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Objective: To explore parents' lived experiences of care and support following stillbirth in urban and rural health facilities. Design: Qualitative, interpretative, guided by Heideggerian phenomenology. Setting: Nairobi and Western Kenya, Kampala and Central Uganda. Sample: A purposive sample of 75 women and 59 men who had experienced the stillbirth of their baby (≤1 year previously) and received care in the included facilities. Methods: In‐depth interviews, analysed using Van Manen's reflexive approach. Results: Three main themes were identified; parents described devastating impacts and profound responses to their baby's death. Interactions with health workers were a key influence, but poor communication, environmental barriers and unsupportive facility policies/practices meant that needs were often unmet. After discharge, women and partners sought support in communities to help them cope with the death of their baby but frequently encountered stigma engendering feelings of blame and increasing isolation. Conclusions: Parents in Kenya and Uganda were not always treated with compassion and lacked the care or support they needed after the death of their baby. Health workers in Kenya and Uganda, in common with other settings, have a key role in supporting bereaved parents. There is an urgent need for context and culturally appropriate interventions to improve communication, health system and community support for African parents. Health‐system response and community support for parents after stillbirth in Kenya and Uganda are inadequate. Health‐system response and community support for parents after stillbirth in Kenya and Uganda are inadequate. [ABSTRACT FROM AUTHOR]

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 a traumatic life-event for parents. Compassionate care from health workers supports grief and adjustment, alleviating psychological distress and minimising serious adverse health and social consequences. Bereavement support in facilities in LMICs, including in sub-Saharan Africa, often fails to meet parents' needs. However, very few studies have explored health worker's experiences in these settings., Aim: To explore the lived experiences of midwives, doctors and others, caring for women after stillbirth in Kenya and Uganda., Methods: Qualitative, guided by Heideggerian phenomenology. Sixty-one health workers, including nurse-midwives (N = 37), midwives (N = 12) and doctors (N = 10), working in five facilities in Kenya and Uganda, were interviewed. Data were analysed following Van Manen's reflexive approach., Results: Three main themes summarised participants' experiences: 'In the mud and you learn to swim in it' reflected a perceived of lack of preparation; skills were gained through experience and often without adequate support. The emotional and psychological impacts including sadness, frustration, guilt and shame were summarised in 'It's bad, it's a sad experience'. Deficiencies in organisational culture and support, which entrenched blame, fear and negative behaviours were encapsulated in Nobody asks 'how are you doing?'., Conclusion: Health workers in Kenya and Uganda were deeply sensitive to the impacts of stillbirth for women and families, and often profoundly and personally affected. Care and psychological support were acknowledged as often inadequate. Interventions to support improved bereavement care in sub-Saharan Africa need to target increasing health worker knowledge and awareness and also embed supportive organisational cultures and processes., Competing Interests: Conflicts of interest The authors declare they have no conflict of interests., (Copyright © 2023 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Background: Communication and interaction with healthcare workers at the time of stillbirth remain in parents' long-term memories and impact on emotional and psychological well-being. Cultural attitudes and norms influence how stillbirth is acknowledged and discussed in society. There is limited evidence on how women from sub-Saharan Africa became aware of the death of their babies. This research explored how women perceived the approach adopted by healthcare workers when the news of their stillbirth was disclosed to them., Methods: Grounded theory study. Women (n = 33) who had birthed a stillborn baby in the preceding 12 months were purposively sampled and participated in in-depth interviews (9 in Zambia, 16 in Tanzania and 8 in Malawi). Informed consent was gained from all participants. Data were analysed via a coding process using constant comparative analysis., Findings: Women sacrificed individualized and personal grieving strategies to conform and behave according to what was expected within their community. An overarching theme of cultural conformity overrides personal grief incorporated four sub-themes: perceiving something was wrong, the unexpected outcome, experience contrasting emotions, bonding with the baby., Discussion and Conclusions: Most participants embarked on a negative 'emotion work' to adapt and suppress emotions and grief due to cultural expectations. Inability to voice the trauma of losing a baby may lead to perinatal mental health issues and needs addressing. Maternity healthcare workers should encourage women to express their feelings and grief. Appropriate training in perinatal bereavement care including good communication, appropriate attitudes and provision of meaningful information to grieving women is recommended., Competing Interests: Conflict of Interest None declared., (Copyright © 2023 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Strengthening the capacity of midwives and nurses in low- and middle-income countries to lead research is an urgent priority in embedding and sustaining evidence-based practice and better outcomes for women and newborns during childbearing. International and local travel restrictions, and physical distancing resulting from the COVID-19 pandemic have compromised the delivery of many existing programmes and challenged international partnerships working in maternal and newborn health to adapt rapidly. In this paper, we share the experiences of a midwife-led research partnership between Kenya, Malawi, Tanzania, Uganda, the UK, Zambia and Zimbabwe in sustaining and enhancing capacity strengthening activities remotely in this period. Whilst considerable challenges arose, and not all were overcome, collectively, we gained new insights and important learning which have shifted perspectives and will impact future design and delivery of learning programmes., Competing Interests: Declaration of competing interest None., (Copyright © 2021. Published by Elsevier Ltd.)

