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Date: Mar 30, 2020
To: "Florence Marie Momplaisir" [email protected] From: "The Green Journal" [email protected]
Subject: Your Submission ONG-20-261
RE: Manuscript Number ONG-20-261
Implementing Couples’ HIV Testing and Counseling in the Antenatal Care Setting Dear Dr. Momplaisir:
Your manuscript has been reviewed by the Editorial Board and by special expert referees. Although it is judged not acceptable for publication in Obstetrics & Gynecology in its present form, we would be willing to give further consideration to a revised version.
If you wish to consider revising your manuscript, you will first need to study carefully the enclosed reports submitted by the referees and editors. Each point raised requires a response, by either revising your manuscript or making a clear and convincing argument as to why no revision is needed. To facilitate our review, we prefer that the cover letter include the comments made by the reviewers and the editor followed by your response. The revised manuscript should indicate the position of all changes made. We suggest that you use the "track changes" feature in your word processing software to do so (rather than strikethrough or underline formatting).
Your paper will be maintained in active status for 21 days from the date of this letter. If we have not heard from you by Mar 26, 2020, we will assume you wish to withdraw the manuscript from further consideration.
REVIEWER COMMENTS:
Reviewer #1:
Precis - Couples' HIV test/Counseling is feasible and acceptable in antenatal care Abstract - Objective - pilot implementation Couples' HIV testing and counseling (CHTC)
Methods - cross sectional design - couples with prenatal care and agree to testing; assessed barriers to recruitment and clinic barriers and facilitators
Results - 41 couples - 68% with no sexual relationship agreement; those with an agreement were more likely to use condoms and have HIV testing
individual barriers were male partner compliance and idea that they were low risk; clinic barriers - training
Background - HIV serodiscordance is a risk if no antiretroviral treatment (ART) - increased risk perinatal transmission;
many men don't know or discuss status
couples' testing can impact primary and secondary HIV transmission Africa - CHTC is recommended by WHO and develop sexual agreements hypothesis - CHTC is needed and acceptable
Methods - Cross sectional design - 41 couples - 4/16- 7/17 - data collected, agreed to testing, sexual agreement, sex related behaviors assessed
CHTC - discuss sexual agreement, rapid HIV testing, acceptability questionnaire and clinic barriers Data Analysis - 41 couples
Results - 73% black, median age 28.4 yr, most lived together and had no sexual relationship agreement those with agreement more likely to use condoms
decliners - why would women decline - perceived as low risk or work/ partners' work schedule acceptability was high - 78% preferred CHTC
Discussion - CHTC is recommended by WHO - implementation/ barriers/ acceptability assessed in urban setting challenges with bringing male partner - scheduling is biggest barrier
systematic reviews have shown efficacious in promoting safer sex and improved adherence to antiretroviral therapy if serodiscordant
CHTC - increase condom use -
CHTC used in community but not antenatal care - high acceptability
limitations - convenience sample, barriers to recruitment, can't assess impact on risk behaviors
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1 of 6 4/13/2020, 1:16 PM
CHTC well established to help increase communication and decrease risk behaviors - integrate into antenatal care Comments -
1. Implementation in antenatal care is useful
2. It states that risk behaviors can't be assessed, but also states that condom use is increased, so that is an impact on risk behavior
3. If it is recommended by WHO and implemented in the community, why wouldn't it have been recommended at
implemented in antenatal care - seems like a pilot study isn't really necessary but more of a quality improvement program
Reviewer #2:
1. Tables should be free-standing so be sure that legends explain relevant statistical tests.
2. In table 1, were the demographic characteristics of the women?
3. In some cases, e.g. living children, the SD is > mean. Would median and range be more appropriate?
4. Table 2, define the educational scoring. The scoring is not clear for many of the variables as they seem to be proportions but then proportions are listed as in parentheses.
Reviewer #3: Momplaisir et al present a cross-sectional study evaluating the implementation of Couples HIV Testing and Counseling in an antenatal clinic.
ABSTRACT:
- Please define "sexual agreement" in the abstract as I imagine that the general audience does not know this term.
INTRODUCTION:
- The introduction is clear and concise.
METHODS:
- Please describe in a bit more detail the recruitment flow for the patients in the study:
- When recruiting patients, were the eligibility questions asked to the couple to to each partner individually (especially reporting no coercion and no IPV)?
- If a partner wasn't at the initial visit but the couple agreed to participate, how was this handled? Was the woman given her first HIV result and then they came in together for CHTC?
- How exactly did you ask about the sexual agreement and what was coded as having a sexual agreement? At some point in your manuscript you comment on an implied versus an actual discussed sexual agreement - please elaborate on this a bit more. Did the couples with an implicit agreement say yes to having a sexual agreement?
- Was the question, "Do you have a sexual agreement and if so, what is it?" or was it "Have you agreed to only have sex with each other? To have sex with outside partners? etc..."
- Did the couples know what a sexual agreement is?
RESULTS:
- Were couples who were having sex outside of their relationship: More likely to have a sexual agreement? More likely to have used a condom the last time they had sex? It seems that perhaps the couples who are not having sex outside of their relationship may not be using condoms, may not feel confident working with their partner to talk about condom use when having sex outside of their relationship, etc.
- How many couples were recruited where the woman came without her partner at the first visit but then brought her partner for the CHTC?
- Do these couples differ in any way from the couples where the partner is there at the first visit?
DISCUSSION:
- Please add comments to the discussion based on any additional results that you add based on my comments above.
