Protocol. This trial protocol has been provided by the authors to give readers additional information about their work.

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1 Protocol This trial protocol has been provided by the authors to give readers additional information about their work. Protocol for: Fox GJ, Nhung NV, Sy DN, et al. Household-contact investigation for detection of tuberculosis in Vietnam. N Engl J Med 2018;378: DOI: /NEJMoa

2 Supplement: Trial Protocol and Statistical Analysis Plan This supplement contains the following items: 1. Original protocol and final protocol. There were no changes to the original protocol. 2. Original and final statistical analysis plan. There were no changes to the original statistical analysis plan.

3 1. Original protocol and final protocol. Study Guideline for the Active Case-finding for Tuberculosis Study Standard Operating Procedures Manual (October 2010).

4 MINISTRY OF HEALTH NATIONAL TUBERCULOSIS PROGRAM VIETNAM THE UNIVERSITY OF SYDNEY WOOLCOCK INSTITUTE OF MEDICAL RESEARCH AUSTRALIA ******************************************************** STUDY GUIDELINE ACTIVE CASE FINDING FOR TUBERCULOSIS STUDY (ACT II) STANDARD OPERATING PROCEDURES (SOP) MANUAL Updated 28 th October

5 Contents LIST OF ABBREVIATIONS...5 GLOSSARY...6 INTRODUCTION... 7 Background... 7 Main contents:... 7 Study aims:... 7 Location and duration of the research... 7 Method of the research... 7 Outcomes: Participating Organizations and Individuals Organizational Flow-chart of participating institutions Roles of staff and subjects in research Chief investigators committee The Advisory Steering committee (SC) Project Coordinator (PCO) Project Officers (PO) Financial Officer National Laboratory Coordinator National Radiology Coordinator Provincial Hospital Coordinator (PC) District Clinic Study Coordinators (DC) in the control group District Clinic Study Coordinators (DC) in the screening group District Assistant at District Clinics in the screening group X-ray technical staff at District Clinics in the screening group Laboratory staff at District Clinics Laboratory staff at the Provincial Hospitals Radiology staff at the Provincial Hospitals Index patient or other key household leader Close contacts Reporting framework for research staff INTRODUCTORY RUN IN PERIOD Overview of Introductory Run-In Period Enrolling patients during the Introductory Period Enrolling Household Contacts during the Introductory Period Check-list after the Introductory Period PROTOCOL FOR DISTRICTS IN SCREENING GROUP Overview of protocol for Screening Districts Protocol for districts in screening group Enrolment of index patients with smear positive pulmonary tuberculosis ,2.2 Enrolling household contacts in a District in the Screening Group Review of household contacts at 6, 12 and 24 months Review of suspects : contacts with symptoms or X-ray changes (at 0, 6, 12 or 24 months or between scheduled visits) Review of suspected Extra Pulmonary Tuberculosis in contacts in Screening Districts

6 The protocol for suspected extrapulmonary tuberculosis is below: PROTOCAL FOR DISTRICTS IN THE CONTROL GROUP Overview of protocol for Control Districts Enrolment of index patients in Districts in the Control Group Enrolling household contacts in a District in the Control Group Review of household contacts 24 months (Control Districts) Household contacts in Control districts that are suspected to have tuberculosis during the study PROTOCOL FOR PROVINCIAL HOSPITALS Introductory Run-In Period and District randomisation Index patients diagnosed with tuberculosis at Provincial Hospital Specimen and Xray handling at Provincial Hospital MONTHLY REPORTING PROTOCOLS FOR COORDINATORS Reporting and financial management at District Clinic Financial records at the District Clinic District Coordinator preparation before the monthly meeting At the monthly meeting Reporting and financial management at Provincial Hospitals Overview of reporting for Provincial Coordinators Monthly Data reporting on the website Posting SD card of written data from Provincial Hospitals to National Lung Hospital Quarterly financial reporting by Provincial Coordinator LABORATORY PROTOCOLS Sputum collection and handling in District Clinics in the Screening Group Specimen handling in District Clinics in the Control Group Sputum collection techniques Specimen handling in Provincial Hospital Laboratories Sputum testing in Provincial Laboratories Quality control Testing of other types of specimens (e.g. lymph nodes, pleural fluid, CSF) Documentation at the Provincial Laboratories RADIOLOGY PROTOCOLS Radiology procedures in District Clinic radiology facilities

7 Protocol for performing chest X-rays for household contacts Financial information for District Xray department Preparing to send X-rays to the Provincial Hospital Radiology procedures in Provincial Hospital radiology facilities Documentation at the Provincial Xray Departments Photography of Xray films VIEWING TRANSPORTATION PROTOCOLS Transfers from District Clinics to Provincial Hospitals Transfers from Provincial Hospitals to District Clinics IMPORTANT TECHNICAL ISSUES Coding of subjects (Study Identification Code) Coding of index tuberculosis patients Numbering for close contacts When does a District stop recruiting new subjects? Monitoring the quality of clinical interviews TIMETABLE FOR STUDY ( ) Overall timetable Timetable for Districts in the Screening Group Timetable for Districts in the Control Group

