Using an experience-based co-design approach to identify touchpoints and develop strategies for implementing an intravenous iron intervention for pregnant women with moderate and severe anaemia in Malawi

doi:10.21203/rs.3.rs-3946504/v1

Background

In low- and middle-income countries, women experiencing anaemia during pregnancy are recommended to take 30 mg to 60 mg of oral iron daily throughout pregnancy. However, oral iron tablets are often poorly tolerated, resulting in low adherence. An alternative to oral iron is intravenous (IV) iron, which is commonly used in high-income countries to enable the rapid restoration of the body’s iron stores. A randomised controlled trial in Malawi is underway to investigate the effectiveness and safety of IV iron compared to standard of care oral iron supplementation to pregnant women with moderate and severe anaemia in in the third trimester (REVAMP-TT). However, strategies for informing the successful implementation of REVAMP-TT trial remain largely unknown. This study used a co-design approach to address this gap.

Methodology:

The co-design process involved two phases: 1) Information gathering—which included conducting interviews with key informants and gathering previous findings from a qualitative formative study on the perceptions and experiences of IV iron treatment for pregnant women experiencing anaemia in Malawi (n = 52) to identify the touchpoints; 2) Two co-design workshops with end-users (n = 20) and healthcare providers (n = 20) to develop strategies for the implementation of REVAMP-TT trial. We mapped the touchpoints to the Consolidated Framework for Implementation Research 2.0 (CFIR 2.0) and matched the strategies to Expert Recommendations for Implementing Change (ERIC) according to the CFIR-ERIC matching tool.

Results

The following touchpoints were identified: cost of IV iron, lack of available resources and knowledge, local attitudes including myths and misconceptions of IV iron, local conditions affecting access to antenatal care, lack of political will and buy-in from high-level leaders, lack of capability from healthcare providers to deliver IV iron and lack of male involvement to support pregnant women accessing care. The suggested strategies included: providing financial strategies, developing stakeholder relationships, training and educating stakeholders, supporting clinicians, and engaging end-users.

Conclusion

We found that the ability of pregnant women in Malawi to access anaemia screening and treatment depends on the ability to address the perceived obstacles. We developed information, education and communication materials about the risks and consequences of anaemia during pregnancy and treatment to improve the recruitment of pregnant women with anaemia in REVAMP-TT trial. Engaging end-users and relevant stakeholders ensured that the IV iron intervention is tailored to meet their needs, and the implementation strategies are culturally appropriate.

Community engagement

experience-based co-design

implementation strategies

anaemia

intravenous iron

pregnant women

antenatal care

Evidence shows that evidence-based interventions are more successfully implemented if the local context is taken into consideration. This research contributes to showcasing experience-based co-design approach as an innovative methodology in successfully implementing health interventions

Our research highlights how involving healthcare providers and pregnant women in co-design leads to improved feasibility and acceptability of health interventions.
Findings from our research show that policymakers buy-in and supporting healthcare providers through providing ongoing professional training, sufficient resources, infrastructure, and incentives are fundamental strategies for the success of implementing health interventions

Anaemia during pregnancy is a global health problem. The World Health Organisation (WHO) reports that nearly half of pregnant women experience anaemia globally, 18% are from high-income countries (HICs) and 35–75% are from low- and middle-income countries (LMICs) (1, 2). The prevalence rate of anaemia during pregnancy in Malawi is 41.8% (Hb < 11.0 g/dl) (3). The WHO recommends the daily uptake of oral iron tablets for managing anaemia in pregnancy (4–7). However, oral iron tablets are often poorly tolerated and adhered to because of significant gastrointestinal effects, tedious daily intake, frequent need to visit antenatal clinics, and low supply (4, 8–10).

A potential alternative to treat moderate and severe anaemia during pregnancy is the use of intravenous (IV) iron, which is commonly used in HICs. Past studies have demonstrated that IV iron is superior to oral iron in managing moderate and severe anaemia during pregnancy, as it allows quick replenishment of the body's iron stores after one or two infusions (7, 11–13). Although IV iron is being routinely used in HICs for the treatment of moderate and severe anaemia during pregnancy when oral iron is not tolerated, there are limited research on the applicability and transferability of this intervention to LMICs,

Furthermore, evidence has shown that clinical interventions are more readily adopted into routine practice if both end-users and healthcare providers are involved in all stages of planning and implementation of the evidence-based interventions (14). As such implementation science plays a role in bridging the gap between research and practice and ensuring that evidence-based interventions are effectively and efficiently translated into real-world settings to improve the quality and effectiveness of health services(15). The systematic application of implementation science methodologies and frameworks can aid in the understanding of different characteristics, behaviours, and needs across contexts and in the identification of barriers and facilitators to implementation (16).

