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0 Federal Ministry of Health Ethiopia Ethiopian Population Based National TB Prevalence Survey Research Protocol Amendment Request July, 2010 Addis Ababa
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Federal Ministry of Health Ethiopia
Ethiopian Population Based National TB Prevalence Survey Research Protocol
Amendment Request
July, 2010
Addis Ababa
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Contents 1. Introduction ............................................................................................................................................ 4 2. Aims an d Objectives ............................................................................................................................. 6 3. Study Design .......................................................................................................................................... 7 4. Sampling methods ............................................................................................................................... 11 5. Screening strategy ........................................................................................................................... 1414 6. Case definition.....18 7. Organization ........................................................................................................................................ 20 8. Training ................................................................................................................................................ 24 9. Survey operation .............................................................................................................................. 2525 10. Data management and analysis...34 11. KAP study ........................................................................................................................................ 3938 12. Quality assurance ............................................................................................................................ 3938 13. Reporting and dissemination of results39 14. Budget (in USD) .................................................................................................................................. 40 15. Ethical Consideration ...................................................................................................................... 4944 16. Timeline ............................................................................................................................................... 51 17. References .......................................................................................................................................... 54 18. Annexes ............................................................................................. Error! Bookmark not defined.55
Annex 1: Census Form (household register) .......................................... Error! Bookmark not defined.55 Annex 2. ID and invitation card ............................................................... Error! Bookmark not defined.56 Annex 3 a: Individual Survey Form ......................................................... Error! Bookmark not defined.57 Annex 3 b: TB history interview ............................................................................................................... 59 Annex 4: Field x-ray log book .................................................................................................................. 60 Annex 5: Central x-ray log book ............................................................................................................... 61 Annex 6: Laboratory Register for TB suspects ........................................................................................ 62 Annex 7: TB cases register ...................................................................................................................... 63 Annex 8: Central x-ray reading and sputum results ................................................................................. 64 Annex 9: Cluster report ........................................................................... Error! Bookmark not defined.65 Annex 11. Questionnaire for KAP study on TB ........................................................................................ 75 Annex 12. Survey Consent Forms and Information sheets ...................................................................... 76
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Abbreviations AFB Acid fast bacilli CXR Chest x-ray CSA Central Statistics Authority DOTS Directly Observed Therapy, Short-course EHNRI Ethiopian Health and Nutrition Research Institute) FMOH Federal Ministry of Health HIV Human immunodeficiency virus ISN Individual Survey Number IUATLD International Union Against TB and Lung Disease LJ Lowenstein-Jensen MDG Millennium Development Goals MDR TB Multi-drug resistant tuberculosis MTB Mycobacterium tuberculosis NTP National TB Programme PI Principal Investigator PPS population proportion to size SC Steering Committee SCT Survey Coordinating Team TAG Technical Advisory Group TB Tuberculosis WHO World Health Organization ZN Ziehl Neelsen SOPs Standard operating procedures
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Summary of the proposed study This proposal is to conduct a nationwide TB prevalence survey to establish the burden of TB
disease, estimate the proportion of cases detected and treated by the National Tuberculosis
Programme and identify causes of low case detection in Ethiopia. This study is being
conducted by a research team from the Ethiopian Health and Nutrition Research Institute
(EHNRI), the Federal Ministry of Health (FMOH), in collaboration with local partners and
technical assistance by the World Health Organization (WHO) and funding through the Global
Fund, USAID/TBCAP and the WHO. The budget is approximately 2.8 million U.S. dollars. The
survey will be held using a representative sample of approximately 46,514 adults in 85
population clusters, stratifying by rural, urban and pastoralist areas. The field operation is
estimated to take approximately 8 months to complete. Cases of TB disease will be detected
using a TB symptom screen and a chest X-ray for all eligible persons aged 15 years and
above. Those with TB symptoms and/or an abnormal chest x-ray will submit two sputum
specimens that will be examined microscopically for acid-fast bacilli and cultured for
Mycobacterium tuberculosis in the National Reference Laboratory (EHNRI) located in Addis
Ababa. Individuals detected with TB will be referrred for appropriate case management.
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1. Introduction Tuberculosis (TB) is a chronic infectious disease caused by Mycobacterium tuberculosis
(MTB). Almost one-third of the world population (about 2 billion people) is infected with M.
tuberculosis and during the past decade there has been a resurgence of tuberculosis.
Currently, TB is the leading cause of mortality among infectious diseases worldwide but 95
percent of TB cases and 98 percent of deaths due to TB occur in developing countries (Blanc
and Uplekar, 2003). TB is one of the diseases covered by the sixth Millennium Development
Goal (MDG), with the target of halting and reversing the prevalence of TB by 2015 (United
Nations, 2010). The DOTS (Directly Observed Therapy, Short course) strategy is the
backbone of global tuberculosis control, with the aim of finding 70 percent of new smear
positive cases of tuberculosis and curing 85 percent of them (WHO, 2009).
TB prevalence is one of the key indicators of the MDGs and the Global Stop TB Plan. TB
prevalence surveys are one of the most effective tools to monitor the impact of the TB
program, especially in countries where the incidence and prevalence are high. In many high
TB incidence countries, routine surveillance data based on TB case notification are limited
because not all persons diagnosed and on treatment for TB may be counted (e.g., under-
reporting in private and some public health facilities).As a result, an unknown proportion of TB
cases remain undiagnosed and untreated. Thus, the true epidemiology of the disease
remains unknown. In addition to monitoring program impact, data on TB incidence and
prevalence are also essential to establish and re-evaluate the national TB programs
objectives, strategies and interventions.
Prevalence surveys have already been conducted in many of the top 22 high TB burden
countries; few countries have conducted more than one. In Ethiopia there has been no
national TB prevalence survey conducted to date.
TB situation in Ethiopia
Ethiopia is located in the northeastern part of Africa, also known as the Horn of Africa, In 2007,
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the total population was estimated to be 74 million (Central Statistical Authority, 2007).
Administratively the country is divided into nine Regional States and two City Administrative
Councils (Addis Ababa and Dire Dawa). Each Regional State is further divided into Zones,
then Woredas and Kebeles. Zones are the second administrative level after Region, and they
are composed of Woredas (similar to districts), which are the third administrative level. Finally,
Kebeles, which are within Woredas, are the lowest administrative level in Ethiopia. Kebeles
consist of blocks or household groups (number and size of blocks vary), which are known as
Gotes (or Gares) and have an average population size of 5,000 persons.
In urban centers, the administrative structure is different, because City Councils dont have
Zones and Woredas. Instead, Addis Ababa is composed by 10 sub-cities, each one
composed of Kebeles. Dire Dawa is directly divided into Kebeles,
At present, in Ethiopia there are a total of 94 Zones, 810 Woredas, and 15,022 Kebeles.
According to the World Health Organization (WHO) Annual Global TB Report (2009), Ethiopia
ranked seventh in the world for TB burden, with an estimated annual TB incidence (all forms)
of 378 new cases per 100,000 persons and 163 new smear positive cases per 100,000
persons per year (WHO, 2009). The estimated prevalence of all forms of TB is 579 per
100,000 population and 286 per 100,000 for smear positive TB.
The national TB control program has achieved 100 percent geographical and 92 percent
health facility DOTS coverage. Despite the extensive expansion of DOTS service in the
country, the program performance indicators, in particular the case detection rate for smear
positive TB, remain unsatisfactorily low. For instance, even though the treatment success rate
was 84 percent in 2007/2008, the case detection rate was 34.5 percent.
