Barbara Kabai Burmen,1,2 Thadeaus Ochieng Ochieng,1 Timothy Malika,3 Wilson Odero2
1Kenya Medical Research Institute Center for Global Health Research, Kisumu, Kenya
2Maseno University, Kisumu, Kenya
3National Tuberculosis, Leprosy and Lung Diseases Control Program, Kisumu County, Kenya
Introduction
Tuberculosis (TB) is a highly infectious disease; a person with active TB can infect up to 15 persons a year through close contact.1 Persons in close proximity with TB patients (e.g. household members) and persons with lowered or impaired immunity (e.g. children or immunosuppressed persons), are therefore at risk of TB infection.2,3
Contact Investigation (CI) of TB patients, though not widely practiced in resource-limited settings, is usually recommended as a means of case finding.3 CI is done to either determine whether a contact has TB and requires TB treatment, or does not have TB but is likely to have latent TB infection (LTBI) and requires TB chemoprophylaxis with Isoniazid Preventive Therapy (IPT).4 Contacts should be invited for screening within 7 days of a TB diagnosis of an index case with repeat screening done after 2 months of initial screening.3 This is to cater for the window period of infection;4 in the literature among contacts who screened smear negative at initial screening, 49% were still symptomatic at month one of follow up and 12% of them were diagnosed with TB.5
In 2006, The Wolfheze conferences of the World Health Organization (WHO), International Union against Tuberculosis and Lung disease (IUATLD) and Koninklijke Nederlandse Centrale Vereniging tot bestrijding der Tuberculose (Dutch Tuberculosis Foundation-KNCV) Tuberculosis recommended that: 90% of TB index cases should have at least one contact screened for TB; 90% of high priority contacts should be evaluated; 80% of all contacts should be screened within 3-4 months of a TB diagnosis in the index case; and 85% of contacts with LTBI should be put on chemoprophylaxis with at least 75% of them completing treatment.1
In 2012, the WHO provided recommendations for investigating contacts of persons with infectious tuberculosis in low and middle income countries.6 The WHO however, did not issue detailed guidelines on how to conduct Contact Investigation or how to prioritize contacts except in children aged less than 5 years and HIV infected individuals.7 There were no specific guidelines to be followed on the circle of contacts to be screened or the actual process of screening. The appropriate rescreening rate of contacts, based on the rate of reactivation rate of latent TB (which is also unknown), was also not recommended. However, for ethical reasons, if a TB diagnosis could be excluded at initial screening, effective preventive therapy could be administered.8
TB programs worldwide have faced challenges in implementing this program. In China, between 1997 and 2007, written national guidelines on Contact Investigation did not exist. There was no standard definition of contacts, no prioritization of contacts to be screened or types of screening tests to use. TB screening programs had employed different investigations with varying yields. “Contacts” had been defined as persons living in the same household with the TB index case; this definition may have (or may have not) stated the duration of contact.7 In 1991, the guidelines for Contact Investigation in Victoria, Australia, were neither updated nor adhered to, patients were not appropriately screened and IPT was not administered to all eligible contacts.4 The Indian National TB program recommends IPT administration for childhood household contacts aged less than 6 years; however the TB treatment cards of index cases did not have details of their household contacts and health care workers were not aware of the policies for CI.9
The TB program in Kenya recommends IPT administration to all household contacts of TB patients who are aged less than five years or HIV-infected and subsequently screen negative for TB.10,11 However, CI has not been scaled up to full implementation as it is resource-intensive, requires funds to track all contacts, test them for TB and initiate them on appropriate therapy.3 The Kenyan TB program practices contact invitation. Furthermore, data on Contact Investigation in Kenya is limited. Of the 11,886 cases reported in the former Nyanza north in 2012, only 2% (281) were by Contact Investigation. In Kenya, there is no current documentation of the total number of household members eligible for screening (Personal Communication, Tuberculosis and Lung Diseases Coordinator, 30th August 2012).
As part of a Tuberculosis household Contact Investigation study, we documented key concerns that the TB program in Kenya could take into consideration when transitioning from routine contact invitation to standardized Contact Investigation.
Methods
Study design
Ethics approval to conduct this mixed methods study that assessed the value of prospective household TB Contact Investigation in control of drug-susceptible TB among children aged 0-5 years who had been in household contact with an index case of TB in Kisumu County, Western Kenya, 2014-2015 (a period prior to the inception of standardized Contact Investigation), was granted by the Kenya Medical Research Institute Senior Scientific Committee (KEMRI SSC # 2408).12 A cross-sectional survey was used to determine the prevalence and risk factors of TB infection as well as IPT uptake and completion rates following household exposure. A cluster-randomized trial was also used to compare the value of TB Contact Investigation to contact invitation in childhood TB control.13 Document analysis was used to systematically review qualitative data concerning experiences of the TB Contact Investigation study’s research team.14 This method offered the distinct advantage of comparison of different methods and their findings.15
Study population
Quantitative data: These were all TB index cases and their child household contacts.
