Downloaded from http://bmjopen.bmj.com/ on June 18, 2017 - Published by group.bmj.com PEER REVIEW HISTORY BMJ Open publishes all reviews undertaken for accepted manuscripts. Reviewers are asked to complete a checklist review form (http://bmjopen.bmj.com/site/about/resources/checklist.pdf) and are provided with free text boxes to elaborate on their assessment. These free text comments are reproduced below. ARTICLE DETAILS TITLE (PROVISIONAL) AUTHORS Exploiting Social Influence to Magnify Population-Level Behavior Change in Maternal and Child Health: Study Protocol for a Randomized Controlled Trial of Network Targeting Algorithms in Rural Honduras Shakya, H; Stafford, Derek; Hughes, D.; Keegan, Thomas; Negron, Rennie; Broome, Jai; McKnight, Mark; Nicoll, Liza; Nelson, Jennifer; Iriarte, Emma; Ferrera, Maria; Airoldi, Edo; Fowler, James; Christakis, Nicholas VERSION 1 - REVIEW REVIEWER REVIEW RETURNED GENERAL COMMENTS David A. Shoham Department of Public Health Sciences, Loyola University Chicago Stritch School of Medicine, Maywood, IL, USA 18-Aug-2016 This is an intriguing study protocol that will test various levels of recruitment to a reproductive, maternal, neonatal, and child health intervention in Honduras that employ social network principles. The rationale for the trial, which will randomize 176 villages (with a total of 30k individuals) to various network-based treatment implementations and with eight proportions of the population targeted in an 8x2 factorial design. The proposal is extremely ambitious but resources commensurate with the effort required appear to be in place. Ultimately, the researchers hope to find treatment thresholds and demonstrate that partial network data collection (eg, targeting friends of randomly selected individuals) will have similar impact as more cumbersome whole-network (sociometric or socioeconomic) network designs. This is a novel approach: while members of the research team have demonstrated effectiveness of this approach for H1N1, it has not, to my knowledge, been applied to a health behavioral intervention I do have some questions about the statistical models to be used. First, the authors focus on analyses at the individual and the ecological (village) level which will ignore the richness of the data nested withing villages. Second, the influence process is modeled as a regression of the ego's behavior on their alters' treatment status (equation 1, SA page 8). They plan to stratify based on number of friends named and combine in a meta-analytic fashion. But this seems like an overly simplistic approach that may obscure important spillover effects. It is encouraging to see that alternative models for alter influence (eg, average alter, model 1b) will be assessed. Third, there is no proposed analysis of the network structure itself Downloaded from http://bmjopen.bmj.com/ on June 18, 2017 - Published by group.bmj.com apart from centrality measures and density. The standard approach for sociometric network data is an exponential random graph model, which will test whether certain ties are more or less likely to be present. There could be heterogeneity of ties across villages, which could impact delivery. I realize the network selection approach, not network structure, is the focus of this protocol, but it seems like a missed opportunity nevertheless. This doesn't impact the basic idea here, as such analyses could be conducted with the type of data they propose collecting. Fourth, there is an assumption that more central nodes will have a greater effect in the diffusion of behavior change. This is true, conditional on the central nodes receiving the treatment or taking on the behavior change. But there is a long literature documenting the resistance of central nodes to novel behaviors. This creates a tension between receptiveness to change and network reach (or the ability to influence others) which might be a wash in the proposed work. Finally, the treatments themselves are only briefly described on p.7. I realize that the network is the focus of the "treatment" here (not the intervention itself) but still the intervention deserves more attention. I look forward to seeing the results of this trial. I believe it will be an important contribution to both public health and network science. REVIEWER REVIEW RETURNED GENERAL COMMENTS Allison Doub Hepworth Penn State University, United States 06-Sep-2016 This protocol describes an ambitious and important study that aims to test how social network targeting could be used to promote the broad uptake of positive reproductive, maternal, neonatal, and child health behaviors and attitudes in rural Honduras. This large-scale, resource-intensive project is expected to yield results that could inform the design of other health behavior change interventions, particularly in developing countries. As written, the manuscript excels in providing an overview of the projects‟ mission and analytic aims. The supplementary materials provide extensive additional information about the statistical techniques that will be used to test the research questions and the network data collection tool. My main concern is that the manuscript does not contain sufficient detail about the intervention. Without information about the efficacy or effectiveness of the intervention, it is difficult for a reader to feel confident that this study will yield the expected results. As a reader, I need to know more about how intervention design and delivery effects (e.g., implementation fidelity, skill-level of the counselor, intervention dosage) will the accounted for when making inferences about what promotes the uptake of the targeted RMNCH attitudes and behaviors. My comments are outlined by page and line number as they appeared in the PDF for review. Abstract Page 2 Lines 5-7 Revise first two sentences to make a more specific statement about the state of reproductive, maternal, neonatal, and child health in developing countries and what interventions can do to help. Downloaded from http://bmjopen.bmj.com/ on June 18, 2017 - Published by group.bmj.com Recommend removing ambiguous words such as “lag” and “demand side” that are not clear to outside readers. Strengths and limitations Page 2 Line 43 Sample or samples? Background Page 3 Lines 29-32 Revise to be less conversational; recommend something like: “To promote improvements in key RMNCH behaviors, change is needed in the provision of services and in community-level demand for services and practices within communities.” Background Page 4 Line 14 Remove parentheses and offset with commas; Change “whereby” to “wherein” or “in which” This Study Page 4 Line 35 Remove “here” Page 4 Lines 41-44 Revise to better describe the role of algorithms. For example, “We will use theoretically derived (?) algorithms to choose a subset of structurally influential individuals from within the population receiving an intervention. Throughout this protocol the term “treatment” refers only to the algorithms used to choose