PONE-D-20-34599

The ARMADILLO Text Message Intervention to Improve the Sexual and Reproductive Health Knowledge of Adolescents in Peru: Results of a Randomized Controlled Trial

PLOS ONE

Dear Dr. Gonsalves,

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.

While the Reviewers found the presentation of the results evaluating the ARMADILLO intervention potentially impactful, they also identified some weaknesses, generally, around the presentation of the results and in putting the study into the proper, larger context (e.g., generalizability). Therefore, considering the manuscript further will require a major revision, addressing each of the Reviewers comments.

Please submit your revised manuscript by Jun 25 2021 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: http://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,

Scarlett L. Bellamy, ScD

Academic Editor

PLOS ONE

Additional Editor Comments:

After careful review, although both Reviewers identified potential strengths of the highlighted intervention and its potential impact on adolescent health, they also identified a number of weaknesses. Taken collectively, in order to consider this publication further, it will need a major revision addressing each of the reviewers noted general critiques regarding the presentation of the results and in presenting the implications of the findings addressing the effectiveness of the intervention on the sexual and reproductive health knowledge of Peruvian adolescents.

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We will update your Data Availability statement on your behalf to reflect the information you provide.

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Reviewers' comments:

Reviewer's Responses to Questions

Comments to the Author

1. Is the manuscript technically sound, and do the data support the conclusions?

The manuscript must describe a technically sound piece of scientific research with data that supports the conclusions. Experiments must have been conducted rigorously, with appropriate controls, replication, and sample sizes. The conclusions must be drawn appropriately based on the data presented.

Reviewer #1: Yes

Reviewer #2: Partly

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2. Has the statistical analysis been performed appropriately and rigorously?

Reviewer #1: No

Reviewer #2: Yes

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3. Have the authors made all data underlying the findings in their manuscript fully available?

The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception (please refer to the Data Availability Statement in the manuscript PDF file). 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: No

Reviewer #2: Yes

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4. 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

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5. Review Comments to the Author

Please use the space provided to explain your answers to the questions above. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. (Please upload your review as an attachment if it exceeds 20,000 characters)

Reviewer #1: Abstract

- it is more typical to include a brief background of the study in addition to the study objective (rather than the objective alone) in the 'background' section of the abstract.

Background

- in the first paragraph you probably mean "In Peru, the rates of adolescent pregnancy has remained unchanged over time..."

Methods

- more information should be provided about how the adolescents were selected; it is not sufficiently clear to say "randomly selected male and female adolescents who met the eligibility criteria".

- please check the parameters cited in your sample size calculation. A quick check (e.g. using the calculator at https://www.sealedenvelope.com/power/binary-superiority/) shows that 373 participants per arm i.e. 746 participants in the main treatment and control arm combined, not counting the third arm, are required to demonstrate a change in outcome from 55% to 65% (10% absolute change) with 80% power at the 5% level of significance; and this is before inflating the sample for expected dropouts. If a different approach has been used for this calculation, e.g. one based on the mean number of correct responses, this should be described more clearly.

- additionally, there needs to be some justification for the assumption of a baseline outcome of 55% and the 10% improvement, e.g. previous work suggesting this baseline level of the outcome; important effect size, e.t.c.

- an analysis of a change-from-baseline score should normally include adjustment for the baseline score as a covariate in the regression model (see the 'change from baseline analysis section in: Committee for Proprietary Medicinal Products. Points to consider on adjustment for baseline covariates. Stat Med 2004;23(5):701–9. Available from: http://www.ncbi.nlm.nih.gov/pubmed/14981670). This is equivalent to modelling the score at endline as the outcome adjusting for baseline score (among other covariates if desired). When you make this change in your analysis please update the abstract to indicate that the outcome was the baseline-adjusted change in the mean score. If the data are in 'long' form (with one variable for the knowledge score and a time indicator for the survey), then a model for the score variable as the outcome with the time variable, group variable (i.e. intervention v. control) and a time-group interaction can be used to estimate baseline-adjusted effects (see doi:10.1016/S0140-6736(18)31782-3 for an example of this and the appendix of doi:10.1186/1471-2431-11-109 for a detailed explanation of this approach, ignoring the adjustments for clustering which are not present in ARMADILLO).

Results

- please include 95% confidence intervals when you report the effect estimates in the main text, i.e. estimate, 95%CI and p-value. Do not report SDs for outcomes in the text of the results or in table 2, as these are used for descriptive purposes and not for inference. However, you may (indeed, should) report baseline scores in Table 1 with their SDs.

