PONE-D-25-06248Feasibility, acceptability, and potential effectiveness of a human-centered design-derived intervention to improve community health workers’ contraception outreach in rural MalawiPLOS ONE

Dear Dr. Vallin,

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.

This study is novel and important, with great potential to improve accessibility and use of contraceptives among hard-to-reach populations of women in Malawi. The project can also be easily translated to other sub-Saharan African countries. However, the manuscript needs strengthening before it can be accepted for publication. Please address the reviewers’ comments and consider the following points in your revised manuscript:

1. Abstract: Add a sentence or two about data analysis.
2. Introduction, Page 4, Lines 67-69: The current text states, "These workers are often people’s first point of contact for health-related issues and are instrumental in promoting and providing contraceptive services, among many other primary care services." This should be reworded to clarify that Health Surveillance Assistants (HSAs) are the first point of contact for health-related issues in areas far from health centres (Primary health care delivery settings). This distinction is important because medical assistants are typically the first point of contact for health-related problems in rural areas. The primary role of HSAs is to promote health and prevent illnesses.
3. Methods (Description of the intervention)- correct the typo on page 7, line 136, where 'Ndingathe' has been written as 'Ngindagthe'. Also, could you please provide more information about the contents of the observation template? Was the template structured or unstructured?
4. Data Analysis: Please provide some details on how the framework analysis was used to analyse the transcripts and develop the themes. Could you also explain how data from observation were analysed?

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Kind regards,

Fatch Welcome Kalembo, Ph.D

Academic Editor

PLOS ONE

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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: Partly

Reviewer #2: Partly

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

Reviewer #1: Yes

Reviewer #2: No

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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: Yes

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: Dear Authors,

Thank you for submitting the data and analysis regarding a strategy to improve the availability and administration of injectable contraceptives in underserved rural regions lacking supplies and healthcare.

The description of the strategy addresses acceptability, feasibility, and potential effectiveness through a training program led by experienced users and an accessibility strategy for self-administration of injectable contraceptives.

Relevant effects were achieved according to the respondents and expected outcomes following the training and improvements in accessibility in situations where the HSA was frequently absent.

Consideration of whether the effectiveness of contraception in a population was evaluated may be beyond the scope of the present evaluation design and should be avoided in the manuscript.

Title:

It is suggested to avoid the concept of effectiveness as there is no adequate population comparator nor an assessment of its contraceptive effect within the present report.

Abstract:

The comments regarding effectiveness also apply here.

Methods:

Regarding Consent, please address the considerations for Medroxyprogesterone Acetate concerning bone mineral density and potential long-term effects on the breast. If it was informed to patients.

It would be appropriate to describe how the temperature of medications was ensured during bicycle transport, as well as the separation from food items.

The direct compensation provided to survey participants by the interviewers could be a variable influencing the acquired responses.

The indirect compensation is linked to the decision to accept the injection. The reasons of individuals who did not accept the medication administration were not explored.

The strategy is evaluated through self-reporting of injectable medication administration instructed by an experienced user but not validated by a healthcare professional at any point, which may have implications for the ultimate objective.

Contraceptive effectiveness in a population cannot be measured with the proposed design, particularly without adequate monitoring of transport temperature and proper review of the administration technique by a healthcare professional.

Discussion:

A strategy that could be sustainable without continuous support is suggested. However, the implementation of the present strategy relies on HSA time (where it was not possible to work with all due to their other activities), the provision of a bicycle in good condition, the provision of lunch allowances, and verification of whether users persist even without compensation for their participation. The aforementioned suggests that the present strategy also requires ongoing investment and sustainability.

Overall Recommendation:

In general, the manuscript with the description of the strategy is suitable for publication with the suggested revisions.

Reviewer #2: Reviewer’s Comments:

Journal: PLOS ONE

Manuscript title: Feasibility, acceptability, and potential effectiveness of a human-centered design-derived intervention to improve community health workers’ contraception outreach in rural Malawi.

First, thank you for the opportunity to review this manuscript. I will say this is a well-structured and timely study addressing a critical gap in contraceptive access in rural Malawi using a human-centered design approach. The mixed-methods design is appropriate. The triangulation of data is also commendable. However, the manuscript requires some improvements in some areas to meet the standard of a peer-reviewed publication. Below are my suggestions for improvement.