Qualitative data: The target population was persons who had been directly involved in the provision of standardized TB Contact Investigation services that included the research study team members and health workers at participating health facilities. This population was chosen because they had first-hand knowledge on the challenges faced and tools that would facilitate the implementation of clinical guidelines.16
Sample size and sampling technique
Quantitative: This included all index cases and their child household contacts recruited through a convenience sampling technique.17
Qualitative: This included all the 46 study team members; a study coordinator, a clinic manager, 2 clinical officers, 5 nurses, 4 field-based and 6 office-based community interviewers and 27 community health volunteers. A convenience sampling method was employed as it was impractical to document the experiences of all health workers at TB clinics and laboratories of participating health facilities.13
Instruments and Procedures for Data collection
Quantitative data: The information following information was collected regarding the index case: X-ray results, Household contact identification and Housing characteristics; for the contact: Contact tracing, Contact eligibility, Contact interview, Contact TST, Contact lab results, Contact HIV test results, Contact Chest X ray results, Contact follow up interview.
Qualitative data: Document analysis14 was done using (i) consent cover sheets that contained participant information and additional details of the consenting process, (ii) appointments schedules that illustrated the number of visits to be made by each participant and procedures to be conducted at each visit, (iii) participant tracking/ activity check list sheet that helped track the service delivery points where the participants had received services and the documents that were filled at each point e.g. triage, clinician’s desk, laboratory, pharmacy etc, (iv) and minutes of weekly meetings that had an agenda item for “Challenges and Successes” for the study team members to discuss their experiences to support study implementation.
Data analysis and data integration
Quantitative data: Logical steps, frequency summaries and field verification of data preceded data analysis. Percentages were used to summarize the number of eligible participants that received specific services as a fraction of the total number of participants eligible for that service.13,18
Qualitative data: Content analysis was used to identify emerging themes.19,20
Data integration: Data were transformed by qualitizing quantitative data and quantitizing qualitative data to allow amalgamation21 and results from quantitative analyses were used to triangulate findings from qualitative data wherever possible.13 Qualitative data was used to generate themes which guided the retrieval of corresponding or refuting quantitative data.22 A modified joint display was used to present the data presented in paragraphs (as opposed to side by side) with themes identified from qualitative data analysis presented in light of corresponding rates from quantitative data in both the results and discussion section akin to convergent mixed methods studies.12,23 Both qualitative and quantitative studies were conducted during the entire duration of the study period.24 Priority and a higher weight was assigned to quantitative data that was used to analyze the main research question.22 All data was archived in institutional archives for period not exceeding 5 years after the last publication from this study.25
Results
Key issues for implementing standardized Tuberculosis Contact Investigation
Identification and recruitment of index cases and their household contacts
Only 554 (12%) of the 4,524 TB index cases diagnosed in Kisumu County during the study period were recruited.26 TB index cases listed a total of 1,974 household contacts. However, upon home visit, only 2,068 household contacts were found. The median number of household contacts per index case was 5 (3-7). A total of 652 home visits were made in attempt to reach 1,945 (94%) household contacts. Upon tracing attempts to households of index cases who had listed at least one household contact, information was obtained about 2,114 contacts of whom 1,315 (62.2%) were interviewed, 579 (27.4%) scheduled an interview at a later date, 97 (4.6%) were not found at home, 90 (4.3%) declined participation, 18 (0.9%) had out-migrated, 14 (0.7%) were unreachable on phone, and 1 (0.0%) had died.
Upon screening of 1,918 contacts linked to 510 of the index cases, 1,896 (98.9%) met the definition of a household contact. The other 22 (1.1%) contacts declined participation (n=11), were ineligible for enrolment (n=4), were untraceable (n=4), had migrated from the study area (n=2), or were mentally handicapped and therefore could not give consent to participate (n=1).
Only 1,519 (82%) household contacts linked to 445 index cases were enrolled; the rest either declined participation (n=286), could not be traced (n=48) or the reasons for non-enrolment were not documented (n=32). The majority (n=445; 80%) had at least one household contact; of these the 243 (55%) that had at least one household contacts aged less than 5 years. Over one fifth of all contacts (n= 345/1519; 22.7%) were aged less than 5 years of age; these contacts were linked to 44% of all the TB index cases in the study (Figure 3). The mean age of all TB index cases and index cases with child contacts was 32.7 (±13.9) and 30.9 (±13.1) years respectively. The ratio of the total number of TB index cases in the study to child contacts was (555: 345 i.e. 1.5: 1) (Figure 1).
