'We no longer experience the same pain': a cross-sectional study assessing the impact of Heart and Sole Africa's podoconiosis prevention education program.

BACKGROUND: Podoconiosis is a non-infectious neglected tropical disease caused by long-term exposure to irritant volcanic soils. It results in severe physical, psychological and financial consequences. Heart and Sole Africa (HASA) is a non-governmental, community-based organization providing management to podoconiosis patients in Rwanda. We sought to analyze the impact of their program on the lives of patients. METHODS: Quantitative surveys recorded the participants' demographics, adherence to HASA's management recommendations and changes in quality of life (QOL). Qualitative questions were used to gather respondent perspectives on HASA programming. RESULTS: We interviewed 127 patients from HASA's Musanze (n=47) and Burera (n=80) clinics. Almost all participants (98.4%) reported statistically significant (p<0.01) improvements in their QOL, and more than one-half (51.2%) had a favorable adherence score of >80%. Qualitative feedback identified specific challenges to adherence and recognition of program success in symptom management. CONCLUSIONS: Our study demonstrated the value of community-based podoconiosis programming in improving the lives of patients. Practices such as regular feet washing, emollient application, shoe wearing and limb raising can result in a marked reduction of morbidity. Our findings support the argument for scaling up these management practices across Rwanda.

Implementing a Multisite Clinical Trial in the Midst of an Ebola Outbreak: Lessons Learned From the Sierra Leone Trial to Introduce a Vaccine Against Ebola.

The Sierra Leone Trial to Introduce a Vaccine against Ebola (STRIVE), a phase 2/3 trial of investigational rVSV∆G-ZEBOV-GP vaccine, was conducted during an unprecedented Ebola epidemic. More than 8600 eligible healthcare and frontline response workers were individually randomized to immediate (within 7 days) or deferred (within 18-24 weeks) vaccination and followed for 6 months after vaccination for serious adverse events and Ebola virus infection. Key challenges included limited infrastructure to support trial activities, unreliable electricity, and staff with limited clinical trial experience. Study staff made substantial infrastructure investments, including renovation of enrollment sites, laboratories, and government cold chain facilities, and imported equipment to store and transport vaccine at ≤-60oC. STRIVE built capacity by providing didactic and practical research training to >350 staff, which was reinforced with daily review and feedback meetings. The operational challenges of safety follow-up were addressed by issuing mobile telephones to participants, making home visits, and establishing a nurse triage hotline. Before the Ebola outbreak, Sierra Leone had limited infrastructure and staff to conduct clinical trials. Without interfering with the outbreak response, STRIVE responded to an urgent need and helped build this capacity. CLINICAL TRIALS REGISTRATION: ClinicalTrials.gov [NCT02378753] and Pan African Clinical Trials Registry [PACTR201502001037220].