A randomised controlled trial (RCT) managed by the Training and Research Unit of Excellence was conducted in Malawi to examine the effectiveness and safety of ferric carboxymaltose (FCM) versus standard-of-care oral iron for the treatment of moderate and severe anaemia in pregnant women in the second trimester (REVAMP) (17). REVAMP was conducted with optimal resources under controlled conditions and did not represent real world of primary health facility settings which limits the applicability and transferability of the intervention to the local context. To address this gap, a similar RCT was subsequently conducted for pregnant women with moderate and severe anaemia in the third trimester (REVAMP-TT), in parallel with an implementation science research program in the primary healthcare facilities involving government healthcare providers, pregnant women, community members and health policy makers (17). Our implementation science research was composed of formative research and an evaluation component to assess the acceptability and feasibility of implementing an IV iron intervention in the healthcare system of Malawi(18). In this manuscript, we describe the use of an experience-based co-design (EBCD) approach to identify touchpoints and develop strategies to support the implementation of IV iron intervention for pregnant women in the third trimester experiencing anaemia in Malawi.

Study setting

We conducted the research program in the eight primary health facilities throughout the Zomba district in Malawi, covering both rural (Likangala, Bimbi, Lambulira, and Domasi) and urban (City Clinic, Sadzi, Matawale, and Naisi) areas. These health facilities served as recruitment locations for eligible pregnant women participating in the REVAMP-TT trial and accessing antenatal care services, including screening and treatment of anaemia.

Experience-Based Co-Design

We used an experience-based co-design (EBCD) approach in this study. EBCD refers to a collaborative and participatory creative process of co-designing health care services with end-users, healthcare providers and policy makers through an equal partnership approach which ensures the development of more engaging and satisfying interventions for potential end-users (20, 21). This approach minimises the waste of funds and resources by designing and developing interventions and implementation strategies that take local needs into consideration and address potential barriers and facilitators from the outset. The process involves two phases: an initial information gathering phase to identify critical moments with emotional significance in end-user’s experience of a service (touchpoints) and a second phase where these touchpoints are shared with other end-users and healthcare providers. Together with the project leaders, they collaboratively develop interventions and implementation strategies. This approach encourages end-users and healthcare providers s to actively participate in the co-design process whilst considering the local context (21). We based our EBCD workshops on the five principles: inclusivity, participation, respectfulness, adaptation, and outcomes (22, 23) to ensure authentic engagement and power sharing amongst participants.

Phase 1: Information (experiences) gathering.

The aim of Phase 1 was to gather information and to identify touchpoints. We did this in two steps.

Step 1. Gathering experiences through interviews with key informants

We (EMM) conducted in-depth interviews with key informants, including policymakers, government partners, health managers and healthcare providers, to understand their experiences working within the Malawian health system and to identify the touchpoints that could affect the implementation of REVAMP-TT trial. We conducted one-on-one interviews and lasted between 45 and 60 minutes. We purposively sampled key informants directly involved in antenatal care services. Snowballing was also used to identify further potential participants.

Step 2. Gathering healthcare providers' and end-users’ experiences.

To complement the above findings, we identified touchpoints from a previously published study which explored the perceptions and experiences of IV iron from pregnant women and healthcare providers participating in REVAMP trial (19).

Findings from the key informant interviews and the above study findings were synthesized to describe the touchpoints during a pregnant woman’s antenatal journey for use in the co-design workshops.

Phase 2: Co-design workshops

We (EMM, EC and LMT) conducted two separate co-design workshops. The first workshop included community members, including pregnant women with experience receiving IV iron, caregivers, mothers-in-law, spouses, village health committee members and village heads. The second workshop included healthcare providers, including doctors, clinicians, nurses and midwives, health surveillance assistants, laboratory technicians, pharmacists and data clerks. The aim of the co-design workshops was to showcase the identified touchpoints and to develop implementation strategies. This process was conducted in several steps.

Step 3. Recruitment of community members and health care providers.

Participants were recruited using the REVAMP trial register. This is a database of all the women who experienced anaemia during pregnancy and received IV iron in their second trimester as part of the REVAMP trial. We systematically identified pregnant women who experienced anaemia in pregnancy and had received IV iron in REVAMP trial to come along with other community members. We visited them in their homes to personally invite them to participate in the co-design workshop. All the approached participants agreed to participate

The research coordinator provided a list of healthcare providers from the health facilities involved in REVAMP-TT trial. Twenty participants were purposively recruited through the District Nursing Officer for Zomba, and we invited them via telephone and email where all the approached participants agreed to participate.

Step 4: Jointly identifying priority touchpoints

We (EMM, EC and LMT) commenced the co-design workshops with an overview of the REVAMP-TT trial, the implementation research program, and the purpose of the workshops. We then described the pregnant women's antenatal care journey and discussed the touchpoints identified in Phase 1 to provide a basis for discussion. Together, we identified the priority touchpoints perceived as barriers to implementing REVAMP-TT trial through group discussions and consensus. To address power dynamics and respect for cultural-gender considerations, community members in the workshops were divided into two gender-based groups (men/women) during discussions, contrasting with the workshop for healthcare providers where both male and female attended together.

Step 5: Jointly developing the implementation strategies

After identifying the priority touchpoints, participants returned to their groups to develop implementation strategies and solutions to address the priority touchpoints that would facilitate the successful implementation of REVAMP-TT trial and inform the IV iron intervention implementation in the healthcare system. One representative from each group shared the findings with the wider group. We conducted the workshops in Chichewa, the local language of Malawi.

