KNH-UoN Ethics and Research Committee

Background: Health-care providers form the backbone of health information and service delivery in many African communities. This study investigated health-care providers' (HCPs) attitudes towards a novel method of HIV prevention for women-a microbicide-embedded intravaginal ring (IVR). Methods: Qualitative interviews were conducted, covering initial attitudes towards IVRs, potential use among female sex workers, herbal practices for sexually transmitted infection (STI) management and the ways in which populations can access the rings should they become available. Twenty HCPs were interviewed in Mukuru and Kibera, which are informal settlements in Nairobi, Kenya, with high HIV prevalence, unemployment and commercial sex work. Results: The majority of HCPs had positive attitudes towards IVRs as a method of HIV prevention in this environment. HCPs liked that IVRs are female controlled and can be used covertly. Overall, HCPs reported a willingness to participate in the distribution of IVRs, and favoured distribution through health facilities at no cost. Conclusion: Findings from this study demonstrate that HCPs are willing to serve as the primary source of IVR information in target communities. However, they require adequate knowledge regarding microbicides and IVRs before these products reach the market

the partograph is a tool used globally to record labour progress. Although it has the potential to improve maternal and neonatal outcomes, some midwives struggle with using it in practice. Training in partograph use is limited, and the theory is often divorced from practice. Innovative ways of improving training are urgently required. We therefore aimed to determine whether the use of an e-learning tool is beneficial for learning partograph skills. an uncontrolled before-and-after study was conducted, informed by Kirkpatrick's four-stage model of evaluation; we report on the first two stages. We included a cohort of third and fourth year midwifery students who were studying at one university in Nairobi. The same hypothetical case scenario was used, pre- and post-implementation of the World Health Organization partograph e-learning tool, to assess students' partograph completion ability. Views on the tool were also sought, using semi-structured questionnaires. Data were analysed using standard statistical techniques and framework analysis. 92 (88%) students participated. Students expressed positive views about the e-learning tool. However, the mean post-intervention score (27.21) was less than half of the maximum obtainable score. There was some improvement in test scores; year three mean score pre-intervention was 21.39 (SD 5.72), which increased to 25.10 (5.41) post-intervention (paired-t=3.47, p=0.001); year four mean score pre-intervention was 24.39 (5.98) which increased to 29.30 (6.77) post-intervention (paired t=3.85, df=91, p<0.001). In the post-test, year four students scored higher than year three students (unpaired t=3.28, df=90, p=0.001). Students were unable to plot cervical dilatation correctly, once established labour had been confirmed. e-Learning training is acceptable to student midwives and has the potential to be an effective means of teaching the practical application of the partograph. However, in this study, their inability to correctly plot transference from the latent to active phase of labour suggests that the partograph itself may be too complicated. Modifications and further evaluation of the e-learning tool would be required before any widespread implementation. Furthermore, students need the clinical support to operationalise their learning; educating qualified midwives and obstetricians to be positive role models when completing the partograph would be one potential solution. Further research is required, taking on board the recommendations from our pilot study, to investigate the impact of partograph e-learning on practice and clinical outcomes.

Previous research has demonstrated the likely benefits of partograph use in low-resourced settings. However, the challenges of completing a partograph are also reported. The objective of this study was to examine students' views and experiences of partograph use to gain understanding of the realities of using this tool in the labour ward. Methods: In a qualitative study, 51 student nurses, undertaking their maternity placement at a university in Nairobi, Kenya, participated in five focus group discussions. Data were audio recorded, transcribed verbatim and analysed thematically. Results: Four main themes emerged from the analyses: challenges to 'doing the right thing'; theory-practice disconnectedness; negative role models; and retrospective recording. Conclusions: The results provide insight into the challenges faced by students when practising in the labour ward environment. A more effective approach to partograph training and implementation should be adopted to support students. However, student midwife training is unlikely to be implemented into practice unless the qualified team supports their learning. Given that the partograph had little status in the labour ward, change may only happen when senior health professionals (midwives and obstetricians) lead by example. Further research is required to explore the views of obstetricians and qualified midwives on partograph use. Appropriate implementation strategies also warrant further investigation

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

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
enrolment.
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: In Africa Health Care Providers form the primary source of information and service provision. Majority of the health work force are nurses/midwives with diverse training and experiences. This study focused on knowledge and Safe motherhood policy implementation.
Method: In a period of 12 months, participants were recruited from all the regions in Kenya. To be eligible for study, participants were required to have a midwife’s practicing license and member of National Midwives Association. A standardized tool was used to collect data regarding social demographics, professional training and practice. Information about uptake of Antenatal care, reasons for home deliveries and causes of infant mortality were also documented. Data was then entered and analyzed using Social Science Package for statistical analysis (SPSS).
Results: A total of 117 nurses participated in the study with a male: female ratio of 1:5. The mean age was 41 years with a minimum age of 24 and maximum 53 years. Abroad professional background was observed with a majority being KRCHN (97%}, BScN (2%) and MScN (1%). All the participants reported having seen the safe motherhood policy document but majority 74% said they had not read the document. Ninety-two percent had attended to mothers who had had a home delivery with 80% of the nurses having attended to one mother who had had FGM. Despite this impressive workload, almost two thirds (63%) had not read the policy on abortion and post abortal care (63%).
Conclusion: The midwife continues to serve communities with diligence and dedication, however practitioners neglect policy interpretation. To breach this gap, midwives need motivation to keep a breast with emerging issues in safe motherhood

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.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.

No Abstract!

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- ) 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.

No Abstract!

MRC Human Immunology Unit, University of Oxford, Oxford, UK. The IFN-y enzyme-linked immunospot (ELI-Spot) assay is often used to map HIV-specific CD8 T-cell responses. We compared overlapping 15-mer pools with optimized CD8 epitopes to screen ELISpot responses in HIV-infected individuals. The 15-mer pools detected responses to previously undefined epitopes, but often missed low-level responses to predefined epitopes, particularly when the epitope was central in the 15-mer, rather than at the N-terminus or C-terminus. These factors should be considered in the monitoring of HIV vaccine trials.