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. Author manuscript; available in PMC: 2022 Dec 1.
Published in final edited form as: Drug Alcohol Depend. 2021 Oct 27;229(Pt A):109124. doi: 10.1016/j.drugalcdep.2021.109124

Acceptability, Feasibility, and Pilot Results of the Tele-Harm Reduction Intervention for Rapid Initiation of Antiretrovirals among People Who Inject Drugs

Hansel E Tookes a, Tyler S Bartholomew b, Edward Suarez c, Elisha Ekowo a, Margaret Ginoza a, David W Forrest d, David P Serota a, Allan Rodriguez a, Michael A Kolber a, Daniel J Feaster b, Angela Mooss e, Derek Boyd e, Candice Sternberg a, Lisa R Metsch f
PMCID: PMC9102418  NIHMSID: NIHMS1756575  PMID: 34781096

Abstract

Background

Persons who inject drugs (PWID) have been a marginalized and a stigmatized population since the beginning of the AIDS epidemic and have not experienced the same life-changing benefits of antiretroviral therapy as others. Tele-Harm Reduction (THR) is a telehealth-enhanced, harm reduction intervention, delivered within a trusted SSP venue. It aims to facilitate initiation of care and achieve rapid HIV viral suppression among PWID living with HIV.

Methods

In this mixed-methods study, we employed the Practical, Robust, Implementation and Sustainability Model (PRISM) implementation science framework to identify multilevel barriers and facilitators to implementing the THR intervention. Focus groups (n=2, 16 participants), stakeholder interviews (n=7) and in-depth interviews were conducted with PWID living with HIV (n=25). In addition, to assess feasibility and acceptability, we pilot tested the THR intervention and reported viral suppression at 6 months.

Results

Focus groups and stakeholder interviews revealed system and organizational level barriers to implementation including requirements for identification and in person visits, waiting times, stigma, case management inexperience, multiple electronic health records, and billing. A potential facilitator was using telehealth for case management and initial provider visit. In the in depth interviews conducted with PWID living with HIV, participants expressed that the SSP creates a convenient, comfortable, confidential environment for delivering multiple, non-stigmatizing PWID-specific services. 35 PWID living with HIV were enrolled in the pilot study, 35 initiated antiretroviral therapy, and 25 (78.1%) were virally suppressed at six months.

Conclusion

Rooted in harm reduction, the THR intervention shows promise in being an acceptable and feasible intervention that may facilitate engagement in HIV care and viral suppression among PWID.

Keywords: people who inject drugs, harm reduction, HIV, telehealth, syringe services program

1. INTRODUCTION

Persons who inject drugs (PWID) have been a marginalized and stigmatized population since the beginning of the AIDS epidemic (Karch, Gray, Shi, & Hall, 2016; Kim et al., 2019) and have not experienced the same life-changing benefits of antiretroviral therapy (ART) as others in the U.S. and developed countries. Even with the advent of ART in the late 1990s, PWID have experienced suboptimal health outcomes in HIV care and have remained disproportionately impacted by the hepatitis C virus (HCV) (Smith, Combellick, Jordan, & Hagan, 2015) and opioid use disorder (OUD). Injection drug use has led to multiple outbreaks of HIV in the U.S. since 2015 (Alpren et al., 2020; Golden et al., 2019; Lyss, Buchacz, McClung, Asher, & Oster, 2020; Peters et al., 2016; Tookes et al., 2020), impeding our efforts in meeting the Ending the HIV Epidemic (EHE) goal of a 90% reduction in incident HIV infections by 2030. The most effective intervention to prevent HIV among PWID remains syringe services programs (SSPs), with decades of evidence demonstrating their effectiveness for HIV and HCV primary prevention (Fernandes et al., 2017; Gibson, Flynn, & Perales, 2001; Hurley, Jolley, & Kaldor, 1997; MacDonald, Law, Kaldor, Hales, & Dore, 2003; Ruiz et al., 2019; Strathdee & Vlahov, 2001). SSPs have been highlighted as a cornerstone intervention in the Prevent pillar of the EHE initiative (Fauci, Redfield, Sigounas, Weahkee, & Giroir, 2019). To combat and effectively respond to the infectious disease and substance use disorder (SUD) syndemic (Perlman & Jordan, 2018), it is critical to investigate the role SSPs play in the remaining EHE pillars (Diagnose, Treat, and Response).

