J Behav Health Serv Res Tookes 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 StudyHansel Tookes Jessica Ucha Allan E. Rodriguez Edward Suarez Elizabeth Alonso Lisa R. Metsch Daniel J. Feaster Tyler S. Bartholomew Kim A. Hoffman

The Journal of Behavioral Health Services & Research, 2021. X‒XX. © 2021, National Council for Mental Wellbeing, . DOI 10.1007/s11414-021-09771-3

Address correspondence to Jessica Ucha, Department of Public Health Sciences, Miller School of Medicine, University of Miami, Miami, FL, USA. jucha@med.miami.edu. Address correspondence to Elizabeth Alonso, Department of Public Health Sciences, Miller School of Medicine, University of Miami, Miami, FL, USA. jucha@med.miami.edu. Address correspondence to Tyler S. Bartholomew, Department of Public Health Sciences, Miller School of Medicine, University of Miami, Miami, FL, USA. jucha@med.miami.edu.

Hansel Tookes, Department of Medicine, Miller School of Medicine, University of Miami, Miami, FL, USA.Allan E. Rodriguez, Department of Medicine, Miller School of Medicine, University of Miami, Miami, FL,

USA.Edward Suarez, Department of Psychiatry and Behavioral Sciences, Miller School of Medicine, University of

Miami, Miami, FL, USA.Lisa R. Metsch, Department of Sociomedical Sciences, Mailman School of Public Health, Columbia University,

New York, NY, USA.Daniel J. Feaster, Division of Biostatistics, Department of Public Health Sciences, Miller School of Medicine,

University of Miami, Miami, FL, USA.Kim A. Hoffman, Oregon Health and Science University-Portland State University School of Public Health,

Portland, OR, USA.P. Todd Korthuis, Department of Medicine, Section of Addiction Medicine, Oregon Health and Science

University, Portland, OR, USA.

J Behav Health Serv Res 2021

P. Todd Korthuis

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, medi-cal 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 com-munity of people who inject drugs can be leveraged in studies aiming to improve health outcomes in this underserved and high-priority population.

IntroductionIn 2018, an estimated 2.0 million people in the USA had an opioid use disorder (OUD).1 Inci-

dence data suggests transmission of HIV through sharing of needles, syringes, or equipment remains significant. According to the CDC, 10% of new HIV diagnoses in the USA in 2018 were among people who inject drugs.2 People living with HIV and OUD are less likely to receive HIV care and can have poor antiretroviral therapy (ART) adherence, thus worsening progression and consequences of HIV compared to their counterparts without an OUD diagnosis.3–5 Integrated treatment for HIV and OUD can improve HIV-related and other health outcomes.6 Notably, retention in OUD treat-ment predicts long-term viral suppression among those who have co-occurring HIV and OUD.4 This improvement in the HIV care continuum highlights the importance of co-prescribing ART and medications for opioid use disorder (MOUD).7,8 A single provider with a more integrated service delivery system can effectively treat the patient without requiring multiple referrals and linkages to other clinical services.

MOUD

Medications for opioid use disorder (MOUDs) are the most effective evidence-based treatment for OUD.6 Behavioral interventions and/or medically supervised withdrawal (“detoxification”) without MOUD have poor outcomes with high rates of return to use.9 MOUD improves mortality and retention in treatment and prevents opioid cravings and return to use.6,10,11 Buprenorphine, naltrexone, and methadone are the three Food and Drug Administration approved medications for the long-term treatment of OUD. Buprenorphine, a partial agonist at the mu opioid receptor, is readily prescribed in an outpatient setting by clinicians with a waiver under the Drug Addiction and Treatment Act of 2000. Extended release naltrexone (XR-NTX), an opioid antagonist, can also be administered in an outpatient setting but has the disadvantage that patients must abstain from opioids for 7–10 days in order to reduce the risk of precipitated withdrawal. Methadone is a long-acting full opioid agonist that is only dispensed through a SAMHSA-certified opioid treatment program. Buprenorphine and methadone typically require closer adherence monitoring,

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whereas XR-NTX releases naltrexone for the duration of 4–5 weeks per injection. These differ-ences are especially important for individuals with limited transportation and access to clinics and physicians.