Step 6: Reflections and celebrations

We held meetings with the research team, policymakers, and health managers for a joint discussion on the findings from the co-design workshops, the selection of implementation strategies, and the development of outcomes. We presented the outcomes of the study at the Malawi National SMTWG (SMTWG) (a group that serves various functions, including policy development, program planning and implementation for maternal health at the national level), the Zomba district health management team (DHMT) and the community for feedback, insights, recommendations and dissemination purposes.

Data analysis

Phase 1

Interviews were audio-recorded and transcribed by a professional transcription service. We (EM, LMT, NVD) developed the codebook independently and coded the same three transcripts to identify the touchpoints. The touchpoints were compared and discussed, leading to an agreed upon codebook. EM coded the rest of the transcripts using NVivo Version 12.

We (EM and HS) mapped the touchpoints to the Consolidated Framework for Implementation Research 2.0 (CFIR 2.0) (appendix 1). CFIR 2.0 is a commonly used determinant framework to assess contextual factors across five domains: the innovation, the process, outer setting, inner setting and individuals. We opted to use the CFIR 2.0 because it acknowledges that the effectiveness of interventions implemented within a health system is influenced by the interaction of environmental/policy within the larger healthcare system and by organisational and individual-level factors.

Phase 2

We (EMM, LMT) recorded data from the co-design workshop through short notes, flip charts, sticky notes, and audio recordings. We (EMM, LMT, EC) together with the participants debated and deliberated on the implementation strategies proposed by the participants. We selected the strategies that were considered to be the most important by the participants based on votes consensus and the feasibility and time required to implement the strategies. We (EMM and HS) mapped the implementation strategies to the Expert Recommendations for Implementing Change (ERIC) process (appendix 2). ERIC is compilation of implementation strategy and it includes 73 defined implementation strategies clustered into nine content areas that track implementation strategies over time(20)

Consent and ethics clearance

We received ethics approval (P.08/20/3114) from the University of Malawi’s College of Medicine Research and Ethics Committee. Permission to collect data from the health facilities was obtained from the Zomba District Health Office (DHO) research committee. Written informed consent was provided in Chichewa (the local language) or English according to the participants’ language preference. Literate participants provided a signature on the consent form, and illiterate participants provided a thumbprint. We informed all participants that confidentiality would be maintained and that no personal details would be divulged. We also explained to the participants that their involvement in the research was voluntary, and that withdrawal was permitted at any time without personal consequences. Finally, we provided all participants with a copy of their written consent form and reimbursed them for their time and travel expenses per the Malawi’s national participant remuneration guidelines (21).

Participant demographics

Table 1 below shows the demographic characteristics of participants from key informant interviews and co-design workshops 1 and 2.

(Insert table 1)

Touchpoints (barriers) mapped to CFIR 2.0

The following sets out our findings from the co-design workshops. The key barriers identified for anaemia screening and IV iron administraton were cost of IV iron, cost of IV iron, lack of available resources and knowledge, local attitudes including myths and misconceptions of IV iron, local conditions affecting access to antenatal care, lack of political will and buy-in from high-level leaders, lack of capability from healthcare providers to deliver IV iron and lack of male involvement to support pregnant women accessing care. The suggested strategies included: providing financial strategies, developing stakeholder relationships, training and educating stakeholders, supporting clinicians, and engaging and they correspond to the following CFIR 2.0 domains; innovation, inner setting, outer setting, individual and implementation process (Table 2)

(Insert table 2)

A. Innovation domain

1. The cost of using IV iron in Malawi

The use of IV iron is a novel intervention in Malawi. KII participants reported concerns about the associated costs related to the administration of IV iron. They indicated that in Malawi, there is a limited supply of essential drugs such as oral iron tablets and other resources, and IV iron would be costly.

“A woman can start antenatal care visits and deliver without receiving a dose of ferrous sulphate. What more with the expensive IV iron? Most often, iron tablets are out of stock. Sometimes, clients are even advised to buy their own drugs. There are no hemocues; we lack BP [blood pressure] machines, weighing scales, and even [birth?] giving sets; we cannot afford this drug.” (Co-design workshop 2: nurse-03)

B. Outer setting domain

1. Local conditions

Participants from the KII questioned the transferability of the intervention from HICs to Malawi because of the challenges involved in accessing antenatal care services. Pregnant women have limited means of transport, must travel long distances over poor terrain. This discourages pregnant women from seeking routine check-ups, including for screening and treatment of anaemia despite that fact that it is important to perform routine check-ups so as to ensure timely diagnosis and treatment.

