Overcoming research challenges in sub-Saharan Africa: insights from the PREECARDIA study

In September 2015, the United Nations General Assembly adopted the Sustainable Development Goals (SDGs), with Goal 3 aiming to “ensure healthy lives and promote well-being for all at all ages” by 2030 [1]. One of the key targets within this goal involves strengthening research capacity in low- and middle-income countries (LMICs) to address pressing health challenges [2]. Clinical and epidemiological research is essential in addressing these challenges, particularly in sub-Saharan Africa (SSA), where disease burden is disproportionately high. Despite contributing to 25% of the global disease burden, SSA produces only 1.3% of health research publications worldwide [3, 4]. These figures reflect a global research agenda that often overlooks the specific health needs of individuals and communities in SSA [5, 6]. For example, routine mammography, which is common in high-income countries (HICs) for breast cancer screening, is generally not feasible in the SSA context because basic radiological equipment is not widely available [7]. As a result, breast self-examination and clinical breast examination are more suitable alternatives for early breast cancer detection [8]. Similarly, in SSA, cervical cancer screening is often based on test and treatment strategies, relying on visual inspection with acetic acid, followed by cryotherapy when needed [9]. This approach bypasses the lack of the necessary lab facilities and trained professionals, as well as difficulties in ensuring follow-up and treatment of females with cervical lesions in these settings [9]. Furthermore, hypertension treatment guidelines from HICs may overlook genetic variations common in individuals of African origin, such as differences in response to angiotensin converting enzyme (ACE) inhibitors [10, 11]. While the necessity for context-specific research in SSA is apparent, its planning and implementation come with unique challenges that are rarely encountered in HICs. Much of the existing literature in SSA predominantly addresses ethical challenges. It focuses less on logistical and practical difficulties that impact the quality and feasibility of clinical research in the region [12]. Hence, in this paper, we discuss the specific implementation challenges faced during a prospective cohort study at the Hospital Nacional Simão Mendes (HNSM) in Bissau, Guinea-Bissau. Our discussion is illustrated with some empirical data from the first year of recruitment and follow-up. Guinea-Bissau, a Portuguese-speaking country in West Africa, has experienced decades of socio-political instability, which has significantly degraded its health system [13]. It is a low-income country with a population of ∼1.8 million inhabitants [14]. The PREECARDIA (PREeclampsia and Early CARDiovascular Impairment in African women) study was initiated in June 2023 at the HNSM, a major referral hospital in Guinea-Bissau, handling ∼6000 births annually [15]. This high volume of deliveries highlights the hospital’s pivotal role in maternal and neonatal health in the country, providing a substantial patient base for the PREECARDIA study. This ongoing prospective cohort study aims to assess the association between preeclampsia and cardiovascular impairment in the year following delivery among young females. Eligible participants were females younger than 25 years who had no history of cardiovascular disease. The study includes both females diagnosed with preeclampsia and those remaining without high blood pressure during pregnancy. A detailed description of the PREECARDIA study objectives and methodology has been previously published elsewhere [16]. As of August 2024, a total of 197 participants consented to participate in the PREECARDIA study, of whom 17 did not meet the eligibility criteria. Despite high engagement during recruitment, attrition exceeded 40% during the first follow-up (at 4 months). Among the 41 eligible participants for 12-month follow-up, 22 successfully completed the follow-up. These figures reflect some of the broader logistical, contextual, and methodological challenges that we encountered during the first 14 months of the implementation of the PREECARDIA study. No significant differences in age or gestational age at baseline were observed between females retained in the study compared to those lost to follow-up. However, the slightly higher body mass index and blood pressure among those with complete data show the importance of ensuring equal retention across exposure groups to minimize bias. Addressing these challenges required the implementation of a range of adaptive measures to improve the participation of eligible females and the completeness and accuracy of the collected data, as described below and summarized in Table 1. Summary of challenges, impacts and adaptive strategies in the PREECARDIA study. Frequent hospital administrative changes ○ Disruption of the relationship between hospital staff and the research team ○ Inconsistent support from the hospital ○ Delays in approvals Frequent health workers’ strike Inconsistent participant recruitment Build and maintain strong relationships with different stakeholders Maintain a flexible research design, including the possibility of adapting procedures and extending the period of recruitment and data collection Lengthy