8 LIST OF ABBREVIATIONS NTP TB National Tuberculosis Program Tuberculosis 5

9 GLOSSARY PATIENT: A person with smear positive pulmonary Tuberculosis in a household in selected areas for the study in a period of time HOUSEHOLD CONTACT/ CLOSE CONTACT: Person enrolled in the study, living together with the patient having smear positive pulmonary Tuberculosis in the same household ACTIVE CASE FINDING: Examine close contacts regularly to find out Tuberculosis patients whether they have Tuberculosis symptoms or not. ROUTINE PROTOCOL: According to National Tuberculosis Program, a Tuberculosis suspect subject is recommended to take sputum microscopy 3 times and other examinations to explore Tuberculosis mycobacterium as assigned. 6

10 1. INTRODUCTION Background Tuberculosis (TB), according the declaration of The World Health Organization (WHO), is a global health emergency for last decade. It influences not only human s well-being but also socio-economic development Despite the fact that Vietnam reached WHO target in TB prevention and treatment, till recently, Vietnam has been the twelfth in TB high-burden countries in the world. As estimated, the overrall prevalence case rate of Tuberculosis is 171/ population and the incidence rate is 76/ population. Moreover, the figure of multi-drug-resistant tuberculosis (MDR-TB) case in 2007 is estimated 6.468, making Vietnam the fiftieth throughout the world. Vietnam National Tuberculosis Program (NTP) aims to reduce prevalence rate, mortality rate, and transmission rate of TB, including reduction of psycho-social influences and MDR-TB prevention in order to enhance contribution to the Poverty Reduction and Growth Strategy in Vietnam. In , NTP conducted a large National Prevalence Survey. The Survey showed that the tuberculosis prevalence in Vietnam is still high, despite a decade of comprehensive tuberculosis control efforts. The research suggests that it is important to identify new strategies to increase the rate of case detection in Vietnam. In 2009 Woolcock Institute of Medical Research (WIMR), the University of Sydney worked in cooperation with NTP and National Lung Hospital in preparation and implementation of active case finding of Tuberculosis study. The study aims to provide recommendations on more effective menthods of active case finding Main contents: The research project finds out whether actively looking for cases of tuberculosis will increase case detection rates. In particular, the Study will screen household contacts of tuberculosis patients. Studies in other countries suggest that the rate of tuberculosis among close contacts is much higher than for the general population. If tuberculosis can be identified early among family members, then we can break the cycle of disease transmission. This research will help to guide tuberculosis policies in Vietnam and other comparable countries. Study aims: The objectives of this research are to: Test the effectiveness of an active case finding strategy in a high yield subgroup of the population, that is, contacts of patients with smear positive pulmonary TB; Estimate the cost-effectiveness of this strategy in this sub-group of population; Examine the factors that influence the effectiveness of active case finding in other settings and sub-groups of the population Location and duration of the research - The study will be conducted within 71 districts in 8 provinces - Duration of the study: within 48 months ( ) Method of the research The longitudinal study will be conducted in household contacts of patients with smear positive pulmonary tuberculosis who are identified within 71 Districts in 8 Provinces. Eligible patients will be recruited through District Clinics. Those who are diagnosed at the Provincial Hospital will be referred to District Clinics for recruitment. Districts will be randomized to one of two groups of approximately equal size (ie 35 Districts in each group): 7

11 Screening Group: In these Districts Clinics will screen the household contacts for TB at baseline and then at 6, 12 and 24 months post-recruitment, in addition to following the usual policies of the National Tuberculosis Program. Screening will comprise a clinical assessment and chest X-ray. TB suspects will be identified on the basis of symptoms or x-ray changes consistent with TB. Control Group: In these Districts Clinics will follow the usual policies of the National Tuberculosis Program. TB suspects will be identified in the usual way. In both groups TB suspects will have 3 sputum samples collected for testing. All sputum will be examined by direct smear in the District laboratory and the specimens will be referred to the nearest reference laboratory for culture. After 2 years follow-up, household contacts in all Districts will also complete a survey of health-care costs during the final 24 months of the follow-up period. We will compare the rate of tuberculosis case detection in these two groups of Districts at the end of the study, and evaluate economic effectiveness as well as other factors that influence the active case finding in close-contact groups. Outcomes: Each District will recruit subjects for approximately 18 months, and then follow all subjects for a total of two years. After the conclusion of the study, the Chief Investigators will evaluate the following outcomes: Compare the rates of tuberculosis diagnosed in the Screening group of Districts compared to the Control group of Districts Compare health care costs for both groups of Districts Determine whether Screening for tuberculosis in Vietnam is cost-effective The results of the research will be submitted for publication in international peer-reviewed journals. The results of the research will assist the National Tuberculosis Program to plan for future policy in relation to tuberculosis control in Vietnam. 1.1 Participating Organizations and Individuals (a) Title: Active Case finding of Tuberculosis (ACT II) Study, (b) Duration: 48 months (c) Program administrator: National Lung Hospital/National Tuberculosis Program (d) Research Director (Vietnam): Dr Nguyễn Viết Nhung Title: Vice Director of the National of TB and Respiratory Diseases Address: National Lung Hospital, 463 Hoàng Hoa Thám street, Ba Đình district, Hà Nội, Vietnam Telephone: Mobile phone: Fax: Research Director (Australia): Professor Guy Marks Title: Head of Respiratory and Environmental Epidemiology, Woolcock Address: Woolcock Institute of Medical Research, the University of Sydney, Australia (e) Co-operating institutions in Vietnam Hanoi Tuberculosis and Lung Disease Hospital, Ha Noi Vinh Phuc Provincal Preventive Center of Social Disease, Vinh Phuc Da Nang Tuberculosis and Lung Disease Hospital, Da Nang Binh Dinh Tuberculosis and Lung Disease Hospital, Binh Dinh An Giang Provincal Preventive Center of HIV/AIDS, An Giang Tien Giang Tuberculosis and Lung Disease Hospital, Tien Giang Can Tho Tuberculosis and Lung Disease Hospital, Can Tho Pham Ngoc Thach Hospital, Ho Chi Minh City (f) Chief Investigators 8

