Participant Information sheet
Arm 1
Title of study: A pragmatic cluster randomized control trial for assessing the effectiveness of two annual rounds of two different community-wide TB screening approaches in reducing TB prevalence in selected municipalities implementing the Swasthya Nagaram Initiative in Hyderabad, India
Principal Investigator name: Dr A Rajesham, Jt. Director (TB) & State TB Officer, Telangana
Address: Directorate of Public Health & Family Welfare DM and HS Campus, National Health Mission, Koti Hyderabad, Telangana, 500001
Contact number: stots@rntcp.org; 040-24747677
You are being invited to take part in a research study. Please take some time to read the information presented here, which will explain the details of this study. Please ask the researcher any questions about any part of this project that you do not fully understand. It is very important that you are fully satisfied that you clearly understand what this research entails and how you could be involved. Your participation is entirely voluntary, and you are free to decline to participate. If you say no, this will not affect you negatively in any way whatsoever, including health care now or in the future. You are also free to withdraw from the study at any point, even if you do agree to take part.
This study has been approved by the Institutional Ethics Committee, Employee State Insurance Corporation Medical College and Hospitals, Hyderabad and The Union’s Ethics Advisory Group and will be conducted according to ethical guidelines and principles of the International Declaration of Helsinki, as well as local ethical guidelines.
1. What is this research study all about?
There are multiple strategies which can be used to detect undiagnosed cases of tuberculosis (TB). This study is being conducted to compare two such strategies against routine programmatic care, to determine the most effective approach. The goal is to determine which screening strategy has the highest uptake, leads to the greatest reduction in cases, and is the most cost saving.
This study is being done because TB is a major health challenge in India, with 2.8 million people developing TB in 2023, the most in the world. Around half of the cases of TB do not have any symptoms, making them hard to detect. The Government of India aims to end TB, by diagnosing and treating all individuals living with TB. Through this study, we hope to identify which strategy should be implemented to screen adults across the country, to help us reach our goal of ending TB.
For this study, the ward you live in has been randomly assigned to be screened using handheld chest X-rays, and you will undergo this screening annually for two years, once you consent to participate
As part of the screening, the community volunteer who has visited your house will ask you some basic details about your household and about adults (> 18 years) residing in your household for at least one month.
You will then be issued an ID card with a pre-printed barcode. You are requested to carry the ID card to project sites in the future.
The community volunteer will then record your cough sounds and ask if you have any of the symptoms that are suggestive of tuberculosis. If you do, you will be enrolled on Nikshay (an online platform managed by the Government of India, where details of TB testing and treatment is entered for all suspected and confirmed cases of TB) and your sputum sample will be collected for testing.
Irrespective of symptoms, you will be asked to visit a camp where your chest X-ray will be done. The campsite is situated close to your house and your appointment will be at a time convenient to you. In case you need special assistance to undergo screening, community volunteers will support you.
The X-ray machine being used in this study is equipped with computer assisted diagnostic technology, which can detect if the X-ray is abnormal within a few minutes. If your X-ray shows lesions suggestive of TB, you will be enrolled on Nikshay and your sputum will be collected for testing. If your X-ray is abnormal but is not suggestive of TB, you will be referred to a doctor for management.
Based on your sputum result, you will be referred for further management, and follow-ups will be conducted as needed. Follow-up care, including diagnostic tests and treatment, is provided free of cost as per the national TB program policies.
The above-mentioned activities will be conducted annually for two years. This is the first round of the screening, and the second round will be carried out during the same time next year. In quarter three or quarter four of 2027, you will be contacted again for a survey to assess the burden of TB in your ward, which will be conducted among all the adults residing in this area. In that survey, your symptom status will be assessed, cough sounds will be recorded and your tongue swab or sputum sample will be collected at home itself and sent for TB testing, free of cost. Based on your sputum/ tongue swab result, you will be referred for further testing and management, and follow-ups will be conducted as needed.
This study also has a qualitative component. If you are willing and consenting to share your experiences with this screening procedure, at a later stage, you may be invited for an interview. We would like to understand your perspectives on the facilitators and barriers in the uptake of this procedure. The interview will be conducted in your preferred language, at a place and time convenient to you.
2. Why have you been invited to participate?
In the Peerzadiguda, Boduppal and Pocharam municipal corporations, the ‘Swasthya Nagaram,’ Urban End TB initiative, under the stewardship of Urban Local Governments, is being implemented. This initiative aims to decrease the burden of TB. This research study is being conducted as part of this initiative, and all adults living in these three municipal corporations are being invited to participate in this study.
3. What will your responsibilities be?
You are expected to provide some details about your household and the adults living in it, to the community volunteer who has visited your house at present.
