PONE-D-22-04234Effectiveness of targeted antenatal family planning information provision on early postpartum family planning uptake in Kisumu county: Study protocol for a Simple Randomized Control TrialPLOS ONE

Dear Dr. Shisanya,

Thank you for submitting your manuscript to PLOS ONE. After careful consideration, we feel that it has merit but does not fully meet PLOS ONE’s publication criteria as it currently stands. Therefore, we invite you to submit a revised version of the manuscript that addresses the points raised during the review process.

Please submit your revised manuscript by May 02 2022 11:59PM. If you will need more time than this to complete your revisions, please reply to this message or contact the journal office at plosone@plos.org. When you're ready to submit your revision, log on to https://www.editorialmanager.com/pone/ and select the 'Submissions Needing Revision' folder to locate your manuscript file.

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We look forward to receiving your revised manuscript.

Kind regards,

Walid Kamal Abdelbasset, Ph.D.

Academic Editor

PLOS ONE

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Reviewers' comments:

Reviewer's Responses to Questions

Comments to the Author

1. Does the manuscript provide a valid rationale for the proposed study, with clearly identified and justified research questions?

The research question outlined is expected to address a valid academic problem or topic and contribute to the base of knowledge in the field.

Reviewer #1: Yes

Reviewer #2: Yes

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2. Is the protocol technically sound and planned in a manner that will lead to a meaningful outcome and allow testing the stated hypotheses?

The manuscript should describe the methods in sufficient detail to prevent undisclosed flexibility in the experimental procedure or analysis pipeline, including sufficient outcome-neutral conditions (e.g. necessary controls, absence of floor or ceiling effects) to test the proposed hypotheses and a statistical power analysis where applicable. As there may be aspects of the methodology and analysis which can only be refined once the work is undertaken, authors should outline potential assumptions and explicitly describe what aspects of the proposed analyses, if any, are exploratory.

Reviewer #1: Partly

Reviewer #2: Yes

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3. Is the methodology feasible and described in sufficient detail to allow the work to be replicable?

Descriptions of methods and materials in the protocol should be reported in sufficient detail for another researcher to reproduce all experiments and analyses. The protocol should describe the appropriate controls, sample size calculations, and replication needed to ensure that the data are robust and reproducible.

Reviewer #1: Yes

Reviewer #2: Yes

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4. Have the authors described where all data underlying the findings will be made available when the study is complete?

The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception, at the time of publication. The data should be provided as part of the manuscript or its supporting information, or deposited to a public repository. For example, in addition to summary statistics, the data points behind means, medians and variance measures should be available. If there are restrictions on publicly sharing data—e.g. participant privacy or use of data from a third party—those must be specified.

Reviewer #1: Yes

Reviewer #2: Yes

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5. Is the manuscript presented in an intelligible fashion and written in standard English?

PLOS ONE does not copyedit accepted manuscripts, so the language in submitted articles must be clear, correct, and unambiguous. Any typographical or grammatical errors should be corrected at revision, so please note any specific errors here.

Reviewer #1: No

Reviewer #2: Yes

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6. Review Comments to the Author

Please use the space provided to explain your answers to the questions above and, if applicable, provide comments about issues authors must address before this protocol can be accepted for publication. You may also include additional comments for the author, including concerns about research or publication ethics.

You may also provide optional suggestions and comments to authors that they might find helpful in planning their study.

(Please upload your review as an attachment if it exceeds 20,000 characters)

Reviewer #1: *The authors have come with an interesting research topic that touches women’s health, paving a way to addressing the unmet contraceptive needs in women living in resource-limited regions. In general, the study protocol is well written, and it should be considered for further research undertaking provided that the suggested modifications from both the reviewer (s) and academic editor(s) are incorporated adequately. Below are the main comments of the review report.

*The researchers have declared that purpose of the study will be explained to the participants. I was wondering of a possibility of Hawthorne effect in which people behave differently (increased postpartum family planning uptake) once they know that they are being studied.