12 The Chief Investigators for this project from Vietnam and Australia are: Hanoi, Vietnam Sydney, Australia Professor Đinh Ngọc Sỹ Professor Guy B. Marks Dr Nguyễn Viết Nhung Professor Warwick Britton (g) List of main persons with responsibility Name Title Office Đinh Ngọc Sỹ Associate Professor National Lung Hospital, Vietnam MD, PhD Nguyễn Viết Nhung MD, PhD National Lung Hospital, Vietnam Guy Marks Professor, MBBS PhD The University of Sydney, Australia Warwick Britton Professor, MBBS PhD The University of Sydney, Australia Lưu Thị Liên Associate Professor MD PhD Hanoi hospital of Tuberculosis and Lung Disease Nguyễn Văn Hưng MD, PhD Department of Microbiology National Lung Hospital, Vietnam Đỗ Trọng Nghĩa MD, M.Sc National Lung Hospital, Vietnam Greg Fox MBBS MIPH The University of Sydney, Australia Nguyễn Kim Cương MD, M.Sc National Lung Hospital, Vietnam Lưu Thị Liên MD, M.Sc Hanoi Tuberculosis and Lung Disease Hospital, Vietnam Nguyễn Huy Dũng MD, M.Sc Pham Ngoc Thach Hospital, Hochiminh city, Vietnam Lê Văn Đức MD, M.Sc Danang Tuberculosis and Lung Disease Hospital, Vietnam Châu Văn Tuấn MD, M.Sc Binh Dinh Tuberculosis and Lung Disease Hospital, Vietnam Nguyễn Văn Sơn MD Tien Giang Tuberculosis and Lung Disease Hospital, Vietnam Nguyễn Thị Thanh Nhàn MD Can Tho Tuberculosis and Lung Disease Hospital, Vietnam Nguyễn Khánh Hải MD Vinh Phuc Preventive Center for Social Disease, Vietnam Mai Hoàng Anh MD An Giang Preventive Center for HIV/AIDS, Vietnam 9

13 1.2 Organizational Flow-chart of participating institutions The following diagram is a summary of the Organizational structure of the research. Steering Committee (Chief Investigators) Steering Sub-Committee Project Coordinator Consultants Clinical Xray Laboratory Project Officer 1 Project Officer 2 Project Assistant Provincial Hospital Chief Provincial Coordinator Provincial Assistant Xray Department Provincial Laboratory District Tuberculosis Unit Chief District Assistant District Tuberculosis Unit Chief District Assistant Clinical Xray technician Laboratory technician Clinical Xray technician Laboratory technician Index patient Index patient Close contact 1 Close contact 2 Close contact 3 Close contact 1 Close contact 2 Close contact 3 Screening Group Control Group 10

14 1.3 Roles of staff and subjects in research Chief investigators committee The four Chief Investigators will have overall authority and responsibility for the research. The roles of this Committee are: To exercise final authority and responsibility for the research To plan the implementation of the study, arrange human resources, the standard operating protocols and budget for the project To monitor the implementation of the study To report annually to the National Health and Medical Research Council (Australia) with regards to the progress of the study To approve the budget for the study The Advisory Steering committee (SC) The Advisory Steering Committee will have an advisory role for the research, and make recommendations to the chief-investigators about technical and practical aspects of the research. It will be particularly focused upon the scientific aspects of the study, and quality control. The roles of the Advisory Steering Committee are: To make recommendations regarding the operation of the research regarding technical and practical aspects of implementation of the study To nominate individuals who can serve as the National Laboratory Coordinator and X-ray Coordinator for the research To work with the National Laboratory Coordinator and National X-ray Coordinator to develop processes for quality control to be implemented during the study Project Coordinator (PCO) The Project Coordinator will be employed to act as a representative of the Chief Investigators. He or she will coordinate the detailed implementation of the study from Ha Noi when possible. He/she will have the following responsibilities: Directly supervising the Project Officers and Project Assistants in their regular duties Coordinating recruitment of the main organizational staff for this research, in cooperation with the Chief Investigators With the Project Officers to report regularly to the Chief Investigators, the Scientific Committee of the National Tuberculosis Program, PACCOM and other relevant committees about the progress of the study Developing study protocols and other relevant documentation Act as an authorised representative of the Woolcock Institute during discussions regarding registration and approval of various aspects of the study in Viet Nam Implement the randomization of the Districts to Control or Screening Groups, in cooperation with the Project Officers Project Officers (PO) Two project officers will be employed to oversee the detailed implementation of the research throughout Viet Nam. There will be one Project Officer responsible for the research in the Northern and Central Provinces, and one responsible for the research in Southern Provinces participating in the study. The Project Officer based in Ha Noi will be responsible for collecting data and X-ray images sent from all Provinces in the study. The major responsibilities of the POs will be to: Work with the staff of the National Tuberculosis Programme to implement the Standard Operating Procedures for the ACT II Study at provincial hospitals and district clinics participating in the study Organize and oversee workshops, training events, protocol development and other documentation required for the research Oversee the budgetary expenditure of the research at the District and Provincial Hospitals, including implementing proper processes for financial accountability 11