Rationale Between 2007 and 2009, the WHO annual estimate of smear positive TB incidence in
Ethiopia has increased from 152 to 163 per 100,000 persons. The current WHO TB estimates
for Ethiopia are extrapolated from an exercise undertaken in 1997, using the assumptions of a
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50 percent case detection rate, 48 percent DOTS coverage and trends based on high HIV
prevalence countries in the region. It is questionable whether these outdated assumptions
take into consideration crucial factors, such as the extensive DOTS service expansion and
the recent establishment and expansion of Health Extension Workers in TB prevention and
control activities in the community. Furthermore, the current adult HIV prevalence in Ethiopia
is 2.3 percent, which is much lower than the prevalence of HIV infection in other sub-Saharan
Africa countries. Thus, these factors might have affected the estimation of the true TB
prevalence and incidence and the distribution of the disease in Ethiopia. However, the quality
of existing program and surveillance information on the ground concerning the TB burden and
trends is not sufficient to decipher this. In order to clarify the TB epidemiological situation in Ethiopia and to strengthen the TB
program using an evidence-based approach, the Ministry of Health is planning to conduct a
population based national TB prevalence survey in 2010, with financial support from Global
Fund TB round six grant, in collaboration with in-country partners working on TB, and
technical support from WHO.
2. Aims and objectives Primary aim The primary aim of the national prevalence survey is to estimate the prevalence of pulmonary
TB in Ethiopia in 2010, as a basis for evaluation of current performance in case detection and
as a baseline measurement for subsequent surveys in the future. To estimate the prevalence
in the general population, the prevalence among adults aged 15 year or more will be
measured.
Primary objectives
1. To determine the prevalence of smear positive TB
2. To determine the prevalence of culture positive TB
3. To determine the prevalence of symptoms suggestive of TB
4. To determine the prevalence of radiological abnormalities suggestive of TB
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Secondary objectives 1. To measure the prevalence of cervical lymphadenitis among study participants;
2. To assess the knowledge, attitude, and practice of the population concerning TB
3. To assess health seeking behavior among participants with TB symptoms
3. Study Design
A national cross-sectional multistage cluster survey will be carried out in 2010. The
prevalence survey is designed to provide a prevalence estimate for the population for the
entire country. It incorporates a representative sample of the national population so that
conclusions can be drawn about the country as a whole. In order to increase the precision of
the study and the accuracy of results, the sampling will be divided in three strata (urban, rural
and pastoralist, as further explained at page12).
Multistage cluster sampling will be performed. The selection of Woredas will be performed
first utilizing probability proportion to size (PPS), followed by sampling of Kebeles (basic
sample unit) by PPS. Within a selected Kebele, Gotes/Gares (household groups) will be
selected to reach the required calculated sample size.
The survey will be conducted among adults (aged 15 years and older). All eligible and
consenting study participants will be screened for TB symptoms during one-on-one interviews
and for radiologic evidence of TB using a chest X-ray (CXR). Screened persons with current
TB symptoms (cough for 2 weeks or more) and/or abnormal CXR results will be asked to
submit two sputum samples (spot and morning samples) for bacteriological confirmation. All
sputum samples will be sent to the National TB Reference Laboratory (Ethiopian Health and
Nutrition Research Institute) and examined with microscopy for acid fast bacilli. Culture will be
performed on all morning specimens.
Prevalent TB cases will be identified based on results of bacteriological examination (smear
and culture) according to the case definitions in this protocol as recommended by the WHO
task force on TB prevalence surveys.
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Inclusion and Exclusion criteria
Exclusion criteria for sampling frame: Of the 810 Woredas within the country, 38 will be excluded from the sampling frame from the
beginning because it is not feasible to conduct the survey in these areas due to security and
logistical reasons. Even though the population living in these 38 Woredas account for only the
3 percent of the total population of Ethiopia, excluding them may bias the results of the survey,
which will be clearly stated in the final survey report and when conclusions are drawn from the
study.
Ultimately, the sampling frame will include 772 Woredas, which account for the 97 percent
(77,174,699 persons) of the total population of the country. The population living in each
Woreda has been derived during the last national census (2007).
Exclusion criteria during Woreda/Kebele sampling: Once sampling is completed and if an entire selected Woreda is determined to not be
accessible or if the survey is unexpectedly found to be not feasible in that Woreda (e.g due to
natural disasters, epidemics, etc) another Woreda from the same Zone will be selected to
replace the first one.
Similarly, if the selected Kebele is not accessible or if the survey is not feasible for major
unexpected reasons another Kebele from the same Woreda will be selected to replace the
first one.
Exclusion criteria in the selected Kebele: To increase the feasibility of data collection, and to avoid bias as a result of inclusion of
special high risk groups, the following settings, which may fall into the selected clusters, will
be excluded from the study:
- Military compound
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- Diplomatic compounds
- Confined setting: Jail/prison, refugee camps
- Hospitals
- Schools and universities and dormitories
- Orphanages
- Monasteries
- Homeless persons
Individual eligibility criteria for participation in the study: The individual eligibility criteria for study participation take into consideration a persons age,
residence in the cluster area and, in case of temporary visitors, length of their stay in the
cluster area.
Because bacteriological positivity is rare and collection of sputum samples is difficult in
persons below 15 years of age, the exclusion of this age group will greatly reduce the
workload while simultaneously having only a small effect on the prevalence estimate for the
total population.
A census will be carried out to provide updated and accurate information on the resident
population in the selected survey areas, specifically focusing on migration and membership
within each household. For this reason, living in the survey area for at least two weeks prior to
the day of the census has been chosen as eligibility criterion.
Individual inclusion criteria:
Age > 15 years
Residents who have stayed at least one night in a household during the 14 days prior
to the census day
Visitors who have stayed in a household for at least the past 14 days prior to the
census day
Individual exclusion eligibility criteria: Age < 15 years
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Residents who have been away during entire past 14 days from a household
Visitors who arrived and stayed in the household less than 14 days prior to the census.
The inclusion/exclusion criteria for participation - involvement in screening take into consideration the eligibility criteria and the provision of informed consent.
Individuals can be included in the survey screening only if they have been fully informed of
the objectives and procedures of the study and have freely given informed consent.
Individuals who are unable or unwilling to provide informed consent will not be included in the
survey screening. The consent procedure will be carefully described and approved by an
ethics review committee. Individuals below 18 years need the informed consent to be
provided by a family member or a guardian 18 years or older.
The individual inclusion criteria for study participation include the following:
Eligible individuals, based on study criteria
Individual informed consent provided (or one family member/guardian 18 years or
older for persons below 18 years or disabled persons who are unable to provide
written consent by themselves). Persons aged 15-17 who live independently, without
any parental or guardian supervision will be asked to provide consent for themselves.
The individual exclusion criteria for study participation include:
Persons who refuse to provide consent
Persons who are unable to provide consent or whose guardians cannot provide
consent (e.g. severe physical or mental disability impairing ability to provide informed
consent, or age
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A KAP survey will be conducted among 10 percent of the study participants in order to
capture information on general knowledge, attitudes and practices about TB. Individuals who
have a positive symptom screening (defined as cough for 2 weeks or more), will be
interviewed about their health seeking behavior, in order to clarify factors which affect service
utilization, to better understand the utilization of the government and private health system,
and possible reasons for not seeking treatment. Furthermore, study participants with a
positive TB history in the last two years, will be interviewed to explore in details the
classification of TB, the previous/current TB treatment, outcome, and responsible health
facility.
All TB cases identified during the survey will be offered HIV counseling and testing, as per
national policy, after linking them with the routine health system.
4. Sampling methods Sample size determination: For the sampling frame, data from Central Statistics Authority (CSA) derived from the last
national census conducted in 2007 were used. According to census data, the projected
population size during the proposed study period (2010) is estimated to be 79,731,054.