Background: Effective antenatal care is fundamental to the promotion of positive maternal and new-born outcomes. International guidance recommends an initial visit in the first trimester of pregnancy, with a minimum of four antenatal visits in total: the optimum schedule being eight antenatal contacts. In low- and middle-income countries, many women do not access antenatal care until later in pregnancy and few have the recommended number of contacts., Aim: To gain understanding of women's antenatal experiences in Tanzania and Zambia, and the factors that influence antenatal engagement., Methods: The study was underpinned by Strauss's grounded theory methodology. Interviews were conducted with 48 women, 16 partners, 21 health care providers and 11 stakeholders, and analysed using constant comparison., Findings: The core category was 'The tipping point of antenatal engagement', supported by four categories: awareness of health benefits, experiential motivators, influential support, and environmental challenges. Although participants recognised the importance of antenatal care to health outcomes, individual motivations and external influences determined attendance or non-attendance. The 'tipping point' for antenatal engagement occurred when women believed that any negative impact could be offset by tangible gain. For some women non-attendance was a conscious decision, for others it was an unchallenged cultural norm., Conclusion: A complex interplay of factors determines antenatal engagement. Short-term modifiable factors to encourage attendance include the development of strategies for increasing respectful care; use of positive women's narratives, and active community engagement. Further research is required to develop innovative, cost-effective care models that improve health literacy and meet women's needs., (Crown Copyright © 2021. Published by Elsevier B.V. All rights reserved.)

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.

Objective: To understand the complexities surrounding unexplained stillbirth for the development and implementation of culturally acceptable interventions to underpin care in Tanzania and Zambia., Design: Mixed-methods study., Setting: Tertiary, secondary and primary care facilities in Mansa, Zambia, and Mwanza, Tanzania., Sample: Quantitative: 1997 women giving birth at two tertiary care facilities (one in each country). Qualitative: 48 women and 19 partners from tertiary, secondary and primary care facilities., Methods: Case review using data from a target of 2000 consecutive case records. Qualitative interviews with a purposive sample of women and partners, using a grounded theory approach., Results: A total of 261 stillbirths were recorded, with a rate of 16% in Tanzania and 10% in Zambia, which is higher than the previous estimates of 2.24 and 2.09%, respectively, for those countries. Women in both countries who reported a previous stillbirth were more likely to have stillbirth (RR 1.86, 95% CI 1.23-2.81). The cause of death was unexplained in 28% of cases. Qualitative findings indicated that not knowing what caused the baby to be stillborn prevented women from grieving. This was compounded by the poor communication skills of health professionals, who displayed little empathy and skill when counselling bereaved families., Conclusions: The stillbirth risk in both facilities was far higher than the risk recorded from national data, with women reporting a previous stillbirth being at higher risk. Women want to know the cause of stillbirth and an exploration of appropriate investigations in this setting is required. Providing health professionals with support and continuing training is key to improving the experiences of women and future care., Tweetable Abstract: Stillbirths receive little investigation and are often unexplained. Communication with women about the death of their baby is limited., (© 2021 The Authors. BJOG: An International Journal of Obstetrics and Gynaecology published by John Wiley & Sons Ltd.)

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.)