15 in partnership with the National Tuberculosis Program; this includes routine meetings with the Financial Officer Represent the Investigators Committee in meetings and events organized as a part of this research, while following the policies of the Chief Investigators Provide written reports about the progress of the ACT II research to the Investigators Committee (including progress with recruitment, accurate records of financial expenditure and upcoming priorities) Maintain accurate electronic records for the research including: Oversee the entry of data collected about the study subjects, such as results of clinical interviews and X-ray images and X-ray reports Maintain detailed records of the contact information of National Tuberculosis Program staff involved in the study throughout Vietnam Monitor the recruitment of subjects each month, and identify districts where greater effort is required Ensure the privacy of staff and subjects enrolled in the study is maintained - Notify the Project Coordinator of any problems with implementation at each study site in a timely fashion Be available during business hours by telephone for queries from staff at District and Provincial sites in the study Oversee the quality assurance process for data collection, X-ray and microbiology testing (this does not require specialized knowledge about these techniques). Maintain regular communication with District clinics and Provincial Hospitals by telephone and , and periodically to visit each District Clinic and Provincial Hospital Oversee the Financial reporting from Provincial Hospitals (in the North and Central or in the South), and take responsibility for overseeing accurate records of financial transactions Financial Officer This person will take responsibility for overseeing the transparent accounting for finances expended at a national level. They will oversee the way that the Project Officers expend funding during the study. The main roles will be: Developing transparent and accurate processes for accounting for financial expenditure for the study at a National level Maintaining detailed and accurate records of financial expenditure for the study in cooperation with the Project Officers Ensuring that the Project Officers account for the proper expenditure of funds at each of the sites participating in the study Reporting directly to the Project Coordinator about the progress of the expenditure for the study, and providing a written budget report every three months to the Project Coordinator (for the Chief Investigators Committee) Identifying any inappropriate expenditure in a timely fashion, and reporting this immediately to the Project Coordinator National Laboratory Coordinator The National Laboratory Coordinator may perform these duties, or a member of staff delegated by the National Laboratory Coordinator. Work with the Project Officer to develop a quality control process for sputum testing to be implemented throughout all districts and provincial health care facilities Advise the Advisory Steering Committee how to achieve a high quality of microbiological testing at the District and Provincial sites Oversee quality control for microbiological specimen handling in the Districts Clinics and Provincial Hospitals by: a. Visiting each Provincial Hospital at least once each year to review the quality of sputum smear processing and educate laboratory staff b. Visiting a proportion of District Clinics each year to review the quality of sputum processing and to educate staff 12

16 Report to the Project Coordinator (on behalf of the Chief Investigators) about the quality control of microbiological specimens National Radiology Coordinator The National Radiology Coordinator may perform these duties, or a member of staff delegated by the National Radiology Coordinator. Work with the Project Coordinator to develop a quality control process for X- ray films to be implemented throughout all districts and provincial health care facilities Advise the Project Coordinator and Provincial Coordinators about how best to achieve high quality chest X-rays at the District and Provincial Hospital Oversee quality control for chest X-ray testing and reporting at the Districts Clinics and Provincial Hospitals by: - Visiting each Provincial Hospital at least once each year to review the quality of how chest X-rays are performed, and educate X-ray technicians about how to improve their techniques Perform an additional report (within 1 months of the films being received) on: a. At least 25% of chest X-rays of household contacts that are identified as abnormal by the Provincial Radiology staff b. At least 2% of normal chest X-rays from household contacts Report to the Chief Investigators about the quality of chest X-rays taken at the District Clinics Provincial Hospital Coordinator (PC) Each of the eight Provincial Hospitals will have one Provincial Hospital Coordinator, to take responsibility for the study in their Province. The Provincial Coordinator may fulfill the following duties themselves, or the Provincial Coordinator may appoint an Assistant to perform some of the duties. The responsibilities of the Provincial Hospital Coordinator are: Work with Project Officer to train staff at provincial hospital and district TB units on Standard Operating Procedures for the ACT II Study Meet with all District Coordinators at least once every month to review the progress of the study in all participating Districts Maintain regular contact with District Coordinators between meetings, to provide assistance and advice Supervise each district TB units at least once within 3 months to review the progress and documentation of the study Before the start of the study: a. Select staff from District Clinics to participate in the research b. Ensure each District Clinic is able to perform good quality chest X-rays, clinical interviews and transport sputum to the Provincial Hospital c. Notify staff from District Clinics about the Workshop At the start of the study a. Arrange a meeting for District Coordinators to prepare for the study b. Attend the Provincial Coordinators Workshop and the District Clinics Workshop c. Help to train staff in the Provincial Hospital and District Clinics with regards to the protocols d. After the Introductory Period, decide when the District Clinics are ready to start recruiting patients, and to be allocated to a group (Screening or Control) e. Make a plan for how each District will transport sputum and X-rays to the Provincial Hospital During the study every month a. Meet with all District Coordinators at least once every month to review the progress of the study in all participating Districts. b. Submit a monthly report about the progress of each District on the website 13

