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DEVELOPING A SCALE-UP STRATEGY FOR A CERVICAL CANCER
PREVENTION PROGRAM IN TANZANIA
Response to Request for Proposal Objective 2:
Identify approaches for facilitating adoption and elimination of barriers to
implementation of effective public health interventions for optimal, timely effect and
impact
Implementation Research to Support Programs that will Advance Population Health and Well-
Being
Johns Hopkins Bloomberg School of Public Health
Principal Investigator:
Olakunle Alonge
Co-Investigators:
Aachal Devi, Jae-Hee Honey, Harsha Rajashekharaiah, and Katrina Weeks
Tanzania
January 2017 – January 2020
1
TABLE OF CONTENTS
ACRONYMS AND ABBREVIATIONS 2
ABSTRACT 3
STUDY OVERVIEW 4
Public Health Problem 4
Study Rationale 4
RESEARCH DESIGN AND METHODS 5
Study Purpose 5
Study Aims 5
AIM 1: Health system readiness assessment for single visit screen-and-treat program 5
AIM 2: Capacity building for screen-and-treat program 6
AIM 3: Developing community awareness to facilitate effective implementation 7
Specific Objectives 7
Hypotheses 8
Conceptual Framework 8
Proposed Study Design 11
LIMITATIONS 13
EFFORTS TO BUILD RESEARCH CAPACITY 13
APPENDICES 14
Appendix 1: WHO Guidelines Flowchart 14
Appendix 2: Conceptual Framework 15
Appendix 3: Implementation and Service Outcomes 16
Appendix 4: Data Sources and Collection 17
Appendix 5: Study Design Timeline 21
Appendix 6: Data Analysis 22
Appendix 7: Division of Labor 23
References 24
2
ACRONYMS AND ABBREVIATIONS
CHW Community Health Worker
HF Health facility
HIV Human immunodeficiency virus
HMIS Health Management Information System
HPV Human papillomavirus
IARC International Agency for Research on Cancer
Jhpiego Non-profit health organization affiliated with Johns Hopkins University
(formerly Johns Hopkins Program for International Education in
Gynecology and Obstetrics)
MCH Maternal and Child Health
M&E Monitoring and Evaluation
MoHSW Ministry of Health and Social Welfare
Nursing staff Nurses and nursing assistants
PHC Primary health center
RMNCH Reproductive, Maternal, Newborn and Child Health
Screen-and-treat VIA screening and cryotherapy treatment of
precancerous lesions during same visit
SCT Social Cognitive Theory
USAID U.S. Agency for International Development
VIA Visual inspection with acetic acid
WHO World Health Organization
3
ABSTRACT
This proposal seeks to explore implementation strategies to increase utilization and coverage of
cervical cancer screening and treatment in Tanzania. This study will evaluate approaches to
eliminating barriers to scaling up a cervical cancer screening and treatment program based on a
successful program piloted by Jhpiego using the single-visit screen-and-treat approach in 20
health facilities across the country.
Two main barriers to cervical cancer screening and treatment in Tanzania have been shown to be
a shortage of health care professionals to deliver the service and a lack of awareness about the
procedure among women of reproductive age (the target population). The first aim of our study
is to conduct a comprehensive assessment of the capacity of the health system in Tanzania and
determine gaps in awareness among the target population. The second aim of our study is to
evaluate the effectiveness of a scale-up strategy that builds capacity of nursing staff in primary
health care facilities to deliver screen-and-treat services. The third aim of this study is to
determine whether capacity building of nursing staff in concert with a communication campaign
to generate awareness and will be more effective in mobilizing women to obtain cervical cancer
prevention services than the capacity building intervention alone.
We propose to assess whether our basic and enhanced strategies increase utilization of screen-
and-treat services among women 18-49 in Tanzania and ultimately increase coverage and
decrease mortality due to cervical cancer among this population. We will measure fidelity to the
screen-and-treat approach, gauge uptake of screen-and-treat services, and assess the
appropriateness of deploying the strategies described above in existing facilities. The results of
this study will determine whether addressing the main barriers to uptake of cervical cancer
screening will be effective in reducing mortality from cervical cancer in Tanzania over the next
10 years.
4
STUDY OVERVIEW
Public Health Problem
Cervical cancer is the leading cause of cancer morbidity and mortality in Tanzania (Ferlay, et al.,
2013). It is the most frequent type of cancer affecting the Tanzanian population, with 7,304 new
cervical cancer cases occurring each year (HPV Information Centre, 2016). Cervical cancer is
also the leading cause of cancer death in the country, with an estimated 4,216 women dying
annually due to cervical cancer alone (Ferlay, et al., 2013).
However, this significant cervical cancer burden is preventable. Cancer of the cervix is a slowly
progressing disease that typically takes 10 to 20 years to develop from a benign pre-cancerous
lesion to invasive cancer (World Health Organization, 2006). If detected early, pre-cancerous
lesions can be successfully treated to prevent the progression to cancer, which can be fatal in its
advanced stages. Not only is there abundant opportunity for detecting and treating cervical
cancer, effective interventions already exist for reducing the burden of cervical cancer and
improving quality of life for populations in low-and middle-income countries. Studies have
demonstrated that screening using visual inspection with acetic acid (VIA) followed by
immediate treatment with cryotherapy for individuals with pre-cancerous lesions can decrease
cervical cancer morbidity and mortality in low resource settings (Blumenthal & McIntosh, 2015;
Denny et al., 2005; Sankaranarayanan et al., 2007). Thus, we have the evidence-based tools to
effectively address the cervical cancer problem in Tanzania. Nonetheless, Tanzania’s high
cervical cancer burden clearly demonstrates that effective secondary prevention interventions,
such as VIA screening and cryotherapy treatment, do not reach much of the country’s population
in need of such services. Attached as Appendix 1 is a flowchart describing the WHO guidelines
for screening and treatment of precancerous lesions for cervical cancer prevention (World Health
Organization 2006).
Study Rationale
A cervical cancer prevention program has been piloted at 20 health facilities in order to address
the cervical cancer burden in Tanzania. Based on the screen-and-treat approach, Jhpiego trained
health professionals to use visual inspection with acetic acid (VIA) to screen women for
precancerous lesions and, if positive, provide treatment with cryotherapy during the same visit.
At pilot sites the screen-and-treat program was an effective method for providing secondary
prevention services for cervical cancer and it was found to be acceptable by the target population
(O. Alonge, group consultation, November 9, 2016).
Given the success of this intervention at 20 pilot sites across Tanzania, this program has the
potential to substantially reduce the cervical cancer burden if scaled up at a national level.
However, it is unclear whether the same outcomes of this program can be expected at scale.
There are considerable challenges confronting successful implementation of cervical cancer
programs in this nation. An acute shortage of skilled human resources, insufficient equipment
and infrastructure, and inadequate funding are the main health systems constraints that limit
implementation of health programs in Tanzania (Kwesigabo et al., 2012; McCree et al., 2015).
There are also many barriers that specifically prevent the uptake of cervical cancer prevention
programs by at-risk women, which contributes to intervention failure in Tanzania. Stakeholders
involved in scale-up of these programs in Tanzania identified sociocultural factors and distrust in
the quality of health system services as a few challenges that impede women from accessing
5
expanded cervical cancer prevention programs (McCree et al., 2015). Limited knowledge of
cervical cancer is also associated with low utilization of these prevention programs in Tanzania
(Perng et al., 2013).
Given the high burden cervical cancer and the multiple challenges associated with the
implementation of these programs in Tanzania, it is unclear whether this cervical cancer
prevention program will have success at scale.
Therefore, this proposal aims to address Objective 2 of the RFP: Identify approaches for
facilitating adoption and elimination of barriers to implementation of effective public
health interventions for optimal, timely effect and impact.
RESEARCH DESIGN AND METHODS
Study Purpose
The purpose of our study is to evaluate the effectiveness of a scale-up strategy that builds
capacity of nursing staff in existing national primary health care services to deliver screen-and-
treat services, which will be complemented with a communication campaign to mobilize women
to obtain cervical cancer prevention services in communities with an awareness gap upon initial
assessment. The goal of this strategy is to reduce cervical cancer mortality among women ages
18-49 in Tanzania over the next 10 years.
In particular, we aim to assess the uptake, fidelity and appropriateness of this strategy, as well as
ascertain its impact on increasing the utilization of screen-and-treat services and hence the
coverage of cervical cancer screening and treatment in the target population.