individuals, while the term “intervention” refers only to the program designed to promote positive RMNCH behaviors and attitudes. Page 4 Line 44-45 Intervention adoption to some people means willingness to deliver the intervention within a community OR the likelihood that someone participates in the intervention when it is offered; If you are measuring whether people are utilizing the behaviors that are promoted in the intervention I would recommend using the term “uptake” although that too can be ambiguous. Recommend revising to be explicit here in this early introductory paragraph with something like: “We will assess whether differential network targeting results in differential uptake (i.e. practice or implementation) of the RMNCH behaviors and attitudes promoted in the intervention.” Methods/Study Design Preliminary Work Page 5 Line 27 Give some examples of such RMNCH outcomes to remind readers (it has been a while since the introductory paragraphs). Page 5 Line 55 – Briefly define 8 x 2 design or say that it is described in detail in aim 2 Page 6 Line 2-3 Are there any differences between those who have declined to participate in the study and those who consented? Network data collection Page 6 Line 14 You already said in Page 6 Line 1 that the photographic census is complete… Measurement Page 6 Give some timeline estimates for when these surveys will be administered – particularly for “baseline” and “final outcome” Downloaded from http://bmjopen.bmj.com/ on June 18, 2017 - Published by group.bmj.com surveys. I see you have this in Figure 4 but it is currently not very clear from this bulleted list. Unless there is a page limit requirement, I recommend adding in some of the text from the supplement about the network level and individual level centrality measures you will be calculating in the “baseline social network survey” and “final outcome survey”. You may think about how to make that more clear in the text that you‟re measuring the whole network twice. Behavioral Health Intervention Page 7 Line 8 I would like to see a reference for “elements that successfully promote RMNCH behaviors” or please make it clear that components are based on theoretical success. In general, I feel the description of the intervention is lacking sufficient details to allow replication. Is there a manual for this intervention? Will there be fidelity checks? I see you have a reference for the counseling method but I do not see a lot of detail about whether this intervention has been piloted or evaluated for efficacy. If the intervention is still in development or if its development and evaluation has been described elsewhere, please make that more clear in the manuscript and/or direct the reader to such resources. It seems to me that knowing your intervention should work for those who receive it is important and I do not see much discussion of that in the current manuscript. As a reader, I am left wondering questions like: “What ability will they have to detect differences in social diffusion if the intervention is ineffective?” and “How will they be able to parse out the differences in uptake related to provider effects (e.g., a particularly skilled and invested counselor) from those associated with social diffusion.” If the intervention is new and has not yet been described in detail in a peer reviewed publication, I recommend referring to a text such as, Specifying and reporting complex behaviour change interventions: the need for a scientific method (Michie, Fixsen, Grimshaw & Eccles, 2009; https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2717906/) and following the guidelines outlined there. Page 9 line 27 – Revise – too conversational. Recommend something like: “This is a central and overarching study objective.” Supplementary material Page 11 line 30 I was surprised by the mention of “wave 2” data collection here, likely because the measurement section currently lacks a clear timeline in the text. Please be sure to revise that. Limitations Page 12 – Please discuss how you plan to handle missing data and what influence that might have on your results. Discuss both missing data that occurs during the consent process and attrition between Wave 1 and Wave 2. How will you handle new people moving in? People moving out or passing away? (Perhaps that is uncommon but please mention it). Consider discussing limitations related to the intervention in both its lack of demonstrated efficacy (if that is true – if not true please add in a reference or narrative demonstrating it already is efficacious) and what that might mean for your results. Downloaded from http://bmjopen.bmj.com/ on June 18, 2017 - Published by group.bmj.com Supplementary material A Individual-level measures Page 22 Line 46 Please revise to be more clear about what measures of centrality you will calculate in this study and what you might expect to find, as you did with the network-level measures section. As written, the section on centrality is too general. There are also a few places where citations are missing as indicated by [REF(S)]. I would remove the term “first-order metric” and use a less field specific term or explain in more detail what you mean by this. The information and examples are helpful to readers unfamiliar with network analysis but please tie it back to your study, as you did with network-level measures. Extra space between given “a unique” code Page 28 Paragraph on randomization showing some odd bolding. Page 28 Line 48 Abbreviation “IDB” is used without defining in supplementary material Page 28 Line 52 I am not clear on what you mean by “However, while we will not explicitly reveal which villages are receiving what dosage, this could be inferred from observing approximately what percent of households are receiving the intervention.” Are you referring the village residents? What would be observed, as these are individual households in counseling sessions? What impact might this have on the study outcomes if participants figure out the dosage? Consider adding this discussion to the limitations section. I hope the authors make these revisions so that the protocol could be considered for review again. Thank you for your time on this very interesting and potentially transformative work. VERSION 1 – AUTHOR RESPONSE Reviewer: 1 Reviewer Name: David A. Shoham Institution and Country: Department of Public Health Sciences, Loyola University Chicago Stritch School of Medicine, Maywood, IL, USA Please state any competing interests or state „None declared‟: None declared Please leave your comments for the authors below This is an intriguing study protocol that will test various levels of recruitment to a reproductive, maternal, neonatal, and child health intervention in Honduras that employ social network principles. The rationale for the trial, which will randomize 176 villages (with a total of 30k individuals) to various network-based treatment implementations and with eight proportions of the population targeted in an 8x2 