Objective: To explore parents' lived experiences of care and support following stillbirth in urban and rural health facilities., Design: Qualitative, interpretative, guided by Heideggerian phenomenology., Setting: Nairobi and Western Kenya, Kampala and Central Uganda., Sample: A purposive sample of 75 women and 59 men who had experienced the stillbirth of their baby (≤1 year previously) and received care in the included facilities., Methods: In-depth interviews, analysed using Van Manen's reflexive approach., Results: Three main themes were identified; parents described devastating impacts and profound responses to their baby's death. Interactions with health workers were a key influence, but poor communication, environmental barriers and unsupportive facility policies/practices meant that needs were often unmet. After discharge, women and partners sought support in communities to help them cope with the death of their baby but frequently encountered stigma engendering feelings of blame and increasing isolation., Conclusions: Parents in Kenya and Uganda were not always treated with compassion and lacked the care or support they needed after the death of their baby. Health workers in Kenya and Uganda, in common with other settings, have a key role in supporting bereaved parents. There is an urgent need for context and culturally appropriate interventions to improve communication, health system and community support for African parents., Tweetable Abstract: Health-system response and community support for parents after stillbirth in Kenya and Uganda are inadequate., (© 2020 The Authors. BJOG: An International Journal of Obstetrics and Gynaecology published by John Wiley & Sons Ltd on behalf of Royal College of Obstetricians and Gynaecologists.)

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.

In low-income settings, partner engagement in HIV testing during pregnancy is well recognised, but uptake remains low. To understand why men fail to engage, 76 in-depth, individual interviews were conducted with women ( n  = 23), men ( n  = 36) and community stakeholders ( n  = 17) in Malawi and Kenya. Transcribed data were analysed thematically. Male engagement was verbally supported. However, definitions of 'engagement' varied; women wanted a shared experience, whereas men wanted to offer practical and financial support. Women and stakeholders supported couples-testing, but some men thought separate testing was preferable. Barriers to couples-testing were strongly linked to barriers to antenatal engagement, with some direct fear of HIV-testing itself. The major themes identified included diverse definitions of male engagement, cultural norms, poor communication and environmental discomfort - all of which were underpinned by hegemonic masculinity. Couples-testing will only increase when strategies to improve reproductive health care are implemented and men's health is given proper consideration within the process. As social norms constitute a barrier, community-based interventions are likely to be most effective. A multi-pronged approach could include advocacy through social media and community forums, the provision of tailored information, the presence of positive role models and a welcoming environment.

Background: The partograph is a tool used to record labour observations and support decision-making. Although used globally, it has not reached its full potential. We aimed to determine whether an educational board game can improve labour-monitoring skills and influence practice., Study Design: A quasi-experimental study, underpinned by Kirkpatrick's evaluation model, was used. Midwives and student midwives from Malawi, Kenya and Tanzania were given an identical hypothetical case-scenario of a woman in labour pre-and post-implementation of a game, to assess recording and interpretation abilities. This was supplemented by qualitative inquiry 3 months post-game-playing using semi-structured interviews (n = 24) and expert case-record reviews (n = 24). Quantitative data were analysed using the paired t-test and qualitative data were subjected to framework analysis., Results: 95 midwives and 97 students participated. In each country the mean test scores improved; Kenya from 86.5 (6.7) to 95.5 (3.7) (paired t = 11.82, p < 0.001), Malawi from 83.6 (6.7) to 94.6 (4.1) (paired t = 13.35, p < 0.001), and Tanzania from 83.8 (6.2) to 94.9 (4.1) (paired t = 15.27, p < 0.001). Qualitative findings revealed six themes: 'an enjoyable way of practicing,' 'learning and re-learning,' 'improved clinical decision-making', 'promoting team-work', 'a catalyst for additional learning' and 'barriers to transference of learning'. Expert case-record review demonstrated good adherence to recommendations., Conclusion: Board games have the ability to improve labour-monitoring knowledge. Retention of information was apparent and application of learning into practice was encouraging. Health-system barriers need to be resolved for midwives to apply theory to practice. Whether such application results in improved clinical outcomes is uncertain and requires further evaluation., (Copyright © 2019 Elsevier B.V. All rights reserved.)