The required sample size for the prevalence survey is estimated to be 46,514. The sample
size was calculated with the assumption that the WHO smear positive TB prevalence
estimation for 2007 (286 per 100,000) might be an over estimation. So, we adjusted our
prevalence estimate to be 200 per 100,000 to be more conservative in order to get an
adequate sample size. To calculate the required sample we used the following formula:
n= Z2p (1-p)/d2
Where n- sample size
p- estimated prevalence of smear positive TB.
z- standard normal value at 95% confidence interval=1.96
d- relative precision
We consider a design effect of 1.5, participation rate of 85% and relative precision of 20%.
The proportion of adult greater than 15 is 55% (data extrapolated from last national census,
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2007).
n=1.962x0.002(1-0.002)x1.5x0.55 = 46,514
(0.2x0.002)2x0.85
In order to select 46,514 individuals, 85 clusters/Kebeles will be selected (548
persons/cluster).
Stratification In order to increase the efficiency of sampling and precision of final results, stratification in
sampling has been applied as follows. The general population of Ethiopia is generally divided
in three sub-groups, according to living area and conditions:
1. Population living in urban area
2. Population living in rural area
3. Pastoralist or nomadic population
In this study, the definition of urban population is for people who live in towns with a minimum population size of 2,000, and which is registered by Ethiopian Central Statistics Authority
(CSA) as urban. The urban population represents the 16 percent of the total population.
The rural population is defined as people whose main source livelihood is agriculture (other than pastoralist); the population living in this area represents the 76 percent of the total
population.
The pastoralist population is defined as people whose main source of livelihood is livestock, with which they move seasonally in search of fresh grazing land and water; pastoralists
represent the 8 percent of the total population.
Hence, this study will be conducted with three strata: rural, urban and pastoralist.
Sample unit and sample size According to the experiences of prevalence surveys in Asia, field activities (census, screening
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and examinations) for a cluster with 520-600 adults are comfortably completed in 5 or 6 days.
In order to complete one cluster within one week, the size of a cluster unit will be
approximately 550 eligible persons (> 15 years old), with accepted ranges of 520-600
persons per cluster. To select 46,514 people, this means a total of 85 clusters will be selected
from the three strata.
The number of clusters per strata will be allocated according to the population proportion of
each stratum: urban, rural and pastoralists. For each stratum, Woredas will be initially
selected by probability proportion to size (PPS) sampling. Then, in each selected Woreda, a
list of Kebeles with the corresponding population will be provided by the Woreda authorities.
Kebeles will be selected by PPS as a basic sampling unit.
Precise mapping will be done in selected Kebeles. In case the selected Kebele is smaller
than the minimum cluster size (520), another Kebele should be added. This will be done by
going to the adjacent Kebele (Note: According to the census data, we do not anticipate this to
be the case).
In most cases the selected Kebele is bigger than the maximum cluster size (600), thus it will
be necessary to conduct the survey in only a limited part of the Kebele. Within each selected
Kebele, there are household groups, or blocks. A serial number will be assigned to each block
and one block will be randomly chosen for the initial survey area. Once that is finished, from
there, the team will continue to the next consecutive block to the north, and then moving in a
clockwise direction until the desired sample size has been achieved. All persons meeting the
eligibility criteria on the first day of the survey (census day) will be included as eligible
persons.
The number of clusters selected from each stratum is proportional to the population size living
in that area:
1. Rural population: 63 clusters
2. Urban population: 14 clusters
3. Pastoralist population: 8 clusters
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Within the pastoralist areas, the Somali region has a unique administrative structure, poor
accessibility and limited availability of census data. Therefore, specific arrangements are
required in order to select a number of pastoralist clusters from Somali region according to
the population size. It was estimated that, out of the 8 pastoralist clusters, 4 clusters from the
Somali region are needed.
5. Screening strategy Individual interviews and chest x-ray screening will be used to screen study participants.
Participants presenting with no TB symptoms and a normal chest x-ray will not have to submit
sputum samples, and will be defined as NOT having pulmonary TB. Individuals with TB
symptoms, specifically cough for at least 14 days, and/or abnormal chest x-ray will be
considered as eligible for sputum examinations and will be asked to provide two sputum
specimens for smear microscopy and culture.
TB symptom screening: Eligible individuals attending the survey site will be informed about the study procedures and
will be asked to sign the informed consent form. Those who consent will be registered as
study participants, and they will be requested to answer study questions from a pre-tested
questionnaire translated into and explained to them in their local language. The inteview will
be conducted by a qualified health worker. The questionnaire includes:
Personal data, including study ID, name, age, sex. (Note: Name will be removed for
data entry.)
Questions concerning the presence of TB symptoms at the time of the survey. The
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symptoms considered suggestive for TB according to the National TB Manual, are
the following:
o Cough and duration. For persons reporting cough for 14 days or more, the
participant will be asked to answer additional questions at the end of the
survey regarding health seeking behavior.
o Presence of the following symptom(s): Expectoration, blood contained
sputum, fever, chest pain, shortness of breath, night sweats, loss of appetite,
body weight loss.
o Enlargement of neck lymph nodes. Each study participant will also be
examined by a health care worker to assess the absence or presence of
swollen cervical lymph nodes.
Past or present anti-TB treatment. In the case of history for TB or ongoing anti-TB
treatment, the participant will be asked to answer a second set of questions at the
end of the survey to explore in detail past TB history, previous treatment, outcomes,
health care facilities, etc.
Persons reporting cough for 14 days or more will be eligible for sputum exams. However, any
of the TB symptoms may be used for eligibility for sputum exams for persons who do not
participate in a chest x-ray. It is not anticipated that there will be many of these cases.
Persons reporting cough for 14 days or more and/or neck lymph node swelling detected by an
interviewer will be assessed and re-interviewed by a physician during the second interview.
Chest x-ray screening All participants who completed the screening interview will proceed to the chest x-ray unit
where an upright posteroanterior chest x-ray (full size film of 40x40cm) will be taken on the
spot using a portable x-ray machine with an automatic processor. Instruction, including a
review of the risks and benefits of the chest x-ray, will be given to the participant by a
healthworker. Consent for the chest x-ray examination is included in the survey consent form.
The film will be immediately developed and then read in the field by one experienced or
trained physician An average of 150 persons per day are expected to receive chest x-ray
examinations. Two x-ray technicians (radiograpers) and an assistant will be assigned to carry
out chest x-ray examinations in the field.
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The chest x-ray results will be classified as one of the following:
Normal
Any abnormality in lung field or mediastinum, including cavities, infiltrates, pleural
effusion, hilar or mediastinal lymphadenopathy, pulmonary nodules, interstitial
abnormalities and healed TB.
Other abnormalities (cardio vascular diseases, goiter, injury, etc)
If there are any abnormalities found in the lung field or mediastinum, participants will be
requested to submit two sputum samples, regardless of the presence or absence of TB
symptoms (cough for 14 days or more).
In cases where the chest x-ray results are either normal or other abnormalities are found, and
the participant didnt report cough for at least 14 days, he/she will not be requested to submit
sputum samples. If abnormalities that require medical attention are detected, such as
cardiovascular diseases, pneumonia, pneumothorax, etc, an efficient referral system to
routine health care will be put in place.
After the field reading, chest x-ray films will be sent to a radiologist in Addis Ababa for a
central reading (St Paul Hospital, Radiology Department) for internal quality control and
further classification.
Bacteriological screening Two sputum specimens, one immediately (spot) and a second one early the next morning,
will be collected from everyone with either TB symptoms, specifically cough for at least 14
days, and/or an abnormal chest x-ray: Persons who did not participate in the chest x-ray
exam and who have any TB symptom are also eligible for sputum examination.
At the survey site, participants will be provided with a labeled sputum container and will be
requested to provide sputum on the spot in a pre-specified sputum collection corner.