factorial design. The proposal is extremely ambitious but resources commensurate with the effort required appear to be in place. Ultimately, the researchers hope to find treatment thresholds and demonstrate that partial network data collection (eg, targeting friends of randomly selected individuals) will have similar impact as more cumbersome whole-network (sociometric or socioeconomic) network designs. This is a novel approach: while members of the research team have demonstrated effectiveness of this approach for H1N1, it has not, to my knowledge, been applied to a health behavioral intervention I do have some questions about the statistical models to be used. First, the authors focus on Downloaded from http://bmjopen.bmj.com/ on June 18, 2017 - Published by group.bmj.com analyses at the individual and the ecological (village) level which will ignore the richness of the data nested withing villages. We appreciate the reviewers concern. We do in fact plan to do subgroup analyses, which we mention in the appendix under Aim 4: “Subgroups such as cliques, components, and communities will be identified within these village networks (in particular, using state-of-the-art community detection algorithms that have recently been invented 13). These subgroups will be identified in two different ways. We will identify subgroups based solely on network properties, independent of any covariate properties; and we will also identify subgroups based upon correlated values of covariates, such as education, income, or gender norms.” Second, the influence process is modeled as a regression of the ego's behavior on their alters' treatment status (equation 1, SA page 8). They plan to stratify based on number of friends named and combine in a meta-analytic fashion. But this seems like an overly simplistic approach that may obscure important spillover effects. It is encouraging to see that alternative models for alter influence (eg, average alter, model 1b) will be assessed. Thank you for your thoughts on this. There are of course many ways of modeling this type of dynamic, which is why we have proposed some alternative models. Third, there is no proposed analysis of the network structure itself apart from centrality measures and density. The standard approach for sociometric network data is an exponential random graph model, which will test whether certain ties are more or less likely to be present. There could be heterogeneity of ties across villages, which could impact delivery. I realize the network selection approach, not network structure, is the focus of this protocol, but it seems like a missed opportunity nevertheless. This doesn't impact the basic idea here, as such analyses could be conducted with the type of data they propose collecting. We appreciate your comment. While we certainly intend to use ERGM models to test our hypotheses, for the sake of space, and due to the complexity of the analyses already, we have simply opted not to mention all possible analytic approaches that we will use with this data. Fourth, there is an assumption that more central nodes will have a greater effect in the diffusion of behavior change. This is true, conditional on the central nodes receiving the treatment or taking on the behavior change. But there is a long literature documenting the resistance of central nodes to novel behaviors. This creates a tension between receptiveness to change and network reach (or the ability to influence others) which might be a wash in the proposed work. We agree that cross-cutting effects are possible. However, our earlier work in Honduras (Kim et al. 2015) leads us to believe that, on balance, network targeting will have a positive effect on the number of individuals reached. Of course, this is why we have proposed to do a trial, since it is uncertain whether we will find what we think we will. We believe it will also be helpful to report a null result if, as the reviewer worries, the effects of centrality are washed out by the difficulty of getting central nodes to change their behavior. Finally, the treatments themselves are only briefly described on p.7. I realize that the network is the focus of the "treatment" here (not the intervention itself) but still the intervention deserves more attention. Thank you for your important comments. We have added more information regarding the intervention on page 7 and in the supplementary appendix. Downloaded from http://bmjopen.bmj.com/ on June 18, 2017 - Published by group.bmj.com In the manuscript: “The implementing partner in this project, the Inter-American Development Bank (IDB) through the Salud Mesoamerica Initiative (SMI), is responsible for designing and implementing an integral intervention to promote RMNCH behavior change in Honduras. To work within the constraints of this study, the intervention had to meet specific requirements including: 1) alignment with priorities of the Ministry of Health (MOH) of Honduras, the Bill & Melinda Gates Foundation (BMGF), and the needs of the population; 2) contain new messages for the targeted population to allow for detection of changes in knowledge, attitudes and practices; 3) include tracers or identifiers which could be detected during follow-up surveys; 4) not use mass-media communication techniques, including radio spots, flyers, posters, as these would contaminate the network effects of the study; 5) have a strong monitoring component; and 6) in order to test the spread of behavior from person to person, have a demonstrated effectiveness in similar settings. The intervention would also have to adopt the targeting strategy provided by YINS, focusing on network position, as opposed to targeting households with primary audiences for the behavior change of interest. For example, the targeting algorithm could hypothetically identify a household with two grandfathers, and therefore select it to receive the intervention. This household would usually not be selected for an intervention on prenatal care or neonatal practices, given that there are no pregnant women living there. Given these requirements, an educational package using the Timed and Targeted Counseling methodology complemented with alternative methods of face-to-face communication including songs, rhymes, and riddles, was designed with World Vision and Child Fund Honduras. The social and behavior change communication strategy for the intervention was designed using the “P-Process”, a tool developed by Johns Hopkins Center for Communication Programs, and used for more than 30 years for planning strategic, evidence-based health communication programs. This intervention will be delivered by trained community health workers for 24 months on a monthly basis to the households selected for the study. Timed and Targeted Counseling (ttC), has been implemented in 20 countries worldwide by World Vision.45 It is targeted in time (when it is needed), in space (by visiting in the home), and in individualized approaches (messages and barriers focus