BackgroundThe MSM population in Kenya contributes to 15% of HIV incidence. This calls for innovative HIV prevention interventions. Pre-exposure prophylaxis (PrEP) has been efficacious in preventing HIV among MSM in trials. There is limited data on the willingness to take daily oral PrEP in sub-Sahara Africa. PrEP has not been approved for routine use in most countries globally. This study aimed to document the willingness to take PrEP and barriers to uptake and adherence to PrEP in Kenya. The findings will inform the design of a PrEP delivery program as part of the routine HIV combination prevention.MethodsEighty MSM were recruited in 2 Counties in December 2013. Quantitative data on sexual behaviour and willingness to take PrEP were collected using semi-structured interviews and analysed using SPSS. Qualitative data on knowledge of PrEP, motivators and barriers to uptake and adherence to PrEP were collected using in-depth interviews and FGDs and analysed using Nvivo. Analysis of data in willingness to take PrEP was conducted on the HIV negative participants (n = 55).Results83% of MSM were willing to take daily oral HIV PrEP. Willingness to take PrEP was higher among the bi-sexual and younger men. Motivators for taking PrEP were the need to stay HIV negative and to protect their partners. History of poor medication adherence, fear of side effects and HIV stigma were identified as potential barriers to adherence. Participants were willing to buy PrEP at a subsidized price.ConclusionsThere is willingness to take PrEP among MSM in Kenya and there is need to invest in targeted education and messaging on PrEP to enhance adherence, proper use and reduce stigma in the general population and among policy makers.

Background While advances have been made in HIV prevention and treatment, new HIV infections continue to occur. The introduction of pre-exposure prophylaxis (PrEP) as an additional HIV prevention option for those at high risk of HIV may change the landscape of the HIV epidemic, especially in sub-Saharan Africa, which bears the greatest HIV burden. Methods: This paper details Kenya’s experience of PrEP rollout as a national public sector program. The process of a national rollout of PrEP guidance, partnerships, challenges, lessons learnt and progress related to national scale up of PrEP in Kenya, as of 2018, is described. National rollout of PrEP was strongly lead by the government, and work was executed through a multidisciplinary, multi-organisation dedicated team. This required reviewing available evidence, providing guidance to health providers, integration into existing logistic and health information systems, robust communication and community engagement. Mapping of the response showed that subnational levels had existing infrastructure but required targeted resources to catalyse PrEP provision. Rollout scenarios were developed and adopted, with prioritisation of 19 counties focusing on high incidence area and high potential PrEP users to maximise impact and minimise costs. Results: PrEP is now offered in over 900 facilities countrywide. There are currently over 14000 PrEP users 1 year after launching PrEP.Conclusions: Kenya becomes the first African country to rollout PrEP as a national program, in the public sector. This case study will provide guidance for low- and middle-income countries planning the rollout of PrEP in response to both generalised and concentrated epidemics.

Quality improvement (QI) has been widely implemented in health services but has not been widely applied in HIV prevention research. Most prevention research centers have commonly employed traditional approaches (e.g., checklists) to quality control that document what has been done but not the quality of what has been done. Unlike other health settings, prevention research settings have unique characteristics and ethical requirements that require the development or adaptation of specific quality indicators. A QI model for health services was adapted for use in prevention research settings and was piloted between August 2006 and July 2007 at three research centers in East Africa. Four hundred and twenty-six volunteers exit interviews were administered in two cycles. Quantitative and qualitative data were analyzed using Excel worksheets. QI meeting reports and QI plans were used to complement data from exit interviews. On average, 52% of total enrolled volunteers participated in the exit interview. The designed QI plans successfully helped reduce volunteers' reported waiting time to see counselors (p<0.001) and pharmacists (p<0.001). It also increased the percentage of interviewed volunteers who reported being counseled on family planning at clinical trials (from 66 to 93%; p=0.02) at follow-up visits, and who were refreshed on informed consent at follow-up visits (from 90 to 96%; p=0.009). The percentage of interviewed volunteers that expressed satisfaction with services received from counselors increased (from 87 to 94%; p=0.009) while the percentage of volunteer satisfied with services from trial physicians remained constant (93%). The majority of volunteers interviewed reported satisfaction with other major components of research such as confidentiality, understanding of trial objectives, benefits and risks of participation, and risk reduction counseling. However, satisfaction with services from community outreach workers and other staff at research centers dropped over the course of the study (from 88% in Cycle 1 to 74% in Cycle 3; p= < 0.001). Increased commitment to QI is crucial in ensuring quality of services and ethical conduct of HIV prevention research centers.