One promising and innovative intervention for PWID, persons living with HIV (PLHIV), and people living with HCV is the use of telehealth (Lin et al., 2019). A telehealth approach has shown promise for physician-patient encounters and remote PrEP initiation among men who have sex with men (MSM; (Refugio et al., 2019; Stekler et al., 2018)). Likewise, telehealth for provider consultation in HIV care is promising and increasingly used for geographically remote populations (Wood et al., 2016). Telehealth also has been used for direct patient consultation for HIV care (Ohl et al., 2013), including with marginalized populations such as PLHIV in the prison system (Young et al., 2014). While a series of recent review articles have demonstrated the positive impact of telehealth on adherence and viral suppression (Daher et al., 2017; Henny, Wilkes, McDonald, Denson, & Neumann, 2018; Mayer & Fontelo, 2017; Muessig, Nekkanti, Bauermeister, Bull, & Hightow-Weidman, 2015), the few conducted studies to assess telehealth acceptability and feasibility among PWID point to reduced access to mobile devices, decreased text messaging and internet access and limited interest (Collins et al., 2016; Genz et al., 2015). PWID living with HIV face a myriad of barriers to entering HIV outpatient care, including intransigent stigma by the healthcare system related to their substance use, HIV and HCV (Biancarelli et al., 2019; Lang et al., 2013) and social disadvantage (Artenie et al., 2021; Fortier et al., 2020). Since there are PWID who do not access formal medical services, but frequent SSPs (Heinzerling et al., 2006), adapting a low-threshold, comprehensive treatment model for PWID requires a paradigm shift of how care is delivered for this overlooked key population. This includes increasing availability of medications for opioid use disorder (MOUD) and direct-acting antivirals (DAA) for HCV through non-stigmatizing healthcare venues.

Given the era of COVID-19 and the potential for future natural or human-made disasters, expanding telehealth for marginalized populations most affected by HIV and SUD is of utmost importance. During the COVID-19 pandemic, there has been a significant reduction in SSP services, especially limited HIV testing, decreased hours of operations for syringe distribution, and reduced outreach in the community (Bartholomew, Nakamura, Metsch, & Tookes, 2020; Glick et al., 2020). While initially necessary, all of these changes may be increasing risk for silent outbreaks of HIV/HCV, contributing to the sharp increase in deaths due to overdose (Hochstatter et al., 2020) and exacerbating the psychosocial and structural factors in the HIV/SUD syndemic (Shiau, Krause, Valera, Swaminathan, & Halkitis, 2020). However, there remains limited research on a comprehensive, efficacious, and feasible intervention at SSPs to address HIV and OUD among PWID (Lucas et al., 2010; Miller et al., 2018; Sullivan et al., 2006).

To fill this service gap, we used community-driven research to develop Tele-Harm Reduction (THR). THR is a telehealth-enhanced, harm reduction intervention, delivered within a an SSP venue that is trusted by PWID (Castillo et al., 2020; Ginoza et al., 2020; Heinzerling et al., 2006). It aims to facilitate initiation of care and achieve rapid HIV viral suppression among PWID living with HIV. In this study, we employed the Practical, Robust, Implementation and Sustainability Model (PRISM) implementation framework (Feldstein & Glasgow, 2008) to identify multilevel (system, organizational, and individual) barriers and facilitators to implementing the THR intervention. In addition, we pilot tested the THR intervention to generate preliminary data on HIV outcomes, such as HIV treatment initiation and viral suppression at 6 months post study enrollment.

2. METHODS

2.1. Human Subjects

This study was approved by the Institutional Review Board at the University of Miami (IRB #20190893) for the formative component and (IRB#20200920) for the pilot. All participants provided verbal informed consent for the in-depth interviews and stakeholder focus groups. The participants in the THR pilot were included via a retrospective chart review with consent waived.

2.2. Study Setting

IDEA Miami SSP was founded in 2016 as the first legal SSP in Florida. There are over 1,700 PWID currently enrolled and 10% of PWID enrolled are living with diagnosed HIV. Miami-Dade County is a high priority county under the EHE plan (Fauci et al., 2019) and has a high prevalence of injection drug use (Brady et al., 2008; Friedman et al., 2004). IDEA Miami is housed within the University of Miami Miller School of Medicine in partnership with the county safety-net hospital, Jackson Health System. IDEA Miami exchanges up to 10,000 syringes weekly and currently operates 3 fixed and 5 mobile sites within Miami-Dade County.