on the circumstances of a specific family). This methodology uses narrative and negotiation in a 1-2 hour visit with families to discuss positive and negative scenarios and create a list of agreements with families to try out new practices. It should be noted that ttC is normally implemented in households with pregnant women and/or children under two, and counseling is provided to all family members based on stage of the pregnancy or age of the child. This methodology was adjusted to include messages for topics of interest to the study based on findings from formative research conducted for intervention design (Annex X) and evidence-based, cost-effective practices related to study outcomes. Study outcomes include: 1) use of folic acid in women of reproductive age to prevent birth defects; 2) receiving prenatal care in the first trimester; 3) having a birth preparation plan for seeking timely prenatal care, institutional birth, post-partum care and emergencies; 4) exclusive breastfeeding for infants under 6 months; 5) immediate breastfeeding after birth; 6) proper thermal and cord care for newborn infants; 7) proper treatment of diarrhea in children, including the use of zinc (which is a new component of the SMI program, here); 8) paternal involvement in child care, particularly for newborns; 9) use of modern family planning methods; and10) delaying pregnancy until 18 years of age. While only very specific households will be targeted according to our randomization methods, participants from target households will not be discouraged from inviting others, and a careful record of attendees will be kept. CHWs have a team of supervisors for intervention quality control and ensure that CHWs are visiting the correct houses. The IDB/SMI team has also incorporated the use of Downloaded from http://bmjopen.bmj.com/ on June 18, 2017 - Published by group.bmj.com mHealth tools to aid in intervention delivery (for example, all stories are available in an animated video format), data quality and timeliness. The IDB is also currently working on supply-side interventions with the Government of Honduras through SMI and other complementary programs, to ensure community members seeking services receive quality care. As part of the intervention protocol, we will keep careful track of which CHWs have visited which households in order to allow us to adjust for possible provider effects that could impact the study outcomes.” In the appendix “Intervention implementation details: 14 visit topics have been created for the intervention. Based on the household diagnosis, the CHW selects where to start and how to advance through the program and visits can be repeated depending on reported behaviors. Topics and order are modified as the family situation changes. The materials for the CWH created for the household intervention include: 1. 4 Counseling Books 2. 3 sets of illustrated cards with information about proper diet and nutrition during pregnancy, danger signs for pregnant, birth, postpartum and postnatal periods 3. 25 stories of 3 to 5 minutes each in a 2D audio-visual format, including sound, music, and the story read aloud. Materials are also provided to the families who partake in the intervention to reinforce key messages and motivate the practices discussed. These materials include: 1. Book of messages and agreements for the family 2. Pictures related to the messages discussed and crayons for coloring 3. House Identifier 4. Calendar with key messages for household 5. Unisex cardboard box with printed lined bearing the logo and slogan of the project. 6. Picture to hang on the wall portraying a sense of maternity lived by the whole family The home visit is divided into four main parts 1) validation of the house; 2) introduction; 3) development; and 4) closing, and contain the following steps: 1. Validation: Per study requirements, the CHW records their GPS location, verifies that the people in the house match the list of people provided by YINS, and record any additional meeting attendees. 2. Introduction: Greeting and check in with the family to determine current situation, and introduction to the theme of the visit. As the family gathers, the CHW will play the song for the intervention, record all members present and conduct a quick survey to determine level of knowledge, attitudes and practices related to the topic. This CHW will also explain the activities to be conducted during the visit. 3. Development: The CHW begins by checking if the family has a priority issue they would like to discuss during the session. After discussing these issues, the CHW begins telling the “problem” story or playing the story animation on the tablet, ensuring that all family members carefully listen, look at the pictures, and answer any questions the family may have. The CHW will then tell the “positive” story, and uses the “guide” questions that accompany the story to have a dialogue about the story and negotiate behavior changes with the family. The CHW will then use complementary tools such as songs, riddles or visual aids to review main ideas with the family. 4. Closing: The CHW will summarize the discussion and write the agreement in the family counseling book regarding what the family wishes to practice and alternative solutions to the potential barriers identified during the visit. As a reaffirmation of the messages of the story, the last activity is to provide coloring book sheets to the family to color pictures of the key messages discussed. Additionally, the date of the next visit will be agreed and included on the family‟s calendar. The CHW will play the intervention song again and thank the family again for their time before leaving.” Downloaded from http://bmjopen.bmj.com/ on June 18, 2017 - Published by group.bmj.com I look forward to seeing the results of this trial. I believe it will be an important contribution to both public health and network science. Reviewer: 2 Reviewer Name: Allison Doub Hepworth Institution and Country: Penn State University, United States Please state any competing interests or state „None declared‟: None declared Please leave your comments for the authors below This protocol describes an ambitious and important study that aims to test how social network targeting could be used to promote the broad uptake of positive reproductive, maternal, neonatal, and child health behaviors and attitudes in rural Honduras. This large-scale, resource-intensive project is expected to yield results that could inform the design of other health behavior change interventions, particularly in developing countries. As written, the manuscript excels in providing an overview of the projects‟ mission and analytic aims. The supplementary materials provide extensive additional information about the statistical techniques that will be used to test the research questions and the network data collection tool. My main concern is that the manuscript does not contain sufficient detail about the intervention. Without