STATISTICAL EDITOR COMMENTS:
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The Statistical Editor makes the following points that need to be addressed:
lines 144-146: How many couples were potentially available, how many eligible and how many consented? Need to answer how representative this sample is.
lines 223-236 and Table 3: The demographic and clinical profile of the CHTC decliners vs those who participated implies that the analysis of the participants cannot be generalized. Need to have a better estimate of how many or what proportion of patients might participate vs decline.
Table 1: Since the total n=82, the %s should all be rounded to nearest integer %, not cited to 0.1% precision. Need units for age. The number of children can only be integers. Given the relatively modest sample and relationship of mean to SD, which implies that the distribution is skewed, should cite as median(range or IQR).
Table 2: Age needs units and should be rounded to nearest 0.1 year. I presume the format is mean(SD), but that should be stated. Need to clarify the meaning of education (Is this number of years beyond HS?) Again, need to clarify whether formatted as mean(SD). See previous comments re: number of children and use of mean(SD). Why is the proportion of used condom = 0 for those with an agreement and = 0.11 for those without an agreement, since lines 75-76 states the opposite is true?
Tables 3, 4: The N = 41, so the %s should be rounded to integer values, just as they should be for the participants, not reported to nearest 0.1% precision.
EDITOR'S COMMENTS:
We no longer require that authors adhere to the Green Journal format with the first submission of their papers. However, any revisions must do so. I strongly encourage you to read the instructions for authors (the general bits as well as those specific to the feature-type you are submitting). The instructions provide guidance regarding formatting, word and reference limits, authorship issues, and other things. Adherence to these requirements with your revision will avoid delays during the revision process, as well as avoid re-revisions on your part in order to comply with the formatting.
Line 66 or thereabouts. As this is relatively unknown and important to your study, please define a sexual relationship agreement in the methods section.
Also, in the methods section of the abstract, please provide the setting for you study ("antepartum (or prenatal) clinic of a large urban US tertiary medical center" or something similar).
Lines 74-8: I’m a bit lost in this section with respect to which partner or partners you are addressing. When you say on line 76 “at their last sexual encounter” was that an encounter between the 2 individuals of the couple in the study or could that include a sexual encounter w/ either outside of the dyad of the study? Likewise, on line 76, I’m uncertain who is the locus for “felt more confident working with their partner on condom use”…..Is that the partner in the dyad or the partner in the sexual relationship outside of the dyadic partnership of the study? Similar for line 78.
Line 78. The journal style does not support the use of the virgule ( / ) except in mathematical expressions. Please remove here and elsewhere.
Line 79 is vague as you haven’t told us what items were measured for acceptability. Can you expand within word limits?
Did results on any measure differ by whether at least one of the members of the dyad was HIV Pos or not?
Line 111: They are at risk even when the partner is on ART if their count is undetectable, correct? Please spell out
“antiretroviral” rather than use ART.
Line 116: not a 100% true statement that women who conceive are having condomless sex. May of course be true, but there are contraceptive failures with condom use.
Line 137: “Need for CHTC” or “benefits of CHTC”?
Line 142: Please define reciprocal dyadic data collection.
Line 144. Please note that your study was conducted from date 1 to date 2, not between those dates. As written, it would exclude the dates given .
Line 141: who approached the patient and partner about participation with CHTC?
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For the woman who came alone and had HIV testing done (Line 150) were the results delayed if she and her partner decided after the visit to participate until he could get tested? Presumably in this case, it wouldn’t be a rapid HIV test.
Please comment.
Who paid for the male partner testing if he did not have insurance?
Line 167:ever tested or ever positive?
Line 175: please provide the full name of the CDC.
Line 176: what do you mean “Explored the couple’s relationship”?
Line 209: P Values vs Effect Size and Confidence Intervals
While P values are a central part of inference testing in statistics, when cited alone, often the strength of the conclusion can be misunderstood. Whenever possible, the preferred citation should be in terms of an effect size, such as odds ratio or relative risk or the mean difference of a variable between two groups, expressed with appropriate confidence intervals.
When such syntax is used, the P value has only secondary importance and often can be omitted or noted as footnotes in a Table format. Putting the results in the form of an effect size makes the result of the statistical test more clinically relevant and gives better context than citing P values alone.
This is true for the abstract as well as the manuscript, tables and figures.
Please provide absolute values for variables, in addition to assessment of statistical significance.
We ask that you provide crude OR’s followed by adjusted OR’s for all relevant variables.
Line 213 “When you say “had a child” this is referencing the couple, correct? Do you mean had a child together?
Line 215 and 216: This is an example of inconsistent use of terms. Is it a sexual relationship agreement or a sexual agreement? Please be consistent throughout.
Lines 218-22: Please address questions for abstract section as they pertain to this section.
Line 265. This is known as a primacy claim: yours is the first, biggest, best study of its kind. In order to make such a claim, please provide the databases you have searched (PubMED, Google Scholar, EMBASE for example), the year ranges, and the search terms used. If not done, please edit it out of the paper.
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9. In your Abstract, manuscript Results sections, and tables, the preferred citation should be in terms of an effect size, such as odds ratio or relative risk or the mean difference of a variable between two groups, expressed with appropriate confidence intervals. When such syntax is used, the P value has only secondary importance and often can be omitted or noted as footnotes in a Table format. Putting the results in the form of an effect size makes the result of the statistical test more clinically relevant and gives better context than citing P values alone.
If appropriate, please include number needed to treat for benefits (NNTb) or harm (NNTh). When comparing two procedures, please express the outcome of the comparison in U.S. dollar amounts.
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If you submit a revision, we will assume that it has been developed in consultation with your co-authors and that each author has given approval to the final form of the revision.
