 6) Perspectives on sustainability of cervical cancer prevention services
- How can cervical cancer prevention services be sustained in your site? How can the Single Visit Approach using VIA and cryotherapy be sustained in the service?
- How would Quality Assuranceincluding such things as supervision and data collectionbe sustained in the country?
- 7) Perspectives on impact of cervical cancer prevention services
- a) How supportive have colleagues and supervisors been towards the See and Treat Approach?
- 8) Perspectives on women's knowledge, attitudes and behavior regarding screening
- How do you think women feel about receiving immediate test results? (versus having to wait for pap smear results).
- How do women understand the meaning of a positive VIA test result? Do they think that they have cancer? Do they think that they have precancer? Or something else?
- If they are VIA positive, then what do they think are their chances of progressing to cancer?
- Do you think the women understand what their real chances are of having precancer when they consent to receiving treatment? Explain.
- To what extent are women satisfied with VIA testing?
- 9) Perspectives on women's knowledge, attitudes and behavior regarding treatment
- How do you think women feel about having the option of immediate, on -the-spot treatment (versus having to come back for test results and travel elsewhere for treatment?)
- Do you think that women accepting treatment are worried about likely side effects and/or possible complications that may occur as a consequence of receiving cryotherapy?
- What do you think the women understand when they consent to receive treatment?
- 10) Perspectives on women's knowledge, attitudes and behavior regarding post-treatment issues
- To what extent to you feel that women with possible health problems post-cryo understand the warning signs indicating they should return to the clinic?
- What is the likelihood that women with post-treatment problems would return to the clinic?
- To what extent are they able to come back if they have side effects or warning signs? What are the barriers?
- To what extent are women with problems who should come back not returning to the clinic?
- To what extent are women satisfied with cryotherapy treatment?
- What has been your experience with women returning for unscheduled "problem" visits after cryotherapy treatment? Do you think women are not coming but should, or are women coming when they don't really need to? Explain.
- 11) Perspectives on barriers to screening, treatment, follow up and adherence to protocol
- In your opinion, what are the reasons that women do not come for screening?
- What are the reasons that women who have a VIA positive test result decline to return for treatment?
- What reasons do women decline to return for post-treatment follow up?
- How easy/difficult do you think it is for women to adhere to the home care requirements after cryotherapy treatment, especially abstinence or condom use for one month? How easy/difficult to you think it is for women to adhere to the home care requirements post-treatment (especially abstinence or condom use for one month)?
- 12) Perspectives on counseling and informed decision making
- Based on your interactions with women, how could counseling be modified?
- How have you modified or how would you modify the content or format of counseling?
- What specific issues do you think need to be addressed /emphasized during counseling sessions with women? What do you feel they are most concerned about? Explain.
- 13) Perspectives on expanding access
- What do you feel are the advantages/disadvantages active, community-based outreach?
- Based on your experience, what is the impact of active, community-based outreach?
Counselling post-cryotherapy
Before leaving the health facility, all women who have had a cryotherapy should be counselled. They should be advised to abstain from sexual intercourse and not use vaginal tampons for 4 weeks, or until the discharge and bleeding are completely gone, in order to avoid acquisition of infections, such as sexually transmitted infections, including HIV, and bleeding. With the patient's permission, her partner should also be counselled on avoiding sexual intercourse. If abstinence from intercourse is not possible, condom use should be recommended and condoms provided.
During the healing process, HIV-positive women might have increased HIV shedding, while HIV-negative women might be more likely to acquire HIV if exposed.
