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The costs, complexity, legal requirements and number of amendments associated with clinical trials are rising constantly, which negatively affects the efficient conduct of trials. In Sub-Saharan Africa, this situation is exacerbated by capacity and funding limitations, which further increase the workload of clinical trialists. At the same time, trials are critically important for improving public health in these settings. The aim of this study was to identify the internal factors that slow down clinical trials in Sub-Saharan Africa. Here, factors are limited to those that exclusively relate to clinical trial teams and sponsors. These factors may be influenced independently of external conditions and may significantly increase trial efficiency if addressed by the respective teams. We conducted sixty key informant interviews with clinical trial staff working in different positions in two clinical research centres in Kenya, Ghana, Burkina Faso and Senegal. The study covered English- and French-speaking, and Eastern and Western parts of Sub-Saharan Africa. We performed thematic analysis of the interview transcripts. We found various internal factors associated with slowing down clinical trials; these were summarised into two broad themes, \"planning\" and \"site organisation\". These themes were consistently mentioned across positions and countries. \"Planning\" factors related to budget feasibility, clear project ideas, realistic deadlines, understanding of trial processes, adaptation to the local context and involvement of site staff in planning. \"Site organisation\" factors covered staff turnover, employment conditions, career paths, workload, delegation and management. We found that internal factors slowing down clinical trials are of high importance to trial staff. Our data suggest that adequate and coherent planning, careful assessment of the setting, clear task allocation and management capacity strengthening may help to overcome the identified internal factors and allow clinical trials to proceed more efficiently.

IntroductionVaccine hesitancy is a complex public health issue referring to concerns about the safety, efficacy or need for vaccination. Relatively little is known about vaccine hesitancy in Switzerland. This ongoing study (2017–2021) focuses on biomedical and complementary and alternative medicine (CAM) providers and their patients since healthcare professionals play important roles in vaccination decision-making. This national research programme seeks to assess the sociocultural determinants of vaccine hesitancy regarding childhood and human papillomavirus vaccines in Switzerland. We aim to provide a detailed characterisation of vaccine hesitancy, including CAM and biomedical perspectives, patient–provider interactions, and sociocultural factors, to establish the mediating effects of vaccine hesitancy on underimmunisation, and to design an intervention to improve vaccination communication and counselling among physicians, parents and adolescents.Methods and analysisOur transdisciplinary team employs a sequential exploratory mixed-methods study design. We have established a network of more than 150 medical providers across Switzerland, including more than 40 CAM practitioners. For the qualitative component, we conduct interviews with parents, youth, and biomedical and CAM providers and observations of vaccination consultations and school vaccination information sessions. For the quantitative component, a sample of 1350 parents of young children and 722 young adults (15–26 years) and their medical providers respond to questionnaires. We measure vaccine hesitancy with the Parent Attitudes about Childhood Vaccines 15-item survey and review vaccination certificates to assess vaccination status. We administer additional questions based on findings from qualitative research, addressing communication with medical providers, vaccine information sources and perceptions of risk control vis-à-vis vaccine-preventable diseases. The questionnaires capture sociodemographics, political views, religion and spirituality, and moral foundations.Ethics and disseminationThe study was approved by the local ethics committee. The results will be published in peer-reviewed journals and disseminated to healthcare professionals, researchers and the public via conferences and public presentations.

Background Universal Health Coverage only leads to the desired health outcomes if quality of health services is ensured. In Tanzania, quality has been a major concern for many years, including the problem of ineffective and inadequate routine supportive supervision of healthcare providers by council health management teams. To address this, we developed and assessed an approach to improve quality of primary healthcare through enhanced routine supportive supervision. Methods Mixed methods were used, combining trends of quantitative quality of care measurements with qualitative data mainly collected through in-depth interviews. The former allowed for identification of drivers of quality improvements and the latter investigated the perceived contribution of the new supportive supervision approach to these improvements. Results The results showed that the new approach managed to address quality issues that could be solved either solely by the healthcare provider, or in collaboration with the council. The new approach was able to improve and maintain crucial primary healthcare quality standards across different health facility level and owner categories in various contexts. Conclusion Together with other findings reported in companion papers, we could show that the new supportive supervision approach not only served to assess quality of primary healthcare, but also to improve and maintain crucial primary healthcare quality standards. The new approach therefore presents a powerful tool to support, guide and drive quality improvement measures within council. It can thus be considered a suitable option to make routine supportive supervision more effective and adequate.