17 c. Send a SD card from the Provinces to the National Lung Hospital each month that contains: Photographs of all X-rays film which are reported at the Provincial Photographs of the subject data from the Study Register Books from all districts Photographs of the Tuberculosis Suspect Forms from all districts Photographs of the Study Laboratory Book and X-ray Book from the Provincial Hospitals Return chest X-rays to the District Clinics within 1 month of receipt at the Provincial Hospital (after they have a report and have been photographed) Receive payment from the National Lung Hospital each quarter, and distribute money to the District Coordinators based upon accurate records Encourage all eligible patients from the participating Districts who are diagnosed at the Provincial Hospital to be involved in the research. Routine supervision a. Maintain regular contact with District Coordinators between meetings, to provide assistance and advice b. Ensure chest X-ray reports are being properly completed by the radiology staff at the Provincial Hospital, and notify the District Coordinators of any abnormal results (if possible) c. Notify the Project Officer every month of the recruitment progress at each District Clinic (using the Study Website where possible), send SD card that contains written reports in details to Project Officer d. Monitor the performance of District staff employed as a part of the study at the District Clinics (including the accuracy of records, the quality of documentation and compliance with the Standard Operating Protocol). e. Ensure that all financial payments for the study (to staff, contacts and patients) are being accurately recorded by the District Coordinators. f. Supervise the reporting of X-rays and the laboratory tests at the Provincial Hospital District Clinic Study Coordinators (DC) in the control group Each of the participating District Clinics will have one nominated District Clinic Study Coordinator to coordinate and oversee research at that District Clinic. They may work with an Assistant or perform all roles themselves. Their roles will be: Before the start of the study a. Select staff to assist with the research (including the collection of sputum, performing chest X-rays, transporting sputum and X-ray films to the Provincial Hospital) b. Discuss with the Provincial Coordinator how they plan to transport sputum to the Provincial Hospitals At the start of the study a. Attend the District Coordinators training workshop b. Follow the protocol of the Introductory run-in Period of the study, and confirm the District is able to undertake the research c. Read the Standard Operating Procedures (SOP) manual Monthly duties during the study a. Meet at least once a month with the Provincial Coordinator (taking the Study Register Books, Tuberculosis Suspect Forms and orginal hardcopies of financial records for review) b. Write a summary Monthly activity and financial report for the Provincial Coordinator c. Oversee payment to all staff, X-ray technicians working at the District Clinic and subjects 14

18 Daily duties during the study at all District Clinics a. Day-to-day oversight of study preparation and implementation at the District Clinic b. Work directly with the Provincial Coordinator to implement the research protocol c. Train new staff at the District Clinic about how to implement the research protocol d. Maintain a record of when contacts are due for a follow-up appointment in the Study Diary e. Oversee payment to subjects Routine work during the study at all District Clinics a. Enroll all consenting eligible tuberculosis patients in the study b. Enroll household contacts of the tuberculosis patients c. Review household contacts of tuberculosis patients at 0 and 24 months d. If a household contact is diagnosed with TB using routine methods, to collect 3 sputum samples and send them to the Provincial Hospital for culture before starting treatment (if possible) District Clinic Study Coordinators (DC) in the screening group Each of the participating District Clinics will have one nominated District Clinic Study Coordinator to coordinate and oversee research at that District Clinic. They may work with an Assistant or perform all roles themselves. Their roles will be: Before the start of the study a. Select staff to assist with the research (including the collection of sputum, performing chest X-rays, transporting sputum and X-ray films to the Provincial Hospital) b. Discuss with the Provincial Coordinator how they plan to transport sputum to the Provincial Hospitals At the start of the study a. Attend the District Coordinators training workshop b. Follow the protocol of the Introductory run-in Period of the study, and confirm the District is able to undertake the research c. Read the Standard Operating Procedures (SOP) manual Monthly duties during the study a. Meet at least once a month with the Provincial Coordinator (taking the Study Register Books, Tuberculosis Suspect Forms and orginal hardcopies of financial records for review) b. Write a summary Monthly activity and financial report for the Provincial Coordinator c. Oversee payment to all staff, X-ray technicians working at the District Clinic and research subjects Daily duties during the study at all District Clinics a. Day-to-day oversight of study preparation and implementation at the District Clinic b. Work directly with the Provincial Coordinator to implement the research protocol c. Train new staff at the District Clinic about how to implement the research protocol d. Maintain a record of when contacts are due for a follow-up appointment in the Study Diary e. Oversee payment to study subjects Routine work for District Clinics in the Screening Group: a. Enroll all consenting eligible tuberculosis patients and their close contacts in the study b. Perform clinical assessments and chest X-ray reading for all household contacts at 0, 6, 12 and 24 months after the start of the study 15