process to assemble a research team Delayed study progress Reduced quality of data (due to lack of experienced staff) Research team emigration for improved career opportunities Recruit motivated individuals such as medical students Provide ongoing training sessions to the research team Create larger research teams to accommodate the expected dropouts Secure funding for financial compensation of the research team in accordance to their expectations Affects participant access and timely interactions ○ Missed hospital visits Provide transportation incentives Adjust the visit schedule to accommodate participant availability Align follow-up visits with participants scheduled hospital visits Unreliable diagnosis Affects the uniformity and reliability of collected data Train staff to standardize diagnosis criteria Monitor the consistency of the practice throughout the study Participants unable to understand the required information Limits communication clarity between interviewers and participants At recruitment, explain to the participant the specific health information that will be required in follow-up visits Errors in the characterization of the exposures and outcomes Discrepancies in recorded ages or names Cross-verify participant information from multiple sources (clinical file, patient, and family members) Difficulties in maintaining communication with participants post-recruitment ○ Participants change provided contact information Collect multiple contact details (including for family members) Use reminder systems Regular telephone follow-up to update contact information Difficulties in setting up equipment and conducting interviews in overcrowded wards ○ Breaches in participant confidentiality ○ Participants withhold sensitive information and provide inaccurate responses Plan data collection schedules to not coincide with healthcare delivery activities Redesigning the existing ward spaces to find space for research activities Misconceptions about blood analysis ○ Participants may believe that only the sick required blood analysis Participants’ expectations for financial incentives or exemptions from hospital costs Clear and consistent communication with participants about the study objectives, processes, risks, and benefits Family and societal pressures affect participation in the study Involve family members in the informed consent process During the first 14 months of the PREECARDIA study, Guinea-Bissau experienced some political instability, marked by three different governments, which led to frequent administrative changes at the HNSM. This resulted in shifts in hospital priorities, policies, and support for ongoing research. For example, our study initially planned to utilize hospital resources for laboratory exams, which were subsequently discontinued due to administrative changes. This resulted in the relocation of laboratory exams to another health facility, negatively affecting the completeness of participant follow-up. To mitigate the impact of these frequent administrative changes, we maintained regular communication with hospital administrators, providing frequent updates on study progress to foster good relationships with the new administrators. Furthermore, repeated strikes by health professionals disrupted hospital activities, partially contributing to the inconsistent flow of participant recruitment in the study, with lingering effects on recruitment extending beyond the duration of each strike (Fig. 1). In response, we implemented flexible recruitment strategies, adjusting the study timeline to mitigate the effects of these disruptions. Trends in participant recruitment (bars) and active interviewers (line) over time, with annotations indicating key events affecting recruitment and study progress. Recruiting and training a team of collaborators with the appropriate knowledge, experience, and motivation is essential for the successful implementation of a study [17]. However, assembling this team at the HNSM, where a limited number of prior studies have been conducted, proved to be challenging. The lack of opportunities for research skills development within the institution meant that few healthcare professionals had the necessary experience to take part in the PREECARDIA study. Additionally, experienced healthcare professionals, accustomed to receiving financial compensation from foreign-funded projects, were reluctant to volunteer for the PREECARDIA study, which lacked comparable resources. Consequently, the assembly of the research team became a lengthy process that delayed the initiation of the study. To overcome this challenge, we invited medical students and recent graduates who were interested in gaining research experience and offered performance-based incentives to ensure high data quality and maintain motivation. Building an operational and successful research team requires continuity and consistency to retain knowledge and refine specific skills [18]. However, like many studies in SSA, the PREECARDIA study faced high turnover rates, as volunteer team members often left to pursue postgraduate studies abroad (Fig. 1). For instance, 6 months after the study began, all original team members had to be replaced after leaving for new opportunities elsewhere, which halted progress for several months. To prevent this from happening again, we recruited two additional interviewers