Effective supportive supervision of healthcare services is crucial for improving and maintaining quality of care. However, this process can be challenging in an environment with chronic shortage of qualified human resources, overburdened healthcare providers, multiple roles of district managers, weak supply chains, high donor fragmentation and inefficient allocation of limited financial resources. Operating in this environment, we systematically evaluated an approach developed in Tanzania to strengthen the implementation of routine supportive supervision of primary healthcare providers. The approach included a systematic quality assessment at health facilities using an electronic tool and subsequent result dissemination at council level. Mixed methods were used to compare the new supportive supervision approach with routine supportive supervision. Qualitative data was collected through in-depth interviews in three councils. Observational data and informal communication as well as secondary data complemented the data set. Additionally, an economic costing analysis was carried out in the same councils. Compared to routine supportive supervision, the new approach increased healthcare providers' knowledge and skills, as well as quality of data collected and acceptance of supportive supervision amongst stakeholders involved. It also ensured better availability of evidence for follow-up actions, including budgeting and planning, and higher stakeholder motivation and ownership of subsequent quality improvement measures. The new approach reduced time and cost spent during supportive supervision. This increased feasibility of supportive supervision and hence the likelihood of its implementation. Thus, the results presented together with previous findings suggested that if used as the standard approach for routine supportive supervision the new approach offers a suitable option to make supportive supervision more efficient and effective and therewith more sustainable. Moreover, the new approach also provides informed guidance to overcome several problems of supportive supervision and healthcare quality assessments in low- and middle income countries.

Background The potential of antenatal care for reducing maternal morbidity and improving newborn survival and health is widely acknowledged. Yet there are worrying gaps in knowledge of the quality of antenatal care provided in Tanzania. In particular, determinants of health workers' performance have not yet been fully understood. This paper uses ethnographic methods to document health workers' antenatal care practices with reference to the national Focused Antenatal Care guidelines and identifies factors influencing health workers' performance. Potential implications for improving antenatal care provision in Tanzania are discussed. Methods Combining different qualitative techniques, we studied health workers' antenatal care practices in four public antenatal care clinics in the Kilombero Valley, south-eastern Tanzania. A total of 36 antenatal care consultations were observed and compared with the Focused Antenatal Care guidelines. Participant observation, informal discussions and in-depth interviews with the staff helped to identify and explain health workers' practices and contextual factors influencing antenatal care provision. Results The delivery of antenatal care services to pregnant women at the selected antenatal care clinics varied widely. Some services that are recommended by the Focused Antenatal Care guidelines were given to all women while other services were not delivered at all. Factors influencing health workers' practices were poor implementation of the Focused Antenatal Care guidelines, lack of trained staff and absenteeism, supply shortages and use of working tools that are not consistent with the Focused Antenatal Care guidelines. Health workers react to difficult working conditions by developing informal practices as coping strategies or \"street-level bureaucracy\". Conclusions Efforts to improve antenatal care should address shortages of trained staff through expanding training opportunities, including health worker cadres with little pre-service training. Attention should be paid to the identification of informal practices resulting from individual coping strategies and \"street-level bureaucracy\" in order to tackle problems before they become part of the organizational culture.

Background There is a growing demand within international health agencies to ensure health research systems (HRSs) are strengthened and well-functioning to support healthcare systems (HCSs). Understanding HRS performance through system actors is an indispensable move in analysing this system. This study aims to examine policy-makers’, academics’ and experts’ satisfaction with overall HRS performance, while also investigating their perceptions about political will and attention towards health research. Ultimately, we want to identify gaps related to performance and generate insights on how to move forward for HRS performance strengthening. Methods This study was carried out in Palestine, targeting three sectors, namely government institutions, public health universities, and major local and international health non-governmental organisations (NGOs). Semi-structured, in-depth interviews (IDIs) and focus group discussions (FGDs) were conducted with participants. The institutions from the three sectors were selected based on stated criteria and peer reviews. Data were translated from Arabic into English, transcribed, content checked by the principal investigator, imported to a software programme (MAXQDA 12), and then coded. Thematic content analysis was used. Results A total of 104 experts participated in 52 IDIs and 52 experts participated in 6 FGDs. Findings revealed three principal domains. First, the HRS in Palestine is remarkably underperforming, and the majority of experts were unsatisfied. Participants perceived the system as ineffective and inefficient, poorly managed and lacking systematic assessment. Second, the factors behind system underperformance were (1) an unstructured system and the lack of a research culture as well as of a governing body or policies; (2) health research was seen as individualistic, non-development driven and unutilised in policy decisions; and (3) considerably deficient coordination and essential resources. The third finding showed inadequate political support and engagement, which then also related to system underperformance. Conclusions The Palestinian HRS is perceived as underperforming by health experts at different levels, where research is not on the leadership agendas. Potential actions should be taken to actively engage the state health decision-makers and inform them of the importance, uses and impacts of performance assessment. Findings urge policy-makers and legislators to build an inclusive and national body of governance with agreed strategies including fundamentally hybrid and aligned performance assessment mechanisms, such as a research observatory platform. In addition, it is recommended to establish a strategic plan to expand professionals’ research awareness and abilities, as well as empower the institution’s research monitoring and evaluation capacities.