Participants will be clearly instructed to ensure that at least 3 ml of good quality sputum
(rather than saliva) is produced. Supervision by field workers will be provided. Poor spot
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specimens may be replaced with an immediate spot collection. A second labeled sputum
container will be given to all persons eligible for sputum examinations and they will be
requested to collect their morning sputum and to bring the container to the survey site the
next morning. Alternatively, the samples may be collected from their homes by survey team
members and placed in an ice box as soon as possible. If the morning sputum is of poor
quality or quantity, an additional early morning sputum sample may be collected. The sputum
samples will be placed immediately upon receipt into cold boxes at 4 degrees and then
transported to the reference laboratory, preferably within 3 days (at most 5 days) and culture
will be done no more than 7 days after sputum collection. Dispatch logs will be maintained for
documentation of sputum transport details.
The bacteriological examination will be performed in the National Reference Laboratory
(EHNRI) located in Addis Ababa. The laboratory at Saint Peters Hospital will be used as a
back up when there is lack of space in EHNRI.
EHNRI is experienced in performing TB diagnosis with microscopy (fluorescence and light),
and culture (solid and liquid media). The institution is currently the countrys research center
for nutritional and public health research, training center for laboratory professionals and
mandated to control the overall laboratory activities performed in the country. The institution is
responsible for conducting quality assurance of regional laboratories. The first national multi-
drug resistant (MDR) TB survey was conducted by this institution.
Laboratory procedures Sputum smear microscopy: Sputum samples received at the laboratory will be prepared on two frost-end labeled glass
slides from each spot and each morning sputum. One slide from each sputum sample will be
air dried, fixed and stained with auramine for fluorescence microscopy. The result of
fluorescence microscopy will be recorded as the study result. The second slide from each
sputum sample will be air dried, fixed and stored for staining with Ziehl Neelsen (ZN) only if
the twin slide is found positive by fluorescence microscopy. The ZN staining will be examined
by light microscopy and findings reported with grading of the concentration of acid fast bacilli
in the sputum for purpose of comparing the results used in routine service (using the IUATLD
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scale). Positive results will be confirmed by a supervisor.
Culture: All morning sputum samples will be processed for culture. Samples will be processed
according to standard procedures using modified Petroffs method for decontamination. Each
processed sputum sample will be inoculated on to a slant of Lowenstein-Jensen (LJ) with
glycerol and a second slant of LJ medium supplemented with pyruvate and incubated at 37
degrees with weekly examination for growth. Specimens that do not have colonies at 8 weeks
will be defined as negative. Specimens with any growth will be examined for AFB using ZN
staining and positive isolates will be characterized by deletion typing for speciation of
mycobacteria (with polymerase chain reaction on heat killed cells using appropriate deletion
primers according to standard procedures). Labratory results, smear, culture and identification
will be recorded per specimen.
Storage: Stained and unstained slides with sputum smears will be stored and made available for
subsequent examination. All morning samples will be discarded after processing for culture.
All spot sputum samples will be discarded without being processed for culture after the
sputum smears have been read for AFB and are confirmed to be negative.
Appropriate safety precautions will be taken during specimen processing and waste disposal.
All sputum samples will be autoclaved before discarding or will be incinerated in closed cups
in tightly sealed autoclave bags.
6. Case definitions Prevalent TB cases will be diagnosed according to the survey case definitions recommended
by WHO task Force.
Bacteriologically definite TB case: Study participant with one culture positive specimen with mycobacterium tuberculosis AND at least one of following conditions:
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AFB-smear positive
Culture positive in another specimen
Chest x-ray positive from audited central reading
TB symptom(s) positive
The chance of cross contamination should be carefully assessed when a culture is positive
with only one test tube with less than five colonies. If this is the case and when the possibility
of cross contamination cannot be negated, this should not be categorized as a culture positive
TB case unless there are also TB consistent chest x-ray findings (e.g. normal, smear negative,
and culture positive with 3 colonies: not categorized as culture positive TB)
Sputum smear-positive case: AFB-smear positive confirmed case, can be definite or probable study TB cases.
Study participant with one AFB-S positive specimen AND at least one of following conditions:
Culture positive TB ---definite case
AFB-smear positive in another specimen AND no culture (TB) positive AND no
isolation of MOTT --probable case
Chest x-ray (audited reading) TB consistent AND no CTB positive AND no isolation of
MOTT - probable case
When culture/identification of mycobacterium tuberculosis is available, the definition of smear
positive case may be different from the clinical definition by the routine programme. Isolation
of mycobacterium other than tuberculosis is not rare in survey specimens. Two positive smear
slides with MOTT isolates may not be considered as TB case in the study analysis.
Bacteriologically confirmed TB case Study participants can be either a definite or probable case. The table below shows summary
of the definition of prevalent TB cases in the survey.
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TABLE. Overview of classifications according to culture and AFB-smear positive results Study TB case
Definite Probable
Classification of definite (CTB positive) TB cases according to AFB-S
AFB-S negative, CTB positive
AFB-S unknown, CTB positive
AFB-S positive, CTB positive
Classification of AFB-S positives
AFB-S positive TB confirmed case
Laboratory results
CTB positive AND AFB-S negative
CTB positive AND AFB-S unknown
CTB positive AND AFB-S positive
CTB indecisive* AND AFB-S positive
CTB: Mycobacterium TB Complex culture positive *Culture results missing, unknown or contaminated Bacteriologically negative, but active TB suggested by chest x-ray:
No evidence of bacteriologically positive TB, but chest x-ray strongly suggests TB
disease, and the final decision is made by a central medical panel, consisting of at
least three chest physicians and/or radiologist
Possible TB cases will not be counted as prevalent TB cases in this study. However, they will
be followed up according to advice by the central medical panel. The panel will review
collected data and examination results of participants with any positive results (chest x-ray,
smear, culture) to classify final study results and to provide advice for treatment or further
medical interventions.
7. Organization Steering committee The steering committee is composed by FMOH directors, NTP managers, and
representatives of national institutes, international organizations and funding agencies. The
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steering committee has the primary responsibility for selecting the survey implementing
organization and the principal investigator, designing the study, eliciting funding, ensuring the
quality of survey implementation and disseminating the survey results. One senior staff of the
Ethiopian Health and Nutrition Research Institute has been nominated as the Principal
Investigator (PI), and he is the chair of the Steering Committee (SC). Specific terms of
reference for the PI have been developed and approved by the SC. The SC meets on a
monthly basis as well as when it is necessary to monitor progress and to provide support to
survey teams. The Steering Committee is advised by a Technical Advisory Group (TAG), and
delegates tasks and responsibilities regarding the day-to-day execution and management of
the survey to the Survey Coordinating Team. Members of the SC may participate in
monitoring and supervisory activities directly both in the field and at the central level.
Survey Coordinating Team / National Survey Coordinator The Survey Coordinating Team (SCT) is composed of chiefs for the Lab, Radiography,
Statistics and Logistic teams as well as the leaders of field teams (figure below). The SCT is
responsible for carrying out the survey and to report to the SC. The Survey Coordinator is the
chair of the SCT and is assisted by a Deputy Survey Coordinator. The Survey Coordinator is
an NTP staff member engaged full time for the whole duration of the survey. He has
responsibility for day-to-day management and is Executive Secretary. His terms of reference
include:
Day-to-day management of survey preparation and implementation
Organizing preparation, training, pilots, field work implementation, data management
and monitoring of progress and data quality
Chair of the Survey Coordinating Team
Report to the Steering Committee on progress and general monitoring issues
22
The Technical Advisory Group, or TAG, consists of national TB experts as well as international
experts in survey, lab, radiology and epidemiology to provide timely technical advice to the
survey coordinator and central units. The TAG also assists the SC and PI in training and
quality assurance activities.