as substitutes to ensure continuity in data collection. In hindsight, implementing training strategies that help collaborators develop research skills aligned with their long-term career development could have reduced collaborators’ turnover. Thus, we plan to introduce training modules, facilitated by experienced researchers from the PREECARDIA study, to support professional growth, skill retention, and overall continuity within the research team. Access to healthcare remains a significant challenge in SSA countries, despite recent improvements. Infrastructural deficits, such as seasonal road inaccessibility, and patients’ economic constraints of patients are key challenges to the implementation of longitudinal research. In our study, participants frequently reported missing hospital visits due to transportation costs. To mitigate this, we scheduled follow-up evaluations to coincide with other healthcare appointments (e.g. children’s vaccinations). In addition, we compensated participants for travel expenses to contribute to a more complete follow-up. During the rainy season, certain roads become inaccessible, resulting in disruptions to scheduled hospital visits. Participants are often unable to reach healthcare facilities on rainy days, leading to missed follow-up appointments. To address this issue, we implemented flexible scheduling for the follow-up periods, allowing participants to complete their evaluations within a broader timeframe. This flexibility ensured that participants could attend follow-up visits on days with more favorable weather, thus reducing the number of missed follow-up visits. Adherence to clinical guidelines is suboptimal in most healthcare facilities in SSA [19]. This leads to differences in how medical services are delivered and consequently becomes a challenge for consistent data collection. A notable example in the PREECARDIA study is observed in the diagnosis of preeclampsia at HNSM. Some clinicians registered the preeclampsia diagnosis without adhering to the established clinical guidelines, which require blood pressure and urine protein measurements on two different occasions, spaced 4 hours apart [20]. Recognizing that this diagnostic definition is not applicable to all patients in the maternity ward, the research team provided targeted training to medical doctors in the maternity ward, covering both clinical guidelines and research procedures. This aimed to promote a better alignment between research goals and patient care dynamics, as well as the use of standardized procedures across diagnosis, treatment, and data collection. Health literacy is an essential aspect of adequate medical care and research, which involves an individual’s ability to understand and make use of health information [21]. In our study, it was common to find participants with generally limited health literacy, which compromised their ability to convey information regarding their medical histories, understand the importance of health conditions, and adhere to medical advice. For instance, obtaining the medical history of participants or health information regarding their infant during follow-up proved particularly challenging. Participants were often unaware of the required information or lacked the necessary records to provide accurate information, such as vaccine cards or medical prescriptions from previous hospitalizations. To mitigate these limitations, at baseline, participants were informed of the specific health information that would be assessed during follow-up, enabling them to be better prepared to provide such information in subsequent evaluations. This included information on medication history, duration of breastfeeding, and infant hospitalization history. We also found some challenges related to the quality of the clinical records at the HNSM. In many cases, patient records were incomplete or inconsistent. For instance, the unavailability of initial blood pressure readings from participants in the emergency room and discrepancies in recorded ages made the determination of eligibility criteria difficult. To overcome these challenges, the research team developed a protocol to validate patient information using multiple sources (clinical files and patient and family questionnaires). Although these strategies are temporary and only beneficial to the study, they highlight a potential low-cost and practical solution that could be integrated into routine clinical practice at the HNSM and other healthcare facilities. For instance, implementing a standardized checklist and verification procedure can improve the accuracy and completeness of medical records in healthcare facilities. In addition, simple staff training similar to that received by research team members could further embed this practice into routine care, improving patient management and clinical decision-making. Maintaining participant follow-up in longitudinal studies is a crucial challenge in SSA [22]. A significant barrier in our study was maintaining communication with participants after the recruitment period ended. Many of them failed to keep the provided contact information, particularly mobile phone numbers, which can result in potential losses during follow-up. In our study, home visits were not a viable solution for ensuring follow-up evaluations because there were no clearly defined addresses in the study