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Recruitment into a Clinical Trial of People Living with Uncontrolled HIV Infection Who Inject Drugs: a Site Case Report from the CTN 67 CHOICES Study

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Abstract

CHOICES was an open-label, randomized, comparative effectiveness trial of office-based extended-release naltrexone versus treatment as usual in people with untreated opioid use disorder and HIV. This study explored facilitators to recruitment in Miami, a successful recruiting site in the national trial. The mixed-methods study included quantitative surveys of randomized participants, medical record abstraction, and qualitative interviews with study staff. Miami recruited 47 (40.5%) of 116 randomized participants in the six-site national trial. In-depth interviews of study staff (n = 6) revealed that Miami had a recruitment approach consisting of street level outreach and a close relationship with the local syringe services program (SSP). Partnership with a local SSP provided access to people living with HIV who inject drugs in Miami. SSPs’ fundamental trust within the community of people who inject drugs can be leveraged in studies aiming to improve health outcomes in this underserved and high-priority population.

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Acknowledgements

We thank the anonymous peer reviewers whose comments and suggestions strengthened the manuscript.

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Authors and Affiliations

  1. Department of Medicine, Miller School of Medicine, University of Miami, 1120 NW 14th St, Miami, FL, 33136, USA

    Hansel Tookes MD, MPH & Allan E. Rodriguez MD

  2. Department of Public Health Sciences, Miller School of Medicine, University of Miami, 1120 NW 14th St, Miami, FL, 33136, USA

    Jessica Ucha M.S.Ed., Elizabeth Alonso PhD & Tyler S. Bartholomew BS

  3. Department of Psychiatry and Behavioral Sciences, Miller School of Medicine, University of Miami, 1120 NW 14th St, Miami, FL, 33136, USA

    Edward Suarez PsyD

  4. Department of Sociomedical Sciences, Mailman School of Public Health, Columbia University, New York, NY, 10027, USA

    Lisa R. Metsch PhD

  5. Division of Biostatistics, Department of Public Health Sciences, Miller School of Medicine, University of Miami, 1120 NW 14th St, Miami, FL, 33136, USA

    Daniel J. Feaster PhD

  6. Oregon Health and Science University-Portland State University School of Public Health, 3181 Sam Jackson Park Rd, Portland, OR, 97239, USA

    Kim A. Hoffman PhD

  7. Department of Medicine, Section of Addiction Medicine, Oregon Health and Science University, Portland, OR, 97239, USA

    P. Todd Korthuis MD, MPH

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  1. Hansel Tookes MD, MPH
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Correspondence to Jessica Ucha M.S.Ed..

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Conflict of Interest

The authors have conflicts of interest to report. An Award from the National Institutes of Health, National Institute on Drug Abuse supported the data collection, analysis and preparation of the manuscript (UG1 DA015815). Dr. Korthuis serves as principal investigator for NIH-funded studies that receive donated study medication from Alkermes and Indivior.

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Tookes, H., Ucha, J., Rodriguez, A.E. et al. Recruitment into a Clinical Trial of People Living with Uncontrolled HIV Infection Who Inject Drugs: a Site Case Report from the CTN 67 CHOICES Study. J Behav Health Serv Res 49, 240–251 (2022). https://doi.org/10.1007/s11414-021-09771-3

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