Impact evaluation of the Care Tipping Point Initiative in Nepal: study protocol for a mixed-methods cluster randomised controlled trial.

introductionGirl child, early and forced marriage (CEFM) persists in South Asia, with long-term consequences for girls. CARE's Tipping Point Initiative (TPI) addresses the causes of CEFM by challenging repressive gender norms and inequalities. The TPI engages different participant groups on programmatic topics and supports community dialogue to build girls' agency, shift inequitable power relations, and change community norms sustaining CEFM. METHODS/ANALYSIS: The Nepal TPI impact evaluation has an integrated, mixed-methods design. The quantitative evaluation is a three-arm, cluster randomised controlled trial (control; Tipping Point Programme (TPP); TPP+ with emphasised social norms change). Fifty-four clusters of ~200 households were selected from two districts (27:27) with probability proportional to size and randomised. A household census ascertained eligible study participants, including unmarried girls and boys 12-16 years (1242:1242) and women and men 25+ years (270:270). Baseline participation was 1134 girls, 1154 boys, 270 women and 270 men. Questionnaires covered agency; social networks/norms; and discrimination/violence. Thirty in-depth interviews, 8 key-informant interviews and 32 focus group discussions were held across eight TPP/TPP+ clusters. Guides covered gender roles/aspirations; marriage decisions; girls' safety/mobility; collective action; perceived shifts in child marriage; and norms about girls. Monitoring involves qualitative interviews, focus groups and session/event observations over two visits. Qualitative analyses follow a modified grounded theory approach. Quantitative analyses apply intention to treat, regression-based difference-in-difference strategies to assess impacts on primary (married, marriage hazard) and secondary outcomes, targeted endline tracing and regression-based methods to address potential selection bias. ETHICS/DISSEMINATION: The Nepal Social Welfare Council approved CARE Nepal to operate in the study districts. Emory (IRB00109419) and the Nepal Health Research Council (161-2019) approved the study. We follow UNICEF and CARE guidelines for ethical research involving children and gender-based violence. Study materials are here or available on request. We will share findings through clinicaltrials.gov, CARE reports/briefs and publications. TRIAL REGISTRATION NUMBER: NCT04015856.