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      Feasibility and Acceptability of the Adherence Connection Counseling, Education, and Support (ACCESS) Proof of Concept: A Peer-Led, Mobile Health (mHealth) Cognitive Behavioral Antiretroviral Therapy (ART) Adherence Intervention for HIV-Infected (HIV+) Adolescents and Young Adults (AYA)

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          Abstract

          Effective antiretroviral therapy (ART) adherence strategies for HIV+ adolescents and young adults (AYA) are needed to prevent HIV-related morbidity, mortality, and onward transmission. In the Adherence Connection for Counseling, Education, and Support (ACCESS) pilot, an exploratory sequential mixed-methods design was used to develop and test a peer-led, mobile health (mHealth) cognitive behavioral ART adherence intervention. HIV+ AYA (ages 16–29 years) with unsuppressed plasma HIV RNA (HIV viral load) were eligible for this five-session intervention directed to improving ART adherence and HIV viral load. A total of 78 peer-led remote videoconferencing sessions (via WebEx) were delivered to 16 participants. High completion rates (97.5%) and client satisfaction scores (mean = 29.13 of 32; SD = 2.45) were observed. Self-reported ART adherence improved (32% increase in doses taken; 95th CI 11.2–53.3) with an annualized average rate of 47.5% (0.28 log 10) reduction in HIV viral load. We established proof of concept for the ACCESS peer-led, mHealth cognitive behavioral ART adherence intervention, with promising adherence and virologic outcome data.

          Resumen

          Se necesitan estrategias efectivas de adherencia a la terapia antirretroviral (TAR) para adolescentes y adultos jóvenes (AAJ) VIH+ para prevenir la morbilidad, la mortalidad y las transmisiones futuras relacionadas con el VIH. En el proyecto piloto Adherence Connection for Counseling, Education, and Support (ACCESS), se utilizó un diseño exploratorio secuencial de métodos mixtos para desarrollar y testear una intervención de adherencia cognitiva conductual de salud móvil (mHealth) dirigida por pares a la TAR. AAJ VIH+ (de 16 a 29 años de edad) con ARN del VIH (carga viral del VIH) en plasma no suprimido fueron elegibles para esta intervención de cinco sesiones dirigida a mejorar la adherencia a la TAR y la carga viral del VIH. Se dictaron un total de 78 sesiones de videoconferencias remotas dirigidas por pares (a través de WebEx) a 16 participantes. Fueron observadas tasas altas de finalización (97.5%) y puntuaciones de satisfacción del cliente (media=29.13 de 32; SD=2.45). La adherencia autoinformada a la TAR mejoró (aumento del 32% en las dosis tomadas; IC del 95=11.2 a 53.3) con una tasa promedio anualizada de reducción en la carga viral del VIH del 47.5% (0.28 log 10). Establecimos una prueba de concepto para ACCESS, la intervención de adherencia a la TAR cognitivo conductual mHealth dirigida por pares, con datos prometedores sobre la adherencia y los resultados virológicos.

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          Three approaches to qualitative content analysis.

          Content analysis is a widely used qualitative research technique. Rather than being a single method, current applications of content analysis show three distinct approaches: conventional, directed, or summative. All three approaches are used to interpret meaning from the content of text data and, hence, adhere to the naturalistic paradigm. The major differences among the approaches are coding schemes, origins of codes, and threats to trustworthiness. In conventional content analysis, coding categories are derived directly from the text data. With a directed approach, analysis starts with a theory or relevant research findings as guidance for initial codes. A summative content analysis involves counting and comparisons, usually of keywords or content, followed by the interpretation of the underlying context. The authors delineate analytic procedures specific to each approach and techniques addressing trustworthiness with hypothetical examples drawn from the area of end-of-life care.
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              Is Open Access