“Women felt it is so tiresome to come for ANC [antenatal care] every month because of the long distances they have to endure to travel to a health facility, hence a missed [opportunity?] for diagnosing anaemia. They normally come when they are nearing delivery. Roads are dangerous during the rainy season and when vegetation grows thick, they cannot travel to the facility alone. If they find no guardian, they stay home.” (KII: policy maker-02)

2. Local attitudes

Myths and Misconceptions about IV Iron

Participants from both the KII and the co-design workshops mentioned that myths and misconceptions about IV iron would likely discourage pregnant women from seeking antenatal care and they discussed their hesitancy to participate in the REVAMP-TT trial. Myths and misconceptions included relating IV iron to COVID-19 vaccine, satanism and vampirism, mistrusted motives on routine follow-ups and invasive medical procedures, as well as fear of pain, resulting in missed opportunities to be screened and treated for anaemia.

“We [pregnant women] are poor in the community. Nobody expects a car to come to our house. When they see the organisation's vehicle coming to our house for follow-up visits, they call on each other to come and witness that we have joined Satanism. Some say that we have sold our babies to satanism because of famine to receive the allowance we get from the project and buy food.” (Co-design workshop 1: pregnant woman-04)

“IV iron looks like blood, and that would be associated with vampirism. Additionally, anything about current injections is related to the COVID-19 vaccine, which people are against. They would also think you are injecting something unknown into their bodies to make them unable to conceive again.” (Co-design workshop 1: pregnant woman-02)

Keeping pregnancy, a secret

Participants from the co-design workshops mentioned cultural factors and personal preferences for hiding pregnancy that influence the ability of pregnant women to seek antenatal care services. Most remote cultures in Malawi encourage women to conceal their pregnancy until the second trimester due to misconceptions that they will miscarry when it is publicly known to the community. This contributes to delayed in early and regular monitoring of the health of both the mother and the child, including screening and management of anaemia.

“Most of them [pregnant women] think they will lose the baby if they announce their pregnancy. Pregnant women used traditional medicine to keep the pregnant without visiting the hospital. They will only come when they know they are due soon. How can anaemia be treated at this stage when it is supposed to be diagnosed early?” (KII- policy maker-04)

C. Inner setting domain

1. Lack of available resources

Lack of private space

Inadequate space in the health facilities was reported as a barrier to providing the IV iron intervention. Given the need for privacy for screening for anaemia and administration of IV iron, healthcare providers complained that there would not be enough rooms to conduct these procedures.

“There is also inadequate space at the health facilities. For example, there are not enough treatment rooms or guardian shelter. Unless you bring the [privacy] screens, maybe we can divide the postnatal ward into a separate room.” (Co-design workshop 2: clinician-07)

Shortage of human resources

Understaffed health facilities were also reported as barriers to timely access to antenatal care because IV iron administration requires at least 15–30 minutes of administration and additional 30 minutes for monitoring. Inadequate healthcare providers were linked to burdening their workload and contributing to long queues and significant waiting times for the pregnant women.

The only thing I see in this [IV iron program] is that nurses and midwives are already overwhelmed with work, like going to a health facility for antenatal care, where approximately 300 or 400 women are being attended to by one or two nurses. This then needs to come with reprogramming because I see that for it to be translated on the ground is an issue of human resources. (KII: policy maker-03)

2. Culture-recipient

Women who participated in the co-design workshop strongly reported that healthcare providers’ poor attitude and inability to provide clear explanations of procedures, such as blood sample collection and drug injection, creates fear and anxiety. However, they feel uncomfortable to share their concerns and experiences with healthcare providers. Consequently, this erodes their trust in them and made them hesitant to attend antenatal care services hence missing appointments for routine anaemia screening and timely treatment.

“Nurses shout a lot, and with this, we [pregnant women] don’t look forward to meeting them in the next appointment, so we just stay home and miss the appointment. I still remember what a nurse said accusing me of going for labour and delivery approximately 1:00 a.m., yet no one chooses when the best time is to go until labour calls” (Co-design workshop 1: pregnant woman-04)

D. Individual characteristics domain

1. Innovation recipient

Lack of knowledge of anaemia screening and treatment

KII reported that the introduction of a new medical intervention involving blood, would be difficult for pregnant women to willingly participate in REVAMP-TT trial and accept the IV iron intervention. Pregnant women lacked information about the benefits, effects and importance of IV iron and participants in the co-design workshops confirmed about this.

“Pregnant women complain that nine months is a long time to visit the health facility every month. As such, they stay at home and ignore headaches and fatigue. They feel it will go away, not knowing that it could be anaemia and will need treatment. By the time they reach the health facility at seven months of pregnancy, the problem is unmanageable. Maybe they don’t know that anaemia is dangerous”. (KII: health manager − 05)

Lack of male/spouse involvement

While healthcare providers encourage men to accompany their wives for antenatal care visits, pregnant women in the co-design workshops highlighted that they lacked this support from their spouses. A lack of male involvement was mentioned as a hindrance to women's ability to decide whether or not to participate in the REVAMP-TT trial. Men in the co-design workshops acknowledged that the fear of being tested for HIV/AIDS and labour commitments as reasons why they do not attend their wife’s antenatal care appointments.

“If men accompany us [pregnant women] to ANC [antenatal care], we feel quickly more comfortable to decide on interventions like these [IV iron] knowing that they agree with the advice we get from the hospital.” (Co-design workshop 1: female participant-03)

2. Innovation delivery

Training for anaemia screening and administration of IV iron

Healthcare providers confirmed that they do not administer IV iron currently in health facilities and hence they will need training on drug preparation, administration and storage.