- Table 2 and Table 3 can and should be improved. They should have the mean scores at endline (with SEs) of each of the three arms in separate columns, and the pairwise unadjusted and adjusted differences with 95%CI and p-values.

Reviewer #2: Thank you for the opportunity to review this manuscript, which describes the results of a rigorously designed study of a SMS to improve sexual and reproductive health knowledge among teens in Lima, Peru. Based on the abstract and the first 14 pages of the submission, I could find little wrong with the study or the paper (though I'd preferred the paper be written in the active voice so that it was clearer who was doing the research rather than it being done by, assumedly, all of the authors at once.)

But on page 14 the authors state as a limitation that of the 236 people randomized into the first of the RCT's three groups "relatively few (28, or 13.4% of participants in the arm)" actually received the full intervention. I'd say that the use of the word "relatively" is a major understatement! Any researcher who claims never to have made a massive blunder in their research at some point is likely a liar, and I think too many of these mistakes never make it to manuscripts, usually because the authors are embarrassed and don't try. So, I appreciate the authors' honesty in including the paragraph about this major mishap on such a big project. But it should not have been relegated to a paragraph about limitations, and this huge problem with the data collection should certainly not have been left out of the abstract, which makes claims about the results of the study and Arm 1 that are extremely suspect with a sample size so small. After the fact, I noticed that the n for the whole study was in the abstract but not the n of each arm.

In addition, I don't think it's a great idea to claim that one of the study's strengths is the use of per protocol analyses that revealed the Arm 1 intervention failure. It's not a strength that no one notice the error until the data analysis. The researchers in Lima should have been monitoring the data flow in real time, and a nearly 90% difference in participation in one arm would have alerted the researchers that something was wrong and needed to be dealt with immediately. Or maybe something else happened -- but whatever it is, it needs to be explained in more detail than what is given.

All this said, I think this paper has potential value simply for the analysis of Arm 2 and Arm 3. But any revision needs to state bluntly and early what the sample size in the arms were and why the discrepancy between Arm 1 and Arms 2 and 3 exists. And since the results of the RCT (with or without Arm 1) are rather unexciting, an examination of what went wrong and the lessons learned would be much more valuable than a formulaic description of a very small, if statistically significant, effect.

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6. 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: No

Reviewer #2: No

[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.

PONE-D-20-34599R1The ARMADILLO Text Message Intervention to Improve the Sexual and Reproductive Health Knowledge of Adolescents in Peru: Results of a Randomized Controlled TrialPLOS ONE

Dear Dr. Gonsalves,

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.

As noted in the reviewers comments, you have been very responsive to prior reviewer comments, resulting in a stronger, clearer manuscript. However, there are a few minor lingering issues noted by reviewers requiring further attention. Specifically, Reviewer 1 has some additional recommendation regarding the presentation of summary statistics in Tables and Reviewer 2 has noted where further clarification regarding 'inclusion criteria' should be considered.

Please submit your revised manuscript by Dec 04 2021 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,

Scarlett L. Bellamy, ScD

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.

Additional Editor Comments (if provided):

As noted in the reviewers comments, you have been very responsive to prior reviewer comments, resulting in a stronger, clearer manuscript. However, there are a few minor lingering issues noted by reviewers requiring further attention. Specifically, Reviewer 1 has some additional recommendation regarding the presentation of summary statistics in Tables and Reviewer 2 has noted where further clarification regarding 'inclusion criteria' should be considered.

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

Reviewers' comments:

Reviewer's Responses to Questions

Comments to the Author

1. If the authors have adequately addressed your comments raised in a previous round of review and you feel that this manuscript is now acceptable for publication, you may indicate that here to bypass the “Comments to the Author” section, enter your conflict of interest statement in the “Confidential to Editor” section, and submit your "Accept" recommendation.

Reviewer #1: (No Response)

Reviewer #2: All comments have been addressed

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2. Is the manuscript technically sound, and do the data support the conclusions?

The manuscript must describe a technically sound piece of scientific research with data that supports the conclusions. Experiments must have been conducted rigorously, with appropriate controls, replication, and sample sizes. The conclusions must be drawn appropriately based on the data presented.