Objective: To gain understanding of the first-hand experience of women prior to and following repair of a vaginal fistula, to determine the most effective support mechanisms., Design: Qualitative phenomenological study using a series of in-depth semi-structured interviews at two time points: prior to fistula repair and 6 months post-surgery. Data were analysed thematically., Setting: Three fistula clinics in three districts in Kenya., Population: A purposive sample of 16 women suffering with vaginal fistula who were seeking fistula repair., Methods: Thrity-two semi-structured interviews were conducted., Results: The two main themes represented the women's journeys from social isolation to social reintegration. Women felt euphoric following fistula repair, believing that a 'miracle' had occurred. However, the 'post-miracle phase' demonstrated that the social and psychological impact of fistula leaves scars that are not easily healed, even when fistula repair is successful., Conclusion: Women's experiences of living with fistula have an impact beyond that which can be repaired solely by surgery. The findings from this study support the need for more active psychological assessment in the management of women with fistula, and the role of targeted psychological support in any package of care given in the post repair phase. The format of this support requires further study. Engagement by health professionals with the wider community could raise awareness of the causes of fistula, and provide support for significant others who may also be feeling vulnerable. It is likely that the collaborative efforts from health professionals and community members will provide the most effective support., Tweetable Abstract: Fistula surgery alone is insufficient for women's physical, social and psychological recovery., (© 2016 Royal College of Obstetricians and Gynaecologists.)

Background: Information technology is a rapidly increasing means of communication in education and healthcare. This is also true in low resource settings, where electronic communication provides an opportunity for sharing information about health and wellbeing and enhancing learning for healthcare professionals., Methods: A qualitative study whereby 51 year 3 and 4 student nurses at the University of Nairobi participated in 5 focus group discussions. Data were recorded, transcribed verbatim and analyzed using a framework approach., Results: Four main themes were identified, 'moving with the times', 'global networking', 'inequity as a barrier' and 'transfer of internet learning into practice'., Conclusions: Information technology is already integral to students' lives both personally and professionally and the students had a strong desire to find out what is happening globally. The familiarity of the internet contributes to the acceptance of e-learning programs as part of educational curricula. Students felt that e-learning 'is here to stay' and wanted to 'embrace the concept.' E-learning was generally welcomed however students suggested that it should be 'supplementary' to face-to-face learning. In order to incorporate e-learning ethically in low resource settings, resources should be sustainable, for example CDROMs and DVDs which are not dependant on internet access. Researching the views of qualified midwives might be the next step in promoting this valuable teaching method., (Crown Copyright © 2013. Published by Elsevier Ltd. All rights reserved.)

Objective: To establish knowledge and practice of contraception among patients presenting with a fistula attending fistula care services at 4 centers in Kenya., Methods: In a descriptive cohort study carried out between January and December 2011, patients presenting with a history of urine and/or stool leakage were screened and those with confirmed diagnosis of fistula were assessed and prepared for surgery. Informed consent was obtained from study participants before surgical intervention. After surgery, a standard questionnaire was used to collect information on sociodemographics, duration of leakage, and reproductive health practices., Results: A total of 206 patients were interviewed. Most of the patients were young (mean age 22 years). Literacy was low: only 1.7% reported tertiary-level education, and 56.7% reported primary-level education. With regard to family planning, 76.2% of patients expressed a willingness to use contraception after fistula repair., Conclusion: Among patients presenting with a fistula in Kenya, the unmet need for family planning was high. There is an urgent need for healthcare providers to integrate family planning services in fistula care programs., (Copyright © 2012 International Federation of Gynecology and Obstetrics. All rights reserved.)

Multiple intravaginal HIV prevention methods, including microbicide gels, barriers, and intravaginal rings, are in clinical development in Africa. Development of intravaginal HIV prevention products requires an understanding of sexual behavior, sexually transmitted infection (STI), and vaginitis prevalences, and sexual and vaginal practices in potential target populations. We assessed these factors in a cohort of Kenyan female sex workers (FSW). Women who reported exchanging sex for money/gifts at least three times in the past month and who were HIV uninfected were enrolled and followed for 6 months. STI prevalence and HIV incidence were analyzed by multivariate logistic regression analysis, controlling for demographic and behavioral factors. Thirty-seven percent (74/200) reported having had anal sex. Frequency of anal sex was higher with regular and casual partners than with primary partners. Women were less likely to use condoms for anal sex than for vaginal sex with regular or casual partners. Vaginal washing was universal (100%). HIV incidence was 5.6 per 100 person-years (95% CI 1.62, 11.67). HIV incidence was not associated with any demographic or risk behavior. The relatively high rate of anal sex and universal vaginal washing may complicate both safety and efficacy evaluation of intravaginal products and should be taken into account in trial design. This FSW population had significant HIV incidence and needs continued HIV prevention interventions.

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.