“It’s a new drug; no one [healthcare providers] is familiar with it, and we don’t know how to prepare and administer IV iron. Does it have any benefits or side effects? Can it be kept in cabinets at room temperature or in refrigerators if a lower temperature is needed? All these are the questions that we have.” (Co-design workshop 2: Pharmacist-02)

E. Implementation process domain

1. Engagement

A lack of stakeholder engagement was listed as the main barrier for buy-in and acceptability of the IV iron intervention. The KIIs stressed that engaging all stakeholders, including the pregnant women, community, healthcare providers, health managers, policymakers and government partners at every phase of the REVAMP-TT trial is important.

2. Reflecting and evaluating

Participants in both the KII and co-design workshops stressed the need to implement evidence-based interventions. They emphasised that this can be achieved only if researchers share their findings and outcomes across all relevant stakeholders’ platforms including the policymakers, healthcare providers and the community.

“For communities, change is something that may meet resistance, or it may be taken on board depending on how the community would perceive it, so once you are bringing a change, it’s good to understand the leadership structures of the community and involve the community. You can do it through the chiefs because they have different structures and they would be able to say, maybe you will meet with such a group. Right now, I know there are community action groups who can agree on the actions they will do, like changes; we no longer take the initiative to say that this is what we want. I think the community has to buy in to see that this is the need, and we will work with you in this way.” (KII: policy maker 01)

Selection and development of IV iron implementation strategies

Once the touchpoints listed above were identified in Phase One, Phase two entailed co-design workshops the aim of which was to agree on priority barriers and implementation strategies that could be used to address them. The participants came up with five strategies as listed in table 2 above. Through discussion amongst the research team, the most feasible implementation strategies were agreed upon based on the feasibility and resource capacity of REVAMP-TT trial. These belonged to the ERIC domains of develop stakeholder relationship, financial strategy, engage the community and train and educate healthcare providers. The following section outlines how they were rolled out.

1. Develop stakeholder relationships

To address the barrier of lack of stakeholder engagement we presented the study protocol and ongoing progress every quarter to the Safe Motherhood Technical Working group and Zomba District Health Management Team for reviews, input, and recommendations. Policymakers, government partners, health managers, healthcare providers, institutional maternal health experts, and others who attended the meetings endorsed and appraised the study progress and outcomes.

2. Financial strategies

To address the barrier of cost of IV iron implementation and resources, REVAMP-TT trial was responsible for covering the intervention costs, including the procurement of drugs and all necessary equipment and the recruitment of additional trial staff to support the implementation of the IV iron intervention.

3. Engage and educate end-users (pregnant women) and the community

a. Community engagement: To dispel myths and misconceptions, encourage male involvement and enhance knowledge, we conducted community awareness and sensitization of the importance of antenatal care services, including anaemia screening and treatment, in the eight communities surrounding the eight health facilities participating in REVAMP-TT trial. This involved four private talks with Community Health Advisory Groups and Village Development Committees, eight mobile public awareness campaign around the communities surrounding the eight health facilities where REVAMP-TT trial will be implemented and eight market days awareness campaign
b. Development of information, education and communication (IEC) materials: The co-design workshops revealed a lack of knowledge about anaemia among pregnant women, leading to late antenatal care visits, diagnosis, and treatment of anaemia. We conducted a national audit that confirmed the absence of anaemia in pregnancy IEC materials in Malawi. An international audit helped create informational material (anaemia in pregnancy posters and wall charts) prototypes in collaboration with various stakeholders, including Reproductive Health Department, Health Education Unit, the Health Promotion Office and the graphic designer. Prototypes were pretested with pregnant women and men and women of reproductive age across Northern, Central and Southern regions of Malawi. We conducted twelve focus group discussions, six with pregnant women and six with community members, to assess whether the intended audience understood the key messages and whether the illustrations were appropriate and culturally acceptable. We refined the IEC materials based on feedback from the pregnant women, community members and stakeholders. We presented the final versions of the poster and wall chart (Figs. 2 and 3, Appendix 3 for Chichewa version) to the Zomba DHMT and the SMTWG. They were endorsed for use at the REVAMP-TT trial sites, aiming to improve pregnant women's knowledge about anaemia and encourage screening and treatment. Scaling up the materials nationally is contingent on funding availability in Malawi's health system.

4. Train, educate and support healthcare providers

a. To address the lack of knowledge gap and unfamiliarity with IV iron for healthcare providers, we organised a three-day protocol training and orientation to the healthcare provider responsible for implementing REVAMP-TT trial on the IV iron profile, preparation, administration, and storage per REVAMP-TT trial protocol. Ongoing profession development was ensured throughout the trial implementation period. All healthcare providers from the health facilities participating in the REVAMP-TT trial underwent comprehensive training to fulfil their trial-related responsibilities, ensuring the quality and protocol adherence of all the activities.

