Implementation of an efficacious intervention for high risk women in Mexico: protocol for a multi-site randomized trial with a parallel study of organizational factors

<p>Abstract</p> <p>Background</p> <p>Studies of implementation of efficacious human immunodeficiency virus (HIV) prevention interventions are rare, especially in resource-poor settings, but important, because they have the potential to increase the impact of interventions by improving uptake and sustainability. Few studies have focused on provider and organizational factors that may influence uptake and fidelity to core intervention components. Using a hybrid design, we will study the implementation of an efficacious intervention to reduce sexually transmitted infections (STIs) among female sex workers (FSWs) in 12 cities across Mexico. Our protocol will test a ‘train-the-trainer’ implementation model for transporting the Mujer Segura (Healthy Woman) intervention into community-based organizations (CBOs).</p> <p>Methods</p> <p>We have partnered with Mexican Foundation for Family Planning (Mexfam), a non-governmental organization that has CBOs throughout Mexico. At each CBO, trained ethnographers will survey CBO staff on characteristics of their organization and on their attitudes toward their CBO and toward the implementation of evidence-based interventions (EBIs). Then, after CBO staff recruit a sample of 80 eligible FSWs and deliver a standard-care, didactic intervention to 40 women randomly selected from that pool, a Mexfam staff person will be trained in the Mujer Segura intervention and will then train other counselors to deliver Mujer Segura to the 40 remaining participating FSWs. FSW participants will receive a baseline behavioral assessment and be tested for HIV and STIs (syphilis, gonorrhea, and chlamydia); they will be reassessed at six months post-intervention to measure for possible intervention effects. At the same time, both qualitative and quantitative data will be collected on the implementation process, including measures of counselors’ fidelity to the intervention model. After data collection at each CBO is complete, the relative efficacy of the Mujer Segura intervention will be analyzed, and across CBOs, correlations will be examined between individual and organizational provider characteristics and intervention efficacy.</p> <p>Discussion</p> <p>This cooperative, bi-national research study will provide critical insights into barriers and facilitating factors associated with implementing interventions in CBOs using the ‘train the trainer’ model. Our work builds on similar scale-up strategies that have been effective in the United States. This study has the potential to increase our knowledge of the generalizability of such strategies across health issues, national contexts, and organizational contexts.</p> <p>Trial registration</p> <p>NCT01465607</p

Mixed-method study of a conceptual model of evidence-based intervention sustainment across multiple public-sector service settings

BACKGROUND: This study examines sustainment of an EBI implemented in 11 United States service systems across two states, and delivered in 87 counties. The aims are to 1) determine the impact of state and county policies and contracting on EBI provision and sustainment; 2) investigate the role of public, private, and academic relationships and collaboration in long-term EBI sustainment; 3) assess organizational and provider factors that affect EBI reach/penetration, fidelity, and organizational sustainment climate; and 4) integrate findings through a collaborative process involving the investigative team, consultants, and system and community-based organization (CBO) stakeholders in order to further develop and refine a conceptual model of sustainment to guide future research and provide a resource for service systems to prepare for sustainment as the ultimate goal of the implementation process. METHODS: A mixed-method prospective and retrospective design will be used. Semi-structured individual and group interviews will be used to collect information regarding influences on EBI sustainment including policies, attitudes, and practices; organizational factors and external policies affecting model implementation; involvement of or collaboration with other stakeholders; and outer- and inner-contextual supports that facilitate ongoing EBI sustainment. Document review (e.g., legislation, executive orders, regulations, monitoring data, annual reports, agendas and meeting minutes) will be used to examine the roles of state, county, and local policies in EBI sustainment. Quantitative measures will be collected via administrative data and web surveys to assess EBI reach/penetration, staff turnover, EBI model fidelity, organizational culture and climate, work attitudes, implementation leadership, sustainment climate, attitudes toward EBIs, program sustainment, and level of institutionalization. Hierarchical linear modeling will be used for quantitative analyses. Qualitative analyses will be tailored to each of the qualitative methods (e.g., document review, interviews). Qualitative and quantitative approaches will be integrated through an inclusive process that values stakeholder perspectives. DISCUSSION: The study of sustainment is critical to capitalizing on and benefiting from the time and fiscal investments in EBI implementation. Sustainment is also critical to realizing broad public health impact of EBI implementation. The present study takes a comprehensive mixed-method approach to understanding sustainment and refining a conceptual model of sustainment. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/s13012-014-0183-z) contains supplementary material, which is available to authorized users