Clinical research and development of tuberculosis diagnostics: moving from silos to synergy.

The development, evaluation, and implementation of new and improved diagnostics have been identified as critical needs by human immunodeficiency virus (HIV) and tuberculosis researchers and clinicians alike. These needs exist in international and domestic settings and in adult and pediatric populations. Experts in tuberculosis and HIV care, researchers, healthcare providers, public health experts, and industry representatives, as well as representatives of pertinent US federal agencies (Centers for Disease Control and Prevention, Food and Drug Administration, National Institutes of Health, United States Agency for International Development) assembled at a workshop proposed by the Diagnostics Working Group of the Federal Tuberculosis Taskforce to review the state of tuberculosis diagnostics development in adult and pediatric populations.

Perspectives on a Novel Culturally Tailored Diabetes Self-Management Program for African Americans: A Qualitative Study of Healthcare Professionals and Organizational Leaders.

BACKGROUND: There is an urgent need for culturally tailored diabetes self-management education to improve health outcomes in African Americans, especially given the disproportionate prevalence of diabetes and medication non-adherence. Stakeholder engagement can guide and enrich the development of these interventions by integrating content directly addressing barriers to African Americans' adherence with existing community-based diabetes self-management education programs. The aim of this study is to explore stakeholder perspectives on a novel culturally tailored diabetes self-management program for African Americans. METHODS: Thirteen semi-structured individual interviews were conducted in a large Midwestern U.S. city with healthcare professionals and organizational leaders serving African American communities and/or providing diabetes education. Transcripts were analyzed using directed content analysis with the Consolidated Framework for Implementation Research and inductive content analysis. RESULTS: Five overarching themes were identified: (1) fulfill needs among stakeholders, (2) creating a supportive and trusting environment to address distrust, (3) building relationships and empowering peers, (4) logistical organization barriers to program implementation and (5) challenges to program acceptance by participants. CONCLUSION: Stakeholders delineated how the new culturally tailored diabetes self-management program aligned with the needs of African American patients. Perceived challenges and corresponding strategies to address barriers to participation were identified to inform program implementation and sustainability.

A Culturally Tailored Diabetes Self-Management Intervention Incorporating Race-Congruent Peer Support to Address Beliefs, Medication Adherence and Diabetes Control in African Americans: A Pilot Feasibility Study.

Introduction: Current diabetes self-management programs are often insufficient to improve outcomes for African Americans because of a limited focus on medication adherence and addressing culturally influenced beliefs about diabetes and medicines. This study evaluated the feasibility and acceptability of a novel culturally tailored diabetes self-management intervention that addressed key psychosocial and sociocultural barriers to medication adherence for African Americans. Methods: The intervention consisted of group education and race-congruent peer-based phone support. Three African Americans who were engaged in taking their diabetes medicines (ambassadors), were matched with 8 African Americans who were not engaged in taking medicines (buddies). We conducted a single group, pre/post study design with African Americans with type 2 diabetes. Wilcoxon signed rank tests assessed mean score differences in outcomes at baseline compared with 6-months follow-up. Semi-structured interviews explored buddies' acceptability of the intervention. Results: Buddies and ambassadors were similar in age and mostly female. Recruitment rates were 80% for buddies and 100% for ambassadors. Retention rate for primary outcomes was 75%. Buddies had a mean completion of 13.4/17 of sessions and phone calls. Ambassadors completed 84% of intervention calls with buddies. Although there were no statistically significant differences in mean A1C and medication adherence, we found a clinically meaningful decrease (-0.7) in mean A1C at the 6-month follow up compared to baseline. Secondary outcomes showed signal of changes. Themes showed buddies perceived an improvement in provider communication, learned goal setting strategies, and developed motivation, and confidence for self-management. Buddies perceived the program as acceptable and culturally appropriate. Conclusion: This culturally tailored diabetes self-management intervention that addresses diabetes self-management, psychosocial and behavioral barriers to medication adherence, and incorporates race-congruent peer support from African Americans engaged in taking medicines seemed feasible and acceptable. The results provide support for a fully powered randomized trial to test the intervention's efficacy. Trial Registration: https://clinicaltrials.gov/ct2/show/NCT04857411. Date of Registration: April 23, 2021.

Engaging communities in tuberculosis research.

According to a growing consensus among biomedical researchers, community engagement can improve the ethics and outcomes of clinical trials. Although successful efforts to develop community engagement practices in HIV/AIDS research have been reported, little attention has been given to engagement with the community in tuberculosis research. This article aims to draw attention to some existing community engagement initiatives in tuberculosis research and to resources that might help tuberculosis researchers to establish and implement community engagement programmes for their trials. One of these resources-the good participatory practice guidelines for tuberculosis drug trials-offers a conceptual framework and practical guidance for community engagement in tuberculosis research. To build momentum and to improve community engagement, lessons need to be shared, and formal assessment strategies for community engagement initiatives need to be developed. To build successfully on the promising activities described in this personal view, research funders and sponsors should show leadership in allocation of resources for the implementation and assessment of community engagement programmes in tuberculosis trials.

TB and HIV Therapeutics: Pharmacology Research Priorities.

An unprecedented number of investigational drugs are in the development pipeline for the treatment of tuberculosis. Among patients with tuberculosis, co-infection with HIV is common, and concurrent treatment of tuberculosis and HIV is now the standard of care. To ensure that combinations of anti-tuberculosis drugs and antiretrovirals are safe and are tested at doses most likely to be effective, selected pharmacokinetic studies based on knowledge of their metabolic pathways and their capacity to induce or inhibit metabolizing enzymes of companion drugs must be conducted. Drug interaction studies should be followed up by evaluations in larger populations to evaluate safety and pharmacodynamics more fully. Involving patients with HIV in trials of TB drugs early in development enhances the knowledge gained from the trials and will ensure that promising new tuberculosis treatments are available to patients with HIV as early as possible. In this review, we summarize current and planned pharmacokinetic and drug interaction studies involving investigational and licensed tuberculosis drugs and antiretrovirals and suggest priorities for tuberculosis-HIV pharmacokinetic, pharmacodynamic, and drug-drug interaction studies for the future. Priority studies for children and pregnant women with HIV and tuberculosis co-infection are briefly discussed.