This study pioneers the use of a co-design approach in Malawi to uncover barriers and opportunities for implementing IV iron in a low and middle-income healthcare setting. Our key findings emphasise the need to build strong partnerships with policymakers, government partners, health managers, healthcare providers, pregnant women, spouses, caregivers and community leaders to enhance the implementation process. We used data from Phase One to inform our data collection activities and data from Phase Two to support our analysis. Specifically, we utilised our data from Phase Two’s co-design workshops to match them with the ERIC process to help our analysis. Our results provide insights and suggestions for guiding the use of IV iron as an intervention for pregnant women with moderate to severe anaemia in comparable healthcare settings. More importantly, our methodological approach illustrates implementation strategies for researchers seeking to replicate our approach. Our discussion focuses on key endeavours and strategies to support the implementation of IV iron in routine healthcare settings, namely, establishing stakeholder relationships, developing effective community engagement strategies and supporting healthcare providers to improve implementation.

Developing Stakeholder Relationships: Key Endeavors for Implementation Buy-in

Stakeholders are equal members and an integral part of successful health intervention implementation. Deep-rooted relationships with stakeholders can be game changers, fostering collaboration, engagement, and mutual understanding to achieve long-term success (22). It was evident in our study that the collaborative efforts among various stakeholders, including policymakers, healthcare providers, pregnant women and community members, allowed the identification of key players and ensured the understanding of diverse perspectives to incorporate their input and working together toward a shared common goal in addressing common needs. Through open communication, regular updates, active engagement and feedback sessions with policymakers, healthcare providers and community members, our study gained endorsement, ongoing support and credibility from stakeholders, enabling a successful environment for the implementation of REVAMP-TT trial. For example, the development of the IEC materials in this study was successful with valuable expertise and insights from stakeholders who were well conversant with the Malawian health systems. Likewise, other studies have reported that stakeholder engagement is vital in implementing health interventions because it reduces barriers, boosts buy-in and eventually grants acceptability (23–25). Ultimately, developing stakeholder relationships fosters collaboration and promotes a sense of ownership, leading to greater commitment, which accelerates inclusive decision-making for successful intervention. In implementation science research, establishing collaborative relationships with stakeholders promotes the principles of co-design and co-production and ensures that research findings are easily disseminated and that stakeholders easily support and advocate for the successful adoption of evidence-based practice care (22, 26, 27)

Developing Effective Community Engagement: Strategies for Implementation Success

The multifaceted challenges hindering access to antenatal care services, if not resolved, have significant complications for the health of both the mother and the child (28, 29). For example, in this study, we discovered that local attitudes, a lack of male involvement and a lack of knowledge contribute to pregnant women avoiding accessing antenatal care services, delaying the timely detection and treatment of anaemia during pregnancy and consequently accessing IV iron. In Malawian culture, men are household decision makers, and our study showed that a lack of male involvement will decrease the demand for IV iron use. The inclusion of men in this study ensured that the intervention was respectful, inclusive, and tailored to the community's perceptions, which increased the sense of control and responsibility to embrace the spouse's acceptance of IV iron. Other studies have shown that effective community engagement and male involvement improve health-seeking behaviours and positively impact local attitudes and cultural beliefs (30–37). It is, therefore, crucial to develop effective community engagement pathways that respect local values and provide open dialogue to enhance knowledge, dispel myths and misconceptions and overcome resistance.

Supporting Healthcare Providers: Implementation Strategies for Success

Supporting healthcare providers is a fundamental strategy for the success of implementing health interventions. As highlighted in this study, providing ongoing professional training, sufficient resources, infrastructure, and incentives guarantees the effective delivery of interventions, thereby contributing to improved health system performance. Similarly, investing in enhancing Healthcare providers’ capabilities and attitudes contributes to improved behaviours, attitudes, skills and knowledge to deliver high skills and expertise towards safe patient-centered care that prioritises patients’ needs, values and satisfaction (38–40). Other studies have also agreed that supporting Healthcare providers is an effective tool for improving the quality of care and improving patient health-seeking behaviours necessary to establish patient motivation, trust, and confidence in seeking medical attention and complying with appointments (41,42). Consequently, a supported workforce delivers compassionate and effective quality care, improving positive health outcomes.

In sum, our implementation science research used an experience-based co-design (EBCD) approach to identify touchpoints and develop strategies to support the implementation of IVs iron intervention for pregnant women in the third trimester experiencing anaemia in Malawi. Based on our co-design experience, we encourage research teams to involve healthcare providers and end-users in projects as early as possible to ensure that the research implementation runs smoothly, promoting a shared understanding of the study's goals and full participation. Additionally, our co-design approach helped the research team develop anaemia in pregnancy education, information and communication materials for use as part of antenatal care health talks. This approach could enhance the acceptability and uptake of IV iron in routine healthcare settings in low-and middle-income countries such as Malawi.