Study Aims
The primary aim of this project is to assess the current capacity of the health system and to
provide responsive strategies to increase the uptake of the piloted cervical cancer screen-and-
treat method to reduce the prevalence of cervical cancer in Tanzania. Our approach will consist
of three phases which will proceed sequentially, as described below:
AIM 1: Health system readiness assessment for single visit screen-and-treat program
Research Question: Does the existing health system in Tanzania has the necessary capacity to
take on the task of delivering the single visit screen-and-treat services to its target population?
(we are mentioning all the components of health system in detail below)
What is the distribution of health care workers and primary health facilities in Tanzania at this
time? Are there any particular gaps that will need to be addressed before moving forward with
our implementation strategies?
Implementation Strategy:
The first phase of our research study will consist of a comprehensive assessment of the capacity
of the health system in Tanzania and the existing barriers to implementation at both the
community level and at targeted health facilities. Our assessment will target facilities providing
primary health care services as these are the facilities in which we ultimately seek to implement
our program at scale. At this stage, we will measure the existing management support and human
6
resources available within targeted health facilities and the extent to which they will be able to
incorporate our cervical cancer screening program. We will be focus our attention on assessing
the appropriateness of integrating the cervical cancer screen-and-treat methodology into the
existing health system.
Our assessment will include an evaluation of the existing infrastructure in health facilities in our
selected districts, levels of deployment and staffing requirements, determining the levels of
commodities available for service implementation, monitoring & evaluation, management
structures and a qualitative needs assessment of the target population.
We will tailor our approach for scaling up cervical cancer screening and treatment in the country
after our initial assessment. Based on a comprehensive literature review, the main barriers for
effective implementation were found to be lack of trained health providers and an awareness gap
within communities (Kwesigabo et al., 2012; McCree et al., 2015; Perng et al., 2013). Under the
assumption that our initial assessment will produce similar results, we propose the following
implementation strategies.
AIM 2: Capacity building for screen-and-treat program
Research Question: Does capacity-building of nursing staff involved in primary healthcare
services facilitate effective implementation of the VIA screen-and-treat program?
Implementation Strategy:
According to interviews with key stakeholders in Tanzania, one of the key determinants for
successful scale up of a cervical cancer screening and treatment program in Tanzania will be
capacity building at both the regional and district levels (McCree, 2015).
Our implementation strategy will initially consist of training nursing staff to implement the VIA
screen-and-treat method. After training, we will put into practice a program to maintain
supervision, assistance, and on-the-job support of nursing staff to monitor and maintain levels of
quality. Through a biennial periodic assessment, we will determine whether quality has
diminished among nursing staff, and when necessary, will provide refresher trainings.
Throughout this process, we will construct a feedback loop to incorporate constructive criticism
and evaluation from staff at the facilities and will provide performance incentives for nursing
staff who provide the screen and treat method with a pre-determined level of quality.
At this stage, we will implement the VIA screening intervention by integrating the program into
existing primary health care services at the district level. Our implementation research outcomes
at this stage will be appropriateness, uptake and fidelity.
AIM 3: Developing community awareness to facilitate effective implementation
Research Question: Do community-based awareness generation campaigns facilitate effective
implementation of the screen-and-treat initiative?
Implementation Strategy:
In addition to assessing and identifying the existing health system capacity in the country, we
will assess the level of knowledge and awareness in the community about the importance, need
and availability of cervical cancer screening and treatment methods. We will design and
7
implement a program to increase awareness and knowledge about cervical cancer and the VIA
screening program. One study in the Kilimanjaro region of Tanzania established that the greatest
barrier to accessing cervical cancer screening services among both urban and rural women was a
lack of awareness that such services existed (Cunningham, 2015). Awareness of cervical cancer,
knowledge of risk factors and knowledge about screening have all been shown to be positively
correlated with the odds of receiving cervical cancer screening in Tanzania (Perng, 2013).
We will incorporate community engagement activities such as meetings, street plays, advocacy
rallies and IEC materials posted in public spaces to disseminate information regarding cervical
cancer screening. We will also identify local celebrities and community champions and employ
them to engage with targeted communities. These activities will work in concert to increase
acceptability and awareness of the screen-and-treat program in targeted regions of Tanzania.
Using a community-based participatory approach, we will deploy community-designed
communications campaigns to increase awareness and acceptability of the screen-and-treat
method. Our implementation research outcomes at this stage will be appropriateness and uptake.
Table 1: Summary of Intervention Packages for Scale-Up of Cervical Cancer Prevention
Baseline Basic Package Enhanced Package
Existing Standard of Care
in Facilities in Tanzania
Capacity building of nursing staff
to provide screen-and-treat
Capacity building of nursing staff
and community awareness campaign
Specific Objectives
This study specifically aims to compare critical service outcomes and implementation outcomes
between sites that receive no intervention, the basic package of interventions, and the enhanced
package of interventions. The outcomes that will be evaluated are the following:
Service Outcomes
1. Assess utilization of screen-and-treat services among women ages 18-49 in Tanzania.
2. Measure coverage of cervical cancer screening and treatment among women ages 18-49
in Tanzania.
Implementation Outcomes
1. Evaluate fidelity to the screen-and-treat approach.
2. Gauge uptake of screen-and-treat services among both nursing staff and target
population.
3. Assess the appropriateness of cervical cancer prevention packages for nursing staff and
target population.
Hypotheses
AIM 1: Based on the challenges identified in the existing literature, we expect our initial
assessment to determine that the main barriers for effective implementation are shortages of
trained health professionals to provide screen-and-treat services and awareness gaps among the
target population.
8
AIM 2: Training of nursing staff in primary care facilities will increase the capacity of those
facilities to provide cervical cancer screening and treatment for the target population.
AIM 3: Capacity building of nursing staff in concert with a comprehensive communication
campaign will result in better service outcomes and implementation outcomes than no
intervention or the basic intervention package.
Conceptual Framework
The conceptual framework contained in Figure 1.1 below illustrates the causal pathways that link
this study’s proposed intervention strategies, implementation strategies, implementation
outcomes, service outcomes, and the anticipated health impact of reduced invasive cervical
cancer and a related decrease in cervical cancer mortality. A larger version of the Conceptual
Framework is attached as Appendix 2.
Figure 1.1 Conceptual Framework for Scale-Up of Cervical Cancer Prevention in Tanzania
Table 2: Implementation Outcomes
Fidelity
% of trained nursing staff correctly recognizing precancerous lesions administering VIA according to
protocol
% of cryotherapy treatments correctly administered according to protocol
Uptake
% of target population that sought screen-and-treat services
% of trained nursing staff who intend to administer screen-and treat services
9
Appropriateness
% of target population who were convinced to get screen-and-treat services
% of trained nursing staff that feel that they can add screen-and-treat to their existing responsibilities
*Target population defined as women living in Tanzania who are 18-49 years of age
Table 3: Service Outcomes
Coverage
% of target population who received screen-and-treat services
Utilization
# of women in target population who received screen-and-treat services
*Target population defined as women living in Tanzania who are 18-49 years of age
As described in the specific objectives, the focus of this research study will be measuring
implementation outcomes and service outcomes associated with no intervention, a basic package
of interventions (composed of capacity building of nursing staff to provide screen-and-treat
services), and an enhanced package of interventions (which combines capacity building of
nursing staff to provide screen-and-treat services with a community-based awareness campaign).
We will measure these outcomes at study sites using the indicators described in Table 2 and
Table 3 attached as Appendix 3 in order to compare the effectiveness of these scale-up strategies.
The conceptual framework above highlights how the proposed scale-up strategies are expected to
have a positive impact on cervical cancer mortality. The health impact column on the right side
of the conceptual framework identifies this study’s overarching goal of reduced cervical cancer
mortality. Cervical cancer is fatal when it is at advanced stages, so a reduction in advanced cases
of invasive cancer is will decrease death due to this disease (World Health Organization, 2006).
Reductions in cervical cancer morbidity has been linked to greater coverage of secondary
prevention programs for cervical cancer, specifically screen-and-treat services in low-and-middle
income countries (Gakidou, Nordhagen, & Obermeyer, 2008; World Health Organization, 2006).
Quality coverage of the population is dictated by the utilization of high-quality screen-and-treat
services at health facilities, as well as the level of scale of the program, since this is a population-
level measure. In order for there to be increased utilization of high-quality screen-and-treat
services, the proposed strategies must improve, or at least not worsen, the uptake, fidelity, and
appropriateness of screen-and-treat services.