Title and Abstract:

• Page 1, Lines 5–6: The title is clear, but slightly long and can confuse. Remember, your work/data reads a pilot study. I will suggest you consider shortening it to read: “Improving Contraception Outreach through Human-Centered Design: A Pilot Study in Rural Malawi.”

• Page 2, Lines 30–54 (Abstract). The abstract is detail but exceeds typical word limits for many journals. It is above 300 words and its current state stresses readers. I will suggest you consider trimming descriptive content, especially in the “Methods” and “Results” subsections, without losing key details. Make it smart and interesting to readers.

Introduction:

• Page 4, Lines 58–87: The introduction somewhat effectively outlines the problem but needs a clearer articulation of the knowledge gap. The authors should more explicitly state why previous approaches have not succeeded and how Ndingathe uniquely addresses this. You may wish to address the question of what’s novel beyond combining peer support and logistics support. Also, what ha previous studies focused on and what gap in the body of knowledge is this study bridging or filling.

• Additionally, please ensure that in-text references follow the PLOS ONE style, with reference numbers inserted before the full stop. This also apply to other sections of the manuscript. I recommend you consulting the PLOS ONE journal's author submission guidelines for detailed instructions on formatting and referencing

Theoretical Framework:

• Page 7, Lines 135–13: The “Contraceptive Agency Framework” is referenced, but there is no adequate explanation of what the framework entails. I will suggest you provide a concise summary of the framework or a figure caption for “Figure 1” that explains the mechanisms and constructs. This will help readers to understand better and be carried along.

Study Design and Methodology:

• Page 9, between lines 153–159: The use of a “reduced intervention package” as a quasi-comparator group is mentioned but not well developed. It doesn’t carry the readers along clearly as expected. Please expand the rationale and design of this comparison arm. If I may ask, were outcomes stratified by intervention exposure level (with vs. without EUs)? If so, please present those comparisons.

• Page 10, Around Lines 168–173: The sampling strategy is not fully described. How were the 450 clients selected? Was there any randomization or consecutive sampling? Please clarify recruitment criteria to assess risk of selection bias. This is very important, please.

• Page 12, Lines 230–236: The observation methodology you used slightly lacks detail. How were the 20 outreach sessions selected? Were observers standardized or trained for consistency? What made up the observation template? Was it only the number of clients that visited by time of day? Please address these in the methodology section.

Data Analysis:

• Page 13, Lines 237–244: On your analysis, while the statistical tests (Wilcoxon, t-tests) seem appropriate and I don’t have problem with you using them, but the manuscript does not address potential confounders or clustering effects (e.g., HSAs nested within districts). Could you please address this? Please address the limitation of not controlling for clustering or interdependence in responses. If clustering wasn't accounted for, acknowledge this as a limitation.

• Please indicate also how missing data were handled (e.g., non-responses, incomplete forms) in your study/analysis.

Results:

• The use of chart in the presentation of your paired t-test may seem pictorial but lacking some key ingredients which are very important, and has pushed me to interrogate the presentation and completeness your statistical test results, especially given the reliance on paired t-tests and Wilcoxon signed-rank tests to establish pre-post differences.

• I notice inadequate presentation of paired t-test and Wilcoxon results across the results. For example, on Page 20, Figure 3 (HSAs’ role conflict, overload, job satisfaction), Page 21, Figure 5 (Client-reported fear before/after interacting with experienced users) and other Figures where you used paired t-tests and Wilcoxon signed-rank tests. The manuscript only presents mean values and p-values via bar charts. While this is helpful for visual readers, bar charts alone are not sufficient to fully interpret statistical results. In fact, key statistical reporting elements are missing, including:

� Mean difference (or median difference for Wilcoxon)

� Standard deviation or standard error

� 95% Confidence Interval (CI) around the difference

� Test statistics (e.g., t-value, z-score, or W-statistic for Wilcoxon)

� Sample size (n) per comparison group clearly labelled

Without this information, readers cannot assess the precision, effect size, or practical significance of the findings, which you will agree with me if you carefully check through your results presentations. As you are aware p-values alone which you used tell us whether a difference is statistically significant but not the magnitude or relevance of that difference.

• I will suggest you use Tables instead of charts format. The Table format allows quick comparison, gives effect size estimates, includes sample size, CI, and test details. In fact, it complies with EQUATOR Network (e.g., CONSORT, STROBE) reporting standards.