SSPs

Syringe services programs (SSPs) are community-based prevention programs that offer various medical and social services to people who inject drugs (PWID) to mitigate the harms associated with drug use while always meeting people where they are and respecting their autonomy. Services include linkage to substance use treatment, access to and disposal of sterile syringes and injection equipment, testing and linkage to care for HIV and hepatitis C (HCV), and overdose prevention thorough naloxone distribution. PWID have reported that medical and mental health treatment at SSPs has been accessible, accommodating, and non-judgmental.12 They trust SSP workers for their acceptance which is conducive to continuity of care.13 This is especially important since stigma has been found to impact multiple aspects of life and health among PWID, including utilization of medical care and drug treatment. PWID and the harm reduction services that improve health out-comes in this community (i.e., SSPs and MOUD) experience extensive discrimination, judgment, and dismissive attitudes from health care providers at clinic and hospital settings, as well as from the community at large.12,14–18 Fundamental to harm reduction and SSPs is respect for the people who use drugs.

Randomized clinical trial

The National Drug Abuse Treatment Clinical Trials Network (CTN), established by the National Institute on Drug Abuse (NIDA), is a platform in which medical and specialty treatment providers, researchers, participating patients, and NIDA can develop, test, refine, and deliver new treatments for substance use disorders. CTN-0067 “Comparing Treatments for HIV-Infected Opioid Users in an Integrated Care Effectiveness Study (CHOICES),” was an open-label, randomized, comparative effectiveness trial of office-based XR-NTX for 24 weeks (6 monthly injections) versus treatment as usual (TAU; typically with buprenorphine/naloxone) in people with untreated OUD and HIV. The primary outcome was HIV viral suppression at 24 weeks. Eligible participants had a moderate or severe OUD and an HIV viral RNA level of ≥ 200 copies/ml. Study staff at six study sites employed a variety of traditional methods for study recruitment, including approaching prospective participants during clinic visits and the use of flyers.

As described by Hoffman et al., enrolling study participants into CTN-0067 CHOICES from HIV clinics was more challenging than expected, resulting in the trial’s early termination.19 Qualitative interviews conducted with CTN-0067 study staff at all sites documented challenges with recruiting persons living with HIV and OUD into the trial, including study eligibility criteria, HIV stigma, lengthy research procedures, participant treatment preferences, and lack of transportation.19 These barriers to recruitment align with prior studies.20,21 Historically, research has shown that individu-als, particularly those who use drugs, have a general mistrust of medical research.21 Many do not understand the benefits of participating and are concerned with being taken advantage of. Further-more, these individuals may not have access or the means to regular transportation to get to and from visits. Focus groups with people who use alcohol and drugs also found that a main deterrent to participation in research was burden.20 Individuals were concerned with frequent and lengthy appointments as well as lab tests, such as blood draws and urine drug screens. The current case report explores an in-depth outlier analysis of recruitment challenges and strategies implemented at a successful site, with the goal of identifying keys to recruitment of a hard to reach population.

The Jackson Memorial Hospital site of CTN-0067 CHOICES, located in Miami, Florida, was one of 6 sites in the national trial. Jackson Health System is the public hospital system in Miami-Dade

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County, and Jackson Memorial is the flagship safety-net hospital. The site research team was based at the University of Miami Miller School of Medicine, which shares a campus and a close partner-ship with Jackson Health System. The Founder and Medical Director of the local syringe services program, the IDEA Exchange (IDEA SSP) also served as the Co-Principal Investigator (HT) for the Miami site in the CTN-0067 trial. The Miami team’s recruitment efforts centered around com-munity outreach, locating individuals with untreated HIV and OUD, and actively linking them to treatment at the site’s adult outpatient HIV clinic. The Miami site randomized 40.5% of the 6-site national trial, so the objective of this report was to understand the contributors to recruitment suc-cess in Miami and identify potential lessons for future research. The current study describes how the use of study outreach workers and the research team’s relationship with IDEA SSP were key to the site’s recruitment success. These two methods were unique to Miami, as the remaining sites used traditional methods for study recruitment, including approaching prospective participants during clinic visits and the use of flyers. The study population of the Miami site is also described, as are specific challenges to recruitment and how the local study team addressed these.

MethodsCase report design and participants

A mixed methods study was carried out to understand the Miami site’s success with recruiting vulnerable participants, many of whom were not engaged in care at the HIV clinic. From February 2018 to May 2019, participants in Miami were enrolled in the CTN-0067 study. Participants for the case report included individuals with untreated HIV and OUD who completed randomization in the CTN-0067 CHOICES study, and research staff at the Miami recruitment site.