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April 10, 2020
Re: Resubmission of manuscript: “Implementing Couples’ HIV Testing and Counseling in the Antenatal Care Setting”
Nancy C. Chescheir, MD
Editor-in-Chief, Obstetrics and Gynecology UNC OB/GYN
101 Manning Drive Chapel Hill, NC27514 Dear Dr. Chescheir,
We are pleased to resubmit the revised version of manuscript # ONG-20-261R1 entitled
“Implementing Couples’ HIV Testing and Counseling in the Antenatal Care Setting” for
publication. The feedback and constructive criticisms provided by the editors and reviewers were greatly appreciated and we have revised the manuscript accordingly: we now provide the
definition of sexual agreement in the abstract, we clarified the recruitment flow, and have include the ORs for having a sexual agreement in Table 2. In addition, we have addressed the reviewers’
and editors’ specific comments below. Changes made in the manuscript are included in track changes.
REVIEWER#1
Reviewer#1 started by providing a summary of our study.
“Precis - Couples' HIV test/Counseling is feasible and acceptable in antenatal care
Abstract - Objective - pilot implementation Couples' HIV testing and counseling (CHTC) Methods - cross sectional design - couples with prenatal care and agree to testing; assessed barriers to recruitment and clinic barriers and facilitators
Results - 41 couples - 68% with no sexual relationship agreement; those with an agreement were more likely to use condoms and have HIV testing.
Individual barriers were male partner compliance and idea that they were low risk; clinic barriers - training
Background - HIV serodiscordance is a risk if no antiretroviral treatment (ART) - increased risk perinatal transmission; many men don't know or discuss status
couples' testing can impact primary and secondary HIV transmission Africa - CHTC is recommended by WHO and develop sexual agreements hypothesis - CHTC is needed and acceptable
Methods - Cross sectional design - 41 couples - 4/16- 7/17 - data collected, agreed to testing, sexual agreement, sex related behaviors assessed
CHTC - discuss sexual agreement, rapid HIV testing, acceptability questionnaire and clinic barriers
Data Analysis - 41 couples
Results - 73% black, median age 28.4 yr, most lived together and had no sexual relationship
agreement those with agreement more likely to use condoms
decliners - why would women decline - perceived as low risk or work/ partners' work schedule acceptability was high - 78% preferred CHTC
Discussion - CHTC is recommended by WHO - implementation/ barriers/ acceptability assessed in urban setting
challenges with bringing male partner - scheduling is biggest barrier
systematic reviews have shown efficacious in promoting safer sex and improved adherence to antiretroviral therapy if serodiscordant
CHTC - increase condom use -
CHTC used in community but not antenatal care - high acceptability
limitations - convenience sample, barriers to recruitment, can't assess impact on risk behaviors CHTC well established to help increase communication and decrease risk behaviors - integrate into antenatal care
RESPONSE TO REVIEWER#1 SUMMARY: We thank reviewer#1 for this succinct summary. We addressed reviewer #1’s comments consecutively below.
Reviewer#1 Comment: 1. Implementation in antenatal care is useful
RESPONSE 1: We agree that implementation of Couples' HIV testing and counseling (CHTC) in antenatal care is useful as it provides an opportunity to assess the partner’s HIV status and engage in discussion around sexual risk behaviors.
Reviewer#1 Comment: 2. It states that risk behaviors can't be assessed, but also states that condom use is increased, so that is an impact on risk behavior
RESPONSE 2: We compared risk behaviors among couple with and without a sexual agreement but this information was collected using the questionnaire administered before the CHTC
session. Because this is a cross-sectional study, we were unable to assess the impact of CHTC on risk behaviors (we had no prospective follow-up).
Reviewer#1 Comment: 3. If it is recommended by WHO and implemented in the community, why wouldn't it have been recommended at implemented in antenatal care - seems like a pilot study isn't really necessary but more of a quality improvement program
RESPONSE 3: We agree with reviewer#1 that CHTC has been widely accepted and
implemented in the U.S. among other populations (men who have sex with men) and globally in the antenatal care setting. We know that CHTC is effective in reducing sexual risk behaviors.
This study was not piloted for effectiveness but to assess barriers and facilitators to
implementing CHTC in antenatal care using a diversity of stakeholder’s perspectives (study
participants, decliners, providers and medical clinic director). This approach is not far from a
quality improvement (QI) program and sometimes QI and implementation projects overlap
because of their shared goal to improve healthcare. One point of differentiation is that QI
projects focus mainly on achieving measurable changes in processes of care and outcomes, and
since we did not collect data prospectively, we think that the wording of pilot implementation is
more appropriate for this study. In addition, implementation science typically begins with an
evidence-based intervention that is under-utilized, and then identifies and addresses resultant quality gaps at the provider, clinic, or healthcare system level. We have modified the
introduction to justify our approach with the use of the Consolidated Framework for
Implementation Research (CFIR) which describes constructs related to implementation including perceived interventions characteristics, outer setting (e.g., patient needs and resources), inner setting (e.g., the implementation climate within the clinic), individuals’ characteristics (e.g., engagement in preventive risk behaviors) and the implementation process. The introduction now reads, page 6, lines 140 to 143:
“ This study seeks to address these gaps by using the Consolidated Framework for Implementation Research (CFIR) to understand contextual factors at the individual and clinic level that may influence program adoption and implementation.”
REVIEWER#2
Reviewer#2 Comment: Tables should be free-standing so be sure that legends explain relevant statistical tests
RESPONSE 4: We have formatted the tables to make them free-standing. The changes include making the titles for Tables 1 and 2 more detailed and include relevant statistical tests as
indicated.
Reviewer#2 comment: 2. In table 1, were the demographic characteristics of the women?