2.3. Tele-Harm Reduction Intervention

The THR intervention is a two-component intervention designed using a community-based approach grounded in knowledge generated from qualitative interviews (presented herein) from current SSP clients living with HIV. Based on existing barriers identified (pervasive stigma in traditional healthcare settings, lack of transportation, inflexibility with appointments, syndemic conditions), we employed a harm reduction framework to develop a low barrier, rapid, flexible, on demand access to HIV care for PWID living with HIV accessing syringe services via remote video technology (i.e. telehealth) integrated at the fixed or mobile SSP sites or the location of the patients’ choosing. (Figure 1). Component 1 of the THR intervention utilized telehealth technology, coupled with our SSP’s Community Engagement Team (CET; a team comprised of peers, social workers and an onsite linkage-to-care coordinator) to connect with medical case managers and enroll patients in Ryan White/AIDS Drug Assistance Program for initiation of HIV treatment. Once enrollment documentation was completed, the CET utilized a HIPAA compliant videoconference platform established by the University of Miami Health System to connect the patient with a Ryan White case manager to process the enrollment, followed by an on-demand visit with an HIV provider. Execution of this portion of the intervention required secure internet access, disposable headphones to ensure the patient privacy, and mobility to meet the patient wherever they were located. Via videoconference, the physician evaluated the patient, utilizing onsite phlebotomy at the SSP to perform the initial clinical encounter and to obtain baseline HIV labs, including HIV viral load. Once the initial visit with the physician was completed, HIV medications were e-prescribed and sent to a local pharmacy in close proximity to the SSP. Third-party authorization and consent for storage of medication was obtained by the CET as part of the initial enrollment documentation, and medications were either picked-up or delivered directly to the SSP for the patient to access. Once ART was obtained by CET, patients were initiated onto treatment through direct observation by the CET on-site or on the mobile unit. The time to complete component 1 of the intervention was approximately 3 hours, compared to 1–7 days after Rapid Test and Treat was implemented in Miami-Dade County in 2016, and 49–73 days prior to establishment of Test and Treat (Rodriguez et al., 2019).

Figure 1.

Figure 1.

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The Tele-Harm Reduction Intervention

Component 2 of the THR intervention, developed in response to qualitative interviews (presented below), utilized the SSP-based CET to work with patients in identifying individual-specific barriers and facilitators to medication adherence. Since the majority of patients were currently experiencing unstable housing, patients were offered flexible medication management protocols that included onsite storage of HIV medications via pill lockers at the SSP. If patients were unable to physically retrieve their medications at the fixed site location, the CET would complete a medication drop, delivering medications directly to the patient where they were in the field. During each medication distribution, the CET worked with clients to improve self-efficacy using evidence-based techniques, such as motivational interviewing (Artenie et al., 2021). If patients had co-occurring mental health disorders, they were connected to the SSP’s onsite psychologist for mental health assessment and treatment.

THR medical services included management of HIV, SUD, and other comorbidities. Physician visits were available to patients on-demand during most business hours and coordinated by the CET. All patients with OUD were repeatedly offered initiation of buprenorphine-naloxone as well as naloxone for overdose prevention. Patients with chronic HCV infection were initiated onto treatment with direct-acting antivirals (DAAs), when feasible. Patients were screened for sexually transmitted infections and navigated to treatment services when needed.

2.4. PRISM Implementation Model

We employed the Practical, Robust Implementation and Sustainability Model (PRISM) to examine organizational and patient perspectives regarding our THR intervention and identify barriers in the external environment that would impede successful implementation and sustainability. PRISM integrates key elements and theory from Diffusion of Innovations (Kaminski, 2011), the Chronic Care Model, and the Model for Improvement (Courtlandt, Noonan, & Feld, 2009) to provide contextual constructs that influence the Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) implementation model outcomes (Feldstein & Glasgow, 2008). PRISM emphasizes the importance of multilevel contextual factors that act as drivers of RE-AIM outcomes, such as the organizational and the patient perspective of the intervention, the external environment (i.e. community-level resources) and the implementation and sustainability infrastructure. Due to the stage of implementation (implementation planning and intervention development), we focused on the organizational perspective (i.e. coordination across organizations, complexity of design, trialability) and the patient perspective (patient-centeredness, patient barriers, access) of the intervention to understand acceptability and feasibility of implementing the THR intervention.

2.5. Data Collection

We conducted a series of in-depth interviews and focus groups with community stakeholders and SSP staff (organizational perspective and implementation and sustainability infrastructure) and in-depth interviews with PWID living with HIV accessing syringe services (patient perspective) to identify barriers to implementation of THR. In addition, quantitative data on THR engagement and viral suppression was collected among individuals enrolling in the pilot study. In 2019, data were collected in a sequential order: First, a focus group (n=6) was held with the IDEA team including program administrators, CET, direct service providers, outreach staff, and a consumer to identify the current client pathway to HIV testing using an anonymous testing model. Additionally, the ideal client pathway (merging IDEA Miami SSP services with the existing Test and Treat infrastructure (Rodriguez et al., 2019)) was discussed citing barriers to implementation.