*The objective of the study (study aim) was added to the methods section of the protocol. Is that appropriate?

*How are the possibility of spillover effect and selective attrition will be addressed? How is the influence of external factors such as mass media and partner’s desire are considered to be handled?

*There are some punctuation errors. For instance, the word ‘respectively’ is not preceded with a comma throughout the document. The word ‘antenatal’ was capitalized inappropriately.

*Study aim section: the researcher or the researchers?

*List of abbreviations/acronyms should be revised. Abbreviations such as SGS, GATHER, BRAIDED should not be mentioned in the list as each one of them have been used only once and under brackets.

Reviewer #2: Dear PLOSE ONE team of editorials, thanks for the chance given to me to review a protocol manuscript titled “Effectiveness of targeted antenatal family planning information provision on early postpartum family planning uptake in Kisumu county: Study protocol for a Simple Randomized Control Trial”. The protocol will have its own importance for future better utilization of the early post partal family planning and maternal health in general. The following are my comments for further improvement of the protocol.

1. General Comments

• The problem statement should be very strong to ensure the need to study ANC FP information provision to improve early PPFP uptake.

• The problem statement should be in line with purpose statement.

• The justifications of the study are not justifications.

• Try to shorten and summarize the analysis section.

• The phases and its intended objective should be clear and concise.

• Are pregnant women best candidate for receiving FP information? How do you manage regret, depression or anxiety if they became pregnant by the failure of family planning?

• It should be ‘clustered randomized trial’.

2. Specific Comments

A. On The Methods Section

� What is unique in standardized intervention for at ANC FP information provision to improve early PPFP uptake when compared with routine one?

� Describe briefly the illegibility criteria i.e. If similar study is running in the health center?

� What type of family planning? I guess it should be reversible long acing contraceptive to have public health significance and to lengthen the birth interval?

� How do you analyze fertility intentions?

� Is the sample adequate to ensure external validity?

� What are the exclusion criteria’s?

� What is the main purpose of the protocol development and what type of protocol is that? It is effectiveness. Hence, what are the pitfalls in detail for the low effectiveness of ANC FP provision to improve early uptake of PPFP?

� Who are those information conveyers? What is their special quality?

� What are the contents of the counselling tool [try to mention by table]?

� What are the frequencies of conveying this advice?

� When do we say early post-partum?

� When do we say post-partal women have early PPFP uptake? Who measures that?

� What extent of early PPFP uptake do you expect as a result of your intervention? Even did early PPFP uptake impact, outcome or an output?

� How do you assess whether your project or other competing programs have impacted uptake of PPFP?

� Did the feasibility will follow the protocol? If so what expected results will derive you to continue to the next phase?

� Why don’t you use ecological framework? Have you consulted normalization theory? Is your comprehensive to cover all the stake holders of the post-partal family planning services actors?

� Simply what is your unit of analysis?

� What is your ratio of matching?

� How did you assure data quality, mention in detail since it is plan?

� Why you prefer to use t-test?

� Generally, it is very good work with ample benefit that need brief refinement.

Regards,

**********

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Reviewer #1: Yes: Subah Abderehim Yesuf

Reviewer #2: No

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PONE-D-22-04234R1Effectiveness of targeted antenatal family planning information provision on early postpartum family planning uptake in Kisumu county: Protocol for a Simple Randomized Control Trial (I DECIDE Study)PLOS ONE

Dear Dr. Shisanya,

Thank you for submitting your manuscript to PLOS ONE. After careful consideration, we feel that it has merit but does not fully meet PLOS ONE’s publication criteria as it currently stands. Therefore, we invite you to submit a revised version of the manuscript that addresses the points raised during the review process.

