Although multiple studies have offered self-collection for human papillomavirus (HPV)-based cervical screening in community settings, there are no randomised controlled trials (RCTs) that have compared implementation outcomes of programme approaches for self-collection. This trial will compare two such approaches in low-resource settings in the states of Tamil Nadu and Mizoram, India.

A cluster RCT will be conducted over a year, offering self-collection to 3000 women aged 30–49 from 28 clusters (average size 101) in selected districts. Clusters in tribal, rural and urban low-income settings will be randomised to two arms. The intervention arm, co-designed with multiple stakeholders, will involve campaigns to offer self-collection in the community. The comparison arm will be offered self-collection at the nearest health facilities.

HPV-based cervical screening will be performed at central laboratories using clinically validated screening assays that can identify the highest risk carcinogenic HPV types (Group 1a–c - HPV16/18/31/33/45/52/58, ±35). Ablative treatment will be based on positivity with this extended genotyping triage, while those with any of the lower carcinogenic HPV types (Group 1d - 39, 51, 56, 59, ±35, Groups 2a/b - 66, 68) will undergo further assessment with visual inspection with acetic acid. Outcomes will be evaluated quantitatively and qualitatively using RE-AIM and the Theoretical Framework of Acceptability.

The primary outcome will be percentage of women well-managed (screened and appropriately treated) in both arms, with secondary outcomes including proportion screened, proportion treated, acceptability (willingness to screen, rescreen, and/or recommend to others) to women, community and healthcare providers, adoption (by providers), implementation fidelity, costs, sustainability assessment and systematically identified implementation barriers and facilitators. The reach, effectiveness and acceptability of community-based self-collection and the use of extended genotyping for triage in resource-constrained, hard-to-reach populations will be assessed, with lessons that can inform future statewide and national programmes.

Ethics approval has been obtained from the Institutional Review Board (IRB) and Ethics Committee of the Christian Medical College Vellore, Tamil Nadu, India (IRB Min. No 14314; INTERVEN), the Alfred Hospital Ethics Committee (HREC Ref 80134, Local Reference: project 601/21), Melbourne, Australia, the IARC Ethics Committee (IEC 21-32), Lyon, France, the Salem Polyclinic Institutional Ethics Committee (SPCIEC/2022/June/01/02), Tamil Nadu, India and the Institutional Ethics Committee, Civil Hospital, Aizawl, Mizoram, India (No.B.12018/1/13-CHA(A)/IEC/115). The study is also approved by the State Scientific Advisory Committee, Directorate of Public Health and Preventive Medicine, Chennai, Tamil Nadu (R. No. 011575/HEB/A2/2023). The Alfred Hospital Approval, as an authorised Australian ethics committee for national mutual recognition, is recognised and registered with the University of Melbourne Human Research Ethics Committee (2024-25255-57650-1). Written informed consent will be obtained from participants. The results of the trial will be disseminated through a peer-reviewed medical journal, and also through workshops, reports and conferences.

The trial has been registered with the Clinical Trials Registry - India: CTRI/2022/04/042327.

The healthcare sector has significant environmental impacts, particularly through greenhouse gas emissions. Reducing its climate footprint is therefore essential for achieving political goals such as net-zero and climate-friendly healthcare. While health economic evaluation (HEE) methods compare the costs and consequences of two or more interventions, these analyses rarely consider climate impacts. Some studies have begun to determine climate impacts parallel to or integrated into HEEs. Life cycle assessment (LCA) could be used to integrate climate impacts by considering these results as effects or monetised climate footprints. However, a reporting standard is needed for using these climate-extended economic evaluations in evidence-based decision-making. This protocol describes using an online Delphi process to incorporate climate impacts into the Consolidated Health Economic Evaluation Reporting Standard (CHEERS), called CHEERS Climate Extension (CHEERS ClimatE).

The development of CHEERS ClimatE will proceed through five key stages. First, the preliminary steering group develops in consultation with an advisory board a proposal for the CHEERS ClimatE reporting standard based on a transparency checklist that combines three standards for carbon footprint calculations into the CHEERS framework. The mapping was complemented by reviewing studies that incorporate climate impacts in HEE. Second, for the Delphi process, international experts in HEE and LCA with at least one year of academic experience will be invited to participate in an online pre-survey. We aim to recruit at least 40 participants. Expecting various drop-outs, we aim to reach a consensus with at least 20 participants per Delphi round. Third, an expected three-round Delphi process will be conducted to validate and refine the proposed elements. Participants will rate each item using a 9-point Likert scale and will have the opportunity to comment on each item and propose new items. Consensus is defined with the target of a 70% agreement. Unless consensus is reached, a moderated video conference may be held as a fourth round. Fourth, following other CHEERS extensions, the consented checklist will be piloted using thematically relevant case studies. While substantial changes are not anticipated, minor revisions to individual items may be considered and ratified by the steering group and advisory board. The fifth stage is the publication of the final checklist.

This study has been approved by the ethics committee of the University of Bremen (2024–25). The findings of the Delphi study will be published in a peer-reviewed journal and presented at conferences.

Amoxicillin is recommended for children with uncomplicated severe acute malnutrition (SAM). However, some trials have shown no difference in amoxicillin for nutritional recovery in children with SAM compared with placebo. In addition, amoxicillin treatment requires two times per day dosing for 7 days, which may influence adherence. Azithromycin is a broad-spectrum antibiotic that can be provided as a single dose and has reduced mortality in children aged 1–59 months when provided by mass drug administration. The AMOUR trial is designed to assess amoxicillin, azithromycin and placebo as part of outpatient treatment of uncomplicated SAM.

This double-masked randomised controlled trial will enrol 3000 children over 3 years in an individually randomised 1:1:1 allocation to azithromycin, amoxicillin or placebo arms and follow them for 12 months. Children eligible to enrol in the study will be aged 6–59 months and have uncomplicated non-oedematous SAM as defined by weight-for-height Z-score

Ethical approval was obtained from the Institutional Review Board at the University of California, San Francisco (Protocol 23–39411) and the Comité d’Ethique pour la Recherche en Santé in Ouagadougou, Burkina Faso (Protocol 2024-01-08). The results of this study will be disseminated to the Ministry of Health, community stakeholders and via peer-reviewed publications and academic conferences.

NCT06010719.