Impact-Oriented Dialogue for Culturally Safe Adolescent Sexual and Reproductive Health in Bauchi State, Nigeria: Protocol for a Codesigned Pragmatic Cluster Randomized Controlled Trial

Background Adolescents (10-19 years) are a big segment of the Nigerian population, and they face serious risks to their health and well-being. Maternal mortality is very high in Nigeria, and rates of pregnancy and maternal deaths are high among female adolescents. Rates of HIV infection are rising among adolescents, gender violence and sexual abuse are common, and knowledge about sexual and reproductive health risks is low. Adolescent sexual and reproductive health (ASRH) indicators are worse in the north of the country. Objective In Bauchi State, northern Nigeria, the project will document the nature and extent of ASRH outcomes and risks, discuss the findings and codesign solutions with local stakeholders, and measure the short-term impact of the discussions and proposed solutions. Methods The participatory research project is a sequential mixed-methods codesign of a pragmatic cluster randomized controlled trial. Focus groups of local stakeholders (female and male adolescents, parents, traditional and religious leaders, service providers, and planners) will identify local priority ASRH concerns. The same stakeholder groups will map their knowledge of factors causing these concerns using the fuzzy cognitive mapping (FCM) technique. Findings from the maps and a scoping review will inform the contextualization of survey instruments to collect information about ASRH from female and male adolescents and parents in households and from local service providers. The survey will take place in 60 Bauchi communities. Adolescents will cocreate materials to share the findings from the maps and survey. In 30 communities, randomly allocated, the project will engage adolescents and other stakeholders in households, communities, and services to discuss the evidence and to design and implement culturally acceptable actions to improve ASRH. A follow-up survey in communities with and without the intervention will measure the short-term impact of these discussions and actions. We will also evaluate the intervention process and use narrative techniques to assess its impact qualitatively. Results Focus groups to explore ASRH concerns of stakeholders began in October 2021. Baseline data collection in the household survey is expected to take place in mid-2022. The study was approved by the Bauchi State Health Research Ethics Committee, approval number NREC/03/11/19B/2021/03 (March 1, 2021), and by the Faculty of Medicine and Health Sciences Institutional Review Board McGill University (September 13, 2021). Conclusions Evidence about factors related to ASRH outcomes in Nigeria and implementation and testing of a dialogic intervention to improve these outcomes will fill a gap in the literature. The project will document and test the effectiveness of a participatory approach to ASRH intervention research. Trial Registration ISRCTN Registry ISRCTN18295275; https://www.isrctn.com/ISRCTN18295275 International Registered Report Identifier (IRRID) DERR1-10.2196/36060


Strengths
The significance of the applicant is well described and the background made a compelling reason why this research is important. One of the most significant strengths of the application is the well-experienced team and their long-term engagement is the province where this proposed is proposed to commence. Another strength is the capacity building that includes various stakeholders that I believe contribute to further research and the sustainability of the intervention. The ethical, risk and mitigations considerations are well described.
Most of the concerns from previous reviewers have been addressed comprehensively.

Weaknesses
The research team proposed the Theory of Planned Behavior CASCADE and although it has been used previously in multiple intervention studies, there is also critique against this theory for example the emphasis on knowledge and behavior.
It ignores other intersecting and larger contextual issues for example the influence of culture, poverty, and other SDOH, ethnicity, religions, gender, power. etc. In the previous review, the use of the Theory of Planned Behaviors was also critiqued and it was addressed very superficially in the resubmitted application. They added a sentence related to patriarchy and power differences without really addressing how they will address the structural and contextual issues. That said they partially address it by using the concept 'choice ability'.
The research team uses the term cultural safety and although it is appropriate, there has recently been critique against the use of this term. As the group continues with this project, I recommend that they look at the different terms; cultural safety and cultural competency versus cultural humility.
During the analysis, they proposed to use Guba's model to ensure trustworthiness. This model is outdated and critiqued intensively. I proposed to used more recent strategies that include reflexivity, consistency, etc. (see: Morse, M. J. (2015). Critical analysis of strategies for determining rigor in qualitative inquiry. Qualitative Health Research, 25(9), 1212-1222. doi:10.1177/1049732315588501). I am not sure how the SEPA is defined as an intervention.
I am still unsure about the management of the project. In some places, the team indicated that the research will be conducted virtual but they emphasize that travelling to Bauchi State is safe. I believe some visits to the research environment will be necessary. Virtual supervision only, in such a complex project will not be sufficient.