Strengths and limitations of the study

This was a cross-cutting study where all views at all levels were consolidated. When data were collected from policymakers, health managers, Healthcare providers, and pregnant women who had experience receiving the IV iron in the previous study, their spouses, caregivers and various community leaders and members ensured that broader perspectives were gathered, strengthening the data triangulation. The study also combined data collection methods to identify touchpoints, including key informant in-depth interviews, literature, and feedback from co-design workshops, strengthening the transferability of the study findings. While we have been able to implement these strategies, especially through the development of posters and wallcharts, their effectiveness should be evaluated by observing and interviewing users (pregnant women) and Healthcare providers to determine their usefulness as educational tools within the antenatal care context. In addition, conducting co-design workshops in one district means that the collection of views represents a small sample. Future studies must consider running co-design workshops in several other districts for further insights.

This manuscript explains how new medical interventions should be implemented in new contexts and real-world settings. The study findings suggest that implementing IV iron intervention in Malawi could be feasible and acceptable if all health system arrangements and support systems are promoted. Of particular importance is the choice of experience-based co-design approach, which allows us to identify the barriers to understanding needs and developing implementation strategies to overcome those obstacles. Using multidisciplinary views to drive the implementation of trials increases acceptability and translates efforts to successful implementation. Future research must evaluate the effectiveness of the generated strategies in this study to enhance the knowledge and foster participant recruitment from the perspectives of both Healthcare providers and end-users.

REVAMP: Randomised controlled trial on the effect of ferric carboxymaltose (FCM) on moderate and severe anaemia in pregnant Malawian women in their second trimester

REVAMP-TT: Randomised controlled trial on the effect of intravenous iron on moderate and severe anaemia in pregnant women in the third trimester

ERIC: Expert Recommendations for Implementing Change

CFIR 2.0: Consolidated Framework for Implementation Research 2.0

IV: IntraVenous

EBCD: Experience Based Co-Design

SMTWG: Safe Motherhood Technical Working Group

DHMT: District Health Management Team

IEC: Information Education and Communication

Availability of data and materials

The datasets generated and analysed during the current study are not publicly available due to participants’ confidentiality.

Acknowledgements

We would like to acknowledge the study participants as well as the dedication of the REVAMP-TT trial staff in Zomba, Malawi and collaborators at the Walter and Eliza Hall Institute in Melbourne, Australia. We are grateful for the support we continue to receive from the District Health Offices in Zomba district, Malawi as well as the managerial and nursing staff of the government health facilities where REVAMP-TT trial is conducted.

Funding

This research program was supported by the Bill and Melinda Gates Foundation under the REVAMP-TT TRIAL[INV-004505]. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

Author Information

Authors and affiliation

Department of Health Systems and Policy, Kamuzu University of Health Sciences, Malawi Elisabeth Mamani-Mategula, Effie Chipeta, Lucinda Manda Taylor.

Population Health and Immunity division, The Walter and Eliza Hall Institute of Research, Melbourne, Australia. Naomi Von-Dinklage

Centre for Health Policy, Melbourne School of Population and Global Health, The University of Melbourne, Australia. Hana Sanabovic, Ebony Verbunt, Khic-Houy Prang.

Contributions

EMM, KHP, EC, and LMT designed the study. EMM conducted the in-depth interviews and EMM, EC, and LMT ran the co-design workshops.;. EMM, NVD, LMT and HS analysed and interpreted the data. EMM drafted the manuscript with KHP, EV, HS, NVD, EC, and LMT critically reviewed and contributed to the manuscript. All authors read and approved the final manuscript.

Corresponding author

Elisabeth Mamani-Mategula

Email: [email protected]

Ethics declaration

Ethics approval and consent

We received ethics approval (P.08/20/3114) from the University of Malawi’s College of Medicine Research and Ethics Committee. All participants signed the informed consent form.

Consent for publication

Not applicable

Competing interests

We know of no conflicts of interest associated with this publication

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Table 1: Key informant interviews and co-design workshops participants' demographic characteristics

		Phase 1: Information gathering	Phase 2: Co-design workshops
Variable		Key informant interviews	Community members	Healthcare providers
Gender
	Male	23	10	10
	Female	29	10	10
Age
	18-30	6	6	2
	30-40	17	5	8
	40-50	24	5	6
	50-60	5	4	4
Marital status
	Married	40	12	13
	Unmarried	7	1	6
	Divorced/Widowed	5	7	1
Education
	Illiterate	-	2	-
	Primary	-	11	-
	Secondary	-	7	3
	Tertiary	52	-	17
Occupation
	Policymaker	11	-	-
	Health manager	5	-	-
	Government partner	5	-	-
	Health facility in-charge	31
	Doctor	-	-	2
	Nurse	-	-	5
	Clinical officer	-	-	3
	Community Midwife			3
	Patient attendant	-	-	3
	Lab technician	-	-	2
	Data clerk	-	-	2
Community role
	Wife (participants in REVAMP trial)		4
	Mother-in-law	-	2	-
	Elderly		2
	Village head	-	3	-
	Village health committee		3
	Husband	-	4	-
	Father/father-in-law	-	2	-

Table 2: Outlining the touchpoints (barriers) identified in phase 1 as mapped to CFIR 2.0 and corresponding strategies identified through a co-design process in phase 2 mapped to the ERIC tool