Please submit your revised manuscript by Jul 07 2022 11:59PM. If you will need more time than this to complete your revisions, please reply to this message or contact the journal office at plosone@plos.org. When you're ready to submit your revision, log on to https://www.editorialmanager.com/pone/ and select the 'Submissions Needing Revision' folder to locate your manuscript file.

Please include the following items when submitting your revised manuscript:

• A rebuttal letter that responds to each point raised by the academic editor and reviewer(s). You should upload this letter as a separate file labeled 'Response to Reviewers'.
• A marked-up copy of your manuscript that highlights changes made to the original version. You should upload this as a separate file labeled 'Revised Manuscript with Track Changes'.
• An unmarked version of your revised paper without tracked changes. You should upload this as a separate file labeled 'Manuscript'.

If you would like to make changes to your financial disclosure, please include your updated statement in your cover letter. Guidelines for resubmitting your figure files are available below the reviewer comments at the end of this letter.

If applicable, we recommend that you deposit your laboratory protocols in protocols.io to enhance the reproducibility of your results. Protocols.io assigns your protocol its own identifier (DOI) so that it can be cited independently in the future. For instructions see: https://journals.plos.org/plosone/s/submission-guidelines#loc-laboratory-protocols. Additionally, PLOS ONE offers an option for publishing peer-reviewed Lab Protocol articles, which describe protocols hosted on protocols.io. Read more information on sharing protocols at https://plos.org/protocols?utm_medium=editorial-email&utm_source=authorletters&utm_campaign=protocols.

We look forward to receiving your revised manuscript.

Kind regards,

Walid Kamal Abdelbasset, Ph.D.

Academic Editor

PLOS ONE

Journal Requirements:

Please review your reference list to ensure that it is complete and correct. If you have cited papers that have been retracted, please include the rationale for doing so in the manuscript text, or remove these references and replace them with relevant current references. Any changes to the reference list should be mentioned in the rebuttal letter that accompanies your revised manuscript. If you need to cite a retracted article, indicate the article’s retracted status in the References list and also include a citation and full reference for the retraction notice.

[Note: HTML markup is below. Please do not edit.]

Reviewers' comments:

Reviewer's Responses to Questions

Comments to the Author

1. Does the manuscript provide a valid rationale for the proposed study, with clearly identified and justified research questions?

The research question outlined is expected to address a valid academic problem or topic and contribute to the base of knowledge in the field.

Reviewer #1: Yes

Reviewer #2: Yes

**********

2. Is the protocol technically sound and planned in a manner that will lead to a meaningful outcome and allow testing the stated hypotheses?

The manuscript should describe the methods in sufficient detail to prevent undisclosed flexibility in the experimental procedure or analysis pipeline, including sufficient outcome-neutral conditions (e.g. necessary controls, absence of floor or ceiling effects) to test the proposed hypotheses and a statistical power analysis where applicable. As there may be aspects of the methodology and analysis which can only be refined once the work is undertaken, authors should outline potential assumptions and explicitly describe what aspects of the proposed analyses, if any, are exploratory.

Reviewer #1: Yes

Reviewer #2: Yes

**********

3. Is the methodology feasible and described in sufficient detail to allow the work to be replicable?

Descriptions of methods and materials in the protocol should be reported in sufficient detail for another researcher to reproduce all experiments and analyses. The protocol should describe the appropriate controls, sample size calculations, and replication needed to ensure that the data are robust and reproducible.

Reviewer #1: Yes

Reviewer #2: Yes

**********

4. Have the authors described where all data underlying the findings will be made available when the study is complete?

The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception, at the time of publication. The data should be provided as part of the manuscript or its supporting information, or deposited to a public repository. For example, in addition to summary statistics, the data points behind means, medians and variance measures should be available. If there are restrictions on publicly sharing data—e.g. participant privacy or use of data from a third party—those must be specified.

