A Methodology for Assessing the Impact of Nutritional Supplementation on Pregnancy Outcomes in HIV-Positive Women in Tigray, Ethiopia

HIV-positive pregnant women in sub-Saharan Africa face heightened risks of adverse pregnancy outcomes, exacerbated by undernutrition. The Tigray Region of Ethiopia has a high prevalence of both HIV and food insecurity. Robust evidence on the efficacy of integrated nutritional support within antenatal care for this population is limited. This methodology article details the design of a study to assess the impact of a six-month nutrition supplementation programme on pregnancy outcomes among HIV-positive women in Tigray. The primary objective is to evaluate the programme's effect on birth weight, gestational age at delivery, and maternal nutritional status. A quasi-experimental, longitudinal design with a comparison group is employed. HIV-positive pregnant women are recruited from selected health centres and allocated to intervention or standard care groups based on centre. The intervention comprises a six-month supplementation of fortified blended food and micronutrients. Data collection includes anthropometric measurements, dietary surveys, clinical records abstraction, and birth outcome assessment. Mixed-effects regression models will analyse outcomes while controlling for confounders. As a methodology article, this paper presents the study design and protocols, not empirical results. Preliminary pilot data indicated feasibility of recruitment and high participant adherence. The described methodology provides a rigorous framework for evaluating a critical public health intervention. It is designed to generate actionable evidence on integrating nutritional support into antenatal care for HIV-positive women in a resource-limited setting. Researchers undertaking similar evaluations should consider context-specific dietary practices and ensure strong collaboration with local health services for participant follow-up. Future studies could adapt this design to include cost-effectiveness analyses. maternal health, HIV, pregnancy outcomes, nutritional supplementation, methodology, Ethiopia, antenatal care This article provides a detailed methodological blueprint for assessing nutrition interventions in a vulnerable obstetric population. It contributes to the field by outlining a pragmatic, contextually adapted study design suitable for resource-limited settings with a high burden of HIV and undernutrition.