RESPONSE 5: We thank Reviewer#2 for asking to clarify this. The demographic characteristics on Table 1 include pregnant women and their partner. We realized that the description of our sample in the title was not clear and have removed the word “Dyad.” The Title for Table 1 now reads:
“Demographic and relationship characteristics of pregnant women and their sex partners seeking antenatal care in a large academic clinic, n=82”, page 18, line 463
Reviewer#2 comment: 3. In some cases, e.g. living children, the SD is > mean. Would median and range be more appropriate?
RESPONSE 6: We thank reviewer#2 for pointing this out. We have replaced the means for medians, SD for range (min and max) for number of children and number of partners. These changes were made on Table 1 and Table 3.
Reviewer#2 comment: 4. Table 2, define the educational scoring.
RESPONSE 7: We now include the categories for education as well as educational scoring in the legend:
“Education included the following categories with consecutive values from 1 to 5: never
attended school or only attended kindergarten, Grades 1 through 8 (Elementary), Grades
9 through 11 (Some high school), Grade 12 or GED (High school graduate), College 1
year to 3 years (Some college or technical school). A higher score indicates higher education .”
Reviewer#2 comment: The scoring is not clear for many of the variables as they seem to be proportions but then proportions are listed as in parentheses
RESPONSE 8: We have clarified the scoring in Table 2. In general, for continuous variables, we displayed the mean and SD; for categorical variables, we displayed the mean proportion and SD.
REVIEWER#3
Reviewer#3 Comments: 1. Abstract: Please define "sexual agreement" in the abstract as I imagine that the general audience does not know this term.
RESPONSE 9: We thank reviewer #3 for this comment and have added the definition of sexual agreement in the abstract and the introduction. The methods section includes a more detailed definition.
Abstract, page 3, line 71-73 now reads:
“We assessed relationship characteristics, HIV risk related behaviors and concordance of couples’ sexual agreement (i.e., mutual agreement about sexual risk behaviors that are permissible within or outside of their relationship).”
Introduction, page 5, line 130-136 now reads:
“In addition to sharing HIV test results, a core aspect of CHTC is the establishment of a sexual agreement which occurs when couples agree on rules related to risk behaviors that are permissible within and outside of their relationship and the conditions under which these risk behaviors are permissible. This is done with the goal of reaching concordance (i.e. the couple agreeing on sexual risk behaviors) and eventually reducing HIV risk.”
Methods, page 7, line 172-177 now reads:
“Sexual agreements were coded as to whether individuals believed they and their partner agreed to: have sex only with each other; have sex with outside partners without
conditions or restrictions; or have sex with outside partners with conditions or
restrictions. To have a sexual agreement, concordance with the perceived nature of the sexual agreement needed to occur. Couples with discordant choices and couples who reported that they did not have or were not sure about having a sexual agreement were categorized as not having a sexual agreement.”
Reviewer#3 Comment: 2. Methods: - Please describe in a bit more detail the recruitment flow for the patients in the study:
RESPONSE 10: We have modified the methods section to clarify the recruitment flow. With
these changes, the first paragraph of the methods section now reads (page 6, line 148-163):
“We used a cross-sectional design with dyadic data collection using identical instruments that couples filled separately in a quiet place. A convenience sample of 82 individuals (41 couples) was recruited from an academic antenatal clinic from April 2016 to July 2017.
Recruitment methods included face-to-face recruitment in the clinic waiting room and during the intake process at the initial visit, using flyers in the clinic, and phone messages during appointment scheduling. Women who came in without a partner were handed a flyer about the study and encouraged to bring their partner to a future visit. In order not to deviate from standard of care, these women received conventional HIV testing followed by CHTC. Before participating in CHTC, couples filled out an eligibility questionnaire administered on an iPad. The questionnaire was filled separately by each partner to ensure that participation was voluntary and that no one felt coerced by their partner to join the study. Couples were eligible if both partners agreed to receive HIV test results together and reported no coercion to participate in CHTC and no intimate partner violence (IPV). Eligible couples provided written informed consent. We then collected demographic and risk behaviors data before the CHTC session and acceptability data after the CHTC session.”
Reviewer#3 Comment: - When recruiting patients, were the eligibility questions asked to the couple to each partner individually (especially reporting no coercion and no IPV)?
RESPONSE 11: Screening for eligibility was always done separately to ensure that there was no coercion for participation on CHTC and no IPV. This is now clarified in the method section as described in the response to the previous question.
Reviewer#3 Comment: If a partner wasn't at the initial visit but the couple agreed to
participate, how was this handled? Was the woman given her first HIV result and then they came in together for CHTC?
RESPONSE 12: If a partner was not present at the initial visit, we did not deviate from standard of care in order not to delay HIV testing. In this case, women received their first trimester test with the initial labs and returned with their partner for CHTC.
Reviewer#3 Comment: - How exactly did you ask about the sexual agreement and what was coded as having a sexual agreement?
RESPONSE 13: The actual wording for having a sexual agreement was as follows:
“Do you and your partner have an agreement about whether you are allowed to have sex with others outside your relationship?
• We have agreed to have sex only with each other - we cannot have any sex with an outside partner
• We can have sex with outside partners, without any conditions or restrictions
• We can have sex with outside partners, but with some conditions or restrictions
• We do not have any agreement about having sex outside the relationship
• I'm not sure if we have an agreement”
The coding for the sexual agreement is reflected in the second paragraph of the methods section, page 7, line 172-177:
“Sexual agreements were coded as to whether individuals believed they and their partner agreed to: have sex only with each other; have sex with outside partners without
conditions or restrictions; or have sex with outside partners with conditions or
restrictions. To have a sexual agreement, concordance with the perceived nature of the sexual agreement needed to occur. Couples with discordant choices and couples who reported that they did not have or were not sure about having a sexual agreement were categorized as not having a sexual agreement.”
