The landscape for HIV pre-exposure prophylaxis during pregnancy and breastfeeding in Malawi and Zambia: A qualitative study

Chifundo Zimba; Suzanne Maman; Nora E. Rosenberg; Wilbroad Mutale; Oliver Mweemba; Wezzie Dunda; Twambilile Phanga; Kasapo F. Chibwe; Tulani Matenga; Kellie Freeborn; Leah Schrubbe; Bellington Vwalika; Benjamin H. Chi

doi:10.1371/journal.pone.0223487

Peer Review History

Original SubmissionJune 14, 2019
5 Aug 2019 Decision Letter - Dhayendre Moodley, Editor PONE-D-19-16981 The landscape for HIV pre-exposure prophylaxis during pregnancy and breastfeeding in Malawi and Zambia: a qualitative study PLOS ONE Dear Dr Chi, 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. We would appreciate receiving your revised manuscript by Sep 19 2019 11:59PM. When you are 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. If you would like to make changes to your financial disclosure, please include your updated statement in your cover letter. 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Please include a copy of the interview guide used in the study, in both the original language and English, as Supporting Information, or include a citation if it has been published previously. 3. We note that you have indicated that data from this study are available upon request. PLOS only allows data to be available upon request if there are legal or ethical restrictions on sharing data publicly. For information on unacceptable data access restrictions, please see http://journals.plos.org/plosone/s/data-availability#loc-unacceptable-data-access-restrictions. In your revised cover letter, please address the following prompts: a) If there are ethical or legal restrictions on sharing a de-identified data set, please explain them in detail (e.g., data contain potentially identifying or sensitive patient information) and who has imposed them (e.g., an ethics committee). Please also provide contact information for a data access committee, ethics committee, or other institutional body to which data requests may be sent. b) If there are no restrictions, please upload the minimal anonymized data set necessary to replicate your study findings as either Supporting Information files or to a stable, public repository and provide us with the relevant URLs, DOIs, or accession numbers. Please see http://www.bmj.com/content/340/bmj.c181.long for guidelines on how to de-identify and prepare clinical data for publication. For a list of acceptable repositories, please see http://journals.plos.org/plosone/s/data-availability#loc-recommended-repositories. We will update your Data Availability statement on your behalf to reflect the information you provide. Additional Editor Comments: Congratulations on a well conducted study and mostly an unbiased account of your diverse findings. A few suggestions to strengthen the readership interest: 1. If available, include recent HIV incidence and MTCT rates in pregnant and breastfeeding populations in these two countries (an indication for prioritising this population in PrEP policies and guidelines). 2. In the Discussion, briefly discuss when Zambia and Malawi implemented the PMTCT programme, current status of the PMTCT programme, whether donor agencies primarily support the programme and your thoughts on how PrEP can be integrated into current PMTCT guidelines. Include discussions with HCW and policy makers if available. 3. Lastly, transcript for PM607 is repeated. You could either find another transcript or consolidate your interpretations/application while citing the transcript once. [Note: HTML markup is below. Please do not edit.] 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 ******** 2. Has the statistical analysis been performed appropriately and rigorously? Reviewer #1: N/A ****** 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 ****** 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 ****** 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: Thanks for the opportunity to review this manuscript. It is clearly written and interesting. Here are my comments: Introduction: 1) Line 54 “Policymakers were identified from existing governmental technical working groups” Is this in both countries? Methods: 2) Please include approximate length of the interviews. 3) Please include the approach for participant selection. 4) Could the authors describe a little more about the participant selection; was the intention to interview 39 women? Was age or parity a criteria? Why 7 men? Please give a little more detail. 5) Please include the theoretical approach for analysis. Results: 1) Could you add the dates to the title in Tables 1& 2 ? 2) Were there any differences in sociodemographics by country? 3) Please remove the participant ID numbers. This is not helpful to the reader. 4) Do we know the HIV status of the male partners? 5) Would be nice to know the gender and age of the health care workers and policy makers. Is this possible? Discussion: Would be nice to discuss how this could be similar or different in different populations. What about younger women 15-18years? What about higher risk groups? Is there any data about PrEP in other groups of adults in Zambia or Malawi? As noted in the limitations – there are PrEP programs already in place in most countries now, this is less interesting since its based on intention rather than on real experience. ****** 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 [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 to be viewed.] 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 us at figures@plos.org. Please note that Supporting Information files do not need this step. https://doi.org/10.1371/journal.pone.0223487.r001
Revision 1
16 Sep 2019 Author Response RESPONSE TO REVIEWERS Editor’s comments Congratulations on a well conducted study and mostly an unbiased account of your diverse findings. A few suggestions to strengthen the readership interest: 1. If available, include recent HIV incidence and MTCT rates in pregnant and breastfeeding populations in these two countries (an indication for prioritising this population in PrEP policies and guidelines). * This has been included in the revised manuscript (lines 51-59). We have included data about HIV incidence among women of reproductive age, based on population-based surveys in Malawi and Zambia. We also include data from historical studies of HIV incidence during pregnancy and breastfeeding in these countries. Finally, we provide estimates from UNAIDS about the relative contribution of new maternal HIV infections to new infant HIV infections in the two target countries. 2. In the Discussion, briefly discuss when Zambia and Malawi implemented the PMTCT programme, current status of the PMTCT programme, whether donor agencies primarily support the programme and your thoughts on how PrEP can be integrated into current PMTCT guidelines. Include discussions with HCW and policy makers if available. * Thank you for this suggestion. We have included a paragraph about the current status of the PMTCT programs in Malawi and Zambia, including their success in expanding antiretroviral therapy coverage. We discuss the concerns raised by policymakers about the prioritization between HIV prevention (PrEP) and treatment (antiretroviral therapy) in the context of donor-funded programs (lines 329-336). In the following paragraph (lines 338-353), we provide suggestions on how national HIV programs might integrate PrEP into existing maternal and child health platforms, including PMTCT. 