19 c. Review the results of the X-rays and clinical assessments to identify possible TB suspects among contacts d. To initiate further interventions (such as sputum testing or referral to the Provincial Hospital for testing for Extra-pulmonary tuberculosis) in household contacts who are suspects e. To arrange for transportation of sputum specimens and chest X-rays to the Provincial Hospitals District Assistant at District Clinics in the screening group The District Coordinator may appoint a District Assistant to help implement the study. Other clinical staff may also help with the study. Their roles are to: Work with District Clinic Study Coordinator to implement the study Make phone calls to remind contacts to attend appointments, and develop follow-up strategies for defaulters who fail to attend Maintain detailed and accurate records of the visits of subjects to the District Clinic Assist the District Coordinator to complete register book for index cases and their contacts X-ray technical staff at District Clinics in the screening group a. Perform good quality posterior-anterior chest X-rays on all household contacts in the Screening Group at baseline and at 6, 12 and 24 months after recruitment b. Check the quality of each X-ray film and repeat performing if needed c. Label each X-ray film with a sticker containing the date, study number and name of the patient d. Clearly and accurately document the cost of chest X-rays e. Work with the District Coordinator to request and receive payment for X-rays performed each month Laboratory staff at District Clinics Laboratory staff at District Clinics in the Screening Group: a. Collect 3 sputum specimens from all tuberculosis suspects (with clinical symptoms or X-ray findings that are suspicious for TB according to the Standard Operating Procedures manual). b. Prepare specimens for transportation to the Provincial Hospital for smear and culture within 24 hours of specimen collection. c. Transport the collected sputum specimens within a day as soon as the household members provide the third sputum specimen Laboratory staff at District Clinics in the Control Group a. Staffs do not need to collect specimens from household members who are suspects unless you would usually do this as a part of the normal National Tuberculosis Program protocol. b. If staff in the Control Districts do collect sputum during the study, they should collect 3 samples and send all of them to the Provincial Hospital for culture within 24 hours of collection Laboratory staff at the Provincial Hospitals At the start of the research a. Read the Standard Operating Procedures Manual (SOP) and prepare the Study Laboratory Book b. Attend the Study Workshop Once every month during the research a. Write a summary of the number of tests performed in the past month b. Calculate the money owing to the Laboratory for the month c. Assist the Provincial Coordinator to photograph the results of all new laboratory tests in the Study Laboratory Book. Routine roles during the study a. Perform a direct smear microscopy examination on all sputum specimens received 16

20 b. Choose the 2 best quality sputum specimens from the 3 specimens that are collected from each subject, and perform a solid culture for at least 8 weeks (Use a separate tube for each of the two cultures.) c. Write down all results in the Study Laboratory Book d. Notify the District Coordinators of positive culture results by telephone e. Notify the Provincial Coordinator of all results (after 8 weeks for negative cultures) Radiology staff at the Provincial Hospitals At the start of the research a. Attend the Study Workshop b. Read the Standard Operating Procedures Manual (SOP) c. Prepare the Study X-ray Book d. Learn how to use the camera for photographing the chest X-rays Once every month during the research a. Prepare a report of the total number of X-rays in that month and the number of abnormal results b. Photograph the X-rays using the camera (with the assistance of the Provincial Coordinator) Routine roles during the study a. Report each X-ray film from the District Hospital and record the result in the Study X-ray Book b. Take a digital photograph of each X-ray film received from the District Hospital c. Store the digital photographs on a computer d. Arrange for two different radiology staff to independently report - One in every 20 X-rays (without looking at the result of the other X-ray report) - All X-rays that are abnormal by the initial reporter Notify the Provincial Coordinator and the District Coordinator (by telephone) if the chest X-ray result is abnormal Index patient or other key household leader Index patients (or another key household leader if appropriate) are given the initial responsibility for counseling and inviting close household contacts to attend the District Clinic for review. This person will be the main contact for District Coordinator to make follow-up appointments for contacts This person will be educated about the symptoms of tuberculosis to increase their role in counseling contacts and referring any symptomatic contacts for early review Close contacts Screening group : Close contacts will be asked to attend the District Clinic four times during the two year follow-up period (at the beginning of the study and at 6, 12 and 24 months). They will also attend if they develop symptoms between reviews. Control group : close contacts in this group will attend the District Clinic for review at the start of the study and at 24 months. They will otherwise have no tests except according to usual National Tuberculosis Program protocol. 17

21 1.4 Reporting framework for research staff The following states that the following individuals will report to during the research: Committee or Individual Chief Investigators Committee Advisory Steering Committee Project Coordinator Project Officer x 2 Project Assistant Financial Officer Provincial Coordinators District Coordinators District Clinic Staff Laboratory Coordinator Radiology Coordinator Radiology staff at District Hospital Laboratory Staff at District Hospital Radiology Staff at Provincial Hospital Laboratory Staff at Provincial Hospital Reports during research to: National Health and Medical Research Council (Australia) Ministry of Health (Viet Nam) University of Sydney Chief Investigators Committee Chief Investigators Committee Project Coordinator Project Officer (Northern and Central Region) National Tuberculosis Program Chief Investigators Committee Project Officer (for either the South or for the North and Central regions of Vietnam) Provincial Coordinator at their Provincial Hospital District Coordinators at the District Hospital Chief Investigators Committee Chief Investigators Committee District Coordinator District Coordinator Provincial Coordinator Provincial Coordinator 18