Reviewer#3 Comment: At some point in your manuscript you comment on an implied versus an actual discussed sexual agreement - please elaborate on this a bit more. Did the couples with an implicit agreement say yes to having a sexual agreement?
RESPONSE 14: Among couples with a sexual agreement, we asked how they reached this agreement using the following question:
“How did you form your relationship agreement?
• We discussed it together
• We did not discuss it, but it is mutually understood”
The first option (when a discussion took place) was coded as having an explicit agreement and the second option (when a discussion did not take place but it was mutually understood) was coded as having an implicit agreement. We added this sentence to the second paragraph of the methods section to clarify this, page 8, line 178-180:
“Among couples with a sexual agreement, we asked whether or not a discussion took place to reach their sexual agreement (explicit agreement) or whether or not this
agreement was mutually understood without having a discussion (implicit agreement).”
Reviewer#3 Comment: - Was the question, "Do you have a sexual agreement and if so, what is it?" or was it "Have you agreed to only have sex with each other? To have sex with outside partners? etc..."
RESPONSE 15: The response to this question was provided on responses 13 and 14.
Reviewer#3 Comment: - Did the couples know what a sexual agreement is?
RESPONSE 16: In the question on sexual agreement, we provided a definition (“Do you and your partner have an agreement about whether you are allowed to have sex with others outside your relationship”), followed by the answer choices. These concepts were also discussed during the CHTC session.
Reviewer#3 Comment: 3. Results: - Were couples who were having sex outside of their
relationship: More likely to have a sexual agreement? More likely to have used a condom the
last time they had sex? It seems that perhaps the couples who are not having sex outside of their relationship may not be using condoms, may not feel confident working with their partner to talk about condom use when having sex outside of their relationship, etc.
RESPONSE 17: There are two variables that assessed whether or not couples were having sex outside of their relationship. The first one was two of the options for the question on sexual agreement:
“Do you and your partner have an agreement about whether you are allowed to have sex with others outside your relationship?
• We can have sex with outside partners, without any conditions or restrictions
• We can have sex with outside partners, but with some conditions or restrictions In this question, having sex outside of the main relationship would be co-linear with having a sexual agreement since this option was embedded within the sexual agreement question.
In another question, we asked about number of sexual partners. We ran an analysis comparing people who reported having more than one sexual partner and condom use at the last sexual encounter. In general, condom use was low: only 6/82 individuals reported using condoms at their last sexual encounter. We found no statistical difference between having more than 1 partner and condom use at the last sexual encounter. Among people with only 1 partner, 4/62 (6%) reported using condoms versus 2/20 (10%) for people with multiple partners (p=0.60). The lack of significance is likely due to our small sample size.
Reviewer#3 Comment: - How many couples were recruited where the woman came without her partner at the first visit but then brought her partner for the CHTC?
RESPONSE 18: We unfortunately did not keep an exact count but we estimated that this
occurred about 50% of the time. We purposely tried to recruit couples during intake or the initial visit because that’s when women are more likely to come with their partner.
Reviewer#3 Comment: - Do these couples differ in any way from the couples where the partner is there at the first visit?
RESPONSE 19: We did not systematically collect that information and are unable to tell.
Reviewer#3 Comment: 4. Discussion: - Please add comments to the discussion based on any additional results that you add based on my comments above
RESPONSE 20: We expand on these points in the limitation section of the discussion, page 15, line 328-331:
“There are several limitations to this study. First, we used a convenience sample for recruitment and as shown in our results, participants and decliners differed across several demographic and risk characteristics. In addition, we have no data comparing couples who initially presented with their partner versus those who brought their partners subsequently.”
STATISTICAL EDITOR COMMENTS
Statistical Editor Comment: 1. Lines 144-146: How many couples were potentially available, how many eligible and how many consented? Need to answer how representative this sample is.
RESPONSE 1: There were approximately 525 couples who were potentially available for CHTC and about 8% (n=41) of eligible couples consented for the study. This low recruitment reflects the challenges of bringing the partner in for testing and is reflected with the barriers reported by participants. We used recruitment approaches that were feasible within our clinic infrastructure such as telephone calls and recruitment during the intake process or in the waiting room. Our approaches and findings reflected what occurred in a real-world setting. This point was added to the results section, page 10, line 229-232, which is included in response#2.
Statistical Editor Comment 2. Lines 223-236 and Table 3: The demographic and clinical profile of the CHTC decliners vs those who participated implies that the analysis of the participants cannot be generalized. Need to have a better estimate of how many or what proportion of patients might participate vs decline.
RESPONSE 2: Out of the 525 eligible couples, 97 were directly approached for recruitment by phone and others were told about the study in the waiting room. We have added these estimates in the results section, page 10, lines 229-232:
“There were approximately 525 couples who were potentially available for CHTC. Out of eligible couples, 97 (18%) were approached for recruitment by phone and the remainder were told about the study in the clinic waiting room or during the intake process. About 8% (n=41) of eligible couples consented for the study.”
Statistical Editor Comment 3. Table 1: Since the total n=82, the %s should all be rounded to nearest integer %, not cited to 0.1% precision. Need units for age. The number of children can only be integers. Given the relatively modest sample and relationship of mean to SD, which implies that the distribution is skewed, should cite as median (range or IQR).
RESPONSE 3: We have made changes to Table 1 (Page 19) to round to the percentages to the nearest integer. We have added the unit for age (years). The number of children is now displayed as an integer. We have replaced the display of mean (SD) with median and range for number of children, as addressed to our comments to reviewer#2, response 6.