information about the efficacy or effectiveness of the intervention, it is difficult for a reader to feel confident that this study will yield the expected results. As a reader, I need to know more about how intervention design and delivery effects (e.g., implementation fidelity, skill-level of the counselor, intervention dosage) will the accounted for when making inferences about what promotes the uptake of the targeted RMNCH attitudes and behaviors. Thank you for your important comments. Please see the additions on page 7 of the manuscript which provide greater detail on the intervention. My comments are outlined by page and line number as they appeared in the PDF for review. Abstract Page 2 Lines 5-7 Revise first two sentences to make a more specific statement about the state of reproductive, maternal, neonatal, and child health in developing countries and what interventions can do to help. Recommend removing ambiguous words such as “lag” and “demand side” that are not clear to outside readers. We appreciate the reviewers suggestion and have revised the abstract to read: “Despite global progress on many measures of child health, rates of neonatal mortality remain high in the developing world. Evidence suggests that substantial improvements can be achieved with simple, low-cost interventions within family and community settings, particularly those that are designed to change knowledge and behavior at the community level.” Strengths and limitations Page 2 Line 43 Sample or samples? We have corrected the sentence to read sample. Downloaded from http://bmjopen.bmj.com/ on June 18, 2017 - Published by group.bmj.com Background Page 3 Lines 29-32 Revise to be less conversational; recommend something like: “To promote improvements in key RMNCH behaviors, change is needed in the provision of services and in community-level demand for services and practices within communities.” We have revised the sentence accordingly. Background Page 4 Line 14 Remove parentheses and offset with commas; Change “whereby” to “wherein” or “in which” We have revised the sentence accordingly. This Study Page 4 Line 35 Remove “here” We have revised the sentence accordingly. Page 4 Lines 41-44 Revise to better describe the role of algorithms. For example, “We will use theoretically derived (?) algorithms to choose a subset of structurally influential individuals from within the population receiving an intervention. Throughout this protocol the term “treatment” refers only to the algorithms used to choose individuals, while the term “intervention” refers only to the program designed to promote positive RMNCH behaviors and attitudes. We appreciate that suggestion and have revised the sentence according to the reviewer‟s recommendation. Page 4 Line 44-45 Intervention adoption to some people means willingness to deliver the intervention within a community OR the likelihood that someone participates in the intervention when it is offered; If you are measuring whether people are utilizing the behaviors that are promoted in the intervention I would recommend using the term “uptake” although that too can be ambiguous. Recommend revising to be explicit here in this early introductory paragraph with something like: “We will assess whether differential network targeting results in differential uptake (i.e. practice or implementation) of the RMNCH behaviors and attitudes promoted in the intervention.” We have included this revision in the manuscript. Methods/Study Design Preliminary Work Page 5 Line 27 Give some examples of such RMNCH outcomes to remind readers (it has been a while since the introductory paragraphs). We appreciate the reviewers suggestions and have revised the document to read: “We developed an extensive survey instrument to capture the various outcomes that will be addressed through the household-level interventions that will be implemented by IDB/SMI, including use of folic acid, prenatal care utilization, birth plan preparation, immediate breastfeeding after birth, exclusive breastfeeding for infants up to 6 months old, proper thermal and cord care for newborns, proper treatment of diarrhea in children, and paternal involvement in child care.” Page 5 Line 55 – Briefly define 8 x 2 design or say that it is described in detail in aim 2 Downloaded from http://bmjopen.bmj.com/ on June 18, 2017 - Published by group.bmj.com We have instructed readers to look at Aim 2 for details on the 8x2 design. Page 6 Line 2-3 Are there any differences between those who have declined to participate in the study and those who consented? We do not know that information. We have a count of the total population over the age of 12 in those areas, but no breakdown of the demographics. Network data collection Page 6 Line 14 You already said in Page 6 Line 1 that the photographic census is complete… We thank the reviewer for catching that detail. We have changed the text to read: “As the photographic census is complete, we will next use bespoke software we have prepared and made publicly available (http://humannaturelab.net/resources/software/trellis/), named Trellis (see Appendix 2), to undertake the main survey, which includes a battery of “name generator” questions to capture social relationships” Measurement Page 6 Give some timeline estimates for when these surveys will be administered – particularly for “baseline” and “final outcome” surveys. I see you have this in Figure 4 but it is currently not very clear from this bulleted list. Unless there is a page limit requirement, I recommend adding in some of the text from the supplement about the network level and individual level centrality measures you will be calculating in the “baseline social network survey” and “final outcome survey”. You may think about how to make that more clear in the text that you‟re measuring the whole network twice. We thank the reviewer for these suggestions. We have included dates for each survey wave, and have also added in text to clarify the calculation of network measures from the network data at each wave. (1) Baseline social networks: The name generator questions to collect sociocentric data will be included in the baseline survey. From these measures we will calculate community level and individual level measures of network connectivity including various measures of centrality (please see online appendix for more details). 2016 (2) Baseline RMNCH care behavior and norms for all individuals in the villages. Specific maternal neonatal, and child health behavior questions will be asked only of individuals who have already had a child. Norms and attitudes questions will be asked of everyone and will include attitudes towards RMNCH behaviors as well as the role of fathers in prenatal and neonatal health. 2016 (3) Concurrent norms and behavior surveys: one year into the intervention, we will administer surveys to track changes in norms and behaviors as well as possible sources of intervention spread. For this survey, we will also monitor the implementation of the intervention by asking questions specific to receiving intervention activities. 