22 2. INTRODUCTORY RUN IN PERIOD 2.1 Overview of Introductory Run-In Period Training Workshop Introductory Run-In period (about 2 weeks) Recruit 2 INDEX PATIENTS Recruit at least 6 HOUSEHOLD CONTACTS Complete the Introductory Check List before randomization Telephone and send Ỉntroductory Register Book (S0) to the Provincial Coordinator when ready for Randomization Randomization District Coordinator telephones Provincial Coordinator Provincial coordinator will check the District meets criteria for randomization (see Check-List below). Provincial Coordinator allocates District to Group through the Study Website Allocation as a Control District Allocation as a Screening District Begin recruitment The District begins recruiting patients and following the Control Group Protocol Beginning at patient number 001 Begin recruitment The District begins recruiting patients and following the Screening Group Protocol Beginning at patient number 001 Each District will begin with an Introductory Run-In period to ensure that the District is able to conduct the study. During this Introductory Run-In period, follow the Introductory Protocol for patients and household members. 19

23 2.2 Protocol during the Introductory Period There is an Introductory Period in order to check that the District Clinic is capable of conducting the study. We need to know that the necessary facilities are available and that the District can follow the procedures for interviewing subjects. Interview smear positive tuberculosis patient INDEX CASES [PTB SS(+), new, relapse, failure] Age <15: - Not eligible - Routine TB treatment registration Detected at districts Age 15: - Provide information - Offer consent form - HIV PITC - Enroll patient if patient agrees and signs the consent form - Counseling, provide info leaflet - List household members and contact details - Plan date for follow up with household Refer to districts with remark Exclude patient if: - Patient refuses - Severe Mental illness - Severe difficulty with communication - Lives alone (has no househoold Detected at Provincial Hospital Does the patient live in a District participating in the study? IF YES: discuss study with patient and call District Coordinator Visit of Contact(s): - Counseling on benefit and requirements - Receive the signed consent form - Check-in to Introductory Register Book (S0) - History of TB treatment Interviews of household contacts Contact is on current TB treatment - Make note on index case file - Exclude from study Contact is not currently on TB treatment Give study information brochure to subject STOP HERE During Introductory Run-In Period Arrange a follow-up interview at 24 months 20

24 2.2.1 Enrolling patients during the Introductory Period STEP 1: Enroll AFB positive tuberculosis* index patient in the study Give Information Brochure (P1 + P10a) Offer consent form (P9): Explain the study and give a consent form to the Patient to sign. Place the completed Consent form (P9) in the Study Folder (S3). Counseling: Explain that we are conducting a study to test the rate of tuberculosis in household contacts of patients. This is the introductory phase. We would like the patient to bring their household contacts for two interview visits only. Complete index patient section in Introductory Register Book (S0): Complete all of the details. The Study Identification Numbers for the Introductory Period will end in XX1, XX2, XX3, XX4 and XX5. Make sure all sections of the form are completed. Perform PITC for HIV according to usual protocol *What is AFB(+) TB? The definition of an index patient with AFB positive TB: follows the usual protocol that requires one of the following: 1 or more initial sputum smear examinations (+) for AFB STEP 2: Make an appointment to interview the household contacts List household members: Record the names and telephone numbers of all household members who have lived at the same house as the patient in the past 2 months (not just family but also friends and other people who live in the same house). Make an appointment to see contacts: Ask the patient to ask these people to visit the District Clinic within 1 week. Record the date and time of the follow-up appointment in the Study Folder (S3) Give the index case reimbursement for participating in the study, and ask them to sign their name when they have received payment in the District Enrolling Household Contacts during the Introductory Period STEP 1: Make contact with Household Contact before the interview 3 days before the interview, call TB patient or contact and confirm appointment Interview all family contacts at the same time if possible (at an appointment) If the subject does not attend the appointment, telephone again and make another time. If the subject does not attend on the second time, send a letter to the house of the Index Patient with information about the study then phone a third time. If they do not attend after this then they are a defaulter. Complete a Defaulter Form (P7) STEP 2: Interview household contacts: Interview the household contact. Decide if they are eligible to be enrolled Eligible Not eligible Any age Refuses to participate Lived in same household as Index Already on treatment for TB Patient in the last 2 months Offer consent form: (P9) the household contact signs a consent form. Place the completed Consent form in the Study Folder (S3) Complete the Introductory Register Book (S0), answering all of the questions for the Introductory Period visit. 21

25 Allocate a Study Identification Code that is derived from the Study Identification Code of the Index Patient (e.g. if index patient is ACT 123 XX1 then the numbers of three household contacts will be 123-XX1-1, 123-XX1-2 and 123-XX1-3). When the patient information is completed, give the household contact reimbursement for participating in the study. Give Information Brochure (P9 + P10a) but not detailed education Arrange a follow-up appointment at 24 months. No tests need to be done in this period, except for routine practice of the National Tuberculosis Program Check-list after the Introductory Period The District Coordinator must complete the following checklist before the District Clinic can complete the Introductory Period and be allocated to a group. The District Coordinator should telephone the Provincial Coordinator when these boxes are all ticked. Then the Provincial Coordinator will allocate them to a group. District Clinic has recruited at least 2 patients (following the Control Protocol) District Clinic has recruited at least 6 household contacts (following the Control Protocol) Access to a good quality X-ray facility close to or in the District Clinic Access to a staff member who is trained to collect sputum samples properly A locked cupboard or room where they can store the Study Documents A suitable examination room where they can enroll patients in the study A District Coordinator who is willing to take on responsibility for running the study All necessary documentation for the study is ready (Forms, the SOP Manual and the District Planning Book) The District Coordinator has a good plan for transporting sputum specimens to the Provincial Hospital within 24 hours of collection (the X-ray films will also be transported by the same person) The Provincial Coordinator approves for the District to begin the study 22