Statistical Editor Comment: 4. Table 2: Age needs units and should be rounded to nearest 0.1 year. I presume the format is mean(SD), but that should be stated. Need to clarify the meaning of education (Is this number of years beyond HS?) Again, need to clarify whether formatted as mean(SD). See previous comments re: number of children and use of mean(SD). Why is the proportion of used condom = 0 for those with an agreement and = 0.11 for those without an agreement, since lines 75-76 states the opposite is true?
RESPONSE 4: We have made the suggested changes to Table 2 (page 21) to add units for age and round to the nearest 0.1. We have specified that age was displayed as mean (SD). Please refer to our response to reviewer#2, response 7 for more details on the meaning of education.
In response to the Editor’s comment #19, we have now included unadjusted odds ratios for all
the variables. In the process, 2 variables had very low variability: “condom use at the last sexual
encounter” and “If tested, most recent results were HIV+.” Consequently, a 95% CI could not be calculated for these 2 variables. Since we are unable to report findings for these 2 variables with confidence, we have removed them from the tables and the text. This omission does not change our results.
Statistical Editor Comment: 5. Tables 3, 4: The N = 41, so the %s should be rounded to
integer values, just as they should be for the participants, not reported to nearest 0.1% precision.
RESPONSE 5: Tables 3 and 4 now display the %s rounded to integer values.
EDITOR’S COMMENTS
Editor’s Comment: 1. We no longer require that authors adhere to the Green Journal format with the first submission of their papers. However, any revisions must do so. I strongly
encourage you to read the instructions for authors (the general bits as well as those specific to the feature-type you are submitting). The instructions provide guidance regarding formatting, word and reference limits, authorship issues, and other things. Adherence to these requirements with your revision will avoid delays during the revision process, as well as avoid re-revisions on your part in order to comply with the formatting.
RESPONSE 1: We have made the following revisions: removed the abbreviations from the title and the precis, and spelled them out the first time they were used in the abstract and in the
manuscript; removed the virgule symbol; and updated the tables according to the table checklist.
Editor’s Comment: 2. Line 66 or thereabouts. As this is relatively unknown and important to your study, please define a sexual relationship agreement in the methods section.
RESPONSE 2: We have addressed this comment in detail in responses 9 and 13 from reviewer#3.
Editor’s Comment: 3. Also, in the methods section of the abstract, please provide the setting for you study ("antepartum (or prenatal) clinic of a large urban US tertiary medical center" or something similar).
RESPONSE 3: The first sentence of the methods section of the abstract now reads, page 3, line 67-68:
“Couples were recruited from an antepartum clinic of a large urban U.S. tertiary medical center.”
Editor’s Comment: 4. Lines 74-8: I’m a bit lost in this section with respect to which partner or
partners you are addressing. When you say on line 76 “at their last sexual encounter” was that
an encounter between the 2 individuals of the couple in the study or could that include a sexual
encounter w/ either outside of the dyad of the study? Likewise, on line 76, I’m uncertain who is
the locus for “felt more confident working with their partner on condom use”. Is that the partner
in the dyad or the partner in the sexual relationship outside of the dyadic partnership of the
study? Similar for line 78.
RESPONSE 4: These questions refer to the partner in dyad. We have changed the wording in the abstract to reflect this, page 3, lines 80 to 84:
“Partners with a concordant sexual agreement (n=26) felt more confident working with their partner on condom use when having sex outside of their relationship (p=0.008) and were more likely to agree with their partner to get tested regularly for HIV and/or STI (p=0.015).”
Editor’s Comment: 5. Line 78. The journal style does not support the use of the virgule ( / ) except in mathematical expressions. Please remove here and elsewhere.
RESPONSE 5: We have modified all the sections where the use of the virgule appeared.
Specifically, the changes were made on page 3, line 84; page 10, line 235; page 11, line 245;
page 19, Table 1; page 23, Table 2; page 24, Table 3; page 26, Table 4.
Editor’s Comment: 6. Line 79 is vague as you haven’t told us what items were measured for acceptability. Can you expand within word limits?
RESPONSE 6a: To address this comment, we have modified the abstract to now read, page 3, line 73-75:
“Acceptability of CHTC (i.e. format, quality of the sessions, ability to meet their needs) was assessed after completing the session.”
Editor’s Comment: Did results on any measure differ by whether at least one of the members of the dyad was HIV Pos or not?
RESPONSE 6b: The numbers were too low to compare, only one person reported being HIV positive.
Editor’s Comment: 7. Line 111: They are at risk even when the partner is on ART if their count is undetectable, correct? Please spell out “antiretroviral” rather than use ART.
RESPONSE 7: If patients living with HIV adhere to their antiretroviral therapy and are undetectable, they are unable to transmit the infection to their sex partners. This finding has revolutionized the field of HIV and the help with the fight against HIV related stigma.
For more on the topic, please visit: https://www.cdc.gov/hiv/risk/art/index.html
Editor’s Comment: 8. Line 116: not a 100% true statement that women who conceive are having condomless sex. May of course be true, but there are contraceptive failures with condom use.
RESPONSE 8: We changed the wording for the following, page 5, line 116-118:
“Furthermore, regardless of pregnancy intention, most women who conceive are having
condomless-sex, which further increases their HIV risk.”
Editor’s Comment: 9. Line 137: “Need for CHTC” or “benefits of CHTC”?
RESPONSE 9: We substituted “need” for benefit, page 6, line 143.
Editor’s Comment: 10. Line 142: Please define reciprocal dyadic data collection.
