Mohan, Sailesh
Chaudhry, Monica
McCarthy, Ona
Jarhyan, Prashant
Calvert, Clara
Jindal, Devraj
Shakya, Rajani
Radovich, Emma
Kondal, Dimple
Penn-Kekana, Loveday
Basany, Kalpana
Roy, Ambuj
Tandon, Nikhil
Shrestha, Abha
Shrestha, Abha
Karmacharya, Biraj
Cairns, John
Perel, Pablo
Campbell, Oona M. R.
Prabhakaran, Dorairaj
Funding for this research was provided by:
Department of Biotechnology (DBT), India (BT/IN/DBT-MRC/DIFD/DP/14/2018-19)
Medical Research Council (MRC), UK (MR/R022127/1)
Article History
Received: 3 October 2022
Accepted: 24 November 2022
First Online: 26 January 2023
Declarations
:
: This study protocol was approved by the Institutional Ethics Committees of the Public Health Foundation of India (PHFI) (Reference number TRC-IEC-386.3/18), London School of Hygiene and Tropical Medicine (LSHTM), UK (Reference number: 25094 ‑ 1), and Dhulikhel Hospital, Nepal (Reference number: 159.18). Any protocol amendments and modifications made further to the study tools including the patient information sheet-informed consent document, will be submitted for review and approval to the ethics committees of the Public Health Foundation of India, LSHTM and Dhulikhel Hospital.Participation by pregnant women in the trial will be voluntary with no coercion and no material compensation will be provided to encourage participation. All participants will be assured that they have the right to voluntarily withdraw from the study at any time, without any repercussions affecting their future medical care.To minimize the risk that data containing personal information are accessed by unauthorized individuals and study participants are identified (either directly or through linkage to other data), identifiable information (names, addresses, etc.) will be replaced with internal identifiers at the earliest opportunity, and personal information will not be kept. Any personal information that must be kept will be held on a secure, isolated machine. All paper consent forms that contain personal information will be stored in secure, locked cabinets within PHFI. Data will only be made available in de-identified form. Any notes with personal identifiers will only be accessible to the research staff that see participants, those responsible for coordinating visits, and study personnel authorized by the principal investigator. The main risk will be to maintain the confidentiality of qualitative data. Every attempt will be made to maintain the confidentiality of study participants.
: Not applicable.
: The authors declare that they have no competing interests.