26 3. PROTOCOL FOR DISTRICTS IN SCREENING GROUP 3.1 Overview of protocol for Screening Districts Interviews of index cases INDEX CASES [PTB SS(+), new, relapse, failure] Age <15: - Not eligible - Routine TB treatment registration Detected at districts First visit of Contact(s): - Counseling on benefit and requirements - Receive the signed consent form - Check-in on Screening Register Book (S2) - Age 15: - Provide information - Offer consent form - HIV PITC Enroll patient if patient agrees and signs the consent form - If index patient has a Study Identification Code ending in 020, 040, 060, 080 collect 3 sputum samples and send to Provincial Hospital with form for smear and culture - Counseling, provide info leaflet - List household members and contact details - Plan date for follow up with household Contact is on current TB treatment - Make note on index case file - Exclude from study Contact is not currently on TB treatment Chest X-ray Clinical screening for TB Refer to districts with remark Exclude patient if: -Patient refuses -Severe Mental illness -Severe difficulty with communication -Lives alone (has no household contacts) Detected at Provincial Hospital Does the patient live in a District participating in the study? IF YES: discuss study with patient and call District Coordinator Interviews of household contacts 2nd, 3rd, 4th times reviewing contact(s) at 6, 12 & 24 months Advise to return early if symptoms of tuberculosis between appointments Complete Health Costs survey at 24 month visit Others TB suspects (complete TB Suspect Form P5) Normal Routine medical care procedure PTB suspect (clinical or/and X-ray) EPTB suspect alone or combination Collect 3 sputums & send to Provincial Hospital Lab Refer the contact to Provincial Hospital for tests Culture the best 2 specimens Culture (-) Culture (+) Notify District Coordinator Direct smear 3 specimens 3 AFB sample (-): Other lab examination 1 AFB sample (+): Diag. as PTB AFB(+) EPTB alone EPTB & PTB AFB(-) Others non TB Already diagnosed at district Complete TB Suspect Form Not yet diagnosed at district Consultation for TB diag. and complete Form Consultation for PTB AFB(-) Lab feedback to district District staff complete TB Suspect Form 23

27 3.2 Protocol for districts in screening group Enrolment of index patients with smear positive pulmonary tuberculosis Use the Screening Study Register Book When you have finished the Introductory Period, then all Districts in the Screening Group should change over to the Screening Study Register Book (S2). You will use this for the rest of the research. STEP 1: Enroll AFB positive tuberculosis* index patient in the study Give Information Brochure (P2 + P10b) Offer Consent form (P9): Explain the study and give a consent form to the Patient to sign. Explain that we are conducting a study to test the rate of tuberculosis in household contacts of patients. Place the completed Consent form in the Study Folder. The purpose of the study is to increase the rate of detection of tuberculosis. We would like the patient to bring their household contacts for four visits (at baseline, 6, 12 and 24 months). We will reimburse the patient and contacts for each visit. The X-ray and sputum tests are free of charge. After the close contact sign in Consent form, district staff saves it in study folder. Complete Screening Register Book (S2): Now use the Screening Register Book (S2) for all new patients and contacts. Start a new page for each new index patient. See Section on Coding of Subjects. Make sure all sections in the Screening Register Book (S2) are completed. Perform PITC for HIV according to usual protocol. Record results of HIV test on the Screening Register Book when it is available. Collect 3 sputum samples from all index patients and send to Provincial Hospital with a completed request form for smear and culture if Study Identification Code ends with a multiple of 20 (e.g. 020, 040, 060, 080 ). Put a sticker on each sputum container with the name and date and Study Identification Code of the patient. We do this to confirm the reliability of the sputum smear at the District Clinic. *What is AFB(+) TB? The definition of AFB positive TB: follows the usual protocol which requires the following: 1 sputum smear (+) for AFB. STEP 2: Make an appointment to interview the household contacts List household members: Record on the Screening Register Book (S2) the names, age and telephone numbers of all household members who have lived with the patient in the past 2 months. They must have shared the same house for a total of at least 8 hours over the last two months. They can be relatives, friends or other people who stayed in their house. Make an appointment to see contacts: Ask the patient to ask their household contacts to visit the District Clinic within 1 week. Record the date and time of the follow-up appointment in the Study Folder (S3) Give the index case reimbursement for participating in the study, and ask them to sign their name in financial form when they have received payment. (This form will be used as financial receipt in study activities) 3,2.2 Enrolling household contacts in a District in the Screening Group STEP 1: Make contact with Household Contact before the interview 3 days before the interview, telephone TB patient or contact and confirm appointment Interview all family contacts at the same time if possible (at an appointment) If the subject does not attend the appointment, telephone again and make another time. 24

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