The director of Medical/Diagnostic panel is in charge of medical decisions. It can be called
upon by field teams, and can overrule the teams decisions on case management. The panel
will be responsible for reviewing documents, x-rays and lab results for all suspected cases.
Field teams Five survey teams will work in rotation; three teams will be on duty in the field to implement
the survey and collect data, while two teams will be back at the center to summarize and
submit field data, get maintenance, if needed, prepare logistics and rest.
Each team consists of a fixed and a flexible part. The fixed part consists of staff from the
23
central level and its team members remain the same for the different clusters. The flexible
part consists of staff from the Regional, Zonal and Woreda levels and differs for each cluster.
Local health workers and community volunteers should be recruited to assist the field
operations.
For each field activity (team leadership, census, interviews, X-ray, lab) standard operating
procedures (SOPs) will be laid out in the field manual. These will describe, for each field day,
the tasks and responsibilities of the field team members.
The fixed part of the field team consists of the following members:
One team leader (physician or senior health professional)
Three census takers/Interviewers
Two radio-technicians
One radiologist or physician as a chest x-ray screening reader
One lab assistant
Two clerks
Three drivers
The flexible part of the team includes local staff from the selected Kebele, and includes at
least 4 members. Training workshops will be held for regional and Woreda staff. Health centre
staff and health workers will receive a brief training during the preparation visit by the central
team approximately one month before the field data collection:
Regional and/or Zonal TB coordinator 1-2 staff
Woreda Health office 1 staff
Hospital/Health center 1 staff
Health extension worker: 1 staff
Community volunteers will be recruited to assist field operations. Instruction will be given
during the preparation visit and on the arrival of the survey team:
Community Chief 1 staff
Assistants/Volunteers 3 staff
Interpreter 1 staff (depending on local conditions)
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Guide 1 staff (depending on local conditions)
Security staff 2 staff (depending on local conditions)
Field team leaders & deputies Each field team will have a field team leader and a deputy field team leader. The field team
leaders have direct responsibility for the implementation of the field work. Their terms of
reference include:
Lead the second pre-survey visits
Responsible for logistics and organization of the field work
Co-ordinate the day-to-day field work
Communicate with local, Woreda and Zonal/provincial authorities on issues regarding
the field work
Responsible for completion of the field report
The deputy field team leader will assist the field team leader and replace the field team leader
when required. Terms of references and standard operating procedures for each unit and
individuals in the organogram will be prepared in the survey operation manual.
8. Training In order to prepare the survey activities, the training of staff is necessary. The training will be
organized in different steps and will include in-house training as well as field visit experience.
Events will be organized at all levels to inform and orient the local authorities and personnel
about the survey activities, including:
Two week workshop to develop SOPs and to develop one field team to test survey
instruments. Participants of the workshop will become trainers for other field team
members.
In-house 1.5 -2 days workshop to give general guidance to all staff members.
Specific capacity building training for lab technicians, x-ray techs, census interviewers,
data management part by part training, also to include training on the forms, survey-
25
specific rules, census and interview procedures. Training will last for one-two weeks for
each group.
After the in-house staff training, an integrated field test will be arranged, in order to
reproduce and gain experience in all field activities, including checking equipment
(chest x-ray), collecting lab samples, sample storage and transportation, form filling,
etc. The field test will take place near Addis Ababa and some modifications to the
forms or to the data and participants flow may be needed after the field test. After
lessons learned from the field test are integrated into the new procedures, these will be
pilot tested in the field. The timeline for these field trainings can happen during two
months time.
Pilot testing will be done by 2-3 teams, including all team leaders as well as some
observers. The pilot survey will be performed in one cluster, which will not be included
in the study sample.
Instructional sessions will be organized for local health workers and volunteers during
the preparation visit approximately one month before the field operations and on arrival
day of the survey team.
All SOPs should be developed before starting the training.
9. Survey operations
The survey will be conducted using SOPs based on this protocol. The following SOPs will be
developed:
SOP Pre-survey visit including sampling step to designate survey census area
SOP Guidance to local health workers and volunteers
SOP Field data collection, including check list of necessary items for each step
o SOP Field Management for team leader including reporting to local authority
(Compile all field SOPs and define the role of team leader)
o SOP Survey Census
o SOP Enrolling participants and informed consent + poster and leaflet
o SOP Group Instruction: standard instruction
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o SOP Receptionist
o SOP Screening interview
o SOP Chest X ray at field level
o SOP Data Checker
o SOP Medical management and referral
o SOP Re- interview
o SOP Laboratory field procedures including collection and transportation instruction
to produce quality sputum
SOP Guidance to local
o SOP Logistics support and administration including check list of necessary items
o SOP Data management
o SOP Chest X ray reading at central level
o SOP Laboratory procedures for central level
o SOP Monitoring and Supervision
o SOP Central Panel to classify and manage detected cases
o SOP Feedback the survey results (individual and cluster reports)
Procedures before field survey Before the start of the field work, all Regional, Zonal, Woreda and Kebele authorities involved
will be informed about the objectives and outline of the survey and clearance, approval for
secondment of staff, and co-operation will be requested. Furthermore, a two day sensitization
workshop for Regional Health Bureau staff and other partners working on TB will be held, and
a two day orientation meeting will be organized addressing the Woreda authorities (District
Health Office and TB focal persons).
Pre-visit Once the Woredas have been selected for the survey sample, the central team will contact
the local authorities requesting the list of Kebeles within that Woreda for the cluster sampling,
using Kebele as the sample unit. After selection of the Kebele, the study team leader will
conduct a pre-visit to the Kebele. The pre-visit takes place two months before the survey, and
the aims of the pre-visit are:
27
Checking accessibility of the Kebele (security, military area, roads, distance from main
road, )
Drafting a map of the area
Assessing infrastructure (health structures nearby, school, water and power supply,
hotels, etc)
Assessing the most convenient time when to conduct the survey, taking into account
seasonality, mobile pastoralist populations, etc.
Identifying a reference lab where to send the specimen
Designating survey areas (survey camp, chest x-ray site, etc.)
Identifying diplomatic compounds/hospitals/boarding schools/jails/refugee camps/etc.
in the Kebele to be excluded from the survey
Meeting the local authorities and local health workers
Informing the local authorities about the survey contents and procedures
Asking local authorities for collaboration for community involvement
If the Kebele is accessible, all the above mentioned activities are carried out in the pre-visit. If
the Kebele is not accessible and the team decides not to conduct the survey in that selected
Kebele, the exact reasons should be recorded and another Kebele in the same Woreda will
be selected to replace the first one. Inaccessibility by car cannot be a reason to exclude the
selected Kebele. Special arrangements will be put in place to reach Kebeles not accessible
by road. A report of the pre-visit will be written by the team, including a map of the area.
Second visit Approximately one month before the survey, the team leader performs the second visit to the
selected Kebele. The aims of the second visit are:
Meeting the local authorities, local leaders and health workers and informing them
about the survey procedures
Designating household blocks to be included in the survey census
Sensitizing the community about the survey
Informing the community about the exact time of the survey
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Creating linkages with health facilities nearby for clinical management of identified
patients/sick people
Asking the local authorities/health workers to prepare the population list and identify
local health worker/volunteers who will assist during survey
Training local health workers and providing instruction to volunteers
Deciding on the survey base (school, community centre, religious facility, house, open
space, etc.) and accommodations of the survey team.
Developing/revising of map of designated survey areas
The community will be informed and sensitized during the second visit of the team. With the
support of local authorities and local health workers, the survey procedures will be explained.
