Data-driven epidemiologic approach to conducting site feasibility for a global phase III tuberculosis vaccine clinical trial.

An efficacious tuberculosis (TB) vaccine is critical to reducing the global burden of TB. TB vaccine trials require the identification of multiple sites globally that have both a high incidence of TB and the capacity to conduct a clinical trial. To expand the diversity of potential phase III TB vaccine trial sites to be considered for inclusion, we describe a novel epidemiologic method that incorporates approaches from a variety of public health practices. Our approach incorporates analytic methodology to enable quantification and validation of qualitative information from disparate data sources, and epidemiologic analysis to systematically assess site-specific TB epidemiology. The integration of robust data-driven practices, and more quantitatively focused analysis, allowed for the objective evaluation of sites, which resulted in the identification of sites and catchment areas with high TB burden that may not have been previously considered. This suggests that an integrated epidemiologic methodology, not traditionally utilized for clinical trial site evaluations, could be integrated into site feasibility assessments as it results in more rapid site identification and reduces unintended bias.

Evaluation of the TRxANSITION Index-Parent Version for Assessment of Readiness to Transition to Adult Care Among Youth with Chronic Conditions.

PURPOSE: To develop and evaluate a parent-proxy measure of youth HCT readiness: the TRxANSITION Index-Parent Version. DESIGN AND METHODS: We recruited parents (77% female) and youth (ages 12 to 25) to complete transition readiness measures during outpatient clinic visits. The TRxANSITION Index-Parent Version contains two domains: the Parent Knowledge Domain assessing a parent's knowledge of their youth's illness, and the Parent Proxy Domain, which provides a parental perspective regarding a youth's transition readiness skills. We evaluated the TRxANSITION Index - Parent Version for differences between parent and youth reports of HCT readiness, associations between parent's score and youth's characteristics, and item-category, item-sub-index, and sub-index category correlations. RESULTS: Data from 93 parents-youth dyads were analyzed. Parents scored significantly higher than youth in the Parent Knowledge Domain and similarly in the Parent Proxy Domain. Parents of daughters had significantly higher scores in the Parent Knowledge Domain than parents of sons and reported similar scores to Parents of sons in the Parent Proxy Domain. Only the self-management sub-index significantly correlated with youth's age. The sub-index-domain, item-sub-index, and item-domain correlations assessed were generally large in magnitude (r > 0.5). CONCLUSIONS: The TRxANSITION Index-Parent Version shows promise as a means of assessing parent knowledge of a youth's illness and may provide an accurate proxy assessment of a youth HCT readiness skills. PRACTICE IMPLICATIONS: Obtaining parental perspective on a youth's HCT readiness may provide useful clinical information during the transition process.

Association of youth health care transition readiness to role overload among parents of children with chronic illness.

BACKGROUND: A parent's level of role overload, a situation in which the demands of an individual's roles are beyond their capacity to perform adequately, has been associated with poor outcomes in adolescents. It is unknown if role overload in parents is associated with less health care transition (HCT) readiness in their children with chronic conditions. We sought to assess this relationship. METHODS: Youth with chronic conditions attending a therapeutic camp and their parents completed online consents/assents and de-identified surveys. Parents reported on parental role overload using the Reilly Role Overload Scale and a proxy assessment of the youth's HCT readiness using the STARx -Parent Questionnaire. Youth self-reported on their HCT readiness using the STARx Questionnaire. Linear regression measured the relationship between parent role overload and HCT readiness, controlling for youth's age, sex, and degree of youth's educational support. RESULTS: One hundred fifty-two parents and 50 youth completed the measures. Greater parental role overload was associated with less overall HCT readiness on the parent proxy measure (ß = -.12, P ≤ .008) and a lower level in the self-management domain on the parent proxy measure (ß = -.20, P ≤ .001). We found no associations between parent role overload and youth self-report of HCT readiness. CONCLUSION: Parent's level of role overload had no association with youth's self-report of HCT readiness but was negatively associated with parent proxy report of their youth's HCT readiness, suggesting that parents with high levels of role overload may perceive their youth as less ready to transition to adult-focused care.