There are also external factors that affect the scale-up of a cervical cancer prevention program in
Tanzania. There are several contextual level factors, such as culture, socioeconomics,
demographics, and political dynamics, that can influence the elements and processes described in
the conceptual framework. Additionally, on the health facility level, the above framework
demonstrates how resources, organizational and infrastructural factors, such as the availability of
exam rooms for pelvic exams, sufficient electricity for staff to carry out VIA screening, or
adequate staff supervision, can mediate both implementation and service outcomes of scale-up.
10
The following section describes the theories that are the basis for the implementation strategies,
as well as the causal linkages, contained in the conceptual framework for this study.
Theoretical Framework
Health system strengthening for screen-and-treat program
In a multi-level socio-ecological intervention model, we propose to intervene at the health
facility level. At the organizational level, we will build social support for health behavior change
and change at this level will have a direct/indirect effect on the lower levels, namely individual
and interpersonal levels (McLeroy et al, 1988). At the individual level, the constructs from The
Social Cognitive Theory (SCT) were used to design the intervention. The SCT states that the
behavior, personal factors, and environment are triadic determinants dependent on each other; so
a change in one determinant will influence other parameters (Bandura, 1986). Training health
professionals at the health facility level will enable there to be an external environment for
women in Tanzania to seek health services and constitute a desired behavior change.
The constructs at the interpersonal level determining the intervention are Behavioral
Capabilities and Self-Efficacy (Bandura, 1986). Behavioral Capabilities posits that the
knowledge and skill about the behavior will promote a specific behavior change (Bandura,
1986). The trained health professional will share their knowledge about cervical cancer with the
women, why women are susceptible to cervical cancer, and their current behaviors that increase
their chances of cervical cancer. This intervention component promotes shaping the knowledge
of women in Tanzania and specifies what and how it should be done. The trained health workers
use the construct of Self-Efficacy to make the women believe that they can prevent cervical
cancer by the screen-and-treat method. Overall, the intervention at this level has an effect at the
individual level where it tries to change the social norms around cervical cancer screening and
treatment.
Developing community awareness to facilitate effective implementation
This intervention strategy is proposed at the community level. A community can have many
meanings but in this particular intervention a community refers to a population in the same
geographical area embracing families, friends, and neighborhoods to make collective decisions
and is seen as a mediating structure (McLeroy et al., 1988). In case of a cervical screen-and-treat
program the communities serve as pivotal role in influencing collective norms and values by
acknowledging the use of cervical cancer prevention services at the health facility. Behavior
changes like visiting the health facility for a regular check-up and treatment of a precancerous
lesion require the affirmation and support from the community (McLeroy et al., 1988). Under the
assumption that communities in Tanzania are a mediating structure for influencing behavior
change, cervical campaign intervention program can have a significant impact on the
acceptability, norm and attitudes towards the behavior. At this level the constructs from Social
Cognitive Theory are applied. Reciprocal Determinism refers to people’s potential ability to
alter their environment along with their capabilities to interact with the environment. A
community designed cervical cancer program will enable an environment that leads to behavior
change (change in the structural environment), thus increasing the capabilities and the conviction
that the individual can perform the behavior that will reduce the incidence of cervical cancer in
the community. Self-Efficacy is the second construct that posits beliefs about a personal ability
to perform behaviors which is reinforced by carrying out the behavior like visiting a health
facility, modeling behavior by others (Observational Learning) and encouragement by others to
11
carry out the behavior; like having women who have had a screen and treat procedure, to talk to
other women in the community about the benefits of screening and early detection of a
precancerous lesion.
Proposed Study Design
The overall research activities proposed to be conducted during our study is depicted in the
conceptual framework included as Appendix 2. At the beginning of our study, we intend to
conduct exhaustive consultation with the Ministry of Health, Jhpiego and other key stakeholders
at the national level. This will serve as an opportunity to establish a platform for discussion,
dissemination and stakeholder engagement during the course of the study and implementation.
Through these discussions, with inputs from the stakeholders we will randomly select 100
districts across 7 zones. Further 4 PHCs will be randomly selected per district to perform an
implementation strength assessment. During this initial assessment, a spectrum of system and
process indicators relevant to the success of the program will be assessed. A standardized
checklist and questionnaire will be developed and utilized during this initial assessment survey.
We will employ the MOH staff and externally hired personnel to complete this initial
assessment. The details of this checklist and questionnaire are provided under Appendix 4.1.
Following the initial assessment, the data will be gathered and analyzed to identify key
implementation barriers for successful role out of screen and treat initiative in Tanzania. This
assessment will also serve as the first large sample survey of implementation strength assessment
spanning across different zones of the country. We will generate a preliminary report based on
our assessment which will be produced to the MOH and discussed with the stakeholders on a
common platform. This serves as a guide to address some of the key implementation barriers
from the offset. It also provides the MOH the time window to address issues like human
resource scarcity or infrastructure among others before the role out of the program at the national
scale. It is important to note at this point that for the purpose of this paper, it was assumed that
our initial assessment will narrow down the issues into two main areas i.e. insufficient number of
trained personnel to deliver the services and awareness gap among the target population. In the
following section we will be discussing the interventions designed to address these two main
areas and how we will be assessing the effectiveness of these interventions and arrive at an
inference about what are best methods to deliver the services effectively.
The details of the study design are depicted in Appendix 5. We chose to do a cluster randomized
study design to assess the effectiveness of our interventions. The choice of cluster
randomization was made based on number of factors such as the level of intervention in the
capacity building arm being at the level of facility, difficult in randomizing the communications
campaign at individual level, tailoring to the design of our initial assessment which was at the
health facility level, and ease of measurement (time, investment, technical capacity). Since the
screen and treat services are delivered at health facilities, we found it was appropriate to utilize
health facilities (PHCs) as our primary unit of study. We set out by randomly selecting one
district per zone (7 districts in total) and further randomly selecting 9 PHCs per district with a
distribution of 5 PHCs from rural areas and 4 PHCs from urban areas. The stratified sampling of
urban-rural areas was based on the fact that the implementation barriers vary between these two
settings (especially with respect to human resources, number and ease of access to facilities,
information gaps etc.) and we are interested in assessing success of our intervention in these two
12
settings. The 63 PHCs selected on random basis are then further randomized into three main
study arms with 21 PHCs each. Each arm will be composed of PHCs selected from rural and
urban areas at a ratio of 2:1.
The first arm of study - “Baseline intervention” refers to the standard of care existing in Tanzania
for prevention of cervical cancer i.e. administering Pap’s smear for women over 30 years of age
at a dose of at least three smears over lifetime. The second arm of study “Basic intervention
package” involves training Physicians and nursing staff at the PHC level to perform VIA
screening and also administer cryotherapy to treat precancerous lesions during the same visit.
This arm will also have physicians providing on-the-job supportive supervision to nursing staff
at the facility level and technical assistance when required for administering cryotherapy. There
will also be an assessment of quality and fidelity of performance which will be supplemented
with needs-based refresher trainings. To ensure quality of services and motivate the healthcare
workers, it will also be tied to performance-based incentives. Our third arm of study “Enhanced
intervention package” is a combination of the basic intervention as described above at the facility
level and supplemented by community level awareness generation activities. These activities
include identification of community champions in the catchment area of the PHCs, to develop
Information - Education - Communication materials like banners, posters, fact sheets, training
materials, dissemination and display of the IEC materials in public spaces, community level
focused group meetings, utilization of common platforms like festivals, rallies, fairs to promote
the agenda, endorsing local celebrities and influential people to advocate for cervical screening
services etc.
At this level of intervention, we will be measuring implementation outcomes such as
appropriateness, fidelity and uptake in each arm of the study. The detailed definitions of these
outcomes are provided in Table 2 in Appendix 3. We will also be measuring the service
outcomes and looking into utilization of the services at the facility level and measuring the
coverage of the services in the target population living the catchment area. The details of data
sources and collection methods are provided under Tables 5 and 6 in Appendices 4.2 and 4.3.
These indicators are periodically collected over a period of two years as depicted in the flow
diagram in Appendix 5. A stratified analysis of the implementation outcomes and service
outcomes is performed according the sampling stratification specified earlier. The specific
elements of measurement are described in Appendix 6. We will be performing a temporal
analysis of the trends in utilization and coverage of the screen and treat services. A comparative
analysis be done between the arms of intervention, between rural-urban areas. We will employ
multivariate regression analysis to look into the effectiveness of the individual arms of
interventions and also the components of these arms of interventions.