setting, making it challenging to locate participants through home visits. To mitigate this threat to the validity and precision of our results, we increased the number of alternative contact details collected from each participant following recruitment. Moreover, participants’ relocation to rural areas to help their families with agricultural practices led to increased losses to follow-up, particularly during the rainy season. To address this issue, we implemented strategies to encourage continued participation, offering flexible appointment dates and continuous education that emphasizes the importance of attending scheduled visits. In many healthcare environments, particularly in countries with underfunded healthcare infrastructures, space constraints are a prevalent challenge to research activities [23]. These limitations not only affect the participant’s privacy and overall experience in the study but also compromise the interviewers’ ability to function efficiently [23]. Overcrowded wards and a lack of privacy may also cause breaches of participant confidentiality, leaving the participants more exposed during the interviews, which might lead them to withhold sensitive information or provide inaccurate responses [24]. In our study, interviewers often found themselves navigating overcrowded wards, struggling with limited space to set up equipment and conduct interviews. To address this challenge, rather than creating a new area to conduct interviews, we worked closely with hospital staff to temporarily repurpose an existing space during specific time slots. This involved using multipurpose rooms or less crowded areas during quieter periods of the day to serve as designated research areas. Although the space was shared, this approach allowed us to create a private and confidential setting for interviews while mitigating the strain on already limited resources. In contexts where information is limited, misconceptions can rapidly gain traction, creating problems for well-intentioned healthcare research [25]. For instance, follow-up visits became challenging for recruited participants who believed that only individuals who are sick require blood analyses. Additionally, many participants expected to receive financial incentives or exemptions from hospital-related costs for their participation. This may be due to the misconception that international donors fund all clinical research and include participant remuneration. To mitigate this challenge, we ensured that participants were informed from the recruitment stage that this study does not offer financial compensation for participation and adequately explained the necessity of blood analyses during follow-up visits. In the SSA context, husbands, mothers-in-law, and other family members’ concerns for the participant’s safety and well-being need to be taken into account. This may become a challenge for research, as participants may initially agree to join a study, only to later drop out later due to familial pressures. At the beginning of the study, the discussion of informed consent involved only the study but a solution to the barrier was keep to the family members informed on the study objectives, risks, and benefits to the and to them in the However, this family also be with concerns for the of the to ensure that the family members are not making for additional during follow-up was that some with team members their To address this issue, the study ensured that follow-up were made by team members when This approach and maintain between participants and the research team. The implementation of the PREECARDIA study three that the initial the of data collection the duration of the study, and consequently the already limited financial concerns about study the completeness of some of the study was also with and less available compared to blood pressure This is because the study had to on private to conduct more creating additional burden for both participants and the attrition in the study was higher than the importance of a of these in accordance with the of the Despite these the study objectives as recruitment was successfully completed and follow-up is ongoing with improved retention These highlight the importance of and logistical in settings and the of adaptive to ensure the feasibility and of longitudinal research in epidemiological and clinical research in SSA with unique challenges. Despite high and study challenges will during adaptive strategies to address to develop a more complete and of these challenges, studies need to include from different SSA countries and The from research in the PREECARDIA study highlight the importance of continuous to new and strong of of research, such as training for the research improved medical and of research to ensure with These are essential for the quality of patient care and creating a where SSA more and to global health research. The PREECARDIA study was by the of the HNSM and by the Nacional in Guinea-Bissau We are to the females who in the study and to the health professionals and staff at Nacional Simão and for their support in recruitment and follow-up. to the of the the and it for its and the for will as for the This research received no specific from funding in the or for an to by the for and the of and are no new data with this No were in the collection or analysis of data, the of or or the of this