The requirement to adhere to multiple appointment schedules
All study participants had to commit to adhere to all study procedures which included a minimum of five health facility visits over a three month period for additional investigations for the index case if required and screening and appropriate management of household contacts. Participants also had to adhere to appointment schedules for TST readings and consent to referral to higher level health facilities for further investigations.
Completion of the TB screening and treatment cascade
Only 82% of contacts had a TST done and 71% of those who were eligible for Chest X-ray had a chest x-ray done. Only 15% of IPT-eligible contacts eligible were put on IPT and 20% completed IPT. There was a decrease in the number of contacts from the point of identification to completion of the cascade. (Figure 7)
Database management
A relational database was used during the study. A TB index case was identified by a unique number linked to the screening center. E.g. “KI”, for Kisumu County followed by a four digit code (index identifier), a hyphen, and another two digit code (contact identifier). For instance, “KI-0001-0” would be the first index case recruited in Kisumu County. All household contacts of this index case would subsequently be identified with a suffix added to the index identification number e.g. “KI-001-1”, “KI-0001-n”. The index identifier was used on all index data tables (which contained 554 observations one for each index case), except the Household contact identification data table where study staff would enter identification details of all the household contacts; this data table had 1,974 observations (one for each contact). Upon visiting the home to trace other contacts, 2,068 other contacts were identified and entered in the Contact tracing data table. However, only 1,945 were found during tracing and were entered into the Contact eligibility data table. Upon interview only 1,855 met the definition of household contact and were entered in the Contact interview data table. These contacts then appeared on the Contact HIV test, Lab results, TST and Chest X-ray and follow-up data tables if they were retained in the study and completed the recommended screening tests. The final database therefore had a number of unique identification numbers dropped during entire cascade (Figure 1).
Resource Implications
This study was conducted over a 2-year period in several facilities in Kisumu County. The study budget was in hundreds of thousands of US dollars (KEMRI TB Program Strengthening section head, Personal communication, 30th June 2016). Additionally, field study personnel therefore had to shuttle between participating health facilities. Additional costs were incurred to make 625 home visits to transport all the contacts from their homes to the health facilities for screening for at least 2 visits (for both inoculation and TST readings) and possibly treatment, to purchase TST kits, to pay for chest x-rays and other laboratory tests. The furthest distance the study team had to travel to transport study participants from their homes to the TB clinics was a round trip of approximately 100 kilometers at a cost of USD 1 per kilometer. A maximum of three home visits were to be made before declaring a participant untraceable. There were also telephone costs to track participants, invite them for an interview or remind them to attend an appointment.
Discussion
This study revealed four major findings that TB programs will have to address specific issues in transitioning from routine contact invitation to standardized Contact Investigation: issues related to identification of contacts, completion of the TB screening cascade, database management and resource implications.
Ninety-nine percent of contacts met the criteria for definition of household contacts. In Uganda, the extension of contact screening to non-household contacts that were first degree relatives of the index cases, increased the yield of Contact Investigation.27 An increase in the yield of contact screening has been achieved, by extending the radius within which to draw contacts for screening,28 screening all persons sharing the same residential address and not only those who share eating arrangements,29 and extension of screening to neighbors.30 However, screening all persons who had been in contact with a TB index case in a supermarket in the Netherlands had a very low yield. Limiting the screening of contacts to those that frequented the store or had a longer duration of contact with the index case increased the yield. Only symptomatic or contacts at most risk of infection should be investigated for TB.31
Four percent (4%) of contacts declined participation. Only 34% of contacts in Ethiopia complied with screening protocols. Higher compliance rates were seen among contacts who were related to the TB index case and had received health education from a health worker on TB.32 TB index cases may have no influence on screening and treatment decisions of contacts that were not related to them.33 In Peru, 2% of households of TB index cases declined participation.30 In a separate study in China, 15% of contacts did not consent to participation.34 This study, as well as the study in Peru and China, did not compare those who declined to those who consented to participate. With a 4% declination rates and based on a prevalence of active TB and LTBI of 3.1% and 45% respectively among household contacts in low and middle income countries, a refusal rate of 4% (n=84) potentially translates to 3 and 39 cases of active TB and LTBI respectively who remain undiagnosed.35
