Strengthening Actions for Menstrual Health and Hygiene Interventions for Promotion of Women's Health in Nepal (SAMIP): Protocol for a Participatory Intervention Development Study Using Realist Synthesis, Human-Centered Design, Intervention Mapping, and Arts-Based Methods.

Background: Menstrual restrictions remain widespread in Nepal, where approximately 90% of women and girls follow at least one restriction. One of the most harmful practices, chhaupadi (severe menstrual seclusion), requires women and girls to isolate in huts during menstruation and is associated with substantial physical and psychological risks, including injury, assault, smoke inhalation, and social exclusion. Although interventions have attempted to address chhaupadi, effectiveness has varied, and no comprehensive assessment has identified which components work, for whom, and under what conditions. Few prior efforts have meaningfully engaged communities in intervention design to ensure contextual relevance and sustainability. Objective: This protocol describes a three-aim study designed to (1) elucidate mechanisms underlying the success or failure of chhaupadi interventions; (2) co-design a culturally grounded, theory- and evidence-informed intervention in partnership with communities; and (3) pilot and evaluate the intervention using a controlled trial design. Methods: This multiphase study integrates realist synthesis, intervention mapping, human-centered design, and arts-based research. In aim 1, we will conduct a realist synthesis of published and gray literature, complemented by knowledge-sharing workshops and expert interviews to identify underlying mechanisms explaining chhaupadi intervention success or failure. In aim 2, synthesis findings will inform participatory intervention development. Using the intervention mapping framework, we will convene a co-design workshop incorporating human-centered design and arts-based research methods (eg, asset mapping, impact ladder, concept posters, and communal storytelling) with women, adolescents, and community collaborators to develop intervention components and implementation strategies. In aim 3, the co-designed intervention will be piloted in a controlled trial comparing intervention communities (full community-designed intervention) with control communities (menstrual health education only). Quantitative measures will assess knowledge, attitudes, and practices related to chhaupadi, self-efficacy, mental health, and reproductive health outcomes. Implementation indicators (eg, enrollment, acceptability, appropriateness, and feasibility) will also be assessed. Qualitative interviews and discussions will examine implementation processes, barriers, facilitators, and contextual influences. Results: The study was funded in September 2023. Aim 1 activities began in April 2024. To date, 69 materials met the inclusion criteria, and a workshop with 8 organizations and 44 interviews has been conducted. Analysis was completed in February 2026, with results expected in the summer of 2026. Aim 2 co-design workshops began in March 2025; eleven women participated in the workshop, and an additional 123 community members have been consulted. This has resulted in a draft intervention called "Our Voice: Transforming Lives through Ending Chhaupadi." Aim 2 results are expected in Fall 2026. Aim 3 data collection will begin in Winter 2027. Conclusions: By systematically identifying effective intervention mechanisms and embedding community leadership throughout design and implementation, this study aims to develop a sustainable strategy to reduce harms associated with chhaupadi and improve women's and girls health. This integrated framework may also inform interventions addressing other socially embedded health practices in low-resource settings.