Sex and/or Gender Considerations/Notions de sexe et/ou de genre:
Gender and biological sex difference are addressed sufficiently. The team will report on the difference between the fuzzy cognitive maps created by boys and girls. Both male and female adolescents will be part of all phases of the study.
Strategies are developed to address sensitive issues and mitigate safety concerns related to discussion between males and females related to SRH of adolescents.

Review Type / Type d'évaluation:
Reviewer This is a participatory research project using a sequential mixed methods design. The objectives are to: (1)Explore priority stakeholder concerns about ASRH in Bauchi, collate the knowledge of female and male adolescents and other stakeholders about causes and protective factors for these concerns, and compare their knowledge with documented associations in the literature; (2)Quantify ASRH-related knowledge, attitudes, experiences and behaviours of female and male adolescents, parents, and service providers, using data collection instruments informed by the collated local knowledge and literature review; (3)Engage adolescents, parents, service providers and decision makers in dialogue about the evidence on ASRH outcomes and causes, to identify and implement locally appropriate interventions at different levels to improve ASRH; (4)Evaluate the intervention process and measure impact on ASRH knowledge, attitudes, experiences and behaviours of female and male adolescents and other stakeholders quantitatively and qualitatively;

Strengths and Weaknesses/Forces et faiblesses:
Clinical significance: The applicants provide a strong rationale for the proposal, citing the high rates of maternal mortality in Nigeria, and the fact that adolescents represent a large proportion of the population and have high pregnancy rates.
Methodological strengths: Participatory approach: A strength of the study is its participatory approach. Adolescents, parents, religious leaders, and providers will be involved in every step of the study, from identification of risk factors, to sharing of information, and development of an intervention to address ASRH concerns.
Capacity building: Government officers will also be trained in data analysis and interpretation, which will contribute to a culture of evidence-based planning of health services.
Partnerships: Another significant strength is its existing partnerships with relevant knowledge users, including the Federation of Muslim Women's Association in Nigeria and the Bauchi State Primary Health Care Development Agency, which have been partners since 2009. They previously partnered with these two groups on a culturally safe study on child spacing, opening the door to this study on ASRH. They also have buy-in from the Muslim community, including the Chief Imam of Bauchi.
Theoretical framework: The applicants use the "CASCADA results chain" to understand the relationships between knowledge, attitudes, and practice. The applicants have used in resource-poor settings previously. The applicants also incorporate ideas of cultural safety in their framework.
Pilot funding: The applicants have pilot funding from the CIHR IPPH Priority Announcement for Global Health, which will fund focus groups to identify priority concerns for ASRH. This, along with a systematic review will be the basis for the first phase of the research, which is "fuzzy cognitive mapping" to depict factors that stakeholders consider to be causes of an outcome.
Methodological weaknesses: Systematic review: Objective 1 is listed as being a systematic review to inform the fuzzy cognitive mapping. This section did not provide sufficient detail to evaluate the rigour of the approach, nor what this systematic review would add to the literature, given that the applicants cite a previous review with over 1,000 articles on the same topic.
Lack of detail on some of the methods: This is an extremely ambitious proposal, which leaves little room to describe in detail some of the methods. For example, under fuzzy cognitive mapping: how does transitive closure analysis work and Response bias: How will response bias influence the results and their interpretation? Is it possible that, especially in evaluation of the intervention, that certain "negative" outcomes will be under-reported, particularly in the communities that received the intervention?
Knowledge translation: Knowledge translation is built into the research design, with buy-in from important stakeholders (adolescents, parents, community leaders, service providers, etc) at every stage, increasing the potential impact and utility of results.
Study team: The study team includes senior investigators, trainees, and several knowledge users. The NPA has 20+ years of experience conducting research related to ASRH in similar regions, with specific experience working in the proposed communities in Nigeria. There is a knowledge user PA who will be instrumental in leading the work in Nigeria.   The proposal will address gender, but not sex. It amplifies voices of adolescent girls in collecting and sharing information about risks to their sexual and reproductive health. The survey sampling method will ensure that there is at least one girl per household included, and the analysis will "include gender as a key variable in examination of ASRH outcomes" (however, I would have liked to see how this will be done -e.g., by adjustment or stratification). 2. Quantify ASRH-related knowledge, attitudes, experiences and behaviours of female and male adolescents, parents, and service providers, using data collection instruments informed by the collated local knowledge and literature review.
3. Engage adolescents, parents, service providers and decision makers in dialogue about the evidence on ASRH outcomes and causes, to identify and implement locally appropriate interventions at different levels to improve ASRH.
4. Evaluate the intervention process and measure impact on ASRH knowledge, attitudes, experiences and behaviours of female and male adolescents and other stakeholders quantitatively and qualitatively.
5. Disseminate the research findings more widely focusing on (i) participatory methods for contextualising ASRH interventions and (ii) the impact of the interventions in Bauchi.
6. Build local capacities to gather stakeholder evidence about health-related concerns, implement locally relevant interventions, and measure their impact. Train a doctoral student at McGill.
The team draws on the CASCADA model (Conscious knowledge, Attitudes, Subjective norms, intention to Change, Agency Discussion and Action), which is based on the Theory of Planned Behaviour, to inform the design of the intervention. They also draw on a concept of choice disability among marginalized women, pointing to the need for for interventions focusing on empowerment and enabling supports to promote individual choices.