The case report drew from multiple sources of data, including (1) participant survey data, (2) participant medical record review, (3) qualitative interviews with staff, and (4) review of site track-ing logs. Participant survey data, medical record review, and qualitative staff interviews were com-pleted as part of the CTN-0067 national trial. Data relevant to the Miami site is discussed in this case report.

Participant survey and medical record data As part of the CTN-0067 national trial, demographic data were gathered from all participants through one-on-one interviews with study staff at baseline, prior to randomization. Study staff also inquired about route of administration of opioids and other substance use behaviors. Medical data were abstracted from the electronic health record at Jackson Memorial Hospital, or through medical release from the patient’s primary care provider. CD4 count (cells/mm3), HIV viral load (copies/mL), and hepatitis C RNA (IU/ml) were abstracted from the medical record, when available, or phlebotomy was performed.

Qualitative interviews Conducted as part of the CTN-0067 national trial, in-depth interviews were carried out with staff at all sites. During qualitative data collection, all efforts were main-tained to ensure consistency across observations. This included several processes. First, the staff were uniformly contacted by the site research staff rather than the lead team researcher to see if they would be willing to take part in an interview. Second, if a respondent agreed to participate in an interview, the site research staff provided the private, secure room where the respondent could speak to the lead team researcher. Third, all interviews underwent the same consent protocols, i.e., the Information Sheet was read to the respondent, any concerns were discussed with the lead team researcher, and then verbal consent was provided. Verbal consent for the qualitative interviews was adequate as the respondents had previously consented to participate in the overall study. Lastly,

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the same semi-structured interview guide was used for each respondent. For the current study, data from the Miami study staff were further analyzed (n = 6). Staff included the site coordinator (n = 1), study clinicians (n = 2), research assistants (n = 2), and outreach worker (n = 1). Interviews averaged 30 min in length and probed staff perspectives on the barriers and facilitators to study recruitment. Interviews explored influences that inhibited eligible individuals from engaging in study recruitment and enrollment procedures. For example, the semi-structured interview guide began with a general question about challenges: “From your perspective as a clinic staff member, what has been the most challenging aspect of implementing CHOICES at this clinic?” This was followed by the more specific question about recruitment: “From your perspective, has CHOICES recruitment been difficult? Why do you think that is? What has worked well or not well in terms of recruitment?” All interviewees were informed about confidentiality and the right to withdraw from the study at any point.

Site tracking log The local site used an internal log to track participants’ progression through milestones that were prerequisites to enrolling in HIV care. Milestones included completing a case management engagement or re-engagement visit, completing a financial eligibility assessment, and enrolling in Ryan White and a drug assistance program.

Analysis

Descriptive statistics were used to describe survey and medical records data. Categorical variables are presented as frequencies and percentages, and continuous variables are presented as medians with interquartile range (IQR).

Qualitative interviews (n = 6) were audio recorded and professionally transcribed. ATLAS.ti 8.0 qualitative software was used to code the transcripts. Codes were developed inductively using a thematic approach.22 Coding categories were mutually agreed upon by three study team members, and several steps were taken to increase methodological rigor: (1) multiple investigators partici-pated in data collection and analysis to ensure multiple viewpoints and discussion of perceptions of data; (2) three investigators identified emerging codes through weekly reviews to refine the coding scheme, ensure consensus, and establish consistency across coders; and (3) 20% of the interviews were double-coded for inter-coder reliability, and coders agreed on 84% of the coding. The remain-ing coding inconsistencies were resolved by group discussion and re-coded for the final dataset. None of the study team members who conducted qualitative data analysis were interviewees in this report. Study staff tracking logs were summarized and incorporated into the results.

Ethics

The national study was approved by the Advarra Institutional Review Board (Pro00022658) and the Clinical Research Review Committee at Jackson Health System.23 All participants provided written informed consent and signed a HIPAA Research Authorization Form to permit medical records abstractions. Participants also completed Medical Records Release Forms for external care providers, as applicable.