BackgroundHealth research initiatives worldwide are growing in scope and complexity, particularly as they move into the developing world [1]. This changing cascade of biomedical research poses new challenges for research ethics committees (RECs) review efficiency and quality. The sheer amount of research now being conducted in Africa has resulted in an unprecedented increase in RECs' workload [2] and the growing trend of multi-centre trials complicate the traditional, institutionoriented oversight system. This places a severe burden on RECs, which have always operated under significant resource constraints [3]. Majority (93% of the mapped 169 RECs in 37 African countries) use complex paper based review systems [4], which have proven to be problematic in terms of providing comprehensive oversight and tracking of submitted research protocols, monitoring and evaluation, effective communication, data storage and poor continuity of work due to the high turnover of REC membership [5]. The ChallengeThe etiology of REC inefficiency is complex. REC members spend a great deal of time preparing REC applications, amendments, renewals, and reports. Poorly functioning review systems can lead to inefficiencies or long review timelines which ultimately lengthens the time to licensure for new medicines, vaccines and medical technologies [6].169 RECs are reported to be operational in 37 African countries, with great variability in skills, membership, capacity and resources [4]. Most of these RECs are facing substantial challenges, including limited financial and human resources, insufficient training and inadequate standard operational procedures (SOPs), and lack of modernised information management technologies [3]. One of the major bottlenecks for ethical clearance is the complex paper based review systems widely used by African RECs, which are unable to absorb significantly increased submission volumes [4]. To address the latter, the Council on Health Research for Development (COHRED), working with partners in Africa, designed an intervention to address the need to provide much faster ethical review of research: the RHInnO Ethics, a cloud-based management information system for RECs (http:// www.rhinno.net) [1]. Since its first rollout in 2012, no study has been conducted to evaluate the platform's impact, nor has any study been conducted to evaluate the technological needs of RECs in Africa, hence the motivation for this survey. MethodologyAn online questionnaire was used to collect both qualitative and quantitative data from the 8 African countries currently using RHInnO Ethics. Enhancing the Efficiency and Quality of African Research Ethics Review Processes -Through an Automated Review PlatformBoitumelo Mokgatla*, Prince Bahati and Carel I Jsselmuiden International AIDS Vaccine Initiative (IAVI), Botswana AbstractBackground: The sheer amount of research being conducted in Africa, the under-resourced research ethics committees (RECs), and the lack of modern review technologies have resulted in unprecedented ethics review tim...

BackgroundCapacity in health research ethics review is key in Africa, given the increase in research activities, complexity, and use of advanced technologies. Harmonising ethics review frameworks can address challenges attributable to these complexities. Establishing an effective harmonised framework that is optimum or protection of the research subjects requires assessment of review capacity.The East African Health Research Commission commissioned a study to assess the capacity of Review Ethics Committees (RECs) in the East African Community (EAC) countries, as a step towards strengthening and harmonising the regions’ capacity and review frameworks.MethodsA desktop review of documentation (national and institutional guidelines, policies and SOPs) was conducted in five EAC countries. Semi-structured questionnaires were used to collect data from key informants. Qualitative interviews were used to collect views on stakeholders’ perception of benefits, opportunities and challenges of harmonisation.ResultsSixty-nine (69) accredited RECs were mapped. All countries had national ethics guidelines and National Research Regulatory Authorities, whose mandates varied across countries. 57% of RECs reviewed local and international research, 43% reviewed local studies only. On average, 91 protocols were reviewed annually across all RECs (range 15 to 200). Membership ranged from 6 to 22 members per REC, with age range of 29 to 75 years.Annual budget allocation ranged from $3000 to $2.9 mil„lion financed through review fees (84%) or/and institutional budget (14%). 71% of RECs had education policy but 41%had members with training in ethics. Review turn-around time ranged from 14 to 90 days. All RECs supported harmonisation and attributed it to improved efficiency, quality and standardised costs.ConclusionSimilarities and dissimilarities were noted in the EAC countries’ ethics review frameworks. Harmonisation should consider 1) harmonisation of policy frameworks and tools; 2) institutionalisation of regional joint review mechanisms, 3) standardisation of training and capacity strengthening, 4) Review of the REC operational and financing models.