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Background  Poverty and lack of a predictable, stable source of food are two fundamental determinants of ill health, including HIV/AIDS. Conversely, episodes of poor health and death from HIV can disrupt the ability to maintain economic stability in affected households, especially those that rely on subsistence farming. However, little empirical research has examined if, and how, improvements in people’s economic status and food security translate into changes in HIV vulnerability.    Methods  In this paper, we describe in detail the methods and protocol of an academic-NGO collaboration on a quasi-experimental, longitudinal study of the mechanisms and magnitude of the impact of a multilevel economic and food security program (Support to Able-Bodied Vulnerable Groups to Achieve Food Security; SAFE), as implemented by CARE. Primary outcomes include HIV vulnerability (i.e., HIV risk behaviors, HIV infection), economic status (i.e., income, household assets) and food security (including anthropometric measures). We recruited participants from two types of areas of rural central Malawi: traditional authorities (TA) selected by CARE to receive the SAFE program (intervention group) and TAs receiving other unrelated CARE programming (controls). In the intervention TAs, we recruited 598 program participants (398 women, 200 men) and interviewed them at baseline and 18- and 36-month follow-ups; we interviewed 301 control households. In addition, we conducted random surveys (n = 1002) in the intervention and control areas with a 36-month assessment interval, prior to and after implementation of SAFE. Thus, we are examining intervention outcomes both in direct SAFE program participants and their larger communities. We are using multilevel modeling to examine mediators and moderators of the effects of SAFE on HIV outcomes at the individual and community levels and determine the ways in which changes in HIV outcomes feed back into economic outcomes and food security at later interviews. Finally, we are conducting a qualitative end-of-program evaluation consisting of in-depth interviews with 90 SAFE participants.    Discussion  In addition to examining pathways linking structural factors to HIV vulnerability, this research will yield important information for understanding the impact of a multilevel environmental/structural intervention on HIV, with the potential for other sustainable long-term public health benefits.

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Methods and protocol of a mixed method quasi-experiment to evaluate the effects of a structural economic and food security intervention on HIV vulnerability in rural Malawi: The SAGE4Health Study