3. Lastly, transcript for PM607 is repeated. You could either find another transcript or consolidate your interpretations/application while citing the transcript once. * Thank you for flagging this repetition. Transcript PM607 is now only cited once. Reviewer #1 Thanks for the opportunity to review this manuscript. It is clearly written and interesting. Here are my comments: Introduction: 1) Line 54 “Policymakers were identified from existing governmental technical working groups” Is this in both countries? * Yes. We have added a phrase to indicate that this applies to both countries Methods: 1) Please include approximate length of the interviews. * Interviews lasted approximately one hour (line 100). 2) Please include the approach for participant selection. * Patients and their partners were recruited via a convenience sample. The eligibility and approach are described further in lines 71-81. 3) Could the authors describe a little more about the participant selection; was the intention to interview 39 women? Was age or parity a criterion? Why 7 men? Please give a little more detail. * The eligibility criteria and approach are described in lines 71-81. Our target accrual was 40 HIV-negative pregnant or breastfeeding women, up to 40 primary male partners (based on the index women’s permission to recruit), 20 HCWs, and 20 policymakers. The sample was divided evenly across the two country sites (lines 81-83). 4) Please include the theoretical approach for analysis. * We have included additional text in the revised manuscript. In lines 61-64, it reads: “We used a qualitative descriptive approach in the design, data collection and analysis of this formative study [18, 19]. Our goal was to provide accurate accounting of events—and their meaning—from the individuals interviewed [18]. We drew from the basic tenets of naturalistic inquiry, with no specific commitment to a pre-defined theoretical framework [20].” Results: 1) Could you add the dates to the title in Tables 1 & 2? * This has been added to the titles for Tables 1 and 2. 2) Were there any differences in sociodemographics by country? * Because of our small sample size, we did not further stratify the participating women and their male partners by country. We were concerned that, with 20 or fewer participants in any one category, differences would be difficult to interpret. 3) Please remove the participant ID numbers. This is not helpful to the reader. * These have been removed as requested. 4) Do we know the HIV status of the male partners? * Out of 14 male partners, 13 were reported to be HIV-negative. Only 1 partner had unknown HIV status (Table 2). 5) Would be nice to know the gender and age of the health care workers and policy makers. Is this possible? * We agree that this information could be helpful. Unfortunately, we did not collect this information for healthcare workers and policy makers for reasons of confidentiality. Because these groups are small, there were concerns that such details could lead in accidental disclosure. This is now explained in lines 89-90. Discussion: 1) Would be nice to discuss how this could be similar or different in different populations. What about younger women 15-18years? What about higher risk groups? * In lines 340-342, we discuss the importance of screening and triage procedures for pregnant/breastfeeding women at elevated risk for HIV acquisition. Currently, there are few validated measures; however, it is acknowledged—including by respondents in this study—that such instruments could help to make PrEP services more efficient and sustainable. 2) Is there any data about PrEP in other groups of adults in Zambia or Malawi? * Data about PrEP use in these countries remains limited. In Malawi, programs are only now beginning. In Zambia, pilot programs have been implemented for other key populations. These are now referenced in lines 365-367. 3) As noted in the limitations – there are PrEP programs already in place in most countries now, this is less interesting since its based on intention rather than on real experience. * As noted in this comment, this limitation has been acknowledged within the paper. However, since the majority of countries have not implemented large-scale programs targeting pregnant and breastfeeding women specifically, we believe this remains a worthy contribution to the public health literature. Attachments Attachment Submitted filename: Response to reviewers.pdf https://doi.org/10.1371/journal.pone.0223487.r002
24 Sep 2019 Decision Letter - Dhayendre Moodley, Editor The landscape for HIV pre-exposure prophylaxis during pregnancy and breastfeeding in Malawi and Zambia: a qualitative study PONE-D-19-16981R1 Dear Dr. Chi, We are pleased to inform you that your manuscript has been judged scientifically suitable for publication and will be formally accepted for publication once it complies with all outstanding technical requirements. Within one week, you will receive an e-mail containing information on the amendments required prior to publication. When all required modifications have been addressed, you will receive a formal acceptance letter and your manuscript will proceed to our production department and be scheduled for publication. Shortly after the formal acceptance letter is sent, an invoice for payment will follow. To ensure an efficient production and billing process, please log into Editorial Manager at https://www.editorialmanager.com/pone/, click the "Update My Information" link at the top of the page, and update your user information. 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 enable them to help maximize its impact. If they will be preparing press materials for this manuscript, you must inform our press team as soon as possible and 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. With kind regards, Dhayendre Moodley Academic Editor PLOS ONE Additional Editor Comments (optional): Reviewers' comments: https://doi.org/10.1371/journal.pone.0223487.r003
Formally Accepted
27 Sep 2019 Acceptance Letter - Dhayendre Moodley, Editor PONE-D-19-16981R1 The landscape for HIV pre-exposure prophylaxis during pregnancy and breastfeeding in Malawi and Zambia: a qualitative study Dear Dr. Chi: I am pleased to inform you that your manuscript has been deemed suitable for publication in PLOS ONE. Congratulations! Your manuscript is now with our production department. If your institution or institutions have a press office, please notify them about your upcoming paper at this point, to enable them to help maximize its impact. If they will be preparing press materials for this manuscript, please inform our press team within the next 48 hours. 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. For any other questions or concerns, please email plosone@plos.org. Thank you for submitting your work to PLOS ONE. With kind regards, PLOS ONE Editorial Office Staff on behalf of Prof. Dhayendre Moodley Academic Editor PLOS ONE https://doi.org/10.1371/journal.pone.0223487.r004

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