Reviewer #1: Yes

Reviewer #2: No

**********

5. Is the manuscript presented in an intelligible fashion and written in standard English?

PLOS ONE does not copyedit accepted manuscripts, so the language in submitted articles must be clear, correct, and unambiguous. Any typographical or grammatical errors should be corrected at revision, so please note any specific errors here.

Reviewer #1: Yes

Reviewer #2: Yes

**********

6. Review Comments to the Author

Please use the space provided to explain your answers to the questions above and, if applicable, provide comments about issues authors must address before this protocol can be accepted for publication. You may also include additional comments for the author, including concerns about research or publication ethics.

You may also provide optional suggestions and comments to authors that they might find helpful in planning their study.

(Please upload your review as an attachment if it exceeds 20,000 characters)

Reviewer #1: The authors have tried to tackle each comment raised by the previous review, and as a consequence, the protocol is now in good stand except for minor capitalization and spacing problems.

Reviewer #2: Dear PONE team of editorials, thank you for the chance given to me to review a manuscript titled “Effectiveness of targeted antenatal family planning information provision on early postpartum family planning uptake in Kisumu country: Protocol for a Simple Randomized Control Trial (I DECIDE Study)”. The paper will have contribution for designing appropriate and effective family planning information and further reached education after giving birth.

The following are my comments;

• Gaps related to the information need and the justification should be strong.

• What are the adverse consequences occurred due to the convey of the conventional [routine standard care] post-partum family planning information?

• The eligibility criteria are not very strong and binding.

• The tool needs face validation.

• The protocol should address;

i. Clear sampling without making ambiguity to the reader.

ii. What are the software’s that are used to calculate the sample size and population allocation.

iii. Face validity of the tool.

iv. Pre-test

v. The power and the effect expected due to the intervention/s

vi. Correction, revisions and actual effective implementations.

vii. Data collectors, their quality and data advanced data quality measures and its management.

viii. Dose, dosage, total duration of the intervention for both the case and the controls.

ix. Expected outcomes

� Primary Outcomes

� Secondary outcomes

x. Ethical Issues: Trial registration, ethics and its intervention.

Regards,

**********

7. PLOS authors have the option to publish the peer review history of their article (what does this mean?). If published, this will include your full peer review and any attached files.

If you choose “no”, your identity will remain anonymous but your review may still be made public.

Do you want your identity to be public for this peer review? For information about this choice, including consent withdrawal, please see our Privacy Policy.

Reviewer #1: Yes: Subah Abderehim Yesuf

Reviewer #2: Yes: Ok

[NOTE: If reviewer comments were submitted as an attachment file, they will be attached to this email and accessible via the submission site. Please log into your account, locate the manuscript record, and check for the action link "View Attachments". If this link does not appear, there are no attachment files.]

While revising your submission, please upload your figure files to the Preflight Analysis and Conversion Engine (PACE) digital diagnostic tool, https://pacev2.apexcovantage.com/. PACE helps ensure that figures meet PLOS requirements. To use PACE, you must first register as a user. Registration is free. Then, login and navigate to the UPLOAD tab, where you will find detailed instructions on how to use the tool. If you encounter any issues or have any questions when using PACE, please email PLOS at figures@plos.org. Please note that Supporting Information files do not need this step.

Effectiveness of targeted antenatal family planning information provision on early postpartum family planning uptake in Kisumu county: Protocol for a Simple Randomized Control Trial (I DECIDE Study)

PONE-D-22-04234R2

Dear Dr. Shisanya,

We’re pleased to inform you that your manuscript has been judged scientifically suitable for publication and will be formally accepted for publication once it meets all outstanding technical requirements.

Within one week, you’ll receive an e-mail detailing the required amendments. When these have been addressed, you’ll receive a formal acceptance letter and your manuscript will be scheduled for publication.

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Kind regards,

Walid Kamal Abdelbasset, Ph.D.

Academic Editor

PLOS ONE

Additional Editor Comments (optional):

Appreciating the authors for their responses to all comments. No further comments are required.

Reviewers' comments: