Clinical Research Directory

Consensus on Low-resource Setting Definition: An inteRnational Delphi sTudY (CLARITY-LRS)

The term "low-resource setting" (LRS) is widely used in global health and critical care, yet no universally accepted definition exists. World Bank income classifications are frequently used as proxies for healthcare resources but may not adequately reflect differences in healthcare capacity and delivery within and across countries. Resource limitations may also exist within high-income countries, emphasizing the need for a multidimensional, setting-specific approach. The Consensus on Low-resource setting definition: An inteRnational Delphi sTudY (CLARITY-LRS) aims to achieve international expert consensus on the limitations of country-level income classifications and to develop a context-sensitive framework for defining and characterizing resource-limited acute and critical care settings. CLARITY-LRS is an international modified Delphi study involving 40-50 multidisciplinary panelists from all inhabited continents, with deliberate representation from low-resource settings and inclusion of patient and caregiver perspectives. At least three anonymous electronic Delphi rounds will be conducted using 9-point Likert scales, multiple-choice and ranking questions, and qualitative feedback. Consensus will be predefined as ≥80% agreement, with response stability assessed across consecutive rounds. The study will follow ACCORD guidance for consensus-based research. The resulting consensus is expected to identify key structural, organizational, workforce-related, technological, and clinical dimensions of resource limitations, provide an operational framework applicable across and within countries, and recommend standardized terminology, including whether the term "low-resource setting" should be retained or replaced. This framework may improve comparability of research, interpretation of evidence, and context-sensitive implementation of interventions across diverse healthcare systems.

Assessing Health System Readiness for Scaling Antenatal MMS in Cambodia

Malnutrition among pregnant women in low- and middle-income countries (LMICs) can cause micronutrient deficiencies that result in adverse maternal and neonatal health outcomes. The World Health Organization has recently recommended antenatal multiple micronutrient supplementation (MMS) that includes iron and folic acid (IFA) to improve maternal and neonatal health outcomes. MMS likely provides additional antenatal benefits over IFA supplementation alone. The Cambodian government, in partnership with Helen Keller International, is piloting MMS implementation in Takeo Province, which will inform nationwide scale-up of MMS. Study Purpose: The Takeo implementation must be evaluated to understand context-specific implementation of MMS and health system readiness for scale-up. This study assesses system readiness through four domains from the Intervention Scalability Assessment Tool (ISAT): (1) fidelity and adaptation, (2) reach and acceptability, (3) delivery setting and workforce capacity, and (4) implementation infrastructure. Population: The pilot involves transitioning to MMS from IFA across all 86 health centers, all 6 referral hospitals, and the provincial hospital in Takeo province. This study includes pregnant women receiving antenatal care, antenatal healthcare providers and facilities, and hospital managers in Takeo. The study also includes national governing bodies for MMS delivery. Methods: This mixed-methods study uses ISAT as a framework for developing data collection methods. Sampling strategies emphasize urban and rural representation across all operational districts in Takeo and diverse stakeholder perspectives at multiple levels of the health system. Data collection includes: * 12 focus group discussions (FGDs) with health center providers to assess provider adherence to MMS delivery guidelines, perspectives on the transition to MMS, and additional resources needed for MMS delivery * Workload assessment surveys at FGDs to quantify any burden on providers and resource gaps to deliver MMS * MMS stockout monitoring at 18 health centers and 7 hospitals to assess supply chain reliability * 15 key informant interviews with hospital managers to assess perspectives on the integration of MMS into antenatal services and facility readiness for MMS delivery * Phone surveys with 630 pregnant women to assess acceptability and adherence to MMS at 90- and 180-days after MMS distribution * One FGD with national-level stakeholders to assess national-level readiness, economic planning, and resource planning for sustainable MMS implementation and scale-up * Rapid economic evaluation to estimate the cost of nationwide scale-up Potential Impact: This study will generate insights into real-world implementation of MMS in Cambodia. It will identify context-specific adaptations, implementation gaps, and resource planning frameworks needed for nationwide scale-up of MMS. Successful scale-up is anticipated to improve maternal and neonatal health in Cambodia. Findings can also be used to guide other LMICs seeking to transition to and sustainably implement MMS.

Digital Data Linkage and Scheduling to Track Pregnancy With or Without Community Data Use to Increase Antenatal Clinic Uptake in Western Kenya.

The investigators propose to increase ANC uptake through a health systems strengthening approach that links digital data platforms and trains community Work Improvement Teams (WITs) to use these data to identify problems and come up with local solutions. Our short name C-it DU-it (pronounced "see-it; do-it") is an acronym intended to convey 'seeing' linked data (C-it) and 'doing' or acting on the data (DU-it). The trial design is a 2-arm, cluster-randomised controlled superiority trial in Homa Bay County to determine the efficacy of 'C-it DU-it' intervention (data use arm) to increase ANC contacts when compared to the 'C-it' enhanced standard of care (control arm).

Implementation and Evaluation of Tailored Interventions to Increase MMR and/or HPV Vaccine

The goal of the study is to monitor and evaluate the implementation of interventions that aim to increase HPV \& MMR vaccines among underserved communities across four European countries: Greece, Netherlands, Poland, and Slovakia. The interventions will target identified health systems barriers in an earlier phase of the project. The interventions that will be implemented employ trusted community members as health promotors whom will provide educational sessions on HPV and MMR vaccination to the target groups. In addition, the cost-effectiveness of vaccine uptake strategies for the target groups is being evaluated. The main research question is: to what extent is the multicomponent tailored intervention effective to increase MMR/HPV intention and vaccine uptake in the target population in Greece, Netherlands, Poland and Slovakia?