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Article History

Received: 24 May 2021

Accepted: 19 January 2022

First Online: 1 March 2022

Declarations

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: Ethical approval has been obtained from UCL ethics committee (Project ID number: 14301/001), Nepal Heath Research Council (NHRC approval number: 353/2019) and London School of Hygiene and Tropical Medicine ethics committee (approval number: 16528).All correspondence with the NHRC is retained in the trial master file. Substantial amendments that require review by NHRC will not be implemented until permission is granted. The Principal Investigator will notify NHRC of the end of the study, and if the study is ended prematurely, including the reasons for the premature termination. Within 1 year after the end of the study, we will submit to NHRC a final report with the results, including any publications and abstracts.Consent is taken on at cluster, household and individual levels.<i>Cluster-level consent:</i> Before initiation of the census, general consent was sought for conducting the trial in that cluster from municipality leaders, municipality-level health system managers and cluster-level guardians, who is the ward representative for that population cluster. We obtained written permissions from all municipality and ward (cluster) offices for conducting the census and formative activities related to the trial. None of the clusters denied consent.<i>Individual level consent / assent</i>: During the census, household heads provided written consent for collection of a household roster, household characteristics and information on women of reproductive age. When a female was found eligible for menstrual monitoring during the census, oral consent was taken for her name to be recorded in the menstrual monitoring register and for the interviewer and FCHV to visit her again at the start of menstrual monitoring to take written consent and initiate the 4-weekly visits. For married girls who are under 18 years of age, informed assent is taken as well as informed consent from their guardian at the onset of menstrual monitoring and when a pregnancy is detected. To obtain consent, women are given an explanation of the trial. After hearing information about the study, participants receive a written information sheet about the study. The interviewer asks 5–6 questions to check their understanding of the information in the patient information sheet and once sufficient understanding has been confirmed, they invite her to give informed written consent / assent, in line with international ethical standards for research involving human subjects. If the woman is illiterate, a thumbprint is taken whereas literate respondents will sign the consent form. Both the participant and HERD international keep a copy the signed consent / assent form. If there is any doubt about whether a participant is happy to participate, the participant will not be enrolled. Every participant is given the opportunity to ask questions, and all participants are free to withdraw their consent at any time without providing any reason. They are free to refuse to answer any question or to stop an interview at any time, should they choose to do so. On the rare occasion that the interviewer does not speak the local language, a local translator is enlisted to provide any translation as necessary, but interviewers speak Awadhi so language should not be a problem. After taking written consent, oral consent is taken at each subsequent interview and home visiting interaction.Informed consent/assent forms and information sheets for menstrual monitoring and full trial participation in English, Nepali and Awadhi are provided in Supplementary Annexes,andand.

: We have not included any details, images or videos relating to an individual person in this protocol. The written informed consent process for participation in the trial follow-up includes the statement ‘I understand that when I consent to have my photos taken while engaging in the research activities during the research period, that these could be published on HERD international’s or UCL’s website or other publications’. If respondent does not reply ‘yes’ to this during the consent process, no photographs will be taken of that respondent at any point during the study so that there will be no photos of non-consenting individuals.

: The authors declare that they have no competing interests.