Field survey procedures Day 1: Census taking The first day of the survey will be dedicated to the census; the census takers (3) of the team
and local volunteers will visit the households where the survey will be undertaken under the
guidance of the team leader. The SOPs for the household census will be developed to
include:
Providing a household number to every household in the designated census area
Checking the pre- list which was to have been already completed by local health staff
and completing the census form to add household members and visitors not already
listed in the pre-list
Confirming study eligibility of household members and visitors and issuing survey
invitation cards with Individual Survey Number (ISN ) to those eligible
Explaining the survey procedures to households members
The team will mark the identified households with a household number. The census form
(also known as the household registry) (see Annex) will capture all individuals living in the
selected households, including children < 15 years old, based on the population list provided
by the local authorities. The purpose of registering even children < 15 years is to identify the
proportion of children in each cluster. Through household visits and rapid interviews with the
household head/members on the census day, the pre-list of registered persons produced by
local authorities will be updated. Each registered inhabitant will receive an Individual Survey
29
Number (a 7 digit ISN). In the Census form, an Individual Survey Number should be allocated
to all family members and also to absentees (eligible but not available on the census day and
for whole survey period) and also to those who refuse to participate to the survey. For each
registered person, the eligibility criteria will be checked; eligible persons will be included in the
study. People who have died or who left the household more than 2 weeks before (according
to exclusion criteria) will be marked as not eligible on the census form, while additional
eligible individuals who meet the inclusion criteria will be added (e.g. temporary inhabitants
who have been in the household for at least 2 weeks). All the eligible persons will receive an
invitation card, with name, ISN and appointment at the survey base (date/time). The finalized
list of eligible persons will then be compiled.
A composite Individual Survey Number (ISN) which serves as the survey individual number,
will be used throughout the survey. It will consist of:
the cluster number (2 digits)
the number of the household as allocated during the census (3 digits).
an individual serial number allocated during the census (2 digits)
The household number will be given to every household by the census team prior to the
household visit. The individual serial number will be assigned by the census team during the
household visit. This allows the use of individual numbering for both adults and children living
in the survey area.
The ISN will be used on all questionnaires, results and request forms, in the survey laboratory
register and on all slides, sputum samples and x-ray films. The census forms will be used as
the primary source of ISNs and thus entered in the computer first. Other data collected
include, name, age, sex, residential status, eligibility and presence at the time of the survey
(to obtain the denominator for the prevalence estimate). Each registered and present person
receives an A5 format double-side printed form on which will be filled in: name, ISN, and date,
time and place for the interview and X-ray examination (see Annex). The person will keep this
and bring it when he/she reports to the survey base for examination. Although names will not
be entered into the survey database, they will be required during data collection in the field in
order to avoid identification error when survey results for detected TB cases need to be given
30
back to patients and providers for case management purposes.
Day 2-5: Interview, chest x-ray and sputum specimen collection At the survey base people are welcomed by a survey team member and a local volunteer (e.g.
TB focal person) who will provide instructions on survey procedures and guidance on the
risks and benefits of survey participation. Then people are led to reception, where a
receptionist and local health worker confirm their eligibility by checking the census list and
survey ISN provided by the census team. The receptionist also asks written informed consent
to participate to the survey and if consent is given, the receptionist will register participants in
the survey registry. The receptionist also prepares an individual survey form, which he/she
fills in with the ISN, name and age and then escorts the participants to be interviewed.
The interviewers ask about TB symptoms and previous anti-TB treatment and then record
answers in the individual survey form (see Annex) during a 5-10 minute interview. After the
interview, the participant is taken to the chest x-ray area, where his/her data are recorded by
the radiologist assistant in the x-ray log book (see Annex), and then the chest x-ray is taken.
The participant waits for the result of the chest x-ray in a waiting area. If the participant
reported cough, current or past TB or lymph nodes during their initial interview, after the chest
x-ray, the participant will be invited to participate in another short interview about their health
seeking behavior (see Annex). Furthermore, KAP interviews will be carried out in a pre-
selected 10 percent of the participants, who will be randomly chosen using the last digit of the
ISN. Another questionnaire will be used for the purposes of this KAP survey (see Annex).
All forms will be evaluated at a specific data check point to ensure all data are entered and
necessary examinations have been performed. All persons with TB symptoms and/or chest x-
ray abnormalities will be taken to the sputum collection area, where they will receive clear
instructions on production and collection of sputum. A second container will be provided to
participants for the morning specimen o be collected the next morning at home or at the
survey site, according to local arrangements. Specimens will be labeled on the container, not
on the lid. Specimens will be stored in ice boxes and then transported within 3-5 days to the
central lab where they will be examined microscopically for acid-fast bacilli.
31
Home visits will be arranged for persons who cannot reach the survey base. If they consent to
participate, they will be interviewed at home and asked to provide sputum there. Especially in
urban settings, special arrangements will be made not to interfere with participants daily
activities by conducting survey activities in the evenings and on weekends, when necessary.
Follow-up of eligible persons who do not show up at the survey base on the designated day
will be undertaken to reduce non-attendance. All eligible persons will be screened in a total of
4 days (days 2-5). The number of participants screened daily may vary from 140 to 200
depending upon the local situation. Details of all activities, including field work, laboratory and
radiology procedures and data management, will be described in the SOPs.
Day 6: Debriefing: reporting to local authorities and the community The sixth day will be utilized to collect the last morning specimens, finish the cluster activities,
and pack up the survey documents, equipment and material. Before leaving, the team will
provide feedback to local authorities and health workers, including information on the number
of people screened, participation rates, number of persons eligible for sputum, etc. A field
report will be developed at the end of the survey activities in each cluster and transmitted to
local authorities and the TAG. The report will include:
Name of village, date of field work, name of survey team leader and team members
Brief description of activities
Number of participants in the survey
Number of participants coughing more than 2 weeks
Number of participants having x-rays taken
Number of abnormal x-rays
Number of participants eligible for sputum examinations
Number of participants who submitted sputum samples,
Number of participants referred to health facilities for medical management
Expected date of further reports
After the results from the lab are dispatched, the following information should be efficiently
sent to the local authorities:
32
Number and names of smear-positive and/or culture positive participants (to be
managed as TB patients)
Number and names of participants with other diseases who require medical
management
Field work duration The amount of time needed for the data collection is estimated to be one week (7 days) per
cluster (520-600 persons per cluster). The census takes one day and field operations take 5-6
days. Hard-to-reach clusters may take 10 days of field operations, including travel to the
survey area. Fieldwork is usually more difficult in urban areas, as the population tends to be
mobile and busy and less inclined to collaborate with a survey. This may be taken into
account by allowing sufficient time for follow-up of non-attendants and adjusting hours to
include working in the evenings and on weekends.
Field work will be done in blocks of 4 weeks (4 clusters), separated by a 2 week pause for
logistics, maintenance of equipment, and retraining, if necessary. Details of the field work will
be described in SOPs. A total of 8-9 months may be necessary to complete 85 clusters.
Field operation (Example):
(Sat &) Sun: Travel
Mon: Census and preparation
Tue-Fri: Screening and sputum collection
Sat: Morning sputum collection and a travel to the 2nd cluster
Central work following field activities The data collected in the field (census data, individual survey form, chest x-ray log book, KAP
questionnaire, laboratory register for TB suspects, etc) will be sent to central level to the
Survey Coordinating Team. Paper forms will be sent from the field to the data center at the
central level in order to be entered into the database. (See data management and analysis
section below.)
33
All chest x-rays will be sent to the central level. Chest x-rays found to be abnormal by field
readers and 10 percent of normal chest x-rays will be read by three radiologists at the central
level and the consensus of the readings of the radiologist is given to the SCT to be entered
into the database.
As soon as they are available, the results of microscopy and culture will also be sent from the
lab to central level daily on weekdays. In the case of positive results (either from lab or
radiologist), the medical panel is consulted. Based on the results of interviews, chest x-ray
and lab, the panel makes the decision about whether a study participant has TB, both for the
study and case management purposes to provide advice to treat and/or follow the TB cases.