2017 (4) Final outcome survey: a second wave of social networks data collection, RMNCH care behavior, and norms questions for all individuals in the villages. Again using this second wave of social network data, we will calculate network connectivity at the individual and community levels. 2018. Behavioral Health Intervention Downloaded from http://bmjopen.bmj.com/ on June 18, 2017 - Published by group.bmj.com Page 7 Line 8 I would like to see a reference for “elements that successfully promote RMNCH behaviors” or please make it clear that components are based on theoretical success. In general, I feel the description of the intervention is lacking sufficient details to allow replication. Is there a manual for this intervention? Will there be fidelity checks? I see you have a reference for the counseling method but I do not see a lot of detail about whether this intervention has been piloted or evaluated for efficacy. If the intervention is still in development or if its development and evaluation has been described elsewhere, please make that more clear in the manuscript and/or direct the reader to such resources. It seems to me that knowing your intervention should work for those who receive it is important and I do not see much discussion of that in the current manuscript. As a reader, I am left wondering questions like: “What ability will they have to detect differences in social diffusion if the intervention is ineffective?” and “How will they be able to parse out the differences in uptake related to provider effects (e.g., a particularly skilled and invested counselor) from those associated with social diffusion.” If the intervention is new and has not yet been described in detail in a peer reviewed publication, I recommend referring to a text such as, Specifying and reporting complex behaviour change interventions: the need for a scientific method (Michie, Fixsen, Grimshaw & Eccles, 2009; https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2717906/) and following the guidelines outlined there. Thank you for your important comments. We have added references and more details in the manuscript and in the appendix as requested by the reviewer. In the manuscript: “The implementing partner in this project, the Inter-American Development Bank (IDB) through the Salud Mesoamerica Initiative (SMI), is responsible for designing and implementing an integral intervention to promote RMNCH behavior change in Honduras. To work within the constraints of this study, the intervention had to meet specific requirements including: 1) alignment with priorities of the Ministry of Health (MOH) of Honduras, the Bill & Melinda Gates Foundation (BMGF), and the needs of the population; 2) contain new messages for the targeted population to allow for detection of changes in knowledge, attitudes and practices; 3) include tracers or identifiers which could be detected during follow-up surveys; 4) not use mass-media communication techniques, including radio spots, flyers, posters, as these would contaminate the network effects of the study; 5) have a strong monitoring component; and 6) in order to test the spread of behavior from person to person, have a demonstrated effectiveness in similar settings. The intervention would also have to adopt the targeting strategy provided by YINS, focusing on network position, as opposed to targeting households with primary audiences for the behavior change of interest. For example, the targeting algorithm could hypothetically identify a household with two grandfathers, and therefore select it to receive the intervention. This household would usually not be selected for an intervention on prenatal care or neonatal practices, given that there are no pregnant women living there. Given these requirements, an educational package using the Timed and Targeted Counseling methodology complemented with alternative methods of face-to-face communication including songs, rhymes, and riddles, was designed with World Vision and Child Fund Honduras. The social and behavior change communication strategy for the intervention was designed using the “P-Process”, a tool developed by Johns Hopkins Center for Communication Programs, and used for more than 30 years for planning strategic, evidence-based health communication programs. This intervention will be delivered by trained community health workers for 24 months on a monthly basis to the households selected for the study. Timed and Targeted Counseling (ttC), has been implemented in 20 countries worldwide by World Vision.45 It is targeted in time (when it is needed), in space (by visiting in the Downloaded from http://bmjopen.bmj.com/ on June 18, 2017 - Published by group.bmj.com home), and in individualized approaches (messages and barriers focus on the circumstances of a specific family). This methodology uses narrative and negotiation in a 1-2 hour visit with families to discuss positive and negative scenarios and create a list of agreements with families to try out new practices. It should be noted that ttC is normally implemented in households with pregnant women and/or children under two, and counseling is provided to all family members based on stage of the pregnancy or age of the child. This methodology was adjusted to include messages for topics of interest to the study based on findings from formative research conducted for intervention design (Appendix 3) and evidence-based, cost-effective practices related to study outcomes. Study outcomes include: 1) use of folic acid in women of reproductive age to prevent birth defects; 2) receiving prenatal care in the first trimester; 3) having a birth preparation plan for seeking timely prenatal care, institutional birth, post-partum care and emergencies; 4) exclusive breastfeeding for infants under 6 months; 5) immediate breastfeeding after birth; 6) proper thermal and cord care for newborn infants; 7) proper treatment of diarrhea in children, including the use of zinc (which is a new component of the SMI program, here); 8) paternal involvement in child care, particularly for newborns; 9) use of modern family planning methods; and10) delaying pregnancy until 18 years of age. While only very specific households will be targeted according to our randomization methods, participants from target households will not be discouraged from inviting others, and a careful record of attendees will be kept. CHWs have a team of supervisors for intervention quality control and ensure that CHWs are visiting the correct houses. The IDB/SMI team has also incorporated the use of mHealth tools to aid in intervention delivery (for example, all stories are available in an animated video format), data quality and timeliness. The IDB is also currently working on supply-side interventions with the Government of Honduras through SMI and other complementary programs, to ensure community members seeking services receive quality care. As part of the intervention protocol, we will keep careful track of which CHWs have visited which households in order to allow us to adjust for possible provider effects that could impact the study outcomes.” In the appendix “Intervention implementation details: 14 visit topics have been created for the intervention. Based on the household diagnosis, the CHW selects where to start and how to advance through the program and visits can be repeated depending on reported behaviors. Topics and order are modified as the family situation changes. The materials for the CWH created for the household intervention include: 4. 