Methods
The team will use a sequential mixed methods design, including qualitative and quantitative data collection phase as well as participatory action to co-design interventions. The project also includes a final evaluation using quantitative and qualitative methods.
Objective 1: Focus groups (to be completed with other funding), fuzzy cognitive mapping (FCM; graphic representation of knowledge about causality in a system) to map factors believed to cause the priority ASRH concerns identified in the focus groups. FCM will be conducted with adolescent groups (separately by age and gender), adults, traditional and religious leaders, and health service providers in 6 communities, including urban, rural, and rural-remote. Objective 2: Baseline household survey of parents and adolescents (6,000 adolescent girls and 4,000 adolescent boys, 4,000 mothers and 2,500 fathers) in 60 communities in 6 wards which will focus on "knowledge, attitudes, and experience amenable to change", informed by the focus groups Objective 3: Three of 6 wards (in 30 communities) will be randomly selected to receive Socializing evidence for participatory action (SEPA), which involves dialogues with stakeholders to review evidence and develop local interventions. Docudramas developed with youth will be used to share evidence on maps from objective 1. SEPA communities (adolescent girls, boys, adults, community and religious leaders, and relevant service providers) will develop local actions based on evidence. Special steps will be taken to ensure that the perspectives of females are listened to and respected.
Objective 4: Process evaluation -towards end of implementation, participants will review SEPA activities and implementation will be Capacity building: The team will hold analysis and interpretation workshops and adolescents will design materials to share the evidence.

Strengths and Weaknesses/Forces et faiblesses:
The team is strong. The NPA has extensive experience conducting community-based participatory research and has worked closely with stakeholders in Nigeria and the state of Bauchi in particular. The team includes Co-PA knowledge user who is the former Director of Nursing Services and Amirah of FOMWAN in Bauchi, and is now heading its Health Committee.
The scope of the project on sexual and reproductive health is, perhaps necessarily, very broad as it touches on HIV risk, unwanted pregnancy, abortion, and sexual violence. Each of these separate outcomes is complex and comes with a large literature. For example, a focus on gender-based violence requires extensive knowledge regarding its causes and best practices for prevention. As such, this is an extremely complex and ambitious endeavour.
If the ultimate goal is to improve the sexual health of girls, it would seem important to consider the literature on effective interventions that have been used in low income countries and draw on this knowledge in the development of interventions and perhaps shared with community stakeholders to inform their planning.
Importantly, while the introduction draws attention to the sexual health of girls, the research plan focuses on both boys and girls (although a larger attention is given to girls), who will participate in all phases of the project. Again, this makes the project very ambitious, challenging and less focused.
Given concerns from previous reviewers that the voices of adolescents may be overshadowed by those of other stakeholders, the team notes that the perspectives of adolescent girls & boys will be given equal weight with those of stakeholders. The perspectives of adolescents should actually be prioritized rather than given equal weight with that of other stakeholders. Ultimately, if the interventions are not meaningful to the target population (i.e., youth) they will not be effective -therefore, engagement with youth is of most importance.
The evaluation component will simply test the overall impact of SEPA (the engagement process), with data pooled across communities, rather than test the effectiveness of the interventions themselves. With SEPA, if every community in the SEPA arm develops its own action plan the interventions are likely to be different in every community. Is there a way to determine which intervention is most effective? Can you take the best of all interventions for scale up across the region? Or will all interventions remain locally specific? Are there learnings from each local area that could be shared in developing an overarching prevention plan? Obviously, the communities in the control arm of the project will not receive SEPA. Are there plans to implement SEPA in the control arm? Perhaps a step-wedge design would be more appropriate.
Additionally, project may benefit from a clearer focus specifically on the sexual health of girls and women and providing a theoretical framing and research around this topic rather than more generally around boys and girls. It may also make sense to engage adult women who have experienced sexual health problems and survivors of gender based violence in the development of interventions. Involving parents in intervention planning may be problematic if they are the perpetrators.