RESPONSE 10: Reciprocal dyadic data collection occurs when each of two parties respond using the same questions and the questionnaires are administered separately. To avoid confusion, this term is removed from the abstract and explained in method section, page 6, line 148-149:
“We used a cross-sectional design with dyadic data collection using identical instruments that couples filled separately in a quiet place.”
Editor’s Comment: 11. Line 144. Please note that your study was conducted from date 1 to date 2, not between those dates. As written, it would exclude the dates given.
RESPONSE 11: This change has been made, page 6, line 151.
Editor’s Comment:12. Line 141: who approached the patient and partner about participation with CHTC?
RESPONSE 12: The patients were approached by the intake counselor who is a nurse
practitioner, the program manager, and research assistant. We have specified our approach in the methods section, page 6, line 151-153:
“Recruitment methods included approaching women in the clinic waiting room and during the intake process at the initial visit, using flyers in the clinic waiting room and exam rooms, and phone messages during appointment scheduling.
Editor’s Comment: 13. Line 137: “Need for CHTC” or “benefits of CHTC”?
RESPONSE 13: Changed “need” for “benefits.”
Editor’s Comment: 14. For the woman who came alone and had HIV testing done (Line 150) were the results delayed if she and her partner decided after the visit to participate until he could get tested? Presumably in this case, it wouldn’t be a rapid HIV test. Please comment.
RESPONSE 14: No, HIV testing or HIV testing results were never delayed. Women received conventional HIV testing if both partners did not want to receive CHTC and if they changed their mind after the visit, they returned for CHTC where a rapid test was done for both partners.
Editor’s Comment: 15. Who paid for the male partner testing if he did not have insurance?
RESPONSE 15: Our clinic received Title X funds which covered the cost for HIV testing.
Editor’s Comment: 16. Line 167:ever tested or ever positive?
RESPONSE 16: It is currently correct as described, ever tested.
Editor’s Comment: 17. Line 175: please provide the full name of the CDC.
RESPONSE 17: This is now provided.
Editor’s Comment: 18. Line 176: what do you mean “Explored the couple’s relationship”?
RESPONSE 18: We used the same language provided by the CDC in the CHTC module. By exploring the couple’s relationship, the facilitator tries to assess the nature and characteristics of the relationship (i.e., short versus long term relationship, social support, etc). For more details, please visit:
https://www.cdc.gov/hiv/pdf/testing/CDC_HIV_PROTOCOL_CARDS_HIV_Testing_Together.
pdf.
Editor’s Comment: 19. Line 209: P Values vs Effect Size and Confidence Intervals
While P values are a central part of inference testing in statistics, when cited alone, often the strength of the conclusion can be misunderstood. Whenever possible, the preferred citation should be in terms of an effect size, such as odds ratio or relative risk or the mean difference of a variable between two groups, expressed with appropriate confidence intervals. When such syntax is used, the P value has only secondary importance and often can be omitted or noted as footnotes in a Table format. Putting the results in the form of an effect size makes the result of the statistical test more clinically relevant and gives better context than citing P values alone.
This is true for the abstract as well as the manuscript, tables and figures.
20. Please provide absolute values for variables, in addition to assessment of statistical
significance. 21. We ask that you provide crude OR’s followed by adjusted OR’s for all relevant variables.
RESPONSE 19-21: Table 2 now includes the ORs and the 95% CI for all the variables.
Editor’s Comment: 22. Line 213 “When you say “had a child” this is referencing the couple, correct? Do you mean had a child together?
RESPONSE 22: Each member of the couple were asked the same questions separately. The exact question was: “How many living children do you have?”. We did not specify if the children were within or outside of their relationship.
Editor’s Comment: 23. Line 215 and 216: This is an example of inconsistent use of terms. Is it a sexual relationship agreement or a sexual agreement? Please be consistent throughout.
RESPONSE 23: To be consistent, we now only use sexual agreement.
Editor’s Comment: 24. Lines 218-22: Please address questions for abstract section as they
pertain to this section.
RESPONSE 24: The abstract has been updated.
Editor’s Comment: 25. Line 265. This is known as a primacy claim: yours is the first, biggest, best study of its kind. In order to make such a claim, please provide the databases you have searched (PubMED, Google Scholar, EMBASE for example), the year ranges, and the search terms used. If not done, please edit it out of the paper.
RESPONSE 25: We have removed the word “novel”, page 13, line 288-289:
“ This study reports on such implementation, including CHTC’s acceptability, barriers, and facilitators in an urban antenatal clinic.”
EDITORIAL OFFICE
Editorial Office Comment:1. The Editors of Obstetrics & Gynecology are seeking to increase transparency around its peer-review process, in line with efforts to do so in international biomedical peer review publishing. If your article is accepted, we will be posting this revision letter as supplemental digital content to the published article online. Additionally, unless you choose to opt out, we will also be including your point-by-point response to the revision letter. If you opt out of including your response, only the revision letter will be posted. Please reply to this letter with one of two responses:
A. OPT-IN: Yes, please publish my point-by-point response letter.
B. OPT-OUT: No, please do not publish my point-by-point response letter.
RESPONSE 1: OPT-IN
Editorial Office Comment 2: 2. As of December 17, 2018, Obstetrics & Gynecology has implemented an "electronic Copyright Transfer Agreement" (eCTA) and will no longer be collecting author agreement forms. When you are ready to revise your manuscript, you will be prompted in Editorial Manager (EM) to click on "Revise Submission." Doing so will launch the resubmission process, and you will be walked through the various questions that comprise the eCTA. Each of your coauthors will receive an email from the system requesting that they review and electronically sign the eCTA.
Please check with your coauthors to confirm that the disclosures listed in their eCTA forms are correctly disclosed on the manuscript's title page.