Case presentation

The Miami site recruited 47 (40.5%) of 116 randomized participants in the six-site national trial. In Miami, 76 people were prescreened, 64 were screened, and 47 participants were randomized in 13 months of study recruitment. The sample is too small to determine significant differences between those prescreened, screened, and ultimately randomized. Patients who were found to be ineligible

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were generally excluded because of a suppressed viral load (n = 12). The majority of Miami site randomized participants were male (55.3%), and the median age was 42 (IQR = 33–55) (Table 1). All participants were positive for HCV antibody, and 51% were HCV RNA positive. In addition, 78.7% reported primarily injecting opioids, and a large proportion of the participants also used stimulants, mostly cocaine (59.6%, both injection and non-injection). The median CD4 count was 474 cells/mm3 (IQR = 271–639). Median HIV viral load was 15,300 copies/mL (IQR = 2462–63,033). Almost half (48.9%) of participants were recruited in partnership with the local SSP, 40.4% through street-level outreach, and 10.6% through the Jackson adult outpatient HIV clinic. Slightly over one-third (36.4%) of patients were diagnosed with HIV within the last year, 25.0% were living with HIV 1–5 years, and 38.6% for over 5 years. A total of 24 patients were randomized to XR-NTX and 23 to TAU. Sublingual buprenorphine-naloxone was the TAU medication at the Miami site.

The partnership of the study team with the IDEA SSP was tightly integrated. IDEA SSP’s com-munity engagement manager was a fully integrated member of the study team. The community engagement manager’s main duty was to screen IDEA clients for HIV/HCV and substance use disorder and link them to care when appropriate. Many IDEA clients engaged in HIV care at Jack-son through the Test and Treat Program, a program of the Florida Department of Health. The Test and Treat Program provided immediate linkage to HIV primary care and initiation of antiretroviral therapy (ART) at the time of HIV diagnosis or a return to care after a gap in services. When a new IDEA client was brought to the Jackson HIV clinic for a Test and Treat appointment, the IDEA com-munity engagement manager would inform the study team outreach worker and research assistant so that study screening could take place on the same day. The study outreach worker also joined the IDEA SSP team on their daily community engagement activities to simultaneously recruit for the study. These engagement activities included visiting local heroin use hotspots in the IDEA mobile unit or on foot to enroll new clients into the IDEA SSP, conducting syringe exchanges and other harm reduction strategies, attending IDEA SSP’s weekly wound care clinic, and attending dinner at the largest homeless shelter in Miami. Partnering with IDEA SSP allowed the study outreach worker direct access to new potential participants to recruit for the study, as the IDEA SSP location often served as a hub for many of the homeless people living with HIV and OUD, a community known for mistrusting people, systems, and organizations due to a long history of systemic stigma and mistreatment.12,24.

Study staff qualitative interviews

Interviews with study staff added context and augmented insights gleaned from participant and program descriptive data. Thematic codes that emerged included both barriers and facilitators to the study. Barriers included cumbersome procedures, stigma, and turbulent living situations, while facilitators included having a study van and recruiting at the syringe exchange program. A site HIV clinician identified failure to espouse harm reduction methods of meeting people where they are as a significant barrier to recruitment in the study. He opined:

So I think that really this whole notion of taking people who inject drugs and putting them into our clinical system which just treats them with like the worst stigma imaginable, I think that’s not the solution to all this.

Recruitment recommendations included phlebotomy on the street, street-based provider visits, and the need to meet people who inject drugs and experience homelessness on their own terms, outside of the formal clinical environment, in a street medicine approach. In a qualitative interview, a study outreach worker described some of the healthcare system barriers:

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Table 1 Miami CTN-0067 CHOICES site participant characteristics (N = 47)

Variable N (%)

Age (median, IQR) 42 (33-55)Age category

  < 40 23 (48.9)  ≥ 40 24 (51.1)

Biological sex  Male 26 (55.3)  Female 21 (44.7)

Race/ethnicity  Non-Hispanic White 20 (44.4)  Non-Hispanic Black 15 (33.3)  Hispanic 10 (22.2)

Homeless in previous 30 days  Yes 31 (66.0)  No 16 (34.0)

Time since HIV diagnosis  ≤1 year 16 (36.4)  1–5 years 11 (25.0)  ≤5 years 17 (38.6)

HIV visit in previous 24 weeks  Yes 30 (63.8)  No 17 (36.2)

Median HIV viral load copies/mL (median, IQR) 15,300 (2,462-63,033)Median CD4 count cells/mm3 (median, IQR) 474 (271, 639)HCV antibody

  Positive 42 (100.0)HCV RNA

  Positive 23 (51.1)  Negative 13 (28.9)

Drugs injected in the past 30 days  Heroin 37 (78.7)  Opiate/analgesics 10 (21.3)  Cocaine 16 (34.0)  Methamphetamine 7 (14.9)