4 Counseling Books 5. 3 sets of illustrated cards with information about proper diet and nutrition during pregnancy, danger signs for pregnant, birth, postpartum and postnatal periods 6. 25 stories of 3 to 5 minutes each in a 2D audio-visual format, including sound, music, and the story read aloud. Materials are also provided to the families who partake in the intervention to reinforce key messages and motivate the practices discussed. These materials include: 7. Book of messages and agreements for the family 8. Pictures related to the messages discussed and crayons for coloring 9. House Identifier 10. Calendar with key messages for household 11. Unisex cardboard box with printed lined bearing the logo and slogan of the project. Downloaded from http://bmjopen.bmj.com/ on June 18, 2017 - Published by group.bmj.com 12. Picture to hang on the wall portraying a sense of maternity lived by the whole family The home visit is divided into four main parts 1) validation of the house; 2) introduction; 3) development; and 4) closing, and contain the following steps: 5. Validation: Per study requirements, the CHW records their GPS location, verifies that the people in the house match the list of people provided by YINS, and record any additional meeting attendees. 6. Introduction: Greeting and check in with the family to determine current situation, and introduction to the theme of the visit. As the family gathers, the CHW will play the song for the intervention, record all members present and conduct a quick survey to determine level of knowledge, attitudes and practices related to the topic. This CHW will also explain the activities to be conducted during the visit. 7. Development: The CHW begins by checking if the family has a priority issue they would like to discuss during the session. After discussing these issues, the CHW begins telling the “problem” story or playing the story animation on the tablet, ensuring that all family members carefully listen, look at the pictures, and answer any questions the family may have. The CHW will then tell the “positive” story, and uses the “guide” questions that accompany the story to have a dialogue about the story and negotiate behavior changes with the family. The CHW will then use complementary tools such as songs, riddles or visual aids to review main ideas with the family. 8. Closing: The CHW will summarize the discussion and write the agreement in the family counseling book regarding what the family wishes to practice and alternative solutions to the potential barriers identified during the visit. As a reaffirmation of the messages of the story, the last activity is to provide coloring book sheets to the family to color pictures of the key messages discussed. Additionally, the date of the next visit will be agreed and included on the family‟s calendar. The CHW will play the intervention song again and thank the family again for their time before leaving.” Page 9 line 27 – Revise – too conversational. Recommend something like: “This is a central and overarching study objective.” We have revised the sentence to now read: “This increased efficiency through the social effect is a central and overarching study objective.” Supplementary material Page 11 line 30 I was surprised by the mention of “wave 2” data collection here, likely because the measurement section currently lacks a clear timeline in the text. Please be sure to revise that. Thank you for pointing that out. We have tried to make the timeline more clear throughout the manuscript. Limitations Page 12 – Please discuss how you plan to handle missing data and what influence that might have on your results. Discuss both missing data that occurs during the consent process and attrition between Wave 1 and Wave 2. How will you handle new people moving in? People moving out or passing away? (Perhaps that is uncommon but please mention it). Consider discussing limitations related to the intervention in both its lack of demonstrated efficacy (if that is true – if not true please add in a reference or narrative demonstrating it already is efficacious) and what that might mean for your results. Thank you for your comments. We have added text regarding limitations on pages 2 and 12, and text on missingness to the Appendix. Downloaded from http://bmjopen.bmj.com/ on June 18, 2017 - Published by group.bmj.com In the appendix “Participant attrition and missing data: Over 90% of community residents have agreed to participate in the study, so bias due to failure to recruit participants is very low. Observations with missing data will be dropped from the analyses, which will also not create bias in the data as assignment to treatment groups, and therefore missingness, is random. We will also make our best effort to keep track of study participants who move from one study village to another, in order to retain them in the study. ” In the manuscript: “Our intervention also has limitations. In the ideal scenario, we would use an evidence-based intervention for community-based neonatal health tested in rural Honduras implemented to “guarantee” behavior change amongst the initially targeted individuals, the ripples of which would be studied in the RTC. However, given the restraints of the study, this “ideal intervention” does not exist. For example, in the ideal gold-standard BCC intervention, the person or group whose behavior change is sought receives the intervention messages as many times as possible. In the typical community based intervention, in addition to face-to-face counseling, community members would be exposed to radio messages, banners, flyers, mass text messages, and other media based communication methods to reinforce messaging. Given that the study relies on information passing through the social network, mass media communication methods cannot be used by the intervention. Even some targeted methods, such as sending text messages only to study participants, cannot be used, because cellphones are distributed unequally throughout the population, affecting its homogeneity. The intervention team has been creative in adding tools to the intervention, and has been mindful of including a variety of behavioral changes along the continuum of pregnancy, childbirth, postnatal care, and child health in order to maximize the possibility that one or more intervention components are adopted. Intervention targeting is