Please cooperate with them to record your cough sounds and honestly answer all the questions they ask regarding symptoms you may have. If any symptoms are present, please provide a sputum sample.
At the time of your appointment, kindly visit the campsite so that your X-ray may be taken. The campsite is situated close to your house, and an appointment for the same can be provided at your convenience. You are required to carry the ID card issued to you to the campsite when you come for your X-ray.
If you have X-ray lesions suggestive of TB, please provide a sputum sample. All testing for TB will be free of cost.
If you are advised to visit a doctor, please do so, and follow their advice, so that your condition does not worsen, or your suspected disease does not spread to others around you.
In case you are selected to take part in the qualitative study, interviews will be conducted at a place convenient to you, at your convenient time and you will be requested to share your opinions and experiences with us.
You are requested to undergo screening by the same procedure next year as well.
Then, in the latter half of 2027, we request you to please answer questions about any symptoms you may have, record cough sounds and provide a sputum sample or tongue swab of TB testing.
4. Will you benefit from taking part in this research?
Yes, you will benefit from taking part in this research.
In case you are suffering from tuberculosis, the disease will be diagnosed through this study, and you will be started on treatment for free. Even if you are asymptomatic and are feeling fine, you may still be suffering from TB, since 50% of TB cases are asymptomatic. Thus, it is very important to get screened for TB.
Even if you do not have tuberculosis, in case your X-ray shows any other abnormalities, those will be diagnosed, and you will be accordingly treated by a doctor.
Through this research, we will also be identifying and treating other TB cases in the community you live in, which will decrease the spread of the disease and lower the chances of you contracting the disease in the future.
At the end of two years, we expect the number of TB cases in your community to decrease through the efforts of this study.
This study will also enable us to determine the most effective screening strategy, which could be implemented to help end TB in India.
5. Will photographs be taken or tape recordings made?
No photographs will be taken, and no video recordings will be made for screening. In case you are selected to take part in the interviews during the study, we will take consent from you to audio record the interviews.
6. Are there any risks involved in your taking part in this research?
The project does not anticipate any medical risks to you. X-rays are a non-invasive procedure and the radiation dose of the ultra-portable X-ray machine that is used is very small to cause any irradiation related adverse event. If you complain of any medical symptom related to your participation, you will be referred to the nearest public health facility for further evaluation and management free of cost.
The screening of female participants is done in the presence of female staff and the screening of male participants in the presence of male staff, to address any cultural sensitivities associated with the interaction between participants and community volunteers of the opposite gender.
To minimize delays, discomforts, and challenges in maintaining confidentiality, due to overcrowding at the campsite, this study is being implemented on an appointment-based system. We are ensuring that fewer than 10 people will be present at the campsite at any given time. Additionally, the camp is situated in an area where there is adequate space to ensure comfort. The field staff are trained on crowd management to help maintain order and efficiency.
You may be exposed to environmental risks such as unhygienic or extreme weather conditions (heat, rain, cold). To mitigate this, the campsite is located at hygienic places, in shaded areas, equipped with cooling systems/fans, or heaters, water drinking facilities and toilets as necessary, and adequate seating is provided to ensure comfort while waiting.
Campsites are located in safe, accessible areas away from high-traffic zones (as much as possible), to avoid traffic-related risks. Junior field officers and community volunteers are assisting in managing traffic flow around the site to ensure participant’s safety. Support from local traffic police is being sought as per the need.
Finally, you may incur financial burden such as out-of-pocket expenses for travel to the campsite and/or loss of wages due to time spent away from work to undergo screening. There are no mechanisms to financially compensate you for these expenses/losses. To minimize this, the project will employ measures like nearer to the home screening (within 100 meters) and convenient scheduling.
While these measures will minimize risks, if you have any other requirements during the project, the project staff will be flexible to incorporate these to create a safe and comfortable experience for you.
7. Who will have access to the results of this study?
The investigators of the study will have access to the results of this study. There will be strict rules to ensure that all the data is strictly confidential, and relevant security measures will be undertaken to ensure confidentiality of data.
Where can participants get the results of the study should they wish to have them?
All research participants have the right to access the results of the data. If you want to view the results, ask your ward’s community volunteer. He/she will inform me, and I will show you the results. Alternatively, you can directly contact me to see the results of the study.
8. Are there any costs involved, and will you be paid to take part in this study?
There are no direct costs involved in taking part in this study, but you may incur a financial burden, such as out-of-pocket expenses for travel to the campsite and/or loss of wages due to time spent away from work to undergo screening. There are no mechanisms to financially compensate you for these expenses/losses. To minimize the financial burden, the project will employ measures like nearer to the home screening (within 100 meters) and convenient appointment scheduling.
