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      Adherence intervention for HIV-infected persons who use drugs: adaptation, open trial, and pilot randomized hybrid type 1 trial protocol

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          HIV-infected people who use drugs (PWUD) exhibit the highest rates of non-adherence to antiretroviral therapy (ART) among people living with HIV. This contributes to poor treatment outcomes, increased morbidity and mortality, and HIV transmission. However, current interventions fail to address the unique barriers to adherence faced by this population. Life Steps is a brief, single session intervention that demonstrated increased ART adherence among HIV-infected individuals. This study protocol seeks to improve clinical practice by adapting Life Steps for HIV-infected PWUD and adding a brief motivational intervention addressing drug use. This intervention will incorporate educational, motivational, and behavioral skills components specifically aimed at improving adherence and linkage to substance use treatment among HIV-infected PWUD.


          This project will consist of three phases using a mixed-methods approach. In Phase 1, qualitative interviews with HIV-infected PWUD and community providers, coupled with feedback from an expert review panel, will be used to enhance the existing Life Steps manual and interventionist training protocol. In Phase 2, the prototype will be pilot tested and qualitative exit interviews with HPWUD will identify the strengths and limitations of the intervention. Data regarding feasibility, acceptability, and barriers to delivery will guide modifications to finalize a modified Life Steps-Drug Use (LS-DU) protocol. In Phase 3, a pilot type 1 hybrid effectiveness-implementation trial will examine the effectiveness of LS-DU relative to a health education intervention control condition on ART adherence and viral load data at 1-, 3-, and 6-months. Data regarding clinic readiness for implementation and intervention sustainability potential will be collected.


          This protocol will adapt and evaluate an intervention to improve adherence among HIV-infected PWUD. Results of this study will provide significant data on the acceptability, initial effectiveness, and sustainability potential of an adherence intervention for a high risk and underserved population.

          Trial registration NCT02907697

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          Most cited references 14

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          Syndemics and Public Health: Reconceptualizing Disease in Bio-Social Context

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            Assessing competence in the use of motivational interviewing.

            This report presents reliability, validity and sensitivity indices for the Motivational Interviewing Treatment Integrity (MITI) scale. Factor analysis of MI treatment sessions coded with the Motivational Interviewing Skills Code (MISC) was used to derive 10 elements of MI practice, forming the MITI. Canonical correlation revealed that the MITI captured 59% of the variability in the MISC. Reliability estimates for the MITI were derived using three masked, independent coders. Intra-class coefficients ranged from .5 to .9 and were generally in the good to excellent range. Comparison of MITI scores before and after MI workshops indicate good sensitivity for detecting improvement in clinical practice as result of training. Implications for the use of this instrument in research and supervision are discussed.
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              Drug use and medication adherence among HIV-1 infected individuals.

              This longitudinal study examined the impact of drug use and abuse on medication adherence among 150 HIV-infected individuals, 102 who tested urinalysis positive for recent illicit drug use. Medication adherence was tracked over a 6-month period using an electronic monitoring device (MEMS caps). Over the 6-month study drug-positive participants demonstrated significantly worse medication adherence than did drug-negative participants (63 vs. 79%, respectively). Logistic regression revealed that drug use was associated with over a fourfold greater risk of adherence failure. Stimulant users were at greatest risk for poor adherence. Based upon within-participants analyses comparing 3-day adherence rates when actively using versus not using drugs, this appears to be more a function of state rather than trait. These data suggest that it is the acute effects of intoxication, rather than stable features that may be characteristic of the drug-using populace, which leads to difficulties with medication adherence.

                Author and article information

                512-495-5945 ,
                Addict Sci Clin Pract
                Addict Sci Clin Pract
                Addiction Science & Clinical Practice
                BioMed Central (London )
                2 April 2018
                2 April 2018
                : 13
                [1 ]ISNI 0000 0004 1936 9924, GRID grid.89336.37, Department of Psychiatry, , The University of Texas at Austin Dell Medical School, ; 1912 Speedway Austin, TX USA
                [2 ]ISNI 0000 0004 1936 9094, GRID grid.40263.33, Department of Medicine, , Alpert Medical School of Brown University, ; Providence, RI USA
                [3 ]ISNI 0000 0004 1936 9094, GRID grid.40263.33, Department of Psychiatry and Human Behavior, , Alpert Medical School of Brown University, ; Box G-BH, Providence, RI 02912 USA
                [4 ]ISNI 0000 0004 1936 9094, GRID grid.40263.33, Center for Alcohol and Addiction Studies, , Brown University School of Public Health, ; 121 South Main Street, Box G-121-5, Providence, RI 02912 USA
                [5 ]ISNI 0000 0004 1936 8606, GRID grid.26790.3a, Department of Psychology, , University of Miami, ; Coral Gables, FL USA
                [6 ]ISNI 0000 0004 0443 5079, GRID grid.240267.5, The Center for Prisoner Health and Human Rights, , The Miriam Hospital, ; Providence, RI 02906 USA
                © The Author(s) 2018

                Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (, which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( applies to the data made available in this article, unless otherwise stated.

                Funded by: FundRef, National Institute on Drug Abuse;
                Award ID: K23DA039037
                Award ID: K24DA022112
                Award ID: K24DA040489
                Award Recipient :
                Funded by: FundRef, National Institute of Allergy and Infectious Diseases;
                Award ID: P30AI42853
                Award Recipient :
                Study Protocol
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                © The Author(s) 2018

                Health & Social care

                hiv/aids, substance use, adherence, motivational interview, mixed methods, protocol


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