Dissemination of the Spear & Shield Project using a Training of Trainers Model: A reflection on challenges and successes.

Several large-scale clinical trials have conclusively demonstrated that voluntary medical male circumcision (VMMC) could provide a 50%-70% reduction in HIV acquisition, but willingness to undergo VMMC has been lowest in Zambia compared to other countries in eastern and southern Africa. This manuscript describes training for "task-shifting" among local healthcare workers at Community Health Centers (CHCs) applying state of the art strategies (e.g., Training of Trainers, i.e., ToT, and Training of Facilitators, ToF) to provide novel clinical services. Staff at 96 CHCs from four Provinces in Zambia were sequentially trained to provide the Spear & Shield intervention. A total of 45,630 men (n = 23,236) and women (n = 22,394) volunteered to participate in the S&S intervention service program when offered in the CHCs. Group session (total = 5313 sessions; 2,736 men's and 2,582 women's sessions) were conducted over 4.5 years. Remarkably, both men and women's groups achieved 97% retention. Of these, 256 sessions recorded from 128 group leaders were assessed and scored for intervention fidelity; fidelity was 80%-90% among the majority of clinics. S&S program sustainment exceeded expectations among 85% of clinics (82/96) in all provinces across the duration of the study. Of note, attendance in the S&S program was encouraged by CHC staff, but no financial incentives were provided to those attending S&S. This study examined the effectiveness of the ToT/ToF model in dissemination of the S&S program, which proved to be feasible even in resource-limited settings. Benefits and challenges are discussed.

Defining Disease, Diagnosis, and Translational Medicine within a Homeostatic Perturbation Paradigm: The National Institutes of Health Undiagnosed Diseases Program Experience.

Traditionally, the use of genomic information for personalized medical decisions relies on prior discovery and validation of genotype-phenotype associations. This approach constrains care for patients presenting with undescribed problems. The National Institutes of Health (NIH) Undiagnosed Diseases Program (UDP) hypothesized that defining disease as maladaptation to an ecological niche allows delineation of a logical framework to diagnose and evaluate such patients. Herein, we present the philosophical bases, methodologies, and processes implemented by the NIH UDP. The NIH UDP incorporated use of the Human Phenotype Ontology, developed a genomic alignment strategy cognizant of parental genotypes, pursued agnostic biochemical analyses, implemented functional validation, and established virtual villages of global experts. This systematic approach provided a foundation for the diagnostic or non-diagnostic answers provided to patients and serves as a paradigm for scalable translational research.