LIMITATIONS
We acknowledge that there are several limitations to this study. One limitation is that the study
will not be conducted at national scale and will only include a sample size of 63 health facilities.
Another limitation is that cryotherapy cannot be used to treat advanced stages of cervical cancer,
meaning that the single-visit screen-and-treat approach cannot be effective in eliminating some
cancerous lesions that lead to cervical cancer death. It will therefore be necessary to ensure that
women receive appropriate follow-up and counseling if their cervical cancer has progressed
beyond the initial stage and they may need to be referred to other facilities for treatment. This
13
will require strengthening of the referral mechanisms for advanced cervical cancer cases. This
study does not directly address the needs of HIV-positive women, who are at the highest risk for
cervical cancer among the target population. Lastly, because our study has multiple arms,
depending on the results, it may be difficult to determine which element of the intervention
package produces the impact if there are variable results.
EFFORTS TO BUILD RESEARCH CAPACITY
We will target six areas in which to build research capacity, described below:
1. Involvement of local staff at all levels of assessment and implementation- Efforts will
be made to involve local staff from all levels to get their input and feedback on
the intervention strategy.
2. Ensure local ownership and secure active support- Training community health
workers from the same community in the screen and treat method will increase the local
ownership of the community health workers and build self-efficacy to successfully carry
out the VIA screening.
3. Build in monitoring, evaluation and learning from the start of the program -
The intervention program has built in monitoring and evaluation such as record keeping
at the health facilities to keep track of the number of patients screened and treated.
Reporting of new cases and referrals to the higher level on a timely basis another way to
monitor the program. Emphasis will be given to timely data collection and statistical
analysis of the data for evaluation of the program.
4. Establish robust research governance and support structures - In order to ensure a
robust research governance, we plan to collaborate with local universities in the planning
of the program.
5. Promote effective leadership - At the end of 12 months of the program, we plan to
transfer the research capacity to the local universities in Tanzania in order to sustain the
program.
6. Embed strong support, supervision and mentorship structures - Timely support,
supervision and mentoring workshops will be conducted in the partner local university to
help in successful transition of research capacity to the local university.
14
APPENDIX 1
15
APPENDIX 2
16
APPENDIX 3
Table 1: Summary of Intervention Packages for Scale-Up of Cervical Cancer Prevention
Baseline Basic Package Enhanced Package
Existing Standard of Care
in Facilities in Tanzania
Capacity building of nursing staff
to provide screen-and-treat
Capacity building of nursing staff
and community awareness campaign
Table 2: Implementation Outcomes
Fidelity
% of trained nursing staff correctly recognizing precancerous lesions administering VIA according to
protocol
% of cryotherapy treatments correctly administered according to protocol
Uptake
% of target population that sought screen-and-treat services
% of trained nursing staff who intend to administer screen-and treat services
Appropriateness
% of target population who were convinced to get screen-and-treat services
% of trained nursing staff that feel that they can add screen-and-treat to their existing responsibilities
*Target population defined as women living in Tanzania who are 18-49 years of age
Table 3: Service Outcomes
Coverage
% of target population who received screen-and-treat services
Utilization
# of women in target population who received screen-and-treat services
*Target population defined as women living in Tanzania who are 18-49 years of age
17
APPENDIX 4.1
Table 4: Implementation strength assessment
Element Indicator Data source and method
1. Infrastructure:
MOH documents
Planned visits
a. Buildings % of health facilities with consistent
water and electricity
b. Privacy % of health facilities with private area to
perform screen and treat
2. Deployment of staff
MOH document review
HMIS
Planned visits
a. Staffing No. of physicians per PHC
No. of nursing staff per PHC
No. of CHW per PHC
b. Retention % of vacant positions for physicians /
nursing staff / CHW per PHC
3. Commodities
a. Supplies % of health facilities having basic
commodities (bed, lighting, specula,
gloves) available to perform screen and
treat
% of health facilities without stock of
HIV kits in last 3 months
% of health facilities with stock
inventory for HIV kits
Planned visits to health
facilities and review of
documents
4. Monitoring and
Evaluation
a. Record keeping % of health facilities with activity
registries maintained for HIV services
Planned visits to health
facilities and review of
documents
b. Reporting No. of completed reports (HIV) sent to
the higher level on timely basis in last 6
months
% of health facilities with data
management system/person in place
18
5. Management % of HF with a logical and explicit
organizational structure
% of HF with operational plan for
provision of HIV test
% of HF with budget linked to
operational plan
Planned visits to health
facilities and review of
documents
6. Needs assessment of
target population
% of sampled population:
• heard about the cervical cancer
• heard about the screening
• believe cervical cancer is fatal
• perceived screening as acceptable
• perceived screening was beneficial
Focused interviews
19
APPENDIX 4.2
Table 5: Basic package of interventions - Capacity building
Implementation Outcomes
Element Indicator Data source and method
Training
Supervision, support and on
the job assistance
Need based refresher training
Performance incentives
Appropriateness:
% of trained nursing staff
who felt it was appropriate to
add screen-and-treat to their
existing responsibilities
Focused interviews
Fidelity:
% of trained nursing staff
correctly recognizing
precancerous lesions
% of cryotherapy treatments
correctly administered
according to protocol
Reexamination
Direct observation
Uptake:
% of trained nursing staff
who intend to administer
screen-and treat services
Focused interviews
20
APPENDIX 4.3
Table 6: Enhanced package – Capacity-building + Community Awareness Campaign
Implementation Outcomes
Element Indicator Data source and method
Identify community
champions and engagement
IEC materials
Community engagement
meetings/talks
Advocacy rallies
Appropriateness:
% of target population who
were convinced to get screen-
and-treat services
Uptake:
% of target population
exposed to community level
activities that sought screen-
and-treat services
Focused interviews conducted
at pre and post community
level activities
Utilization data from the
facility - pre and post
community level activities
Service outcome
Element Indicator Data source and method
Utilization of screen and treat
services
No. of women screened
• at PHC level
• at District level
• at Regional level
• Service provision registry
• Audits
Coverage of screen and treat
services
% of target population who
received screening
• at PHC level
• at District level
• at Regional level
• Sample surveys
21
APPENDIX 5
22
APPENDIX 6
Data Analysis
• Measures of appropriateness, fidelity and uptake are used as implementation outcome
• Utilization & coverage of screen-and-treat services in PHCs under all 3 arms of
intervention: service outcome measure
• Comparative and temporal analysis of change in utilization and coverage rates across
three different arms
• Stratified analysis: Urban-rural, zonal, age group etc.
• Multivariate regression analysis for attribution of effectiveness of a given intervention
23
APPENDIX 7
Division of Labor
We broke up the assignment into component parts in order to distribute separate sections to
members of the team to write up for the proposal. Katrina contributed the Study Overview,
Specific Objectives, and created and described the Conceptual Model. Jae contributed the
Abstract, Study Purpose, Specific Aims, Hypotheses and Limitations. Aachal contributed the
Theoretical Framework, Limitations, and Efforts to Build Research Capacity. Harsha contributed
the portion describing the Proposed Study Design and created the accompanying tables.
24
REFERENCES
Alonge, O. (2016, November 9). Group Consultation.
Bandura A. (1986). Social foundations of thought and action: A social cognitive theory. Prentice-
Hall, Inc.
Blumenthal, P. D., & McIntosh, N. (2015). Cervical cancer prevention guidelines for low-
resource settings. Baltimore: Jhpiego.
Cunningham, M. S., Skrastins, E., Fitzpatrick, R., Jindal, P., Oneko, O., Yeates, K., . . . Aronson,
K. J. (2015). Cervical cancer screening and HPV vaccine acceptability among rural and urban
women in kilimanjaro region, tanzania. BMJ Open, 5(3) doi:10.1136/bmjopen-2014-005828
Denny, L., Kuhn, L., Souza, M. D., Pollack, A. E., Dupree, W., & Wright, T. C. (2005). Screen-
and-treat approaches for cervical cancer prevention in low-resource settings: A randomized
controlled trial. Jama, 294(17), 2173-2181. doi:10.1001/jama.294.17.2173
Ferlay, J., Soerjomataram, I., Ervik, M., Dikshit, R., Eser, S., Mathers, C., … Bray, F. (2013).
GLOBOCAN 2012 v1.0, Cancer Incidence and Mortality Worldwide: IARC CancerBase No. 11.