In case you must undergo further diagnostic testing and treatment for TB, follow-up care, including diagnostic tests and treatment, is provided free of cost as per government policies.
9. Do you have any questions about the research?
If there is anything else that you want to know, if you have any further queries or encounter any problems you can contact Dr Jyoti Jaju/ Dr Rajesham
You will receive a copy of this information for your record
Participant Information sheet
Arm 2
You are being invited to take part in a research study. Please take some time to read the information presented here, which will explain the details of this study. Please ask the researcher any questions about any part of this project that you do not fully understand. It is very important that you are fully satisfied that you clearly understand what this research entails and how you could be involved. Your participation is entirely voluntary, and you are free to decline to participate. If you say no, this will not affect you negatively in any way whatsoever, including health care now or in the future. You are also free to withdraw from the study at any point, even if you do agree to take part.
This study has been approved by the Institutional Ethics Committee, Mahavir Hospital and Research Centre and The Union’s Ethics Advisory Group and will be conducted according to ethical guidelines and principles of the International Declaration of Helsinki, as well as local ethical guidelines.
1. What is this research study all about?
There are multiple strategies which can be used to detect undiagnosed cases of tuberculosis (TB). This study is being conducted to compare two such strategies against routine programmatic care, to determine the most effective approach. The goal is to determine which screening strategy has the highest uptake, leads to the greatest reduction in cases, and is the most cost saving.
This study is being done because TB is a major health challenge in India, with 2.8 million people developing TB in 2023, the most in the world. Around half of the cases of TB do not have any symptoms, making them hard to detect. The Government of India aims to end TB, by diagnosing and treating all individuals living with TB. Through this study, we hope to identify which strategy should be implemented to screen adults across the country, to help us reach our goal of ending TB.
For this study, the ward you live in has been randomly assigned to be screened using handheld chest X-rays, and you will undergo this screening annually for two years, once you consent to participate
As part of the screening, the community volunteer who has visited your house will ask you some basic details about your household and about adults (> 18 years) residing in your household for at least one month.
You will then be issued an ID card with a pre-printed barcode. You are requested to carry the ID card to project sites in the future.
The community volunteer will then record your cough sounds and ask if you have any of the symptoms that are suggestive of tuberculosis. If you do, you will be enrolled on Nikshay (an online platform managed by the Government of India, where details of TB testing and treatment is entered for all suspected and confirmed cases of TB) and your sputum sample will be collected for testing.
Irrespective of symptoms, you will be asked to visit a camp where your chest X-ray will be done. The campsite is situated close to your house and your appointment will be at a time convenient to you. In case you need special assistance to undergo screening, community volunteers will support you.
The X-ray machine being used in this study is equipped with computer assisted diagnostic technology, which can detect if the X-ray is abnormal within a few minutes. If your X-ray shows lesions suggestive of TB, you will be enrolled on Nikshay and your sputum will be collected for testing. If your X-ray is abnormal but is not suggestive of TB, you will be referred to a doctor for management.
Based on your sputum result, you will be referred for further management, and follow-ups will be conducted as needed. Follow-up care, including diagnostic tests and treatment, is provided free of cost as per the national TB program policies.
The above-mentioned activities will be conducted annually for two years. This is the first round of the screening, and the second round will be carried out during the same time next year. In quarter three or quarter four of 2027, you will be contacted again for a survey to assess the burden of TB in your ward, which will be conducted among all the adults residing in this area. In that survey, your symptom status will be assessed, cough sounds will be recorded and your tongue swab or sputum sample will be collected at home itself and sent for TB testing, free of cost. Based on your sputum/ tongue swab result, you will be referred for further testing and management, and follow-ups will be conducted as needed.
This study also has a qualitative component. If you are willing and consenting to share your experiences with this screening procedure, at a later stage, you may be invited for an interview. We would like to understand your perspectives on the facilitators and barriers in the uptake of this procedure. The interview will be conducted in your preferred language, at a place and time convenient to you.
2. Why have you been invited to participate?
In the Peerzadiguda, Boduppal and Pocharam municipal corporations, the ‘Swasthya Nagaram,’ Urban End TB initiative, under the stewardship of Urban Local Governments, is being implemented. This initiative aims to decrease the burden of TB. This research study is being conducted as part of this initiative, and all adults living in these three municipal corporations are being invited to participate in this study.
3. What will your responsibilities be?
You are expected to provide some details about your household and the adults living in it, to the community volunteer who has visited your house at present.
Please cooperate with them to record your cough sounds and honestly answer all the questions they ask regarding symptoms you may have. If any symptoms are present, please provide a sputum sample.
At the time of your appointment, kindly visit the campsite so that your X-ray may be taken. The campsite is situated close to your house, and an appointment for the same can be provided at your convenience. You are required to carry the ID card issued to you to the campsite when you come for your X-ray.