The results of sputum microscopy and culture, will be sent (on paper) via mail or fax to the
local health center, together with the participants file (interview record) for further follow-up
and medical management. Details provided in SOPs. The identified TB patients will be also
referred to the health care system for an HIV test, as recommended by the National TB/HIV
guidelines (FMOH, 2008). Per contact investigation guidelines, the children living in the same
household of confirmed TB patients will be screened for TB and, if necessary, provided
prophylaxis (FMOH, 2008a).
Case management: Clinical actions to be taken according to survey findings Survey participants for whom an illness and/or chest x-ray abnormalities were detected by the
doctor in the field during the survey and who require medical intervention will be referred to a
nearby health facility (health centre or district hospital) with a referral form and chest x-ray
reports. In the case of conditions which require urgent referral to the local health system,
arrangements will be made. Details are provided in SOPs. First aid will be ensured by the
survey team.
Detected TB cases will be notified to the local health authority, and provision of free TB
treatment is guaranteed. Individuals identified with smear- or culture-positive TB should be
put on anti-TB treatment as soon as possible and will be offered counseling and testing
through routine TB and TB/HIV services.
10. Data management and analysis
34
Data management includes all processes and procedures for collecting, handling,
manipulating, analyzing, and storing/archiving data from the start of the study to its
completion. Managing survey data appropriately ensures that the data are complete, reliable,
and processed correctly, and that data integrity is preserved. The databases should be
managed from a central location, and a database manager should be appointed to take
charge of the process.
Data management should follow a series of steps to produce high-quality data on individual
characteristics and aggregated indicators of TB prevalence.
Suggest add the following overview of data flows
The steps involved in data management include the following.
Survey cluster site
Central x-ray unit Central laboratorySurvey coordinator + central data management unit
Medical panel
District TB coordinators
census, interview and KAP forms + other documents
sputumsamples + field laboratory register
x-ray films + x-ray log book
x-ray log book Daily results sheet
Final reportCase management: MO review and confirm TB case details (real time) before notifying local health officials
35
Questionnaires should be checked, edited and coded in the field (1) to correct errors
on the questionnaire, (2) to code special responses (such as from open-ended
questions) to facilitate ease of data entry and analysis and (3) to report back to field
workers on common errors made in the field to improve the fieldwork. Where errors
were made on the questionnaire, going back to the household to obtain the correct
information is sometimes necessary.
A database should be created, and data entry, checking and editing programmes
should be written for entering data from the questionnaires into the electronic database
and to check information in the database for potential data errors. Programmes need to
be written and tested at the pilot stage. These programmes can include acceptable
ranges for variables (such as allowing only valid entries within a certain range for a
particular variable) or checks for internal consistency, which will help with data cleaning.
Name and address of study participants will not be entered in the database.
Questionnaires should be logged and tracked to ensure that planned interviews have
been completed and to keep track and provide a count of the number of questionnaires
that have been entered into the database. They need to be stored in an accessible
manner in case they need to be referred to during data editing.
Information recorded on the questionnaires will be entered into an electronic database.
Data entry should be done concurrently and continuously during the survey as data are
collected. Data should be entered twice, ideally by two independent data encoders, to
minimize data entry errors. Once entered, the two data sets should be compared and
discrepancies corrected.
Laboratory and CXR data should be managed separately in such a way that they are
linked to the general questionnaire using the special pre-assigned individual survey
code.
Once entered onto a computer, electronic data will be checked for errors and outlying
values, and all inconsistencies should be corrected, so that data files accurately reflect
the responses to the questions in the questionnaires. Information generated on the
quality of the data from the questionnaires can also be fed back to the field teams in an
attempt to improve the quality of the fieldwork. Frequency tables can be prepared for
all variables to check for outliers (singly and in logical pairs). Variables related to each
other can be cross-tabulated to check for inconsistencies, Distributions and scatter
36
diagrams of variables should be plotted and checked for plausibility. Decisions have to
be made about whether to impute or eliminate clear mistakes or missing data or
whether to simply flag the relevant fields as invalid.
A mechanism will be in placed to document changes in the database, keeping a record
of past and new values where data are corrected, along with dates when changes
were made.
Data should be backed up at the end of everyday that data files are entered and
should be stored in a safe place in a separate room.
The data manager should validate double-entered data files using a validation
programme or script and discrepancies should be checked against the raw data and
update in the validated file..
Progress analysis should be done systematically; like every three months to provide
comprehensive feed back on the quality of data collected and appropriate planning of
corrective measures.
Forms that allow linkage of personal identifier numbers with names of individuals (or
any other information that permits an individual to be identified) should be kept under
lock at the data management unit, under the supervision of the data manager.
Analyses and reports must not contain the names of surveyed individuals.
Data will be collected in predesigned forms, log books or survey records according to
standard operating procedures (data management SOPs). Source documents will be defined
[and listed]. All hard copy entries will be made in blue ink and corrections recorded with
signature and date.
The following forms and logs will constitute the survey source documents: List of selected Woredas
List of Kebeles in selected Woredas
Clusters list
Survey plan and dates (logistic plan)
Census list (household members list with attendance)
Invitation card
37
Informed consent signature page
Survey register
List of interviewed
Survey individual interview forms
log book of CXR examination
CXR films
CXR report forms examiner 1 (field level)
CXR report forms examiner 2 (central level)
List of participants with no symptoms or CXR findings (who go home)
TB suspects register with sputum sample collection
sputum samples log book List of participants referred to health facility for follow up
Lab registry (reception of sputum samples)
Sputum smear examination report fluorescence microscope
Sputum smear examinatiom report ZN
List of specimens processed for culture
Culture form (date of inoculation, number of tubes, remarks, reading week one, two
etc, isolate AFB results, further processing subculture, etc),
Culture result report form
XRay equipment maintenance form
Specimen transport form
Logbook for specimen transport and receipt
Specimen storage form
Temperature monitoring form
Individual case record form per participant
Field reports from last day of cluster plus daily summary
Defaulter tracing list
Second questionnaire on past history of TB in the last 2 years
KAP survey and risk factors questionnaire
Post-survey questionnaire to TB cases
TB cases register
38
The survey will identify a central data management unit in a research or academic facility where data management experience and facilities exist. A well trained qualified data manager
will be recruited to lead data management team which will include at least one statistician
and data entry clerks. The data manager will participate in the planning of the survey and
contribute to the planning of field site activities during the survey. The data management team
will consult with an international expert to guarantee the smooth conduct of the work. The
central data management unit will prepare all lists and forms for data entry, receive, check,
index and file data and follow up on the progress of the data flow in the field with the aim of
early detection and resolution of queries and missing data. All data will be double entered
continuously by data entry clerks. Care will be taken to ensure confidentiality of data.
Appropriate protection and back up will be maintained to guarantee against loss, corruption
by virus or accidents. An appropriate database will be developed for the study.
An appropriate database, data entry screens and standard reports will be developed for the
study and will be managed to ensure high levels of data security and integrity. Access and
authentication controls will be implemented to ensure that only authorized staff can view or
modify data. The data management plan will contain a data dictionary and SOPs for backup
procedures, hardware, software and data security, and a disaster recovery plan.
A data management plan will be developed to guide the data handling. A data analysis plan
will be produced as part of the SOPs and interim analysis conducted for reporting to the data
monitoring board. For all eligible participants point estimate and 95 %confidence intervals
will be calculated for prevalence of smear positive TB, smear-negative/culture-positive TB,
bacteriologically positive (smear positive and/or culture-positive) TB and bacteriologically
negative/chest x-ray suggesting pulmonary TB and finally an estimation of smear positive TB
among all age group will be done.