CFIR 2.0 Domains	Phase 1: Information gathering (touchpoints)		Phase 2: Co-design workshops
	Barriers from key informant interviews	Barriers from qualitative study (19)	Strategies s identified	Action points	ERIC tool Content area-strategy
Innovation domain	Cost of IV iron	Cost of IV iron	IV iron should be included in healthcare budget	Prioritised. REVAMP-TT trial to cover treatment costs	Financial strategies
Inner setting domain	Lack of knowledge and information about anaemia amongst healthcare providers		Development and dissemination of IV iron information	Prioritised: To conduct education meetings and outreach activities to healthcare providers	Train and educate stakeholders
	Lack of available resources: human resources	Relative disadvantage: time to deliver IV iron	Recruitment of additional healthcare providers	Prioritised: To REVAMP-TT to recruit additional healthcare providers for the trial	Financial strategies
	Lack of available resources: private spaces, equipment	Lack of available resources	Provision of additional resources	Prioritised: i Equipment and resources for treatment to be provided by REVAMP-TT	Financial strategy
	Workplace culture is not patient-centered		Improve healthcare providers’ attitudes	Prioritised: To provide incentives or counselling to healthcare providers	Support clinicians
Outer setting domain	Local attitudes: myths and misconceptions relating IV iron to vampirism and satanism	Procedures related to satanism and vampirism	Community engagement	Prioritised: Mass media to reach large numbers of people in the community to dispel myths and misconceptions and increase demand for IV iron	Engage consumers
	Local conditions e.g. lack of transport and difficulty accessing health services		Strengthening the referral systems	Not prioritised as beyond scope of study	Financial strategies
	External pressure: culturally keeping pregnancy as a secret	Cultural beliefs that IV iron will cause miscarriage	Community sensitisation and awareness	Prioritised: Mass media to reach large numbers of people in the community to increase demand for IV iron	Engage consumers
Individual domain	High level leaders: lack of political will and buy-in from the policy makers		Stakeholder engagement through SMTWG and district health management team	Prioritised: Attend advisory SMTWG and district health management team meetings to provide input and elicit recommendations for the implementation of REVAMP-TT trial	Develop stakeholder relationships
	Innovation deliverers: need for training to deliver IV iron		Training and orientation of healthcare providers for anaemia screening and IV iron preparation and administration	Prioritised: To revise REVAMP-TT trial training protocol including roles of healthcare providers	Support clinicians
	Opinion leaders: Lack of male involvement in antenatal care hinders pregnant women receiving IV iron	Lack of male participation in antenatal care	Identify male champions	Prioritised: Men to promote antenatal care and pregnant women to consult their husbands before enrolling in REVAMP-TT trial	Engage consumers
	Need: Lack of knowledge on anaemia screening and management amongst pregnant women		Community education and sensitisation	Prioritised: To develop information education and communication materials to provide knowledge to pregnant women on anaemia screening and management	Train and educate stakeholders
Implementation process domain	Engage: Lack of stakeholder’s engagement		Stakeholder engagement	Prioritised: To conduct stakeholder engagement meetings with SMTWG and district health management team,	Develop stakeholder relationships
	Reflecting and evaluating emphasis		Dissemination of research findings	Prioritised: To present and review our findings with the SMTWG, district health management team and community members	Develop stakeholder relationship

CFIR : Consolidated Framework for Implementation Research 2.0

ERIC: Expert Recommendations for Implementing Change

SMTWG: Safe Motherhood Technical Working Group

DHMT: District Health Management Team

Appendix.docx

Using an experience-based co-design approach to identify touchpoints and develop strategies for implementing an intravenous iron intervention for pregnant women with moderate and severe anaemia in Malawi

Status:

Version 1

Abstract

Background

Methodology:

Results

Conclusion

Figures

Contributions to the literature

Background

Methodology

Study setting

Experience-Based Co-Design

Step 1. Gathering experiences through interviews with key informants

Phase 2: Co-design workshops

Step 4: Jointly identifying priority touchpoints

Step 5: Jointly developing the implementation strategies

Step 6: Reflections and celebrations

Data analysis

Phase 1

Phase 2

Consent and ethics clearance

Results

Participant demographics

Touchpoints (barriers) mapped to CFIR 2.0

1. The cost of using IV iron in Malawi

1. Local conditions

2. Local attitudes

Myths and Misconceptions about IV Iron

Keeping pregnancy, a secret

1. Lack of available resources

Lack of private space

Shortage of human resources

2. Culture-recipient

1. Innovation recipient

Lack of knowledge of anaemia screening and treatment

Lack of male/spouse involvement

2. Innovation delivery

Training for anaemia screening and administration of IV iron

1. Engagement

2. Reflecting and evaluating

Selection and development of IV iron implementation strategies

1. Develop stakeholder relationships

2. Financial strategies

Discussion

Developing Stakeholder Relationships: Key Endeavors for Implementation Buy-in

Developing Effective Community Engagement: Strategies for Implementation Success

Supporting Healthcare Providers: Implementation Strategies for Success

Strengths and limitations of the study

Conclusion

Abbreviations

Declarations

References

Tables

Supplementary Files

Status:

Version 1