also affected. Normally in an intervention targeted at changing behaviors in maternal and neonatal health, households would be selected depending on where pregnant women live. We could not take these criteria into consideration, given that the targeting mechanism is based on position in the network, rather than whether or not a woman in the household is pregnant. Finally, not all aspects of the desired behavior change rely on adequate knowledge, attitudes and practices at the household level. A clear example is how the conditions in health centers and hospitals affect behaviors of the population. Although messaging is provided to families regarding the importance of male involvement in birth, if the hospital or health centers does not have adequate infrastructure to have private birthing rooms (the norm in Central America), men cannot be in the room during the birth if another women is also in labor. Although SMI works closing with the MOH to improve supply-side conditions, some aspects are out of the scope of the program. The study team is aware of these limitations and is documenting them to have a clear picture of these external factors which also impact the success of the community-based behavior change intervention.” Supplementary material A Individual-level measures Page 22 Line 46 Please revise to be more clear about what measures of centrality you will calculate in this study and what you might expect to find, as you did with the network-level measures section. As written, the section on centrality is too general. There are also a few places where citations are missing as indicated by [REF(S)]. I would remove the term “first-order metric” and use a less field specific term or explain in more detail what you mean by this. The information and examples are Downloaded from http://bmjopen.bmj.com/ on June 18, 2017 - Published by group.bmj.com helpful to readers unfamiliar with network analysis but please tie it back to your study, as you did with network-level measures. We appreciate the reviewers concerns and have moved the list of specific types of questions that can be answered using individual network measures from the analytic section further down in the document, to the section in which we introduce centrality measures. “The most frequently measured individual-level network metric is centrality- which is relatively intuitive in concept and is a measure of how “central” an individual is within any given network. In these analyses we will be able to investigate to what degree individual network centrality can impact the adoption of the intervention components by any individual within the population. (1) Do participants with higher centrality adopt the new intervention more readily than those with lower centrality? (2) Do individuals connected to high centrality social contacts adopt the new intervention more readily? (3) Are socially isolated individuals less likely to adopt the new intervention? (4) Is the relationship between intervention adoption and education moderated by network characteristics (e.g., will educated women who are less socially connected adopt the intervention less readily than educated women who are well connected)?” Extra space between given “a unique” code We fixed that, thank you. Page 28 Paragraph on randomization showing some odd bolding. We fixed that, thank you. Page 28 Line 48 Abbreviation “IDB” is used without defining in supplementary material We fixed that, thank you. Page 28 Line 52 I am not clear on what you mean by “However, while we will not explicitly reveal which villages are receiving what dosage, this could be inferred from observing approximately what percent of households are receiving the intervention.” Are you referring the village residents? What would be observed, as these are individual households in counseling sessions? What impact might this have on the study outcomes if participants figure out the dosage? Consider adding this discussion to the limitations section. We thank the reviewer for this questions. We have modified the text to make it clear that we mean the implementing partner: “However, while we will not explicitly reveal which villages are receiving what dosage, this could be inferred by implantation partner from observing approximately what percent of households are receiving the intervention.” I hope the authors make these revisions so that the protocol could be considered for review again. Thank you for your time on this very interesting and potentially transformative work. Downloaded from http://bmjopen.bmj.com/ on June 18, 2017 - Published by group.bmj.com VERSION 2 – REVIEW REVIEWER REVIEW RETURNED GENERAL COMMENTS Allison Doub Hepworth Penn State University, USA 17-Nov-2016 Thank you to the authors for taking the time to respond in depth to each of my prior comments, and to those of the other reviewer. Combined with the supplementary material, this manuscript is a thorough protocol description. I do not have any substantive concerns; there is a lot of information for readers to wade through, but this is a complex study so I think it is all necessary. In my opinion the manuscript stands sufficiently on its own and interested readers can look further to the supplementary material for more detail. You have presented a transparent look into your research plan, which is a terrific step forward in the behavioral and health sciences. Best wishes with this important work. One very minor revision P7 line 42 – indicate which online appendix you are referring to Downloaded from http://bmjopen.bmj.com/ on June 18, 2017 - Published by group.bmj.com Exploiting social influence to magnify population-level behaviour change in maternal and child health: study protocol for a randomised controlled trial of network targeting algorithms in rural Honduras Holly B Shakya, Derek Stafford, D Alex Hughes, Thomas Keegan, Rennie Negron, Jai Broome, Mark McKnight, Liza Nicoll, Jennifer Nelson, Emma Iriarte, Maria Ordonez, Edo Airoldi, James H Fowler and Nicholas A Christakis BMJ Open 2017 7: doi: 10.1136/bmjopen-2016-012996 Updated information and services can be found at: http://bmjopen.bmj.com/content/7/3/e012996 These include: References This article cites 48 articles, 7 of which you can access for free at: http://bmjopen.bmj.com/content/7/3/e012996#BIBL Open Access This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: http://creativecommons.org/licenses/by/4.0/ Email alerting service Receive free email alerts when new articles cite this article. Sign up in the box at the top right corner of the online article. Topic Collections Articles on similar topics can be found in the following collections Epidemiology (2038) Global health (441) Research methods (588) Sociology (103) Notes To request permissions go to: http://group.bmj.com/group/rights-licensing/permissions To order reprints go to: http://journals.bmj.com/cgi/reprintform To subscribe to BMJ go to: http://group.bmj.com/subscribe/
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