International Agency for Research on Cancer. Retrieved from http://globocan.iarc.fr
Gakidou, E., Nordhagen, S., & Obermeyer, Z. (2008). Coverage of cervical cancer screening in
57 countries: Low average levels and large inequalities. PLoS Medicine, 5(6)
doi:10.1371/journal.pmed.0050132
HPV Information Centre. (2016). Human papillomavirus and related diseases report: United
Republic of Tanzania. Barcelona, Spain: Institut Català d’Oncologia.
Kwesigabo, G., Mwangu, M. A., Kakoko, D. C., Warriner, I., Mkony, C. A., Killewo, J., . . .
Freeman, P. (2012). Tanzania's health system and workforce crisis. Journal of Public Health
Policy, 33 Suppl 1, 35. doi:10.1057/jphp.2012.55
McCree, R., Giattas, M. R., Sahasrabuddhe, V. V., Jolly, P. E., Martin, M. Y., Usdan, S. L., . . .
Lisovicz, N. (2015). Expanding cervical cancer screening and treatment in tanzania:
Stakeholders’ perceptions of structural influences on scale-up. The Oncologist, 20(6), 621.
doi:10.1634/theoncologist.2013-0305
McLeroy, K.R., Bibeau, D., Steckler, A., & Glanz, K. (1988). An ecological perspective on
health promotion programs. Health Education Quarterly, 15(4), 351-77.
Perng, P., W., Ngoma, T., Kahesa, C., Mwaiselage, J., Merajver, S. D., & Soliman, A. S. (2013).
Promoters of and barriers to cervical cancer screening in a rural setting in tanzania. International
Journal of Gynaecology and Obstetrics: The Official Organ of the International Federation of
Gynaecology and Obstetrics, 123(3), 221-225. doi:10.1016/j.ijgo.2013.05.026
25
Sankaranarayanan, R., Esmy, P. O., Rajkumar, R., Muwonge, R., Swaminathan, R.,
Shanthakumari, S., . . . Cherian, J. (2007). Effect of visual screening on cervical cancer incidence
and mortality in tamil nadu, india: A cluster-randomised trial. Lancet (London, England),
370(9585), 398-406. doi:10.1016/S0140-6736(07)61195-7
World Health Organization. (2006). Comprehensive cervical cancer control: A guide to essential
practice. Geneva: World Health Organization.

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IRP-Proposal FINAL

  • 1. DEVELOPING A SCALE-UP STRATEGY FOR A CERVICAL CANCER PREVENTION PROGRAM IN TANZANIA Response to Request for Proposal Objective 2: Identify approaches for facilitating adoption and elimination of barriers to implementation of effective public health interventions for optimal, timely effect and impact Implementation Research to Support Programs that will Advance Population Health and Well- Being Johns Hopkins Bloomberg School of Public Health Principal Investigator: Olakunle Alonge Co-Investigators: Aachal Devi, Jae-Hee Honey, Harsha Rajashekharaiah, and Katrina Weeks Tanzania January 2017 – January 2020
  • 2. 1 TABLE OF CONTENTS ACRONYMS AND ABBREVIATIONS 2 ABSTRACT 3 STUDY OVERVIEW 4 Public Health Problem 4 Study Rationale 4 RESEARCH DESIGN AND METHODS 5 Study Purpose 5 Study Aims 5 AIM 1: Health system readiness assessment for single visit screen-and-treat program 5 AIM 2: Capacity building for screen-and-treat program 6 AIM 3: Developing community awareness to facilitate effective implementation 7 Specific Objectives 7 Hypotheses 8 Conceptual Framework 8 Proposed Study Design 11 LIMITATIONS 13 EFFORTS TO BUILD RESEARCH CAPACITY 13 APPENDICES 14 Appendix 1: WHO Guidelines Flowchart 14 Appendix 2: Conceptual Framework 15 Appendix 3: Implementation and Service Outcomes 16 Appendix 4: Data Sources and Collection 17 Appendix 5: Study Design Timeline 21 Appendix 6: Data Analysis 22 Appendix 7: Division of Labor 23 References 24
  • 3. 2 ACRONYMS AND ABBREVIATIONS CHW Community Health Worker HF Health facility HIV Human immunodeficiency virus HMIS Health Management Information System HPV Human papillomavirus IARC International Agency for Research on Cancer Jhpiego Non-profit health organization affiliated with Johns Hopkins University (formerly Johns Hopkins Program for International Education in Gynecology and Obstetrics) MCH Maternal and Child Health M&E Monitoring and Evaluation MoHSW Ministry of Health and Social Welfare Nursing staff Nurses and nursing assistants PHC Primary health center RMNCH Reproductive, Maternal, Newborn and Child Health Screen-and-treat VIA screening and cryotherapy treatment of precancerous lesions during same visit SCT Social Cognitive Theory USAID U.S. Agency for International Development VIA Visual inspection with acetic acid WHO World Health Organization
  • 4. 3 ABSTRACT This proposal seeks to explore implementation strategies to increase utilization and coverage of cervical cancer screening and treatment in Tanzania. This study will evaluate approaches to eliminating barriers to scaling up a cervical cancer screening and treatment program based on a successful program piloted by Jhpiego using the single-visit screen-and-treat approach in 20 health facilities across the country. Two main barriers to cervical cancer screening and treatment in Tanzania have been shown to be a shortage of health care professionals to deliver the service and a lack of awareness about the procedure among women of reproductive age (the target population). The first aim of our study is to conduct a comprehensive assessment of the capacity of the health system in Tanzania and determine gaps in awareness among the target population. The second aim of our study is to evaluate the effectiveness of a scale-up strategy that builds capacity of nursing staff in primary health care facilities to deliver screen-and-treat services. The third aim of this study is to determine whether capacity building of nursing staff in concert with a communication campaign to generate awareness and will be more effective in mobilizing women to obtain cervical cancer prevention services than the capacity building intervention alone. We propose to assess whether our basic and enhanced strategies increase utilization of screen- and-treat services among women 18-49 in Tanzania and ultimately increase coverage and decrease mortality due to cervical cancer among this population. We will measure fidelity to the screen-and-treat approach, gauge uptake of screen-and-treat services, and assess the appropriateness of deploying the strategies described above in existing facilities. The results of this study will determine whether addressing the main barriers to uptake of cervical cancer screening will be effective in reducing mortality from cervical cancer in Tanzania over the next 10 years.
