Journal Article

Barriers and facilitators to recruitment and enrollment of HIV-infected individuals with opioid use disorder in a clinical trial

Lum, Paula J., Waddell, Elizabeth Needham, Baker, Robin, Hoffman, Kim A., Kunkel, Lynn E., McCarty, Dennis, Korthuis, P. Todd

2019

Overview

Background The CTN-0067 CHOICES trial tests implementation of extended-release naltrexone (XR-NTX) versus treatment-as-usual (TAU) for opioid use disorders (OUD) in HIV clinics to improve HIV viral suppression. The study team investigated recruitment strategies to elucidate the barriers and facilitators to recruitment and enrollment in the study. Main text Methods: Semi-structured, in-depth, digitally recorded interviews were completed with study recruitment-related staff and medical providers ( n  = 26) from six participating HIV clinics in the fall of 2018. Interviews probed 1) factors that might prevent prospective participants from engaging in study recruitment and enrollment procedures and 2) strategies used by study staff that encourage eligible patient participation. Interviews were transcribed and thematically analyzed using a content analysis approach. Results: All respondents reported that barriers to recruitment and enrollment included challenging patient social and structural factors (e.g., homelessness or living environments with high substance use, criminal justice involvement), difficulty locating patients with unsuppressed HIV viral load and OUD within the HIV clinic, time-consuming study enrollment processes, and stigma around HIV and OUD which inhibited treatment seeking. Some respondents observed that distrust of research and researchers impeded recruitment activities in the community. A specific medication-related barrier was patient fear of opioid abstinence required prior to XR-NTX induction. Facilitators of recruitment included use of trusted peer outreach/recruitment workers in the community, hospitalizations that offered windows of opportunities for screening and XR-NTX induction, providing participant transportation, and partnerships with harm reduction organizations for referrals. Conclusions Though study personnel encountered barriers to recruitment in the CHOICES study, persons with untreated HIV and OUD can be enrolled in multisite clinical trials by using enhanced recruitment strategies that extend outside of the HIV clinic. Employing peer outreach workers and collaborating with syringe service programs may be especially helpful in facilitating recruitment and merit inclusion in similar study protocols.

• Publisher: BioMed Central,BioMed Central Ltd,Springer Nature B.V,BMC
• Subject: Adult / Aged / Alcohol / Antiretroviral drugs / Clinical trials / Clinical Trials as Topic - organization & administration / Clinics / Content analysis / Delayed-Action Preparations - therapeutic use / Drug dosages / Drug use / FDA approval / Female / Health Administration / Health Informatics / Health services / Health Services Accessibility / Health Services Research for Opioid Use Disorders / HIV / HIV carriers discrimination / HIV infections / HIV Infections - drug therapy / HIV Infections - epidemiology / Homelessness / Human immunodeficiency virus / Humans / Interviews / Male / Medical research / Medicine / Medicine & Public Health / Methamphetamine / Middle Aged / Naltrexone / Naltrexone - therapeutic use / Narcotics / Nursing Research / Opioid abuse / Opioid-Related Disorders - drug therapy / Opioid-Related Disorders - epidemiology / Organization / Organizations / Partnerships / Patient Selection / Patients / Prospective Studies / Public Health / Qualitative Research / Research Article / Stigma / structure and delivery of healthcare / Substance abuse / Substance abuse treatment / Substance use disorder / Workers / Young Adult