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Background. The increased number of clinical trials taking place in developing countries and the complexity of trial protocols mandate that local ethics review committees (ERCs) reviewing them have the capacity to ensure that they are conducted to the highest ethical standards. Methods. The Kenya AIDS Vaccine Initiative (KAVI) Institute of Clinical Research (ICR) (KAVI-ICR) and the Kenyan National Council for Science and Technology (NCST) embarked on an exercise to enhance the capacity of ERCs in Kenya to review such protocols. This process involved conducting an audit of all ERCs in the country, and performing training needs assessments to identify knowledge and capacity gaps. Information obtained was used to develop training materials for ERC members at workshops conducted in different parts of the country. Results. Five accredited and 13 non-accredited ERCs were identified. Four of the accredited ERCs were located in the capital city of Kenya, Nairobi. The most common challenges cited by participants during the needs assessments were excess workload, and a lack of co-ordination and/or communication between the ERCs. Subsequently, 140 ERC members from 17 institutions across the country were trained as follows: 36 from institutions in the western part of Kenya, 38 from institutions in the south-eastern coastal region, 38 from the eastern region and 44 from Nairobi. Conclusion. The KAVI-ICR and the NCST have developed training modules for training ERC members in Kenya and are in the process of developing a manual to train members. The Kenyan experience may be used to enhance the capacity of ERCs in the East African region. [ABSTRACT FROM AUTHOR]

Background: Stillbirth and (obstetric) fistula are traumatic life events, commonly experienced together following an obstructed labour in low- and middle-income countries with limited access to maternity care. Few studies have explored women's experiences of the combined trauma of stillbirth and fistula., Aim: To explore the lived experiences of women following stillbirth and fistula., Methods: Qualitative, guided by Heideggerian phenomenology. Twenty women who had experienced a stillbirth were interviewed while attending a specialist Hospital fistula service in urban Kenya. Data were analysed following Van Manen's reflexive approach., Results: Three main themes summarised participants' experiences: 'Treated like an alien' reflected the isolation and stigma felt by women. The additive and multiplying impacts of stillbirth and fistula and the ways in which women coped with their situations were summarised in 'Shattered dreams'. The impact of beliefs and practices of women and those around them were encapsulated in 'It was not written on my forehead'., Conclusion: The distress women experienced following the death of a baby was intensified by the development of a fistula. Health professionals lacked an understanding of the pathophysiology and identification of fistula and its association with stillbirth. Women were isolated as they were stigmatised and blamed for both conditions. Difficulty accessing follow-up care meant that women suffered for long periods while living with a constant reminder of their baby's death. Cultural beliefs, faith and family support affected women's resilience, mental health and recovery. Specialist services, staff training and inclusive policies are needed to improve knowledge and awareness and enhance women's experiences., Patient or Public Contribution: A Community Engagement and Involvement group of bereaved mothers with lived experience of stillbirth and neonatal death assisted with the review of the study protocol, participant-facing materials and confirmation of findings., (© 2023 The Authors. Health Expectations published by John Wiley & Sons Ltd.)

