To identify stakeholder perceived challenges and facilitators for implementing a clean fuel and clean stove intervention to reduce household air pollution and hypertension in Lagos, Nigeria.

Qualitative study guided by the Exploration and Preparation phases of the Exploration, Preparation, Implementation, and Sustainment (EPIS) framework, using focus group discussions and in-depth semi-structured interviews with inductive and deductive thematic analysis.

Peri-urban communities across the five administrative divisions of Lagos State, Nigeria.

128 stakeholders from 32 communities, including community, religious, market and youth leaders, primary healthcare staff, and household decision makers. Approximately half were female.

This was a pre-implementation needs assessment that included demonstrations of the clean stove and fuel.

Thematic domains describing barriers and enablers to adoption and implementation, mapped to EPIS inner, outer, and bridging factors.

Stakeholders reported barriers that included stove stacking, upfront stove cost, concerns about long-term fuel price and availability, equipment durability and maintenance, safety, mistrust of new technology, and uncertainty about stove performance for dishes requiring high heat and long cooking times. Reported facilitators included payment flexibility and subsidies, opportunities to test the stove, perceived benefits of cleaner and faster cooking with less soot, endorsement by community leaders, and interest in local retail and distribution to improve access.

Implementation planning for clean fuel and clean stove programmes should address affordability, reliable fuel supply chains, durability and service, culturally relevant cooking needs, and trust building through community leadership. These findings inform adaptation strategies for scale-up in similar low-resource settings.

NCT05048147.

To understand the regulatory landscape in the UK and globally before the introduction of the Medicines and Healthcare Products Regulatory Agency’s (MHRA) International Recognition Procedure (IRP). This paper aims to inform on the IRP’s potential impact on access to innovative medicines, by comparing medicines approval in the UK with other international regulatory agencies.

A retrospective analysis of 154 technologies (medicine(s) + studied indication(s)) was conducted based on the National Institute for Health and Care Research Innovation Observatory technology briefings submitted to the National Institute for Health and Care Excellence (NICE) in 2020. These briefings serve as the trigger for the NICE Technology Assessment process. Data on the medicines’ submission and approval dates were extracted across five IRP reference regulators, which are the regulators from the US (Food and Drug Administration (FDA)), European Union (EU) (European Medicines Agency (EMA)), Japan (Pharmaceuticals and Medical Devices Agency (PMDA)), Australia (Therapeutic Goods Administration (TGA)) and Singapore (Health Science Authority (HSA)). The dates were compared with data from the UK (MHRA).

95 (62%) medicines were approved by at least one regulatory agency, while 59 (38%) medicines were not approved by any regulatory agency. The number of medicines approved by the following regulatory agencies is FDA (n=84, 55%), EMA (n=80, 52%), MHRA (n=71, 46%), TGA (n=51, 33%), HSA (n=41, 27%) and PMDA (n=38, 25%). The first submissions were primarily to the FDA (n=64) or the EMA (n=24). The FDA had the highest number of first approvals (n=70), followed by the EMA (n=17), PMDA (n=5) and the MHRA (n=1). The FDA used more expedited pathways than other regulators (n=61). Compared with the MHRA, FDA approvals were on average 360 days faster and EMA approvals 86 days faster.

There were significant differences in market access timelines across the five reference regulators, with the FDA and EMA having the highest number of approved medicines, first submissions and first approvals. IRP applications with the FDA or EMA as reference regulators may expedite access to innovative medicines in the UK by reducing the approval dates gap between the FDA/EMA and the MHRA. This understanding of the regulatory landscape will help inform future planning to accommodate the disruption that the IRP may cause.

In Africa, 75% of households are exposed to household air pollution (HAP), a key contributor to cardiovascular disease (CVD). In Nigeria, 90 million households rely on solid fuels for cooking, and 40% of adults have hypertension. Though clean fuel and clean stove (CF-CS) technologies can reduce HAP and CVD risk, their adoption in Africa remains limited.

Using the Exploration, Preparation, Implementation and Sustainment framework, this cluster-randomised controlled trial evaluates the implementation and effectiveness of a community mobilisation (CM) strategy versus a self-directed condition (i.e., receipt of information on CF-CS use without CM) on adoption of CF-CS technologies and systolic blood pressure (SBP) reduction among 1248 adults from 624 households across 32 peri-urban communities in Lagos, Nigeria. The primary outcome is CF-CS adoption at 12 months; secondary outcomes are SBP reduction at 12 months and sustainability of CF-CS use at 24 months. Adoption is assessed via objective monitoring of stove usage with temperature-triggered iButton sensors. SBP is assessed in 2 adults per household using validated automated blood pressure monitor. Generalised linear mixed-effects regression models will be used to assess study outcomes, accounting for clustering at the level of the peri-urban communities (unit of randomisation) and households. To date, randomisation is completed, and a total of 1248 households have enrolled in the study. The final completion of the study is expected in June 2026.

The study was approved by the Institutional Review Boards (IRB) of NYU Grossman School of Medicine (primary IRB of record; protocol ID: i21-00586; Version 6.0 approved on 4 June 2024), and Lagos State University Teaching Hospital (protocol ID: LREC 06/10/1621). Written consent was obtained from all participants. Findings will inform scalable and culturally appropriate strategies for reducing HAP and CVD risk in low-resource settings. Results will be disseminated through peer-reviewed publications, conference presentations and stakeholder engagements.

NCT05048147