Non-injection in the past 30 days (oral, nasal, smoking)  Heroin 9 (19.2)  Opiate/analgesics 15 (31.9)  Cocaine 28 (59.6)  Methamphetamine 6 (12.8)  Sedatives/tranquilizers 21 (44.7)  Cannabis 40 (85.1)

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And in terms of the services or — what the study can and cannot do, we are very limited. We can — TAU we can refer but it’s up to them to actually go and make the appointment and go to the appointment and these are people who are not used to keeping — making appointments let alone keeping them. So we have … to hand hold, there’s people who don’t even have medi-cal coverage who haven’t even applied for Ryan White and you know, all these other barriers that within themselves are a time consuming bureaucratic and a lot of red tape and you have to have an ID and you know — so many times we have clients who don’t even have an ID you know, and we have to start from square one.

Qualitative interviews with other study personnel revealed themes associated with homeless-ness, socioeconomic factors, transportation, and severe OUD as the largest barriers to recruitment in the study.

Most of these participants are either homeless or have a very unstable living situation. That’s a big big deterrent in terms of trying to get healthy and to maintain themselves being healthy. I always tell them you can’t be healthy in an unhealthy environment and if they are in an unhealthy environment, even though if they decide to go to some treatment or you know, once they get back they are back in the same neighborhood or they are back in the same hangout area.

Access to a clinic vehicle was helpful for addressing the transportation barrier by picking up and dropping off participants for their clinic visits.

Miami has really bad public transportation. So that’s something that has helped — having the van available and [outreach worker] to go and pick them up or transport them.

In interviews with the study team, including research assistants and study clinicians, the partner-ship with the SSP was identified as the most essential facilitator of recruitment. Street level outreach in partnership with IDEA SSP staff, including point of care HIV screening, recruited the majority of participants in the Miami site. The site coordinator reported that:

Patients usually discover the exchange before they discover us. Sometimes it happens in the other direction but usually not because the exchange is in their community and they go together, they go in groups and so it has become kind of a well-known place in their com-munity.

Likewise, one of the study recruitment staff echoed the importance of the relationship with the SSP:

I think for our particular site, the needle exchange has been a god send because— they— they are out there in the front line on a daily basis so people come to them to exchange needles and since they have the HIV testing and once— and once an HIV positive individual is identified they immediately contact us and or you know, [recruiter] who is there on a regular basis so she’s able to approach the person you know, so the needle exchange has been a great resource.

DiscussionThe CTN-0067 CHOICES Manual of Operations (MOP) provided guidance on methods of

recruitment for their six national sites. It was expected that participants would be identified as exist-ing or new to care patients at each site’s HIV clinic. Once recruitment from the clinics proved to be challenging, sites had to expand recruitment methods, as suggested in the Manual of Operations, to

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include advertisements at other treatment providers and community centers. It was at this moment that the Miami site began to see success directly related to their outreach worker’s partnership with IDEA Syringe Service Program. A later version of the trial’s manual of operations was modified to include identifying individuals on the street through a dedicated outreach worker as a suggested recruitment method.

The Miami site recruited 40.5% of the sample in the CTN-0067 CHOICES study by using a tailored, two-pronged recruitment approach consisting of street-level outreach and a close relation-ship with the local IDEA Syringe Service Program. Syringe Service Programs meet people with opioid use disorder where they are, without judgment, and have been successfully partnered with for study recruitment, as with Neufeld et al.’s study of community syringe exchange participants versus other referrals.25 This acceptance that is fundamental to harm reduction works to counteract the stigma associated with HIV, medications for opioid use disorder, people who inject drugs, and syringe exchange programs. Staff identified meeting people outside of HIV and addiction treatment settings as a key component of successful recruitment. The trust between SSP staff and participants is paramount to engagement of a group of individuals with a deep history of marginalization and mistrust of medical institutions. For example, Biancarellia et al. found that research participants described non-stigmatizing environments within the community-based organizations they worked with, including feelings of acceptance, mutual respect, and strong connections with staff.13 Like-wise, the IDEA Syringe Service Program also served as a community “home base” for many of the CTN-0067 participants and was actively implementing routine HIV/HCV screening at the time of the study that ultimately identified an HIV outbreak in this community.26,27 The study team met weekly to discuss recruitment activities and developed a tailored approach for each study participant.