              CONSORT 2010 statement: extension to randomised pilot and feasibility trials

              The Consolidated Standards of Reporting Trials (CONSORT) statement is a guideline designed to improve the transparency and quality of the reporting of randomised controlled trials (RCTs). In this article we present an extension to that statement for randomised pilot and feasibility trials conducted in advance of a future definitive RCT. The checklist applies to any randomised study in which a future definitive RCT, or part of it, is conducted on a smaller scale, regardless of its design (eg, cluster, factorial, crossover) or the terms used by authors to describe the study (eg, pilot, feasibility, trial, study). The extension does not directly apply to internal pilot studies built into the design of a main trial, non-randomised pilot and feasibility studies, or phase II studies, but these studies all have some similarities to randomised pilot and feasibility studies and so many of the principles might also apply. The development of the extension was motivated by the growing number of studies described as feasibility or pilot studies and by research that has identified weaknesses in their reporting and conduct. We followed recommended good practice to develop the extension, including carrying out a Delphi survey, holding a consensus meeting and research team meetings, and piloting the checklist. The aims and objectives of pilot and feasibility randomised studies differ from those of other randomised trials. Consequently, although much of the information to be reported in these trials is similar to those in randomised controlled trials (RCTs) assessing effectiveness and efficacy, there are some key differences in the type of information and in the appropriate interpretation of standard CONSORT reporting items. We have retained some of the original CONSORT statement items, but most have been adapted, some removed, and new items added. The new items cover how participants were identified and consent obtained; if applicable, the prespecified criteria used to judge whether or how to proceed with a future definitive RCT; if relevant, other important unintended consequences; implications for progression from pilot to future definitive RCT, including any proposed amendments; and ethical approval or approval by a research review committee confirmed with a reference number. This article includes the 26 item checklist, a separate checklist for the abstract, a template for a CONSORT flowchart for these studies, and an explanation of the changes made and supporting examples. We believe that routine use of this proposed extension to the CONSORT statement will result in improvements in the reporting of pilot trials. Editor’s note: In order to encourage its wide dissemination this article is freely accessible on the BMJ and Pilot and Feasibility Studies journal websites.
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                Author and article information

                Contributors
                amd363@nyu.edu
                Journal
                AIDS Behav
                AIDS Behav
                AIDS and Behavior
                Springer US (New York )
                1090-7165
                1573-3254
                27 December 2022
                : 1-17
                Affiliations
                [1 ]GRID grid.137628.9, ISNI 0000 0004 1936 8753, Rory Meyers College of Nursing, , New York University, ; 433 First Avenue, New York, NY 10010 USA
                [2 ]GRID grid.414636.2, ISNI 0000 0004 0451 9117, Division of Infectious Diseases, Department of Pediatrics, , Jacobi Medical Center, ; Bronx, NY USA
                [3 ]GRID grid.63054.34, ISNI 0000 0001 0860 4915, University of Connecticut, , School of Nursing, ; Storrs, CT USA
                [4 ]GRID grid.21729.3f, ISNI 0000000419368729, Columbia University School of Nursing, , Columbia University, ; New York, NY USA
                [5 ]GRID grid.47100.32, ISNI 0000000419368710, Yale School of Nursing, , Yale University, ; Orange, CT USA
                [6 ]GRID grid.137628.9, ISNI 0000 0004 1936 8753, Silver School of Social Work, , New York University, ; New York, NY USA
                [7 ]GRID grid.137628.9, ISNI 0000 0004 1936 8753, Department of Population Health, , New York University Grossman School of Medicine, ; New York, NY USA
                Author information
                http://orcid.org/0000-0002-4633-5135
                Article
                3913
                10.1007/s10461-022-03913-0
                9792943
                36574184
                d95f8ce6-7119-40df-ba8f-f8fa4f3444ae
                © The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature 2022, Springer Nature or its licensor (e.g. a society or other partner) holds exclusive rights to this article under a publishing agreement with the author(s) or other rightsholder(s); author self-archiving of the accepted manuscript version of this article is solely governed by the terms of such publishing agreement and applicable law.

                This article is made available via the PMC Open Access Subset for unrestricted research re-use and secondary analysis in any form or by any means with acknowledgement of the original source. These permissions are granted for the duration of the World Health Organization (WHO) declaration of COVID-19 as a global pandemic.

                History
                : 25 October 2022
                Funding
                Funded by: FundRef http://dx.doi.org/10.13039/100000056, National Institute of Nursing Research;
                Award ID: K23NR015970
                Award Recipient :
                Funded by: FundRef http://dx.doi.org/10.13039/100000009, Foundation for the National Institutes of Health;
                Award ID: 1R01NR019535
                Award Recipient :
                Categories
                Original Paper

                Infectious disease & Microbiology
                hiv,adherence,patient compliance,retention in care,smartphone,technology,community health worker,peer support,behavioral interventions,health disparities

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