Background: Stillbirth is an extremely traumatic and distressing experience for parents, with profound and long-lasting negative impacts. Cultural beliefs and practices surrounding death vary considerably across different contexts and groups, and are a key influence on individual experiences, impacting grief, adjustment, and support needs. Few studies have explored cultural influences surrounding stillbirth in an African context. This study explored the influence of cultural beliefs and practices on the experiences of bereaved parents and health workers after stillbirth in urban and rural settings in Kenya and Uganda., Methods: A qualitative descriptive study design was employed. Face to face interviews were conducted with parents (N = 134) who experienced a stillbirth (≤ 1 year) and health workers (N = 61) at five facilities in Uganda and Kenya. Interviews were conducted in English or the participants' local language, audio-recorded and transcribed verbatim. Analysis was conducted using descriptive thematic analysis., Results: Commonalities in cultural beliefs and practices existed across the two countries. Three main themes were identified: 1) Gathering round, describes the collective support parents received from family and friends after stillbirth. 2)'It is against our custom' addresses cultural constraints and prohibitions impacting parents' behaviour and coping in the immediate aftermath of the baby's death. 3) 'Maybe it's God's plan or witchcraft' summarises spiritual, supernatural, and social beliefs surrounding the causes of stillbirth., Conclusions: Kinship and social support helped parents to cope with the loss and grief. However, other practices and beliefs surrounding stillbirth were sometimes a source of stress, fear, stigma and anxiety especially to the women. Conforming to cultural practices meant that parents were prevented from: holding and seeing their baby, openly discussing the death, memory-making and attending the burial. The conflict between addressing their own needs and complying with community norms hindered parents' grief and adjustment. There is an urgent need to develop culturally sensitive community programmes geared towards demystifying stillbirths and providing an avenue for parents to grieve in their own way.

Background: Quality of maternal and newborn care is integral to positive clinical, social and psychological outcomes. Respectful care is an important component of this but is suboptimum in many low-income settings. A renewed energy among health professionals and academics is driving an international agenda to eradicate disrespectful health facility care around the globe. However, few studies have explored respectful care from different vantage points., Methods: We used Strauss and Corbin's grounded theory methodology to explore intrapartum experiences in Tanzania and Zambia. In-depth interviews were conducted with 98 participants (48 women, 18 partners, 21 health-providers and 11 key stakeholders), resulting in data saturation. Analysis involved constant comparison, comprising three stages of coding: open, axial and selective. The process involved application of memos, reflexivity and positionality., Results: Findings demonstrated that direct and indirect social discrimination led to inequity of care. Health-providers were believed to display manipulative behaviours to orchestrate situations for their own or the woman's benefit, and were often caring against the odds , in challenging environments. Emergent categories were related to the core category: respectful care, an added extra , which reflects the notion that women did not always expect or receive respectful care, and tolerated poor experiences to obtain services believed to benefit them or their babies. Respectful care was not seen as a component of good quality care, but a luxury that only some receive., Conclusion: Both quality of care and respectful care were valued but were not viewed as mutually inclusive. Good quality treatment (transactional care) was often juxtaposed with disrespectful care; with relational care having a lower status among women and healthcare providers. To readdress the balance, respectful care should be a predominant theme in training programmes, policies and audits. Women's and health-provider voices are pivotal to the development of such interventions., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: The 3-Delays Model has helped in the identification of access barriers to obstetric care in low and middle-income countries by highlighting the responsibilities at household, community and health system levels. Critiques of the Model include its one-dimensionality and its limited utility in triggering preventative interventions. Such limitations have prompted a review of the evidence to establish the usefulness of the Model in optimising timely access to intrapartum care., Objective: To determine the current utility of the 3-Delays Model and its potential for supporting a solution-based approach to accessing intrapartum care., Methods: We conducted a qualitative evidence synthesis across several databases and included qualitative findings from stand-alone studies, mixed-methods research and literature reviews using the Model to present their findings. Papers published between 1994 and 2019 were included with no language restrictions. Twenty-seven studies were quality appraised. Qualitative accounts were analysed using the 'best-fit framework approach'., Results: This synthesis included twenty-five studies conducted in Africa, Asia, Latin America and the Caribbean. Five studies adhered to the original 3-Delays Model's structure by identifying the same factors responsible for the delays. The remaining studies proposed modifications to the Model including alterations of the delay's definition, adding of new factors explaining the delays, and inclusion of a fourth delay. Only two studies reported women's individual contributions to the delays. All studies applied the Model retrospectively, thus adopting a problem-identification approach., Conclusion: This synthesis unveils the need for an individual perspective, for prospective identification of potential issues. This has resulted in the development of a new framework, the Women's Health Empowerment Model, incorporating the 3 delays. As a basis for discussion at every pregnancy, this framework promotes a solution-based approach to childbirth, which could prevent delays and support women's empowerment during pregnancy and childbirth.