  • 5. 4 STUDY OVERVIEW Public Health Problem Cervical cancer is the leading cause of cancer morbidity and mortality in Tanzania (Ferlay, et al., 2013). It is the most frequent type of cancer affecting the Tanzanian population, with 7,304 new cervical cancer cases occurring each year (HPV Information Centre, 2016). Cervical cancer is also the leading cause of cancer death in the country, with an estimated 4,216 women dying annually due to cervical cancer alone (Ferlay, et al., 2013). However, this significant cervical cancer burden is preventable. Cancer of the cervix is a slowly progressing disease that typically takes 10 to 20 years to develop from a benign pre-cancerous lesion to invasive cancer (World Health Organization, 2006). If detected early, pre-cancerous lesions can be successfully treated to prevent the progression to cancer, which can be fatal in its advanced stages. Not only is there abundant opportunity for detecting and treating cervical cancer, effective interventions already exist for reducing the burden of cervical cancer and improving quality of life for populations in low-and middle-income countries. Studies have demonstrated that screening using visual inspection with acetic acid (VIA) followed by immediate treatment with cryotherapy for individuals with pre-cancerous lesions can decrease cervical cancer morbidity and mortality in low resource settings (Blumenthal & McIntosh, 2015; Denny et al., 2005; Sankaranarayanan et al., 2007). Thus, we have the evidence-based tools to effectively address the cervical cancer problem in Tanzania. Nonetheless, Tanzania’s high cervical cancer burden clearly demonstrates that effective secondary prevention interventions, such as VIA screening and cryotherapy treatment, do not reach much of the country’s population in need of such services. Attached as Appendix 1 is a flowchart describing the WHO guidelines for screening and treatment of precancerous lesions for cervical cancer prevention (World Health Organization 2006). Study Rationale A cervical cancer prevention program has been piloted at 20 health facilities in order to address the cervical cancer burden in Tanzania. Based on the screen-and-treat approach, Jhpiego trained health professionals to use visual inspection with acetic acid (VIA) to screen women for precancerous lesions and, if positive, provide treatment with cryotherapy during the same visit. At pilot sites the screen-and-treat program was an effective method for providing secondary prevention services for cervical cancer and it was found to be acceptable by the target population (O. Alonge, group consultation, November 9, 2016). Given the success of this intervention at 20 pilot sites across Tanzania, this program has the potential to substantially reduce the cervical cancer burden if scaled up at a national level. However, it is unclear whether the same outcomes of this program can be expected at scale. There are considerable challenges confronting successful implementation of cervical cancer programs in this nation. An acute shortage of skilled human resources, insufficient equipment and infrastructure, and inadequate funding are the main health systems constraints that limit implementation of health programs in Tanzania (Kwesigabo et al., 2012; McCree et al., 2015). There are also many barriers that specifically prevent the uptake of cervical cancer prevention programs by at-risk women, which contributes to intervention failure in Tanzania. Stakeholders involved in scale-up of these programs in Tanzania identified sociocultural factors and distrust in the quality of health system services as a few challenges that impede women from accessing
  • 6. 5 expanded cervical cancer prevention programs (McCree et al., 2015). Limited knowledge of cervical cancer is also associated with low utilization of these prevention programs in Tanzania (Perng et al., 2013). Given the high burden cervical cancer and the multiple challenges associated with the implementation of these programs in Tanzania, it is unclear whether this cervical cancer prevention program will have success at scale. Therefore, this proposal aims to address Objective 2 of the RFP: Identify approaches for facilitating adoption and elimination of barriers to implementation of effective public health interventions for optimal, timely effect and impact. RESEARCH DESIGN AND METHODS Study Purpose The purpose of our study is to evaluate the effectiveness of a scale-up strategy that builds capacity of nursing staff in existing national primary health care services to deliver screen-and- treat services, which will be complemented with a communication campaign to mobilize women to obtain cervical cancer prevention services in communities with an awareness gap upon initial assessment. The goal of this strategy is to reduce cervical cancer mortality among women ages 18-49 in Tanzania over the next 10 years. In particular, we aim to assess the uptake, fidelity and appropriateness of this strategy, as well as ascertain its impact on increasing the utilization of screen-and-treat services and hence the coverage of cervical cancer screening and treatment in the target population. Study Aims The primary aim of this project is to assess the current capacity of the health system and to provide responsive strategies to increase the uptake of the piloted cervical cancer screen-and- treat method to reduce the prevalence of cervical cancer in Tanzania. Our approach will consist of three phases which will proceed sequentially, as described below: AIM 1: Health system readiness assessment for single visit screen-and-treat program Research Question: Does the existing health system in Tanzania has the necessary capacity to take on the task of delivering the single visit screen-and-treat services to its target population? (we are mentioning all the components of health system in detail below) What is the distribution of health care workers and primary health facilities in Tanzania at this time? Are there any particular gaps that will need to be addressed before moving forward with our implementation strategies? Implementation Strategy: The first phase of our research study will consist of a comprehensive assessment of the capacity of the health system in Tanzania and the existing barriers to implementation at both the community level and at targeted health facilities. Our assessment will target facilities providing primary health care services as these are the facilities in which we ultimately seek to implement our program at scale. At this stage, we will measure the existing management support and human
  • 7. 6 resources available within targeted health facilities and the extent to which they will be able to incorporate our cervical cancer screening program. We will be focus our attention on assessing the appropriateness of integrating the cervical cancer screen-and-treat methodology into the existing health system. Our assessment will include an evaluation of the existing infrastructure in health facilities in our selected districts, levels of deployment and staffing requirements, determining the levels of commodities available for service implementation, monitoring & evaluation, management structures and a qualitative needs assessment of the target population. We will tailor our approach for scaling up cervical cancer screening and treatment in the country after our initial assessment. Based on a comprehensive literature review, the main barriers for effective implementation were found to be lack of trained health providers and an awareness gap within communities (Kwesigabo et al., 2012; McCree et al., 2015; Perng et al., 2013). Under the assumption that our initial assessment will produce similar results, we propose the following implementation strategies. AIM 2: Capacity building for screen-and-treat program Research Question: Does capacity-building of nursing staff involved in primary healthcare services facilitate effective implementation of the VIA screen-and-treat program? Implementation Strategy: According to interviews with key stakeholders in Tanzania, one of the key determinants for successful scale up of a cervical cancer screening and treatment program in Tanzania will be capacity building at both the regional and district levels (McCree, 2015). Our implementation strategy will initially consist of training nursing staff to implement the VIA screen-and-treat method. After training, we will put into practice a program to maintain supervision, assistance, and on-the-job support of nursing staff to monitor and maintain levels of quality. Through a biennial periodic assessment, we will determine whether quality has diminished among nursing staff, and when necessary, will provide refresher trainings. Throughout this process, we will construct a feedback loop to incorporate constructive criticism and evaluation from staff at the facilities and will provide performance incentives for nursing staff who provide the screen and treat method with a pre-determined level of quality. At this stage, we will implement the VIA screening intervention by integrating the program into existing primary health care services at the district level. Our implementation research outcomes at this stage will be appropriateness, uptake and fidelity. AIM 3: Developing community awareness to facilitate effective implementation Research Question: Do community-based awareness generation campaigns facilitate effective implementation of the screen-and-treat initiative? Implementation Strategy: In addition to assessing and identifying the existing health system capacity in the country, we will assess the level of knowledge and awareness in the community about the importance, need and availability of cervical cancer screening and treatment methods. We will design and
  • 8. 7 implement a program to increase awareness and knowledge about cervical cancer and the VIA screening program. One study in the Kilimanjaro region of Tanzania established that the greatest barrier to accessing cervical cancer screening services among both urban and rural women was a lack of awareness that such services existed (Cunningham, 2015). Awareness of cervical cancer, knowledge of risk factors and knowledge about screening have all been shown to be positively correlated with the odds of receiving cervical cancer screening in Tanzania (Perng, 2013). We will incorporate community engagement activities such as meetings, street plays, advocacy rallies and IEC materials posted in public spaces to disseminate information regarding cervical cancer screening. We will also identify local celebrities and community champions and employ them to engage with targeted communities. These activities will work in concert to increase acceptability and awareness of the screen-and-treat program in targeted regions of Tanzania. Using a community-based participatory approach, we will deploy community-designed communications campaigns to increase awareness and acceptability of the screen-and-treat method. Our implementation research outcomes at this stage will be appropriateness and uptake. Table 1: Summary of Intervention Packages for Scale-Up of Cervical Cancer Prevention Baseline Basic Package Enhanced Package Existing Standard of Care in Facilities in Tanzania Capacity building of nursing staff to provide screen-and-treat Capacity building of nursing staff and community awareness campaign Specific Objectives This study specifically aims to compare critical service outcomes and implementation outcomes between sites that receive no intervention, the basic package of interventions, and the enhanced package of interventions. The outcomes that will be evaluated are the following: Service Outcomes 1. Assess utilization of screen-and-treat services among women ages 18-49 in Tanzania. 2. Measure coverage of cervical cancer screening and treatment among women ages 18-49 in Tanzania. Implementation Outcomes 1. Evaluate fidelity to the screen-and-treat approach. 2. Gauge uptake of screen-and-treat services among both nursing staff and target population. 3. Assess the appropriateness of cervical cancer prevention packages for nursing staff and target population. Hypotheses AIM 1: Based on the challenges identified in the existing literature, we expect our initial assessment to determine that the main barriers for effective implementation are shortages of trained health professionals to provide screen-and-treat services and awareness gaps among the target population.