Statistical method Sample weight in the sample design (cluster sampling with PPS0 cluster size should be
identical to ensure an equal contribution of sample from each cluster to arrive at a national
average. After implementation there re may be variability in size of eligible population. If so
the survey will be weighted so that contribution of the results from each cluster to the national
39
figure will be the same as planned.
Statistical method considering design effect. Using stata such analysis will be conducted by
using svy family commands. For hypothesis tests of the factors associated with prevalence,
such as rural/urban/pastoralist, sex, the syvlogit command will be used.
Data analysis will be done using WHO standard operating procedure for TB prevalence
survey with technical support from WHO.
11. KAP (Knowledge, Attitudes and Practice) study A random selection of 10 percent of participants in the symptom screening will be invited to
participate in a KAP study, which has the aim of learning about participants knowledge,
attitudes and practice surrounding TB. For those selected, a second interview will be
conducted using a structured questionnaire (see Annex Social scientists are involved in both
at the design stage and analysis of KAP study. Information garnered during these interviews
will help in designing appropriate TB interventions.
12. Quality assurance All laboratory investigations will follow standard procedures (SOPs will be developed).
Quality controls will be put in place for each assay. All new lots of reagents will be tested with
known positive and negative control slides. Reference strains will be inoculated with each
new batch of LJ slants to assess the medium quality. All positive microscopy slides and ten
percent of negative slides will be examined by a second microscopist for confirmation.
Discrepant results will be noted and read by both microscopists to reach a consensus.
Monitoring and supervision Monitoring of the survey activities is conducted in two different ways: internal and external
monitoring.
Internal monitoring The team leader has the responsibility to monitor and supervise the team members
throughout the duration of field activities. He/she remains in the field during survey operations,
checks the quality of activities performed, as well as attitudes of team members, consistency
and accuracy of data collected, quality of chest x-rays, sputum collection, etc. Each field team
40
should be also be periodically supervised by a member of the central team (lab, chest x-ray,
survey coordinator, data manager, etc), who may visit the field operation 3-4 days to check
the quality of the activities. Internal quality control will be put in place to ensure good quality is
maintained throughout the survey.
External monitoring (mid-term review) External monitoring is conducted by the TAG, which also includes experts from the WHO and
other international organizations. A data safety monitoring board will be established by the
Steering Committee to assess data handling. It will report its findings to the survey Steering
Committee. An independent study monitor will be assigned to report on adherence to
standard procedures to the Steering Committee.
13. Reporting and dissemination of results By four-six months after the completion of field operations, a workshop will be conducted to
discuss survey processes and preliminary results of the prevalence of TB. Participation rates
and the crude TB prevalence will be presented and disseminated to stakeholders. The
detailed results will be presented in closed consultation, in a scientific meeting in order to
discuss further analysis. Within six months after the workshop on preliminary results, a
consensus meeting will be organized by the Steering Committee to finalize the results.
Scientific findings will be presented in international conferences and research meetings. The
official report will be published. Standardized reporting formats (provided by WHO Task Force)
will be used to make international comparison possible. The results also will be posted to
major international scientific journals. An editor will be recruited (or consulted) to support for
reporting work.
14. Budget (in USD)
S/No Item From when to when Unit # of units# of subjects
Unit Cost USD
Total Cost USD
Budget Source Remarks
1 Human Resource
1.1 For Central Team
Survey October Month 17 2 USAID/TB-
41
Coordinators 2009-March 2011
2,000.00 68,000.00 CAP,GF
Laboratory Coordinator
December 2009-March 2011 Month 16 1
1,700.00
27,200.00
USAID/TBCAP
Procurement and Logistics assistant with accounting skills
January 2010-December 2010 Month 12 1
1,000.00
12,000.00 GF
Data Manager/Statistician
October 2009 - March 2011 Month 17 1
1,700.00
28,900.00
USAID/TBCAP
Data clerk
February 2009-January 2010 Month 12 2
400.00
9,600.00 GF
Radiologist
January 2009-December 2010 Month 12 1
1,700.00
20,400.00 GF
Social Since Advisor
questionnaire preparation-data analysis Day 90 1
40.00
3,600.00 GF
Medical/diagnostic panel (part-time) Half day 100 3
30.00
9,000.00 GF
Driver
October 2009 - March 2011 Month 18 1
400.00
7,200.00 GF
IT assistant on demand Days 120 1
30.00
3,600.00 GF
Sub-Total
189,500.00 1.2 For Field Team (5 teams)
Team leader (logistics, data and facilitation)
January 2009-December 2010 Month 12 5
1,500.00
90,000.00 GF
GP/HO/X-Ray reader
January 2009-December 2010 Month 12 5
1,300.00
78,000.00 GF
Interviewers Nurse/EHT
January 2009-December 2010 Month 12 15
1,000.00
180,000.00 GF
X- ray technician
January 2009- Month 12 10
1,000.00
120,000.00 GF
42
December 2010
Laboratory assistant / junior staff
January 2009-December 2010 Month 12 5
400.00
24,000.00 GF
Clerk (registration, receptionist, etc)
January 2009-December 2010 Month 12 10
400.00
48,000.00 GF
Sub-Total
540,000.00
1.3 For Central Laboratory
MLT/Microbiologist 2 people for 2 central lab
March 2009-February 2010 Month 12 4
1,300.00
62,400.00 GF
Lab assistant/runner
March 2009-February 2010 Month 12 3
400.00
14,400.00 GF
Allowance for Laboratory staffs 15person days per cluster on demand
person days 15 85
30.00
38,250.00 GF
Sub-Total
115,050.00
2 Per diem and logistic Unit Quantity/amount
# of clusters Unit cost Total cost
Budget source
2.1 Field activities
Per diem for field supervision
person days 15 25
30.00
11,250.00 GF
Fuel for supervision fuel day 5 25
40.00
5,000.00 GF
First previsit per diem for central staff
person days 4 85
30.00
10,200.00 GF
Fuel for first previsit fuel day 3 85
40.00
10,200.00 GF
Vehicle rental for first previsit car days 3 85
80.00
20,400.00 GF
Second visit per diem for central staff
person days 6 85
30.00
15,300.00 GF
Fuel for second visit fuel day 4 85
40.00
13,600.00 GF
Vehicle rental for second visit car days 4 85
80.00
27,200.00 GF
Per diem for central team during field
person days 70 86
30.00
180,600.00 GF
43
activities
Per diem for Regional coordinator
person days 7 85
30.00
17,850.00 GF
Allowance for District senior staff
person days 12 85
15.00
15,300.00 GF
Allowance for HEWs
person days 12 85
10.00
10,200.00 GF
Allowance for translator and road guide
person days 7 85
10.00
5,950.00 GF
Security measure (2 policeman for cluster)
person days 12 85
10.00
10,200.00 GF
Extra per diem in remote area for central staff
person days 30 30
30.00
27,000.00 GF
Extra per diem in remote area for regional staff
person days 3 30
30.00
2,700.00 GF
Extra per diem in remote area for district staff
person days 6 30
15.00
2,700.00 GF
Extra per diem in remote area for HEWs
person days 6 30
10.00
1,800.00 GF
Extra per diem in remote area for translator and road guide
person days 3 30
10.00
900.00 GF
Extra per diem in remote area for security reason
person days 6 30
10.00
1,800.00 GF
Vehicle rental for field operation car days 21 86
80.00
144,480.00 GF
Fuel for field operation fuel days 21 86
40.00
72,240.00 GF
Extra vehicle rental for remote areas car days 9 30
80.00
21,600.00 GF
Extra Fuel for remote area fuel days 9 30
40.00
10,800.00 GF
Porter transportation
person days 10 85
10.00
8,500.00 GF
Extra Porter transportation
person days 10 30
10.00
3,000.00 GF
44
(for remote areas)
Fuel for generator fuel days 6 85
15.00
7,650.00 GF
Extra Fuel for remote area fu