The Miami site began recruitment efforts as prescribed in the study protocol, focusing primarily on patients of the site’s HIV clinic.19 It quickly became evident that the study population, persons living with an unsuppressed HIV viral load and untreated OUD, was generally not engaged in care at this clinic. Few HIV clinic patients used opioids, and those that did tended to adhere to their HIV treatment and ART medications and were therefore virally suppressed. Consequently, staff turned their efforts to identifying and screening individuals that were not engaged in HIV care. Based on experience with past CTN studies, where community outreach had been central to the site’s ability to recruit from the large community of persons who use drugs and are sometimes homeless in the area, site leadership designated an experienced, full-time outreach worker to the study.28,29.

Engaging homeless adults who use drugs in research is challenging, on top of known challenges to accessing HIV care in Miami.30 Limited access to transportation for research visits was a barrier overcome by having the outreach worker complete daily street-level outreach in the community in the site’s dedicated research van. Outreach consisted of informal “check-ins” and conversations with current and potential participants, providing water and snacks and providing rides to and from the HIV clinic. The study outreach worker was very familiar with the neighborhoods surrounding the study site and was well known by the “locals.” She maintained a non-judgmental attitude, which helped to facilitate rapport with potential participants.

Enrolling individuals living with untreated HIV and OUD from the community into care at the Jackson HIV clinic also proved challenging and complex. Many patients, whether they were newly diagnosed, had never been in care, or were currently out of care, did not have active insurance cover-age which was required before they could be seen by a clinician. Patients had to complete various, lengthy appointments which included a “test and treat” engagement or re-engagement visit, Ryan White enrollment, financial eligibility assessment, and enrollment into the AIDS Drug Assistance Program (ADAP). Guiding patients through these steps and appointments required intensive col-laboration between the study staff/IDEA SSP staff and the case managers at Jackson’s Ryan White case management agency.

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There were many barriers to recruitment identified in qualitative interviews. This study experience suggests that SSPs are well-suited sites to conduct a trial with initiation of MOUD for those who are interested, due to the fundamental principles of harm reduction and street medicine and meeting people where they are, on their own terms. Similar results were reported in a randomized clinical trial which evaluated the efficacy of three treatment initiation strategies for improving retention to methadone maintenance for opioid-dependent individuals referred from a syringe exchange program (SEP).31 Inclusion of people who inject drugs in the planning of the study could have avoided some of the encountered problems with recruitment.32 Decades of intransigent stigma in the US health-care system against people who use drugs provide an opportunity to look for alternative venues to bring lifesaving care to people living with HIV and OUD.33 For example, Surratt et al. found that most participants recruited into their study in three county health department syringe service programs (SSPs) reported experiencing stigma from traditional healthcare providers.34 Similar to the current findings, participants had a comfort level with staff at their SSP that facilitated dialogue and engagement.

There are several limitations to this case report. First, the information provided is applicable to study recruitment in Miami but might not be applicable to all other jurisdictions with different cultures, populations, and settings. The Miami site also included a large HIV clinic with greater than 3000 annual patients which could have facilitated recruitment. This study draws conclusions based on a limited sample size that may be insufficient at achieving data saturation when generat-ing themes. Additionally, the interviews are subject to social desirability bias, an inherent desire to please interviewers during site visits. Nonetheless, the performance of the Miami site in recruitment for CTN-0067 CHOICES was rooted in a harm reduction and street-level approach as evidenced by the site’s recruitment numbers as well as interviews with study staff and participants.

This work highlights the importance of partnership with an SSP for recruitment of people with co-occurring HIV and OUD into a clinical trial. Partnership with the IDEA SSP in Miami provided access to a large population of people living with HIV who inject drugs. In future investigations, SSPs’ fundamental trust within the community of PWID should be leveraged in studies aiming to improve health outcomes in this underserved and high-priority population. Partnering with the com-munity and offering free services and opportunities produces trust through the act of giving. This offers researchers the opportunity to give back to their communities in meaningful ways.

Implications for Behavioral HealthThe objective of this study was to understand the contributors to recruitment of people with co-

occurring HIV and OUD into a clinical trial in Miami. This study investigated recruitment success in the Miami site of CTN-0067 CHOICES and identified potential lessons for future research. The performance of the site was rooted in a harm reduction and street-level approach. Staff described meeting people with OUD where they are and identifying potential participants outside of HIV and addiction treatment settings. The use of study outreach workers and the research team’s relationship with the local syringe services program, the IDEA Exchange (IDEA SSP), were key to the site’s recruitment success. SSPs’ fundamental trust within the community of PWID can be leveraged in future studies aiming to improve health outcomes in this underserved and high priority population.

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

Declarations

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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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