  • 9. 8 AIM 2: Training of nursing staff in primary care facilities will increase the capacity of those facilities to provide cervical cancer screening and treatment for the target population. AIM 3: Capacity building of nursing staff in concert with a comprehensive communication campaign will result in better service outcomes and implementation outcomes than no intervention or the basic intervention package. Conceptual Framework The conceptual framework contained in Figure 1.1 below illustrates the causal pathways that link this study’s proposed intervention strategies, implementation strategies, implementation outcomes, service outcomes, and the anticipated health impact of reduced invasive cervical cancer and a related decrease in cervical cancer mortality. A larger version of the Conceptual Framework is attached as Appendix 2. Figure 1.1 Conceptual Framework for Scale-Up of Cervical Cancer Prevention in Tanzania Table 2: Implementation Outcomes Fidelity % of trained nursing staff correctly recognizing precancerous lesions administering VIA according to protocol % of cryotherapy treatments correctly administered according to protocol Uptake % of target population that sought screen-and-treat services % of trained nursing staff who intend to administer screen-and treat services
  • 10. 9 Appropriateness % of target population who were convinced to get screen-and-treat services % of trained nursing staff that feel that they can add screen-and-treat to their existing responsibilities *Target population defined as women living in Tanzania who are 18-49 years of age Table 3: Service Outcomes Coverage % of target population who received screen-and-treat services Utilization # of women in target population who received screen-and-treat services *Target population defined as women living in Tanzania who are 18-49 years of age As described in the specific objectives, the focus of this research study will be measuring implementation outcomes and service outcomes associated with no intervention, a basic package of interventions (composed of capacity building of nursing staff to provide screen-and-treat services), and an enhanced package of interventions (which combines capacity building of nursing staff to provide screen-and-treat services with a community-based awareness campaign). We will measure these outcomes at study sites using the indicators described in Table 2 and Table 3 attached as Appendix 3 in order to compare the effectiveness of these scale-up strategies. The conceptual framework above highlights how the proposed scale-up strategies are expected to have a positive impact on cervical cancer mortality. The health impact column on the right side of the conceptual framework identifies this study’s overarching goal of reduced cervical cancer mortality. Cervical cancer is fatal when it is at advanced stages, so a reduction in advanced cases of invasive cancer is will decrease death due to this disease (World Health Organization, 2006). Reductions in cervical cancer morbidity has been linked to greater coverage of secondary prevention programs for cervical cancer, specifically screen-and-treat services in low-and-middle income countries (Gakidou, Nordhagen, & Obermeyer, 2008; World Health Organization, 2006). Quality coverage of the population is dictated by the utilization of high-quality screen-and-treat services at health facilities, as well as the level of scale of the program, since this is a population- level measure. In order for there to be increased utilization of high-quality screen-and-treat services, the proposed strategies must improve, or at least not worsen, the uptake, fidelity, and appropriateness of screen-and-treat services. There are also external factors that affect the scale-up of a cervical cancer prevention program in Tanzania. There are several contextual level factors, such as culture, socioeconomics, demographics, and political dynamics, that can influence the elements and processes described in the conceptual framework. Additionally, on the health facility level, the above framework demonstrates how resources, organizational and infrastructural factors, such as the availability of exam rooms for pelvic exams, sufficient electricity for staff to carry out VIA screening, or adequate staff supervision, can mediate both implementation and service outcomes of scale-up.
  • 11. 10 The following section describes the theories that are the basis for the implementation strategies, as well as the causal linkages, contained in the conceptual framework for this study. Theoretical Framework Health system strengthening for screen-and-treat program In a multi-level socio-ecological intervention model, we propose to intervene at the health facility level. At the organizational level, we will build social support for health behavior change and change at this level will have a direct/indirect effect on the lower levels, namely individual and interpersonal levels (McLeroy et al, 1988). At the individual level, the constructs from The Social Cognitive Theory (SCT) were used to design the intervention. The SCT states that the behavior, personal factors, and environment are triadic determinants dependent on each other; so a change in one determinant will influence other parameters (Bandura, 1986). Training health professionals at the health facility level will enable there to be an external environment for women in Tanzania to seek health services and constitute a desired behavior change. The constructs at the interpersonal level determining the intervention are Behavioral Capabilities and Self-Efficacy (Bandura, 1986). Behavioral Capabilities posits that the knowledge and skill about the behavior will promote a specific behavior change (Bandura, 1986). The trained health professional will share their knowledge about cervical cancer with the women, why women are susceptible to cervical cancer, and their current behaviors that increase their chances of cervical cancer. This intervention component promotes shaping the knowledge of women in Tanzania and specifies what and how it should be done. The trained health workers use the construct of Self-Efficacy to make the women believe that they can prevent cervical cancer by the screen-and-treat method. Overall, the intervention at this level has an effect at the individual level where it tries to change the social norms around cervical cancer screening and treatment. Developing community awareness to facilitate effective implementation This intervention strategy is proposed at the community level. A community can have many meanings but in this particular intervention a community refers to a population in the same geographical area embracing families, friends, and neighborhoods to make collective decisions and is seen as a mediating structure (McLeroy et al., 1988). In case of a cervical screen-and-treat program the communities serve as pivotal role in influencing collective norms and values by acknowledging the use of cervical cancer prevention services at the health facility. Behavior changes like visiting the health facility for a regular check-up and treatment of a precancerous lesion require the affirmation and support from the community (McLeroy et al., 1988). Under the assumption that communities in Tanzania are a mediating structure for influencing behavior change, cervical campaign intervention program can have a significant impact on the acceptability, norm and attitudes towards the behavior. At this level the constructs from Social Cognitive Theory are applied. Reciprocal Determinism refers to people’s potential ability to alter their environment along with their capabilities to interact with the environment. A community designed cervical cancer program will enable an environment that leads to behavior change (change in the structural environment), thus increasing the capabilities and the conviction that the individual can perform the behavior that will reduce the incidence of cervical cancer in the community. Self-Efficacy is the second construct that posits beliefs about a personal ability to perform behaviors which is reinforced by carrying out the behavior like visiting a health facility, modeling behavior by others (Observational Learning) and encouragement by others to
  • 12. 11 carry out the behavior; like having women who have had a screen and treat procedure, to talk to other women in the community about the benefits of screening and early detection of a precancerous lesion. Proposed Study Design The overall research activities proposed to be conducted during our study is depicted in the conceptual framework included as Appendix 2. At the beginning of our study, we intend to conduct exhaustive consultation with the Ministry of Health, Jhpiego and other key stakeholders at the national level. This will serve as an opportunity to establish a platform for discussion, dissemination and stakeholder engagement during the course of the study and implementation. Through these discussions, with inputs from the stakeholders we will randomly select 100 districts across 7 zones. Further 4 PHCs will be randomly selected per district to perform an implementation strength assessment. During this initial assessment, a spectrum of system and process indicators relevant to the success of the program will be assessed. A standardized checklist and questionnaire will be developed and utilized during this initial assessment survey. We will employ the MOH staff and externally hired personnel to complete this initial assessment. The details of this checklist and questionnaire are provided under Appendix 4.1. Following the initial assessment, the data will be gathered and analyzed to identify key implementation barriers for successful role out of screen and treat initiative in Tanzania. This assessment will also serve as the first large sample survey of implementation strength assessment spanning across different zones of the country. We will generate a preliminary report based on our assessment which will be produced to the MOH and discussed with the stakeholders on a common platform. This serves as a guide to address some of the key implementation barriers from the offset. It also provides the MOH the time window to address issues like human resource scarcity or infrastructure among others before the role out of the program at the national scale. It is important to note at this point that for the purpose of this paper, it was assumed that our initial assessment will narrow down the issues into two main areas i.e. insufficient number of trained personnel to deliver the services and awareness gap among the target population. In the following section we will be discussing the interventions designed to address these two main areas and how we will be assessing the effectiveness of these interventions and arrive at an inference about what are best methods to deliver the services effectively. The details of the study design are depicted in Appendix 5. We chose to do a cluster randomized study design to assess the effectiveness of our interventions. The choice of cluster randomization was made based on number of factors such as the level of intervention in the capacity building arm being at the level of facility, difficult in randomizing the communications campaign at individual level, tailoring to the design of our initial assessment which was at the health facility level, and ease of measurement (time, investment, technical capacity). Since the screen and treat services are delivered at health facilities, we found it was appropriate to utilize health facilities (PHCs) as our primary unit of study. We set out by randomly selecting one district per zone (7 districts in total) and further randomly selecting 9 PHCs per district with a distribution of 5 PHCs from rural areas and 4 PHCs from urban areas. The stratified sampling of urban-rural areas was based on the fact that the implementation barriers vary between these two settings (especially with respect to human resources, number and ease of access to facilities, information gaps etc.) and we are interested in assessing success of our intervention in these two