• If at all visual presentation is retained, annotate bar charts with exact mean/median values, n, and 95% CI bars is preferred. You should include footnotes stating the test used and p-values. Avoid using bar graphs for ordinal scales (e.g., Likert-based fear levels). Boxplots or stacked bar charts showing distribution would be more appropriate for Wilcoxon tests. Despite this, I will still suggest, you use table format to align with scientific writing. It is not a policy brief. It is an original research manuscript.

• You interpretation also need to improve. Add interpretation of Practical Significance. May it not only statistically significant, but meaningful? The authors should discuss what the results mean in practice to be clinically or programmatically relevant?

• Page 15, Line 284: Statement: “...suggesting that offering afternoon clinics was helpful...” This is an inference not strongly supported by comparative data. I would have said authors should consider including pre-intervention time-use data or more rigorous client preference analysis. However, I do hope, a table presentation of the paired test results showing all the statistical test information should address this.

• Page 16, Lines 295–303: The quote from the 22-year-old client is strong. However, please consider providing more thematic synthesis across quotes to highlight commonalities, not just illustrative anecdotes. Using only a quote from a respondent to address this very theme is disturbing. Since the authors used a software for analysis, I was expecting to see thematic analysis running through quotes. Could you address this, please?

• Page 20, Line 369–371 (Fig. 3): The reductions in role conflict and overload are statistically significant, but the clinical or programmatic relevance of these changes is not discussed. In addressing this, please provide effect sizes or interpretation of whether these are considered “meaningful” changes in workload and motivation. I want to believe your table presentation of results will assist in this aspect also.

Discussion:

• Page 26, Lines 499–507: The discussion reiterates findings but still lacks important reflection on what did not work. For example, the issue of delayed lunch allowances (page 18, lines 346–348) should be discussed more critically in terms of sustainability and implementation fidelity.

• On Page 27, Lines 525–529, the authors mention continued mnemonic use after the pilot, which is encouraging. However, it's unclear whether this was tracked systematically or anecdotal. Please clarify whether this finding was emergent from interviews or formally evaluated.

• Please also support your findings with previous studies showing aspects of agreements and disagreements with past studies. This is very important.

Limitations:

• Page 28, Lines 559–568: The limitations are appropriately acknowledged which are good, but the absence of a control group should be emphasized more strongly as a major constraint to attributing effects to the intervention. I know that you mentioned control group but clearly state that is a major constraint to attributing effects to the intervention.

Writing and Clarity:

Here, I will say that there are some aspects of the manuscript that contain grammatical errors or awkward phrasing, for example:

• Page 9, Line 108: “so that there would not be any overlap”. Consider rephrasing to read “to avoid overlap in outreach areas.”

• Page 27, Line 546: “...generally well-received”. Please also consider saying “broadly acceptable and culturally appropriate.”

I will suggest that a thorough copyedit is needed to correct minor grammar and enhance readability.

Figures and Tables:

• For your Figure 1, I will suggest you ensure the figure is well-labelled and visually communicates the causal logic between intervention components and contraceptive agency outcomes.

• For your Tables 1 and 2 (Page 14), though they are information, I will still suggest you consider including a footnote indicating how missing data were handled (e.g., non-responses, incomplete forms). I have also included this also be addressed in methodology.

References:

Again, please ensure that in-text references follow the PLOS ONE style, with reference numbers inserted before the full stop. Additionally, in the reference list, include the full DOI (https://doi.org/) or web address where applicable. I recommend consulting the journal's author submission guidelines for detailed instructions on formatting and referencing

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Reviewer #1: Yes: MD PhD Daniel Humberto Mendez Lozano

Reviewer #2: Yes: Turnwait Otu Michael

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Attachments

Attachment

Submitted filename: Contraception Outreach in Rural Malawi.docx

Improving Contraception Outreach through Human-Centered Design: A Pilot Study of the Ndingathe (“I Can”) intervention in Rural Malawi

PONE-D-25-06248R1

Dear Dr. Vallin,

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,

Fatch Welcome Kalembo, Ph.D

Academic Editor

PLOS ONE

Additional Editor Comments (optional):

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

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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

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

Reviewer #1: Yes

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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: 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

**********

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: Dear Authors,

I have reviewed your revised manuscript and am pleased with the thoroughness of your response. The changes you have made have significantly improved the data analysis for the intervention under study.

Congratulations on the progress. I look forward to seeing your work published.

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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: Yes: MD PhD Daniel Humberto Mendez Lozano

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