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

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

Research output: Contribution to journalArticle

Abstract

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.

Original languageEnglish (US)
Number of pages1
JournalBMC health services research
Volume19
Issue number1
DOIs
StatePublished - Nov 21 2019

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Opioid Analgesics
Clinical Trials
HIV
Interviews
Personnel Selection
Harm Reduction
Patient Participation
Homeless Persons
Naltrexone
Criminal Law
Medical Staff
Syringes
Viral Load
Fear
Hospitalization
Referral and Consultation
Research Personnel
Organizations
Therapeutics
Research

ASJC Scopus subject areas

  • Health Policy

Cite this

Barriers and facilitators to recruitment and enrollment of HIV-infected individuals with opioid use disorder in a clinical trial. / Hoffman, Kim A.; Baker, Robin; Kunkel, Lynn E.; Waddell, Elizabeth Needham; Lum, Paula J.; McCarty, Dennis; Korthuis, P. Todd.

In: BMC health services research, Vol. 19, No. 1, 21.11.2019.

Research output: Contribution to journalArticle

Hoffman, Kim A. ; Baker, Robin ; Kunkel, Lynn E. ; Waddell, Elizabeth Needham ; Lum, Paula J. ; McCarty, Dennis ; Korthuis, P. Todd. / Barriers and facilitators to recruitment and enrollment of HIV-infected individuals with opioid use disorder in a clinical trial. In: BMC health services research. 2019 ; Vol. 19, No. 1.
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abstract = "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.",
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