Background In Tanzania, teenage pregnancy rates are still high despite the efforts being made to reduce them. Not enough is known about how adolescents experience and cope with sexuality and teenage pregnancy. Over the past few decades, most studies have focused on vulnerability and risk among youth. The concept of ‘ reproductive resilience ’ is a new way of looking at teenage pregnancy. It shifts the perspective from a deficit-based to a strength-based approach. The study presented here aimed to identify factors that could contribute to strengthening the reproductive resilience of girls in Dar es Salaam, Tanzania. Methods Using a cross-sectional cluster sampling approach, 750 female adolescents aged 15–19 years were interviewed about how they mobilize resources to avoid or deal with teenage pregnancy. The main focus of the study was to examine how social capital (relations with significant others), economic capital (command over economic resources), cultural capital (personal dispositions and habits), and symbolic capital (recognition and prestige) contribute to the development of adolescent competencies for avoiding or dealing with teenage pregnancy and childbirth. Results A cumulative competence scale was developed to assess reproductive resilience. The cumulative score was computed based on 10 competence indicators that refer to the re- and pro-active mobilization of resources. About half of the women who had never been pregnant fell into the category, ‘high competence’ (50.9%), meaning they could get the information and support needed to avoid pregnancies. Among pregnant women and young mothers, most were categorized as ‘high competence’ (70.5%) and stated that they know how to avoid or deal with health problems that might affect them or their babies, and could get the information and support required to do so. Cultural capital, in particular, contributed to the competence of never-pregnant girls [OR = 1.80, 95% CI = 1.06 to 3.07, p  = 0.029], pregnant adolescents and young mothers [OR = 3.33, 95% CI = 1.15 to 9.60, p  = 0.026]. Conclusions The reproductive resilience framework provides new insights into the reproductive health realities of adolescent girls from a strength-based perspective. While acknowledging that teenage pregnancy has serious negative implications for many female adolescents, the findings presented here highlight the importance of considering girls’ capacities to prevent or deal with teenage pregnancy.

Background The importance of a health research system (HRS), namely an instrument for developing and enabling health systems, is increasing, particularly in developing countries. Assessing the perceptions of system performers is a necessary part of system analysis, which seeks to recognize a system’s strengths and limitations aiming towards improvement. This study assesses the perceptions of policy-makers, academicians and experts regarding the HRS concept and its importance to generate insights for system strengthening. In Palestine, HRS is just emerging, helping to address the many public health-related challenges faced by the country. Methods The study was implemented from January until July 2016, targeting three sectors, namely relevant government institutions, schools of public health, and major local and international health agencies. Data was collected through 52 in-depth interviews and six focus group discussions (FGDs) with policy-makers, academics, directors and experts. Participants and institutions were selected based on stated criteria and peer review. Data were translated, transcribed, checked and then imported to a software program (MAXQDA 12) for thematic and content analysis. Results A total of 104 experts participated, wherein 52 were interviewed and 52 participated in the six FGDs. The HRS concept, as defined by WHO, was conceptualized differently among participants with unclear delineations between various components. Inconsistencies appeared when participants attempted to conceptualize HRS in broader contexts, though HRS goals and functions were sufficiently delineated. The majority of participants agreed that HRS correlates with notions of ‘improvement’ and recognized HRS ‘as a significant gain’. Neglect of HRS was perceived as a big loss. Conclusions The study revealed that the level of understanding of HRS among health experts in Palestine is inadequate and not sufficiently conceptualized for its application. Findings also underlined the need to establish a central governance coordination body that promotes HRS understanding, awareness and culture as an enabler for HRS strengthening.