Background: Timely intrapartum referral between facilities is pivotal in reducing maternal/neonatal mortality and morbidity but is distressing to women, resource-intensive and likely to cause delays in care provision. We explored the complexities around referrals to gain understanding of the characteristics, experiences and outcomes of those being transferred., Methods: We used a mixed-method parallel convergent design, in Tanzania and Zambia. Quantitative data were collected from a consecutive, retrospective case-note review (target, n = 2000); intrapartum transfers and stillbirths were the outcomes of interest. A grounded theory approach was adopted for the qualitative element; data were collected from semi-structured interviews (n = 85) with women, partners and health providers. Observations (n = 33) of transfer were also conducted. Quantitative data were analysed descriptively, followed by binary logistic regression models, with multiple imputation for missing data. Qualitative data were analysed using Strauss's constant comparative approach., Results: Intrapartum transfer rates were 11% (111/998; 2 unknown) in Tanzania and 37% (373/996; 1 unknown) in Zambia. Main reasons for transfer were prolonged/obstructed labour and pre-eclampsia/eclampsia. Women most likely to be transferred were from Zambia (as opposed to Tanzania), HIV positive, attended antenatal clinic < 4 times and living > 30 min away from the referral hospital. Differences were observed between countries. Of those transferred, delays in care were common and an increase in poor outcomes was observed. Qualitative findings identified three categories: social threats to successful transfer, barriers to timely intrapartum care and reparative interventions which were linked to a core category: journey of vulnerability., Conclusion: Although intrapartum transfers are inevitable, modifiable factors exist with the potential to improve the experience and outcomes for women. Effective transfers rely on adequate resources, effective transport infrastructures, social support and appropriate decision-making. However, women's (and families) vulnerability can be reduced by empathic communication, timely assessment and a positive birth outcome; this can improve women's resilience and influence positive decision-making, for the index and future pregnancy.

Background: With the persistent challenges towards controlling the HIV epidemic, there is an ongoing need for research into HIV vaccines and drugs. Sub-Saharan African countries--worst affected by the HIV pandemic--have participated in the conduct of clinical trials for HIV vaccines. In Kenya, the Kenya AIDS Vaccine Initiative (KAVI) at the University of Nairobi has conducted HIV vaccine clinical trials since 2001., Methodology: Participants were recruited after an extensive informed consent process followed by screening to determine eligibility. Screening included an assessment of risk behavior, medical history and physical examination, and if clinically healthy, laboratory testing. In the absence of locally derived laboratory reference ranges, the ranges used in these trials were derived from populations in the West., Principal Findings: Two hundred eighty-one participants were screened between 2003 and 2006 for two clinical trials. Of these, 167 (59.4%) met the inclusion/exclusion criteria. Overall, laboratory abnormalities based on the non-indigenous laboratory references used were the most frequent reasons (61.4%) for ineligibility. Medical abnormalities contributed 30.7% of the total reasons for ineligibility. Based on the laboratory reference intervals now developed from East and Southern Africa, those ineligible due to laboratory abnormalities would have been 46.3%. Of the eligible participants, 18.6% declined enrollment., Conclusions: Participant recruitment for HIV vaccine clinical trials is a rigorous and time-consuming exercise. Over 61% of the screening exclusions in clinically healthy people were due to laboratory abnormalities. It is essential that laboratory reference ranges generated from local populations for laboratory values be used in the conduct of clinical trials to avoid unnecessary exclusion of willing participants and to avoid over-reporting of adverse events for enrolled participants., Trial Registration: Protocol IAVI VRC V001 [1]. ClinicalTrials.gov NCT00124007 Protocol IAVI 010 [2](registration with ClincalTrials.gov is in progress) Protocols IAVI 002 and IAVI 004 are Phase 1 trials only mentioned in introductory paragraphs; details will not be reported. Registration was not required when they were conducted.