Implementing an Ebola Vaccine Study - Sierra Leone.

In October 2014, the College of Medicine and Allied Health Sciences of the University of Sierra Leone, the Sierra Leone Ministry of Health and Sanitation, and CDC joined the global effort to accelerate assessment and availability of candidate Ebola vaccines and began planning for the Sierra Leone Trial to Introduce a Vaccine against Ebola (STRIVE). STRIVE was an individually randomized controlled phase II/III trial to evaluate efficacy, immunogenicity, and safety of the recombinant vesicular stomatitis virus Ebola vaccine (rVSV-ZEBOV). The study population was health care and frontline workers in select chiefdoms of the five most affected districts in Sierra Leone. Participants were randomized to receive a single intramuscular dose of rVSV-ZEBOV at enrollment or to receive a single intramuscular dose 18-24 weeks after enrollment. All participants were followed up monthly until 6 months after vaccination. Two substudies separately assessed detailed reactogenicity over 1 month and immunogenicity over 12 months. During the 5 months before the trial, STRIVE and partners built a research platform in Sierra Leone comprising participant follow-up sites, cold chain, reliable power supply, and vaccination clinics and hired and trained at least 350 national staff. Wide-ranging community outreach, informational sessions, and messaging were conducted before and during the trial to ensure full communication to the population of the study area regarding procedures and current knowledge about the trial vaccine. During April 9-August 15, 2015, STRIVE enrolled 8,673 participants, of whom 453 and 539 were also enrolled in the safety and immunogenicity substudies, respectively. As of April 28, 2016, no Ebola cases and no vaccine-related serious adverse events, which by regulatory definition include death, life-threatening illness, hospitalization or prolongation of hospitalization, or permanent disability, were reported in the study population. Although STRIVE will not produce an estimate of vaccine efficacy because of low case frequency as the epidemic was controlled, data on safety and immunogenicity will support decisions on licensure of rVSV-ZEBOV.The activities summarized in this report would not have been possible without collaboration with many U.S. and international partners (http://www.cdc.gov/vhf/ebola/outbreaks/2014-west-africa/partners.html).

Provider experience of uterine balloon tamponade for the management of postpartum hemorrhage in Sierra Leone.

OBJECTIVE: To understand healthcare providers' experience of incorporating uterine balloon tamponade (UBT) into the national postpartum hemorrhage (PPH) clinical pathway after UBT training. METHODS: In a qualitative study, semi-structured interviews were undertaken with healthcare providers from 50 centers in Freetown, Sierra Leone, between May and June 2014. All eligible healthcare providers (undergone UBT training, actively conducted deliveries, and treated cases of PPH since UBT training) on duty at the time of center visit were interviewed. RESULTS: Sixty-one providers at 47 facilities were interviewed. Bleeding was controlled in 28 (93%) of 30 cases of UBT device placement. Participants reported that UBT devices were easy to insert with only minor challenges, and enabled providers to manage most cases of uncontrolled PPH at their own facility and to refer others in a stable condition. Reported barriers to optimal UBT use included insufficient training and practical experience, and a scarcity of preassembled UBT devices. Facilitators of UBT use included widespread acceptance of UBT, comprehensive and enthusiastic training, and ready availability of UBT devices. CONCLUSION: UBT-used either as a primary endpoint or en route to obtaining advanced care-has been well accepted and integrated into the national PPH pathway by providers in health facilities in Freetown.

Using scorecards to achieve facility improvements for maternal and newborn health.

The Government of Sierra Leone launched the Free Health Care Initiative in 2010, which contributed to increased use of facility based maternity services. However, emergency obstetric and neonatal care (EmONC) facilities were few and were inadequately equipped to meet the increased demand. To ensure provision of EmONC in some priority facilities, the Ministry of Health and Sanitation undertook regular facility assessments. With the use of assessment tools and scorecards it is possible to make improvements to the services provided in the period after assessment. The exercise shows that evidence that is shared with providers in visually engaging formats can help decision-making for facility based improvements.