Background: Female participants in AIDS candidate vaccine clinical trials must agree to use effective contraception to be enrolled into the studies, and for a specified period after vaccination, since the candidate vaccines' effects on the embryo or foetus are unknown., Objectives: To review data on female participants' pregnancy rates from phase I and IIA AIDS vaccine clinical trials conducted at the Kenya AIDS Vaccine Initiative (KAVI) and to discuss the challenges of contraception among female participants., Design: Descriptive observational retrospective study., Setting: KAVI clinical trial site, Kenyatta National Hospital and University of Nairobi, Kenya., Subjects: Thirty nine female participants were enrolled into these trials. They received family planning counselling and were offered a choice of different contraceptive methods, as per the protocols. All contraception methods chosen by the participants were offered at the study site at no cost to the participant., Results: Four women conceived during the study period when pregnancies were to be avoided. All four had opted for sexual abstinence as a contraceptive method, but reported having been coerced by their partners to have unprotected sexual intercourse., Conclusion: Abstinence is clearly not a reliable contraceptive option for women in developing-country settings. Effective female-controlled contraceptives, administered at the clinical trial site, may empower female participants to better control their fertility, leading to more complete clinical trial data.

Purpose: We sought to assess the potential acceptability of intravaginal rings (IVRs) as an HIV prevention method among at-risk women and men., Methods: We conducted a qualitative assessment of initial attitudes toward IVRs, current HIV prevention methods, and common behavioral practices among female sex workers (FSWs) and men who frequent FSWs in Mukuru, an urban slum community in Nairobi, Kenya. Nineteen women and 21 men took part in six focus group discussions., Results: Most participants, both male and female, responded positively to the concept of an IVR as a device for delivering microbicides. Women particularly liked the convenience offered by its slow-release capacity. Some female respondents raised concerns about whether male customers would discover the ring and respond negatively, whereas others thought it unlikely that their clients would feel the ring. Focus groups conducted with male clients of FSWs suggested that many would be enthusiastic about women, and particularly sex workers, using a microbicide ring, but that women's fears about negative responses to covert use were well founded. Overall, this high-risk population of FSWs and male clients in Nairobi was very open to the IVR as a potential HIV prevention device., Conclusion: Themes that emerged from the focus groups highlight the importance of understanding attitudes toward IVRs as well as cultural practices that may impact IVR use in high-risk populations when pursuing clinical development of this potential HIV prevention device.

The safety and immunogenicity of plasmid pTHr DNA, modified vaccinia virus Ankara (MVA) human immunodeficiency virus type 1 (HIV-1) vaccine candidates were evaluated in four Phase I clinical trials in Kenya and Uganda. Both vaccines, expressing HIV-1 subtype A gag p24/p17 and a string of CD8 T-cell epitopes (HIVA), were generally safe and well-tolerated. At the dosage levels and intervals tested, the percentage of vaccine recipients with HIV-1-specific cell-mediated immune responses, assessed by a validated ex vivo interferon gamma (IFN-gamma) ELISPOT assay and Cytokine Flow Cytometry (CFC), did not significantly differ from placebo recipients. These trials demonstrated the feasibility of conducting high-quality Phase 1 trials in Africa.

Objective: To assess utilization of partner notification as a tool in prevention and control of Sexually transmitted infections in Nairobi City Council clinics., Design: A cross-sectional study carried out between April and September 2000., Setting: Nairobi City Council health clinics were stratified into eight administrative divisions and a total of 16 out of 54 primary health clinics with at least four STIs patients per day were selected. A standard questionnaire was administered to every fourth patient with clinical diagnosis of STIs who gave consent on exist. Sexual partners referred by index cases during the five day period from each clinic were also enrolled into the study. An additional questionnaire was administered to HCP who were managing STIs patients and their sex partners., Results: Of 407 STIs patients recruited between April and September 2000, 20.6% were primary and 2% were secondary referrals giving an average referral rate of 23%. Respondents with multiple sex partners were less likely to refer their partners compared to those who had one partner (17.9% vs 82.1%, p < 0.005). Counseling of STI patients on the importance of partner referral was more effective than issuing referral cards alone (72.8% vs 56.8% % p = < 0.006). Barriers to partner notification included partners being out of town (44.6%) fear of quarrels and violence from partners (32.5%) and casual partners (15.1%) whose sex partners were unknown., Conclusion: Counseling and understanding of STIs patients on the need to treat all sexual partners is pivotal to the success of partner referral.