  • 13. 12 settings. The 63 PHCs selected on random basis are then further randomized into three main study arms with 21 PHCs each. Each arm will be composed of PHCs selected from rural and urban areas at a ratio of 2:1. The first arm of study - “Baseline intervention” refers to the standard of care existing in Tanzania for prevention of cervical cancer i.e. administering Pap’s smear for women over 30 years of age at a dose of at least three smears over lifetime. The second arm of study “Basic intervention package” involves training Physicians and nursing staff at the PHC level to perform VIA screening and also administer cryotherapy to treat precancerous lesions during the same visit. This arm will also have physicians providing on-the-job supportive supervision to nursing staff at the facility level and technical assistance when required for administering cryotherapy. There will also be an assessment of quality and fidelity of performance which will be supplemented with needs-based refresher trainings. To ensure quality of services and motivate the healthcare workers, it will also be tied to performance-based incentives. Our third arm of study “Enhanced intervention package” is a combination of the basic intervention as described above at the facility level and supplemented by community level awareness generation activities. These activities include identification of community champions in the catchment area of the PHCs, to develop Information - Education - Communication materials like banners, posters, fact sheets, training materials, dissemination and display of the IEC materials in public spaces, community level focused group meetings, utilization of common platforms like festivals, rallies, fairs to promote the agenda, endorsing local celebrities and influential people to advocate for cervical screening services etc. At this level of intervention, we will be measuring implementation outcomes such as appropriateness, fidelity and uptake in each arm of the study. The detailed definitions of these outcomes are provided in Table 2 in Appendix 3. We will also be measuring the service outcomes and looking into utilization of the services at the facility level and measuring the coverage of the services in the target population living the catchment area. The details of data sources and collection methods are provided under Tables 5 and 6 in Appendices 4.2 and 4.3. These indicators are periodically collected over a period of two years as depicted in the flow diagram in Appendix 5. A stratified analysis of the implementation outcomes and service outcomes is performed according the sampling stratification specified earlier. The specific elements of measurement are described in Appendix 6. We will be performing a temporal analysis of the trends in utilization and coverage of the screen and treat services. A comparative analysis be done between the arms of intervention, between rural-urban areas. We will employ multivariate regression analysis to look into the effectiveness of the individual arms of interventions and also the components of these arms of interventions. LIMITATIONS We acknowledge that there are several limitations to this study. One limitation is that the study will not be conducted at national scale and will only include a sample size of 63 health facilities. Another limitation is that cryotherapy cannot be used to treat advanced stages of cervical cancer, meaning that the single-visit screen-and-treat approach cannot be effective in eliminating some cancerous lesions that lead to cervical cancer death. It will therefore be necessary to ensure that women receive appropriate follow-up and counseling if their cervical cancer has progressed beyond the initial stage and they may need to be referred to other facilities for treatment. This
  • 14. 13 will require strengthening of the referral mechanisms for advanced cervical cancer cases. This study does not directly address the needs of HIV-positive women, who are at the highest risk for cervical cancer among the target population. Lastly, because our study has multiple arms, depending on the results, it may be difficult to determine which element of the intervention package produces the impact if there are variable results. EFFORTS TO BUILD RESEARCH CAPACITY We will target six areas in which to build research capacity, described below: 1. Involvement of local staff at all levels of assessment and implementation- Efforts will be made to involve local staff from all levels to get their input and feedback on the intervention strategy. 2. Ensure local ownership and secure active support- Training community health workers from the same community in the screen and treat method will increase the local ownership of the community health workers and build self-efficacy to successfully carry out the VIA screening. 3. Build in monitoring, evaluation and learning from the start of the program - The intervention program has built in monitoring and evaluation such as record keeping at the health facilities to keep track of the number of patients screened and treated. Reporting of new cases and referrals to the higher level on a timely basis another way to monitor the program. Emphasis will be given to timely data collection and statistical analysis of the data for evaluation of the program. 4. Establish robust research governance and support structures - In order to ensure a robust research governance, we plan to collaborate with local universities in the planning of the program. 5. Promote effective leadership - At the end of 12 months of the program, we plan to transfer the research capacity to the local universities in Tanzania in order to sustain the program. 6. Embed strong support, supervision and mentorship structures - Timely support, supervision and mentoring workshops will be conducted in the partner local university to help in successful transition of research capacity to the local university.
  • 17. 16 APPENDIX 3 Table 1: Summary of Intervention Packages for Scale-Up of Cervical Cancer Prevention Baseline Basic Package Enhanced Package Existing Standard of Care in Facilities in Tanzania Capacity building of nursing staff to provide screen-and-treat Capacity building of nursing staff and community awareness campaign Table 2: Implementation Outcomes Fidelity % of trained nursing staff correctly recognizing precancerous lesions administering VIA according to protocol % of cryotherapy treatments correctly administered according to protocol Uptake % of target population that sought screen-and-treat services % of trained nursing staff who intend to administer screen-and treat services Appropriateness % of target population who were convinced to get screen-and-treat services % of trained nursing staff that feel that they can add screen-and-treat to their existing responsibilities *Target population defined as women living in Tanzania who are 18-49 years of age Table 3: Service Outcomes Coverage % of target population who received screen-and-treat services Utilization # of women in target population who received screen-and-treat services *Target population defined as women living in Tanzania who are 18-49 years of age
  • 18. 17 APPENDIX 4.1 Table 4: Implementation strength assessment Element Indicator Data source and method 1. Infrastructure: MOH documents Planned visits a. Buildings % of health facilities with consistent water and electricity b. Privacy % of health facilities with private area to perform screen and treat 2. Deployment of staff MOH document review HMIS Planned visits a. Staffing No. of physicians per PHC No. of nursing staff per PHC No. of CHW per PHC b. Retention % of vacant positions for physicians / nursing staff / CHW per PHC 3. Commodities a. Supplies % of health facilities having basic commodities (bed, lighting, specula, gloves) available to perform screen and treat % of health facilities without stock of HIV kits in last 3 months % of health facilities with stock inventory for HIV kits Planned visits to health facilities and review of documents 4. Monitoring and Evaluation a. Record keeping % of health facilities with activity registries maintained for HIV services Planned visits to health facilities and review of documents b. Reporting No. of completed reports (HIV) sent to the higher level on timely basis in last 6 months % of health facilities with data management system/person in place
  • 19. 18 5. Management % of HF with a logical and explicit organizational structure % of HF with operational plan for provision of HIV test % of HF with budget linked to operational plan Planned visits to health facilities and review of documents 6. Needs assessment of target population % of sampled population: • heard about the cervical cancer • heard about the screening • believe cervical cancer is fatal • perceived screening as acceptable • perceived screening was beneficial Focused interviews
  • 20. 19 APPENDIX 4.2 Table 5: Basic package of interventions - Capacity building Implementation Outcomes Element Indicator Data source and method Training Supervision, support and on the job assistance Need based refresher training Performance incentives Appropriateness: % of trained nursing staff who felt it was appropriate to add screen-and-treat to their existing responsibilities Focused interviews Fidelity: % of trained nursing staff correctly recognizing precancerous lesions % of cryotherapy treatments correctly administered according to protocol Reexamination Direct observation Uptake: % of trained nursing staff who intend to administer screen-and treat services Focused interviews
  • 21. 20 APPENDIX 4.3 Table 6: Enhanced package – Capacity-building + Community Awareness Campaign Implementation Outcomes Element Indicator Data source and method Identify community champions and engagement IEC materials Community engagement meetings/talks Advocacy rallies Appropriateness: % of target population who were convinced to get screen- and-treat services Uptake: % of target population exposed to community level activities that sought screen- and-treat services Focused interviews conducted at pre and post community level activities Utilization data from the facility - pre and post community level activities Service outcome Element Indicator Data source and method Utilization of screen and treat services No. of women screened • at PHC level • at District level • at Regional level • Service provision registry • Audits Coverage of screen and treat services % of target population who received screening • at PHC level • at District level • at Regional level • Sample surveys
  • 23. 22 APPENDIX 6 Data Analysis • Measures of appropriateness, fidelity and uptake are used as implementation outcome • Utilization & coverage of screen-and-treat services in PHCs under all 3 arms of intervention: service outcome measure • Comparative and temporal analysis of change in utilization and coverage rates across three different arms • Stratified analysis: Urban-rural, zonal, age group etc. • Multivariate regression analysis for attribution of effectiveness of a given intervention
  • 24. 23 APPENDIX 7 Division of Labor We broke up the assignment into component parts in order to distribute separate sections to members of the team to write up for the proposal. Katrina contributed the Study Overview, Specific Objectives, and created and described the Conceptual Model. Jae contributed the Abstract, Study Purpose, Specific Aims, Hypotheses and Limitations. Aachal contributed the Theoretical Framework, Limitations, and Efforts to Build Research Capacity. Harsha contributed the portion describing the Proposed Study Design and created the accompanying tables.
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  • 26. 25 Sankaranarayanan, R., Esmy, P. O., Rajkumar, R., Muwonge, R., Swaminathan, R., Shanthakumari, S., . . . Cherian, J. (2007). Effect of visual screening on cervical cancer incidence and mortality in tamil nadu, india: A cluster-randomised trial. Lancet (London, England), 370(9585), 398-406. doi:10.1016/S0140-6736(07)61195-7 World Health Organization. (2006). Comprehensive cervical cancer control: A guide to essential practice. Geneva: World Health Organization.