The success of TB household Contact Investigation depends on the willingness of TB index cases and their household contacts to consent.35 Consenting to screening of close contacts may lead to unintended disclosure of a TB diagnosis.36 Unwillingness to participate may be linked to the stigma associated with TB and the communities’ perceived link between TB and HIV.37 Due to the high TB/HIV co-infection rate in the study area, disclosing a TB diagnosis is akin to the disclosure of a HIV diagnosis.35 The rights to decline participation in a research setting are well defined.38 Contacts therefore maybe regarded as ‘TB suspects’ by the TB program as they likely to have TB and are thus potentially infectious.10 There exist laws and regulations regarding the management of persons with notifiable diseases which may be applied to compel contacts to present themselves for screening (like TB).39 However, such public health laws may infringe on individualism.40
A high TB screening rate and low TB diagnostic rates was observed among contacts. Our screening rates in a research setting were higher than those documented in Ethiopia (55%) in a programmatic setting.41 Screening rates of over 90% with diagnostic rates of 3% have been observed in Kenya among HIV infected patients. This was due to the use of screening tests with low sensitivity and specificity.42 Screening rates of 72% and 60% among household contacts and neighbors of TB index cases who presented with cough were seen in Peru where sputum samples were used for screening. Nevertheless, children aged less than 10 years are less likely to give sputum samples and require alternative case detection methods.30
The data demands for this study were huge and complex. At the time of the study there were no tools to support TB Contact Investigation within routine clinical care. In India, the introduction of linked IPT family cards and IPT registers, supported by health worker training, led to a three-fold increase in the proportion of contacts screened for TB.43 In the literature, paper-based tools having been used to implement TB Contact Investigation with success.44 The regular monitoring and evaluation of programmatic activities has been shown to facilitate the effective implementation of TB programmatic activities.45 However, the use of an electronic relational database supported by a clinical decision support system would be preferable as it can turn disparate pieces of information into a valuable resource.43,46
Contact Investigation is resource intensive.41 It also requires a huge investment in infrastructural support.44 This study had external funding to support its activities. The costs of tracing, screening and tracking all contacts will vary based on the TB burden and the average number of contacts per case.47 With a TB burden of 348 per 100,000 WHO,48 and most an average of 4.2 members per household in Kenya, the TB programs will have to screen a higher number of contacts than in low TB burden sparsely populated regions KNBS.49 In Benin where TB Contact Investigation was conducted successfully, only 23% of TB index cases had a child contact compared to 44% in this study.44 We had a TB index case to child contact ratio of 1.5:1. Indian investigators attempting to estimate the number of IPT-eligible children found a ratio of sputum positive TB index cases to child contacts of 5:1. However, the mean age of the TB index cases in our study was 32 years whereas this was 46 years in India, where the majority did not have child contact aged less than 6 years.50 The WHO and Kenyan TB treatment recommend that for every TB case diagnosed, at least one child contact aged less than 5 years be initiated on IPT WHO.6 This ratio may have been higher with enhanced linkages between the study teams and the TB program. In a different region in Kenya, the screening of child contacts of TB patients was hampered by the costs that are higher than the daily wage of most citizens that had to be borne by the patient.33 Although research has shown that the absence of Chest x-rays and TST should not be a deterrent to screening and management of children,44 this will require clear guidelines on monitoring of contacts who initially screen negative for TB.51
Although document analysis draws its strength from countering concerns related to reflexivity, the information was not recorded under the researchers’ oversight and may have been incomplete. The study was also unable to triangulate qualitative findings through other qualitative data collection methods that would have enriched study findings.14
In conclusion, considerable resource investment is required to implement contact investigation. This includes costs of tracing a large number of household contacts in high-TB burden densely populated settings; availing point of care diagnostics and continued supply of preventive medication; cost of supporting the monitoring and evaluation of this program. TB programs are also facing challenges in tracing a large number of contacts who may be unwilling to undergo screening or adhere to prescribed preventive medication.
We recommend that Contact Investigation be implemented within existing community health systems, with a possibility of home screening and delivery of isoniazid to limit programmatic costs. Health workers should be equipped with job aids to facilitate the completion of the TB screening cascade. An electronic relational database ingrained with a clinical decision support system should be used to aid the monitoring of index case-contact dyads that should have synchronized clinic appointment schedules. To manage the large number of contacts eligible for screening, retrospective Contact Investigation could also be employed due to the possibility of finding incident cases of TB. Further research should be conducted to assess the actual costs of Contact Investigation incurred by patients and their families and the TB program.
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Corresponding author: Barbara Kabai Burmen, KEMRI CGHR, P.o. Box 1578-40100, And Kisumu, Kenya Tel 254733983432 Email: drburmen@gmail.com