Longitudinal Self-Management and/or Transition Readiness per the TRxANSITION Index among Patients with Chronic Conditions in Pediatric or Adult Care Settings.

OBJECTIVE: To evaluate the roles of key individual, family, and illness characteristics on the levels of and gains in longitudinal healthcare transition (HCT) readiness in the pediatric setting and/or self-management skills (SMS) in the adult-focused setting, we used a large dataset with longitudinal measurements from 2006 to 2015. STUDY DESIGN: This longitudinal observational study followed 566 adolescents and young adults with chronic conditions at University of North Carolina Hospitals. TRxANSITION Index measurements, which represent learning outcomes rather than health outcomes, were collected multiple times per patient and analyzed using a novel application of an education-based approach. RESULTS: Levels of and gains in HCT/SMS scores increased with age (P < .001) with smaller increases at older ages. Mastery of skills varied by age with self-management achieved after 20 years of age. Scores varied positively by father's education and negatively by mother's education and duration of diagnosis. Gains in scores further varied positively with private insurance and negatively with mother's education and duration of diagnosis. CONCLUSIONS: We found diminishing positive increases in HCT/SMS scores as patients become older and smaller levels of and gains in readiness among younger patients with more educated mothers. Risk factors for absolute level of HCT/SMS readiness and inadequate longitudinal gains are not always the same, which motivates a deeper understanding of this dynamic process through additional research. This information can guide providers to focus HCT/SMS preparation efforts on skills mastered at particular ages and to identify patients at risk for inadequate development of HCT/SMS skills.

Contraceptive implants in Kenya: current status and future prospects.

BACKGROUND: Since introducing Norplant over 20 years ago in Kenya, demand for contraceptive implants has remained high and implant costs are dropping substantially. METHODS: An assessment of the Kenyan experience with implants was conducted to understand level of demand, capacity to provide services and reproductive health impact of possible increased use. Interviews were conducted with 35 key Kenyan informants. By modeling increases in national implant use (at the expense of oral contraceptives), reductions in the annual number of unintended pregnancies were estimated. RESULTS: Kenya has an unmet need for implants and the current network of trained providers appears ready to increase the volume of services. If 100,000 users of oral contraceptives switch to implants, then an estimated 26,000 unintended pregnancies can be averted over a 5-year period. CONCLUSION: With increased purchases of implants by international donor agencies, Kenya can reduce reliance on short-term hormonal methods and reduce the 45% prevalence rate of unintended pregnancy.

Short-course and single-dose antimicrobial therapy for chancroid in Kenya: studies with rifampin alone and in combination with trimethoprim.

Tetracyclines and sulfonamides are no longer effective for the treatment of chancroid in many parts of the world. Rifampin and trimethoprim both possess in vitro activity against Haemophilus ducreyi, the causative agent of chancroid. In a randomized, controlled study, 22 patients with H. ducreyi-positive genital ulcers received 600 mg of rifampin once daily for three days, and 32 patients received 600 mg of rifampin plus 160 mg of trimethoprim once daily for three days. Both regimens rapidly eradicated H. ducreyi from ulcers, with subsequent healing of ulcers and buboes. Two relapses of ulcers and one therapeutic failure were observed in the rifampin-trimethoprim group, whereas no relapses or failures were noted in the rifampin group. In addition, all of 16 H. ducreyi-negative ulcers responded rapidly to treatment with either regimen. In an uncontrolled, open study, 22 H. ducreyi-positive ulcers were treated with a single dose of rifampin (600 mg) plus trimethoprim (160 mg). Ulcers and buboes resolved by day 14 in all but one patient. Thus, these short-course and single-dose regimens are effective against chancroid.