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

Abstract

BackgroundThe 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 textMethods: 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.ConclusionsThough 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.

Promoting inclusion in clinical trials—a rapid review of the literature and recommendations for action

“…For potential participants, having a lack of trust in research, doctors, investigators, drugs, and the medical industry was a recurring theme across the literature [ 14 – 16 , 19 , 20 , 22 – 24 ]. This may arise from previous bad experiences and previous severe adverse events in reported studies [ 25 ] and was often compounded by related beliefs or fears [ 23 ].…”

Perspectives on extended-release naltrexone induction among patients living with HIV and opioid use disorder: a qualitative analysis

“…Our results are also consistent with another recent investigation which found that it is more difficult to induct patients onto XR-NTX than buprenorphine, though requirements for a negative-buprenorphine urine sample before XR-NTX induction may have exacerbated the underlying withdrawal tolerance issues [ 19 ]. Additionally, in a previous study of CHOICES study staff, Hoffman et al [ 21 ] found that a specific medication-related barrier to induction was patient fear of opioid abstinence required prior to XR-NTX induction. Similar results have been found in other studies of individuals using stimulants and opioids [ 31 ].…”

“…While long-acting formulations may improve treatment adherence, a recent study found that it was more difficult to initiate XR-NTX than buprenorphine in patients with OUD [ 19 ]; the process of initiating XR-NTX so that someone receives their first injection (a.k.a. “induction”) requires an opioid-free state several days prior to initiation, and opioid withdrawal can be difficult to complete even in inpatient settings with supportive medication [ 21 ]. In contrast, buprenorphine induction does not require complete abstinence from opioids; first dose of buprenorphine may be administered 12–24 h after last use of opioids.…”

“…Themes were identified which related to opioid withdrawal and XR-NTX induction experiences and barriers to induction using an inductive approach at the semantic level. Three PhD level investigators (KH, RB, DM) with extensive experience in qualitative data collection, analysis and publication [ 21 , 28 – 31 ] drafted a list of preliminary themes after reading interview transcripts and two coded transcript themes (KH, RB). An inter-coder reliability process assessed coding discrepancies and a third coder (DM) adjudicated the coding [ 32 ].…”

Opioid Use Disorders in People Living with HIV/AIDS: A Review of Implications for Patient Outcomes, Drug Interactions, and Neurocognitive Disorders

“…Furthermore, PLWHA with substance use disorders face additional challenges due to unique economic and racial/ethnic disparities. Recent works identified poverty as a risk factor for lower rates of linkage to care [ 26 ] and enrollment in supportive services within this unique population [ 27 ]. There were also several studies that evaluated racial and ethnic differences among PLWHA with substance use disorders.…”