If you have X-ray lesions suggestive of TB, please provide a sputum sample. All testing for TB will be free of cost.
If you are advised to visit a doctor, please do so, and follow their advice, so that your condition does not worsen, or your suspected disease does not spread to others around you.
In case you are selected to take part in the qualitative study, interviews will be conducted at a place convenient to you, at your convenient time and you will be requested to share your opinions and experiences with us.
You are requested to undergo screening by the same procedure next year as well.
Then, in the latter half of 2027, we request you to please answer questions about any symptoms you may have, record cough sounds and provide a sputum sample or tongue swab of TB testing.
4. Will you benefit from taking part in this research?
Yes, you will benefit from taking part in this research.
In case you are suffering from tuberculosis, the disease will be diagnosed through this study, and you will be started on treatment for free. Even if you are asymptomatic and are feeling fine, you may still be suffering from TB, since 50% of TB cases are asymptomatic. Thus, it is very important to get screened for TB.
Even if you do not have tuberculosis, in case your X-ray shows any other abnormalities, those will be diagnosed, and you will be accordingly treated by a doctor.
Through this research, we will also be identifying and treating other TB cases in the community you live in, which will decrease the spread of the disease and lower the chances of you contracting the disease in the future.
At the end of two years, we expect the number of TB cases in your community to decrease through the efforts of this study.
This study will also enable us to determine the most effective screening strategy, which could be implemented to help end TB in India.
5. Will photographs be taken or tape recordings made?
No photographs will be taken, and no video recordings will be made for screening. In case you are selected to take part in the interviews during the study, we will take consent from you to audio record the interviews.
6. Are there any risks involved in your taking part in this research?
The project does not anticipate any medical risks to you. X-rays are a non-invasive procedure and the radiation dose of the ultra-portable X-ray machine that is used is very small to cause any irradiation related adverse event. If you complain of any medical symptom related to your participation, you will be referred to the nearest public health facility for further evaluation and management free of cost.
The screening of female participants is done in the presence of female staff and the screening of male participants in the presence of male staff, to address any cultural sensitivities associated with the interaction between participants and community volunteers of the opposite gender.
To minimize delays, discomforts, and challenges in maintaining confidentiality, due to overcrowding at the campsite, this study is being implemented on an appointment-based system. We are ensuring that fewer than 10 people will be present at the campsite at any given time. Additionally, the camp is situated in an area where there is adequate space to ensure comfort. The field staff are trained on crowd management to help maintain order and efficiency.
You may be exposed to environmental risks such as unhygienic or extreme weather conditions (heat, rain, cold). To mitigate this, the campsite is located at hygienic places, in shaded areas, equipped with cooling systems/fans, or heaters, water drinking facilities and toilets as necessary, and adequate seating is provided to ensure comfort while waiting.
Campsites are located in safe, accessible areas away from high-traffic zones (as much as possible), to avoid traffic-related risks. Junior field officers and community volunteers are assisting in managing traffic flow around the site to ensure participant’s safety. Support from local traffic police is being sought as per the need.
Finally, you may incur financial burden such as out-of-pocket expenses for travel to the campsite and/or loss of wages due to time spent away from work to undergo screening. There are no mechanisms to financially compensate you for these expenses/losses. To minimize this, the project will employ measures like nearer to the home screening (within 100 meters) and convenient scheduling.
While these measures will minimize risks, if you have any other requirements during the project, the project staff will be flexible to incorporate these to create a safe and comfortable experience for you.
7. Who will have access to the results of this study?
The investigators of the study will have access to the results of this study. There will be strict rules to ensure that all the data is strictly confidential, and relevant security measures will be undertaken to ensure confidentiality of data.
Where can participants get the results of the study should they wish to have them?
All research participants have the right to access the results of the data. If you want to view the results, ask your ward’s community volunteer. He/she will inform me, and I will show you the results. Alternatively, you can directly contact me to see the results of the study.
8. Are there any costs involved, and will you be paid to take part in this study?
There are no direct costs involved in taking part in this study, but you may incur a financial burden, such as out-of-pocket expenses for travel to the campsite and/or loss of wages due to time spent away from work to undergo screening. There are no mechanisms to financially compensate you for these expenses/losses. To minimize the financial burden, the project will employ measures like nearer to the home screening (within 100 meters) and convenient appointment scheduling.
In case you must undergo further diagnostic testing and treatment for TB, follow-up care, including diagnostic tests and treatment, is provided free of cost as per government policies.
9. Do you have any questions about the research?
If there is anything else that you want to know, if you have any further queries or encounter any problems you can contact Dr Jyoti Jaju/ Dr Rajesham