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      Community-based implementation and effectiveness in a randomized trial of a risk reduction intervention for HIV-serodiscordant couples: study protocol

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          Abstract

          Background

          The HIV/AIDS epidemic continues to disproportionately affect African American communities in the US, particularly those located in urban areas. Despite the fact that HIV is often transmitted from one sexual partner to another, most HIV prevention interventions have focused only on individuals, rather than couples. This five-year study investigates community-based implementation, effectiveness, and sustainability of ‘Eban II,’ an evidence-based risk reduction intervention for African-American heterosexual, serodiscordant couples.

          Methods/design

          This hybrid implementation/effectiveness implementation study is guided by organizational change theory as conceptualized in the Texas Christian University Program Change Model (PCM), a model of phased organizational change from exposure to adoption, implementation, and sustainability. The primary implementation aims are to assist 10 community-based organizations (CBOs) to implement and sustain Eban II; specifically, to partner with CBOs to expose providers to the intervention; facilitate its adoption, implementation and sustainment; and to evaluate processes and determinants of implementation, effectiveness, fidelity, and sustainment. The primary effectiveness aim is to evaluate the effect of Eban II on participant (n = 200 couples) outcomes, specifically incidents of protected sex and proportion of condom use. We will also determine the cost-effectiveness of implementation, as measured by implementation costs and potential cost savings. A mixed methods evaluation will examine implementation at the agency level; staff members from the CBOs will complete baseline measures of organizational context and climate, while key stakeholders will be interviewed periodically throughout implementation. Effectiveness of Eban II will be assessed using a randomized delayed enrollment (waitlist) control design to evaluate the impact of treatment on outcomes at posttest and three-month follow-up. Multi-level hierarchical modeling with a multi-level nested structure will be used to evaluate the effects of agency- and couples-level characteristics on couples-level outcomes ( e.g., condom use).

          Discussion

          This study will produce important information regarding the value of the Eban II program and a theory-guided implementation process and tools designed for use in implementing Eban II and other evidence-based programs in demographically diverse, resource-constrained treatment settings.

          Trial registration

          NCT00644163

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          Most cited references37

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          Estimation of HIV incidence in the United States.

          Incidence of human immunodeficiency virus (HIV) in the United States has not been directly measured. New assays that differentiate recent vs long-standing HIV infections allow improved estimation of HIV incidence. To estimate HIV incidence in the United States. Remnant diagnostic serum specimens from patients 13 years or older and newly diagnosed with HIV during 2006 in 22 states were tested with the BED HIV-1 capture enzyme immunoassay to classify infections as recent or long-standing. Information on HIV cases was reported to the Centers for Disease Control and Prevention through June 2007. Incidence of HIV in the 22 states during 2006 was estimated using a statistical approach with adjustment for testing frequency and extrapolated to the United States. Results were corroborated with back-calculation of HIV incidence for 1977-2006 based on HIV diagnoses from 40 states and AIDS incidence from 50 states and the District of Columbia. Estimated HIV incidence. An estimated 39,400 persons were diagnosed with HIV in 2006 in the 22 states. Of 6864 diagnostic specimens tested using the BED assay, 2133 (31%) were classified as recent infections. Based on extrapolations from these data, the estimated number of new infections for the United States in 2006 was 56,300 (95% confidence interval [CI], 48,200-64,500); the estimated incidence rate was 22.8 per 100,000 population (95% CI, 19.5-26.1). Forty-five percent of infections were among black individuals and 53% among men who have sex with men. The back-calculation (n = 1.230 million HIV/AIDS cases reported by the end of 2006) yielded an estimate of 55,400 (95% CI, 50,000-60,800) new infections per year for 2003-2006 and indicated that HIV incidence increased in the mid-1990s, then slightly declined after 1999 and has been stable thereafter. This study provides the first direct estimates of HIV incidence in the United States using laboratory technologies previously implemented only in clinic-based settings. New HIV infections in the United States remain concentrated among men who have sex with men and among black individuals.
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            National Institutes of Health approaches to dissemination and implementation science: current and future directions.

            To address the vast gap between current knowledge and practice in the area of dissemination and implementation research, we address terminology, provide examples of successful applications of this research, discuss key sources of support, and highlight directions and opportunities for future advances. There is a need for research testing approaches to scaling up and sustaining effective interventions, and we propose that further advances in the field will be achieved by focusing dissemination and implementation research on 5 core values: rigor and relevance, efficiency, collaboration, improved capacity, and cumulative knowledge.
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              Issues in disseminating and replicating effective prevention programs.

              The new frontier for prevention research involves building a scientific knowledge base on how to disseminate and implement effective prevention programs with fidelity. Toward this end, a brief overview of findings from the Blueprints for Violence Prevention-Replication Initiative is presented, identifying factors that enhance or impede a successful implementation of these programs. Findings are organized around five implementation tasks: site selection, training, technical assistance, fidelity, and sustainability. Overall, careful attention to each of these tasks, together with an independent monitoring of fidelity, produced a successful implementation with high fidelity and sustainability. A discussion of how these findings inform the present local adaptation-fidelity debate follows.
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                Author and article information

                Contributors
                Journal
                Implement Sci
                Implement Sci
                Implementation Science : IS
                BioMed Central
                1748-5908
                2014
                20 June 2014
                : 9
                : 79
                Affiliations
                [1 ]UCLA Department of Psychiatry and Biobehavioral Sciences, 760 Westwood Plaza, 38-240 NPI, Box 175919, 90024-1759 Los Angeles, CA, USA
                [2 ]VA Greater Los Angeles Healthcare System, 16111 Plummer Street, 91343 Sepulveda, CA, USA
                [3 ]UCLA Department of Medicine, 760 Westwood Plaza, 90024-1759 Los Angeles, CA, USA
                Article
                1748-5908-9-79
                10.1186/1748-5908-9-79
                4085467
                24950708
                ba352087-341b-4bfb-ac54-4e29a3473424
                Copyright © 2014 Hamilton et al.; licensee BioMed Central Ltd.

                This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

                History
                : 19 March 2014
                : 11 June 2014
                Categories
                Study Protocol

                Medicine
                implementation science,hybrid design,hiv prevention,serodiscordance,couples,african americans,behavioral intervention,sustainability

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