RESPONSE 2: Thank you. We will follow-up with co-authors regarding their disclosures.
Editorial Office Comment 3: 3. Standard obstetric and gynecology data definitions have been developed through the reVITALize initiative, which was convened by the American College of Obstetricians and Gynecologists and the members of the Women's Health Registry Alliance.
Obstetrics & Gynecology has adopted the use of the reVITALize definitions. Please access the obstetric and gynecology data definitions at https://www.acog.org/About-ACOG/ACOG- Departments/Patient-Safety-and-Quality-Improvement/reVITALize. If use of the reVITALize definitions is problematic, please discuss this in your point-by-point response to this letter.
RESPONSE 3: N/A, our manuscript does not use obstetric data.
Editorial Office Comment 4: 4. Because of space limitations, it is important that your revised manuscript adhere to the following length restrictions by manuscript type: Original Research reports should not exceed 22 typed, double-spaced pages (5,500 words). Stated page limits include all numbered pages in a manuscript (i.e., title page, précis, abstract, text, references, tables, boxes, figure legends, and print appendixes) but exclude references.
RESPONSE 4: Our manuscript is currently at 2955 words, under the word count limit of 5,500 words.
Editorial Office Comment: 5. Specific rules govern the use of acknowledgments in the journal.
Please note the following guidelines:
* All financial support of the study must be acknowledged.
* Any and all manuscript preparation assistance, including but not limited to topic development, data collection, analysis, writing, or editorial assistance, must be disclosed in the
acknowledgments. Such acknowledgments must identify the entities that provided and paid for this assistance, whether directly or indirectly.
* All persons who contributed to the work reported in the manuscript, but not sufficiently to be authors, must be acknowledged. Written permission must be obtained from all individuals named in the acknowledgments, as readers may infer their endorsement of the data and conclusions.
Please note that your response in the journal's electronic author form verifies that permission has been obtained from all named persons.
* If all or part of the paper was presented at the Annual Clinical and Scientific Meeting of the American College of Obstetricians and Gynecologists or at any other organizational meeting, that presentation should be noted (include the exact dates and location of the meeting).
RESPONSE 5: We have specified in the acknowledgment section of the Title page that there was no financial support for this study and we did not use manuscript preparation assistance.
Presentation dates are included in the title page.
Editorial Office Comment: 6. The most common deficiency in revised manuscripts involves the abstract. Be sure there are no inconsistencies between the Abstract and the manuscript, and that the Abstract has a clear conclusion statement based on the results found in the paper. Make sure that the abstract does not contain information that does not appear in the body text. If you submit a revision, please check the abstract carefully.
In addition, the abstract length should follow journal guidelines. The word limits for different article types are as follows: Original Research articles, 300 words. Please provide a word count.
RESPONSE 6: We have revised the abstract. The word count without the subheadings is at 300.
Editorial Office Comment: 7. Only standard abbreviations and acronyms are allowed. A selected list is available online at http://edmgr.ovid.com/ong/accounts/abbreviations.pdf.
Abbreviations and acronyms cannot be used in the title or précis. Abbreviations and acronyms
must be spelled out the first time they are used in the abstract and again in the body of the
manuscript.
RESPONSE 7: Our use of acronyms are limited to commonly used acronyms such as HIV and STI. The abbreviations have been removed from the title and précis and have been spelled out the first time in the abstract and the manuscript.
Editorial Office Comment: 8. The journal does not use the virgule symbol (/) in sentences with words. Please rephrase your text to avoid using "and/or," or similar constructions throughout the text. You may retain this symbol if you are using it to express data or a measurement.
RESPONSE 8: All virgule symbols have been replaced with “or” throughout the document.
Editorial Office Comment: 9. In your Abstract, manuscript Results sections, and tables, the preferred citation should be in terms of an effect size, such as odds ratio or relative risk or the mean difference of a variable between two groups, expressed with appropriate confidence intervals. When such syntax is used, the P value has only secondary importance and often can be omitted or noted as footnotes in a Table format. Putting the results in the form of an effect size makes the result of the statistical test more clinically relevant and gives better context than citing P values alone.
If appropriate, please include number needed to treat for benefits (NNTb) or harm (NNTh).
When comparing two procedures, please express the outcome of the comparison in U.S. dollar amounts.
Please standardize the presentation of your data throughout the manuscript submission. For P values, do not exceed three decimal places (for example, "P = .001"). For percentages, do not exceed one decimal place (for example, 11.1%").
RESPONSE 9: All the data has been standardized, the p values are reported with three decimals places and the percentages do not exceed one decimal place.
Editorial Office Comment: 10. Line 264-266: We discourage claims of first reports since they are often difficult to prove. How do you know this is the first report? If this is based on a
systematic search of the literature, that search should be described in the text (search engine, search terms, date range of search, and languages encompassed by the search). If on the other hand, it is not based on a systematic search but only on your level of awareness, it is not a claim we permit.
RESPONSE 10: Please refer to response 25 from the Editor’s comment.
Editorial Office Comment: 11. Please review the journal's Table Checklist to make sure that your tables conform to journal style.
RESPONSE 11: We have updated all the tables to conform to the journal’s checklist.
12. Authors whose manuscripts have been accepted for publication have the option to pay an article processing charge and publish open access. With this choice, articles are made freely available online immediately upon publication.
RESPONSE 12: Thank you for the information.
We appreciate the insightful comments of the reviewers and have tried to improve the
manuscript by responding to their suggestions. If there are any future comments or questions, please let us know. We hope that you will find the revised manuscript appropriate for
publication. Thank you again for taking the time to review and consider our work.
Sincerely,
Florence Momplaisir MD, MSHP