Nigeria has the highest number of maternal deaths globally, and maternal peripartum sepsis is one of the leading causes of maternal mortality. A single oral dose of azithromycin (AZM; 2 g) is safe and effectively reduces 33%–60% of maternal sepsis during planned vaginal birth in low- and middle-income countries (LMICs). However, the clinical and cost-effectiveness of oral AZM during vaginal birth in Nigeria remains unknown in the context of poor antimicrobial stewardship practices, significant antimicrobial resistance and healthcare financing. Evidence is also lacking on the standard care for the prevention of maternal sepsis among pregnant women undergoing vaginal births in Nigeria. The AZIN-V trial is a hybrid type 2 effectiveness-implementation trial to determine the safety, clinical and cost-effectiveness of intrapartum oral AZM versus usual care in the prevention of peripartum maternal sepsis. The trial will also examine the impact of implementation strategies in enhancing adherence to the oral AZM protocol during planned vaginal births and identify effective strategies to improve adherence (fidelity) to the protocol in real-world LMIC settings.

This is a multicentre hybrid type 2 trial conducted in six Nigerian states: Ebonyi, Edo, Gombe, Kano, Kwara and Lagos. The study aims to simultaneously test the clinical and cost-effectiveness of AZM (clinical trial) and the impact of implementation strategies (implementation research) in Nigeria’s unique healthcare context. The clinical trial is a two-arm, cluster-randomised controlled trial conducted across 48 health facilities, randomly assigned (1:1) to either intrapartum administration of oral AZM (intervention group) or usual care—the current routine practice (control group). A total of 5040 study participants (2520 in each group) will be enrolled in the clinical trial. The implementation trial is a two-arm cluster non-randomised controlled trial conducted in 12 health facilities (1:1) allocated to either a bottom-up approach using the Plan-Do-Study-Act cycle or a usual top-down approach with a one-time training workshop and distribution of clinical guidelines, with both arms administering oral AZM during vaginal birth while assessing fidelity (primary outcome).

For the clinical trial, data will be analysed using intention-to-treat statistical methods. The cost-effectiveness outcome will be analysed using the Incremental Cost-Effectiveness Ratio. Implementation outcomes will be analysed using descriptive statistics and a thematic approach.

This study has been approved by the National Health Research Ethics Committee, Nigeria (NHREC/01/01/2007-30/09/2024), the ethics committees of the participating health institutions (Lagos University Teaching Hospital Research Ethics Committee: ADM/DSCST/HREC/APP/6325; University of Ilorin Teaching Hospital Health Research Ethics Committee: ERC/PAN/2025/03/0581; University of Benin Teaching Hospital Health Research Ethics Committee: ADM/E22/A/VOL. VII/483117141; Aminu Kano Teaching Hospital Research Ethics Committee: AKTH/MAC/SUB/12 A/P-3/VI/2509 and Irrua Specialist Teaching Hospital Research Ethics Committee: ISTH/HREC/20241507/605), the Ministries of Health of the six states and the National Agency for Food and Drug Administration and Control. Written informed consent will be obtained from all eligible study participants before enrolment. Results will be shared with communities and policy stakeholders and through peer-reviewed journals and will be presented at conferences.

ISRCTN16415327.

Patient-centred care (PCC) is associated with better experiences for chronic care encounters and better outcomes. However, its assessment and resultant management outcomes have not been well documented in Malawi. As Malawi strives to institutionalise PCC in its quality-of-care initiatives, documenting its correlates and outcomes is a good starting point in the implementation and advocacy of PCC among chronic care patients, particularly those living with diabetes mellitus (DM).

We sought to assess the level of diabetic patients’ perception of PCC and its relationship to self-efficacy, adherence and glycaemic control among patients with DM.

This study was done in DM clinics of two district and two central hospitals in southern Malawi.

This was a cross-sectional analytical study. We studied 607 subsequent consenting adult patients with DM. We assessed the level of perception of using a locally generated and validated tool and its correlation with self-efficacy, adherence and long-term glycaemic control after a medical encounter. We used K-means clustering, linear and logistic regression, and path analysis in the analysis.

The study’s outcome measures included adherence, self-efficacy, long-term glycaemic control. Adherence included aspects related to medication, diet, lifestyle and appointment keeping and was assessed using the Hill-Bone tool. Self-efficacy was assessed using a Stanford self-efficacy tool while long-term glycaemic control was determined through haemoglobin A1c (HbA1c) point-of-care testing.

Overall, the mean score for PCC was 62.86 (SD 14.78). The study highlighted two groups of patients with statistically distinct mean scores of 51.6 (7.8) vs 77.1 (7.2) out of a possible 92 (p

Although this study did not find a direct correlation between PCC and glycaemic control, it has demonstrated that PCC medical encounters could potentially improve glycaemic control by enhancing patients’ adherence to their diabetes management plans. Even though PCC is not an end in itself, medical encounters that prioritise good relational ambience, patient involvement and capacitation are promising interventions in DM care, especially for patients with or at risk of DM complications. The general lack of patient individualisation and involvement elements found in the medical encounters in our study could explain why PCC hardly has an impact on self-efficacy. The study highlights the importance of PCC in DM patient management and outlines important innovative adaptations towards transforming medical education to equip and appraise interpersonal skills that have an impact on patient-reported experiences and outcomes.