Reviewer #1: Yes

Reviewer #2: Yes

**********

3. Has the statistical analysis been performed appropriately and rigorously?

Reviewer #1: Yes

Reviewer #2: Yes

**********

4. Have the authors made all data underlying the findings in their manuscript fully available?

The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception (please refer to the Data Availability Statement in the manuscript PDF file). 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: No

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: Yes

Reviewer #2: Yes

**********

6. Review Comments to the Author

Please use the space provided to explain your answers to the questions above. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. (Please upload your review as an attachment if it exceeds 20,000 characters)

Reviewer #1: If the last two rows of Table 1 are showing mean and standard deviation (SD) like the age row at the top, please indicate this as you have done for other continuous variables in the table.

As indicated in the previous round of comments, Table 1 (descriptive results) should normally report means and SDs for continuous variables - you have done this. However inferential results such as have been reported in Table 2 and 3 should report means and standard errors (SE) not SDs for continuous outcomes. The rest of Table 2 and 3 are fine.

I am satisfied with the other changes made in response to previous reviews.

Reviewer #2: Thank you for the chance to review this revision. The authors did a fantastic job responding to the comments, and I greatly appreciated the detail in the discussion of what went wrong and why. I think this makes the paper more valuable than the data alone. My one suggestion is minor. On page 13 of the revision, the authors state, "The criteria for

inclusion in this analysis resulted in a very small sample size for on-demand arm..." and I eventually figured out what they meant, because of the wording I initially thought they were referring to the inclusion criteria for participants (which was discussed just on the previous page, 12) rather than the criteria for inclusion in the ITT data (explained on page 10). I suggest rephrasing the sentence to be clearer on that issue. Otherwise, this paper looks great. Thank you again for the chance to review the original and revision.

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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: No

Reviewer #2: No

[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.

The ARMADILLO Text Message Intervention to Improve the Sexual and Reproductive Health Knowledge of Adolescents in Peru: Results of a Randomized Controlled Trial

PONE-D-20-34599R2

Dear Dr. Lianne Gonsalves,

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.

An invoice for payment will follow shortly after the formal acceptance. To ensure an efficient process, please log into Editorial Manager at http://www.editorialmanager.com/pone/, click the 'Update My Information' link at the top of the page, and double check that your user information is up-to-date. If you have any billing related questions, please contact our Author Billing department directly at authorbilling@plos.org.

If your institution or institutions have a press office, please notify them about your upcoming paper to help maximize its impact. If they’ll be preparing press materials, please inform our press team as soon as possible -- no later than 48 hours after receiving the formal acceptance. Your manuscript will remain under strict press embargo until 2 pm Eastern Time on the date of publication. For more information, please contact onepress@plos.org.

Kind regards,

Eugene Demidenko, Ph.D.

Academic Editor

PLOS ONE

Additional Editor Comments (optional):

I read the paper myself and I believe that the paper is in a publishable form. I have just one editorial remark on the citation syntax. (a) Instead of ".[1]" use "[1]." That is, put the period after the citation bracket. (b) Instead of "interventions[24]" use "interventions [24]". That is use the space before the citation bracket.

Reviewers' comments:

Reviewer's Responses to Questions

Comments to the Author

1. If the authors have adequately addressed your comments raised in a previous round of review and you feel that this manuscript is now acceptable for publication, you may indicate that here to bypass the “Comments to the Author” section, enter your conflict of interest statement in the “Confidential to Editor” section, and submit your "Accept" recommendation.

Reviewer #1: All comments have been addressed

Reviewer #2: All comments have been addressed

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2. Is the manuscript technically sound, and do the data support the conclusions?

The manuscript must describe a technically sound piece of scientific research with data that supports the conclusions. Experiments must have been conducted rigorously, with appropriate controls, replication, and sample sizes. The conclusions must be drawn appropriately based on the data presented.

Reviewer #1: (No Response)

Reviewer #2: Yes

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3. Has the statistical analysis been performed appropriately and rigorously?

Reviewer #1: (No Response)

Reviewer #2: Yes

**********

4. Have the authors made all data underlying the findings in their manuscript fully available?

The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception (please refer to the Data Availability Statement in the manuscript PDF file). 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: (No Response)

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 Response)

Reviewer #2: Yes

**********

6. Review Comments to the Author

Please use the space provided to explain your answers to the questions above. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. (Please upload your review as an attachment if it exceeds 20,000 characters)

Reviewer #1: (No Response)

Reviewer #2: All of my questions and revisions have been addressed. Thank you for the ioppurtunity to review your work.

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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: No

Reviewer #2: No