Background Extramarital sex is a potential driver of human immunodeficiency virus (HIV) transmission for long-term couples in sub-Saharan Africa. It is increasingly recognized that preventing sexual risk behaviours requires an understanding and adjustment of sexual relationship factors beyond the individual level. We investigated the association between extramarital affairs and HIV status, factors associated with extramarital affairs, and created insights in the context and pathways for married men and women in rural Tanzania who engage in extramarital affairs. Methods A cross-sectional sequential explanatory mixed method design was employed. The WHO-Social determinants of health perspective guided the study. Using logistic regression, we analysed the MZIMA project community surveillance representative sample of 3884 married partners aged 15+ residing in Ifakara town, Tanzania (2012–2013). Multinomial logistic regression analysis established the relative risk ratio (RRR) of different social and economic factors with lifetime (proxy) and recent (12 months prior to survey) extramarital affairs. Logistic regression analysis determined the association between extramarital affairs and HIV status. Semi-structured interviews and focus group discussions explored the quantitative findings, capturing the experiences and norms regarding extramarital affairs. Results We found a significant association between lifetime (proxy) extramarital affairs and HIV infection among women only. The RRR of having extramarital affairs (lifetime proxy) was significantly higher among Village Community Bank (VICOBA) members, the re-married, consumers of alcohol, those from southern regions, non-Muslims, and those with older age. In the case of recent extramarital affairs (12 months prior to survey), associations were significant for the same variables except for religion, having an income was also associated with the outcome. Qualitative narratives reflected that, desire to prove manhood (masculinity) supported by societal normative beliefs such as; ‘it is not realistic for a man to stay without extramarital partner’ and religious beliefs; ‘a man shall dominate a woman’ encouraged men’s extramarital affairs. For women, striving for financial autonomy, obligations to pay back debts borrowed from several VICOBA, and limited support from their husbands encouraged their engagement in extramarital affairs. Low relationship quality (conflict and sexual dissatisfaction) were reported to encourage both men and women’s extramarital affairs. Conclusions The findings show that the link between extramarital affairs and HIV has a gender dimension in which women are more likely to acquire HIV through extramarital affairs (case of recent extramarital affairs (12 months prior to survey). Future programs seeking to address risk sexual behaviors in Tanzanian marriages can consider context-sensitive interventions which address aspects beyond ‘individual risk’ and women’s financial uncertainties, and include couple’s relationship quality, excessive alcohol behaviors, normative masculinity ideology and societal norms, that encourage women’s economic dependence and men’s engagement in multiple sexual partnerships. Microfinance projects (e.g. VICOBA) could be a platform for gender-transformative approaches, combining economic empowerment and HIV risk protection strategies.

Background Progress in health service quality is vital to reach the target of Universal Health Coverage. However, in order to improve quality, it must be measured, and the assessment results must be actionable. We analyzed an electronic tool, which was developed to assess and monitor the quality of primary healthcare in Tanzania in the context of routine supportive supervision. The electronic assessment tool focused on areas in which improvements are most effective in order to suit its purpose of routinely steering improvement measures at local level. Methods Due to the lack of standards regarding how to best measure quality of care, we used a range of different quantitative and qualitative methods to investigate the appropriateness of the quality assessment tool. The quantitative methods included descriptive statistics, linear regression models, and factor analysis; the qualitative methods in-depth interviews and observations. Results Quantitative and qualitative results were overlapping and consistent. Robustness checks confirmed the tool’s ability to assign scores to health facilities and revealed the usefulness of grouping indicators into different quality dimensions. Focusing the quality assessment on processes and structural adequacy of healthcare was an appropriate approach for the assessment’s intended purpose, and a unique key feature of the electronic assessment tool. The findings underpinned the accuracy of the assessment tool to measure and monitor quality of primary healthcare for the purpose of routinely steering improvement measures at local level. This was true for different level and owner categories of primary healthcare facilities in Tanzania. Conclusion The electronic assessment tool demonstrated a feasible option for routine quality measures of primary healthcare in Tanzania. The findings, combined with the more operational results of companion papers, created a solid foundation for an approach that could lastingly improve services for patients attending primary healthcare. However, the results also revealed that the use of the electronic assessment tool outside its intended purpose, for example for performance-based payment schemes, accreditation and other systematic evaluations of healthcare quality, should be considered carefully because of the risk of bias, adverse effects and corruption.