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      Rapid start antiretroviral therapies for improved engagement in HIV care: implementation science evaluation protocol

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          Abstract

          Background

          In 2020, the Health Resources and Services Administration’s HIV/AIDS Bureau funded an initiative to promote implementation of rapid antiretroviral therapy initiation in 14 HIV treatment settings across the U.S. The goal of this initiative is to accelerate uptake of this evidence-based strategy and provide an implementation blueprint for other HIV care settings to reduce the time from HIV diagnosis to entry into care, for re-engagement in care for those out of care, initiation of treatment, and viral suppression. As part of the effort, an evaluation and technical assistance provider (ETAP) was funded to study implementation of the model in the 14 implementation sites.

          Method

          The ETAP has used implementation science methods framed by the Dynamic Capabilities Model integrated with the Conceptual Model of Implementation Research to develop a Hybrid Type II, multi-site mixed-methods evaluation, described in this paper. The results of the evaluation will describe strategies associated with uptake, implementation outcomes, and HIV-related health outcomes for patients.

          Discussion

          This approach will allow us to understand in detail the processes that sites to implement and integrate rapid initiation of antiretroviral therapy as standard of care as a means of achieving equity in HIV care.

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          Most cited references46

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          Antiretroviral Therapy for the Prevention of HIV-1 Transmission.

          An interim analysis of data from the HIV Prevention Trials Network (HPTN) 052 trial showed that antiretroviral therapy (ART) prevented more than 96% of genetically linked infections caused by human immunodeficiency virus type 1 (HIV-1) in serodiscordant couples. ART was then offered to all patients with HIV-1 infection (index participants). The study included more than 5 years of follow-up to assess the durability of such therapy for the prevention of HIV-1 transmission.
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            Psychometric assessment of three newly developed implementation outcome measures

            Background Implementation outcome measures are essential for monitoring and evaluating the success of implementation efforts. Yet, currently available measures lack conceptual clarity and have largely unknown reliability and validity. This study developed and psychometrically assessed three new measures: the Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), and Feasibility of Intervention Measure (FIM). Methods Thirty-six implementation scientists and 27 mental health professionals assigned 31 items to the constructs and rated their confidence in their assignments. The Wilcoxon one-sample signed rank test was used to assess substantive and discriminant content validity. Exploratory and confirmatory factor analysis (EFA and CFA) and Cronbach alphas were used to assess the validity of the conceptual model. Three hundred twenty-six mental health counselors read one of six randomly assigned vignettes depicting a therapist contemplating adopting an evidence-based practice (EBP). Participants used 15 items to rate the therapist’s perceptions of the acceptability, appropriateness, and feasibility of adopting the EBP. CFA and Cronbach alphas were used to refine the scales, assess structural validity, and assess reliability. Analysis of variance (ANOVA) was used to assess known-groups validity. Finally, half of the counselors were randomly assigned to receive the same vignette and the other half the opposite vignette; and all were asked to re-rate acceptability, appropriateness, and feasibility. Pearson correlation coefficients were used to assess test-retest reliability and linear regression to assess sensitivity to change. Results All but five items exhibited substantive and discriminant content validity. A trimmed CFA with five items per construct exhibited acceptable model fit (CFI = 0.98, RMSEA = 0.08) and high factor loadings (0.79 to 0.94). The alphas for 5-item scales were between 0.87 and 0.89. Scale refinement based on measure-specific CFAs and Cronbach alphas using vignette data produced 4-item scales (α’s from 0.85 to 0.91). A three-factor CFA exhibited acceptable fit (CFI = 0.96, RMSEA = 0.08) and high factor loadings (0.75 to 0.89), indicating structural validity. ANOVA showed significant main effects, indicating known-groups validity. Test-retest reliability coefficients ranged from 0.73 to 0.88. Regression analysis indicated each measure was sensitive to change in both directions. Conclusions The AIM, IAM, and FIM demonstrate promising psychometric properties. Predictive validity assessment is planned. Electronic supplementary material The online version of this article (doi:10.1186/s13012-017-0635-3) contains supplementary material, which is available to authorized users.
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              Implementation strategies: recommendations for specifying and reporting

              Implementation strategies have unparalleled importance in implementation science, as they constitute the ‘how to’ component of changing healthcare practice. Yet, implementation researchers and other stakeholders are not able to fully utilize the findings of studies focusing on implementation strategies because they are often inconsistently labelled and poorly described, are rarely justified theoretically, lack operational definitions or manuals to guide their use, and are part of ‘packaged’ approaches whose specific elements are poorly understood. We address the challenges of specifying and reporting implementation strategies encountered by researchers who design, conduct, and report research on implementation strategies. Specifically, we propose guidelines for naming, defining, and operationalizing implementation strategies in terms of seven dimensions: actor, the action, action targets, temporality, dose, implementation outcomes addressed, and theoretical justification. Ultimately, implementation strategies cannot be used in practice or tested in research without a full description of their components and how they should be used. As with all intervention research, their descriptions must be precise enough to enable measurement and ‘reproducibility.’ We propose these recommendations to improve the reporting of implementation strategies in research studies and to stimulate further identification of elements pertinent to implementation strategies that should be included in reporting guidelines for implementation strategies.
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                Author and article information

                Contributors
                Beth.Bourdeau@ucsf.edu
                Journal
                BMC Health Serv Res
                BMC Health Serv Res
                BMC Health Services Research
                BioMed Central (London )
                1472-6963
                17 May 2023
                17 May 2023
                2023
                : 23
                : 503
                Affiliations
                [1 ]GRID grid.266102.1, ISNI 0000 0001 2297 6811, Division of Prevention Science, , University of California, San Francisco, ; San Francisco, CA USA
                [2 ]GRID grid.454842.b, ISNI 0000 0004 0405 7557, Division of Policy and Data, , Health Resources and Services Administration HIV/AIDS Bureau, ; Rockville, MD USA
                Article
                9500
                10.1186/s12913-023-09500-w
                10189984
                2e21dcf5-94f6-4f18-bc72-c9fd25f4939c
                © The Author(s) 2023

                Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. 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 in a credit line to the data.

                History
                : 1 March 2023
                : 4 May 2023
                Funding
                Funded by: FundRef http://dx.doi.org/10.13039/100000102, Health Resources and Services Administration;
                Award ID: U90HA39730
                Award ID: U90HA39730
                Award ID: U90HA39730
                Award ID: U90HA39730
                Award ID: U90HA39730
                Award ID: U90HA39730
                Award ID: U90HA39730
                Categories
                Study Protocol
                Custom metadata
                © BioMed Central Ltd., part of Springer Nature 2023

                Health & Social care
                hiv,rapid start antiretroviral therapy,implementation science,evaluation,mixed methods,learning collaborative,united states

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