Next, seven key stakeholder interviews were held via phone and in-person with individuals working within the HIV/AIDS community including those in funding and administrative positions (e.g., Miami-Dade County Ryan White Program, Florida Department of Health). These non-structured interviews resulted in identification of key policy stakeholders and provided insight on which community partners were necessary to remove barriers to implement and sustain the ideal client pathway for the THR intervention at IDEA. Then, a final group of “stakeholder champions” were identified by the lead research team and convened for a second focus group (n=10) (Table 1). These persons were selected based on three factors; 1) leadership position, 2) ability to make decisions/remove barriers, and 3) organizational proximity to barriers identified in stakeholder interviews and the initial focus group. To ensure barriers were addressed with consumer voice in mind, a member of the impacted community (a former SSP client living with HIV) provided consistent feedback. This second focus group was used to generate solutions to barriers identified for implementing the THR intervention into IDEA Miami SSP processes and to assign champions to effectively execute solutions.

Table 1.

Key stakeholders and organizations who participated in interviews and focus groups

Organization Organization Type Stakeholder(s) participating
IDEA SSP Syringe Services Program (SSP) Program Director, Medical Director, Community Engagement Supervisor, Community Outreach Coordinator
Miami-Dade County Department of Health Local Health Department STD-HIV Prevention and Control Director, Manager
Florida Department of Health State Health Department HIV/AIDS Medical Director
Ryan White Program County Administration Site Program Administrator
Ryan White HIV provider HIV/AIDS Service Provider Case Management Supervisor, Case Managers
University HIV/AIDS program Direct Service Provider & University Governance Director-Adult HIV Services; Core Director- Miami Center for AIDS Research
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After community stakeholder interviews were conducted, a purposive sample of PWID living with HIV accessing services at the SSP (N=25) were recruited between August and November 2020 at the fixed SSP site for a 25–30 minute interview. Inclusion criteria included 1) 18 years of age or older; 2) Enrolled in the IDEA Miami SSP; 3) newly or previously diagnosed with HIV confirmed with a reactive HIV rapid test; 4) English or Spanish speaking. Those who are eligible for the study were verbally consented and asked to participate in a 30-minute interview conducted at the IDEA Miami SSP for which they received $50.

All interviewers received training on qualitative methods and interviewing procedures, and standardized interview guides were used to facilitate discussion. In-depth interviews explored patient-level acceptability of the THR intervention, barriers and facilitators to engagement in the intervention, intervention complexity and recommendations on how to improve the design and delivery of the intervention.

Once all qualitative data on acceptability, feasibility, and intervention design were analyzed, the THR intervention was implemented and integrated into the workflow at the SSP. One staff member at the SSP was identified as an intervention “champion” and was trained on the entire THR intervention. The champion then trained a team of outreach staff (i.e. CET) to perform intervention-specific activities. Participants were offered THR if they were initiating, returning to, or completing required Ryan White/AIDS Drug Assistance Program updates to continue HIV care.

Participants were recruited at both the fixed and mobile SSP sites. Basic socio-demographics (age, biological sex, race/ethnicity, educational attainment, annual income, housing status, sexual orientation) and substances used via injection (heroin, cocaine, methamphetamine, speedball, and fentanyl) were collected during the enrollment process. Data on HIV treatment outcomes were abstracted from onsite medication logs to examine medication adherence and patient medical records to assess 6-month viral suppression.

2.6. Data Analysis

2.6.1. Qualitative data analysis:

Interviews and focus groups were audio-recorded, transcribed verbatim by an external transcription company, and uploaded into Dedoose software (Talanquer, 2014) for analysis. Data collected from interviews and focus groups with stakeholders was analyzed separately from the in-depth interviews conducted with PWID living with HIV. Data analysis was guided by PRISM constructs and employed a general inductive approach to generate emergent themes. Two study members independently generated codes on a subsample of transcripts to create the initial codebook. Codes were compared across coders and collapsed based on coder agreement. Once the final codebook was generated, each coder applied the codebook to a new subsample of transcripts, independently, and consistency between coders was found to be satisfactory (k ≥ 0.70) (Cohen, 1960). The remaining transcripts were coded and analyzed. Qualitative data are presented using direct quotes to increase reliability of the analysis.

2.6.2. Quantitative Data Analysis:

Descriptive statistics of the sample enrolling in the THR pilot (N=35) are presented as counts and percentages for categorical variables and median and interquartile range for continuous variables. Data abstracted from medical records are presented as counts and percentages of individuals completing each step in the HIV care cascade (HIV/AIDS, 2014). Two participants were missing 6-month HIV viral load results and were included in the non-suppressed group.

3. RESULTS

3.1. Organizational Perspective

Results from the first focus group elucidated the optimal pathway to implement the THR intervention within the IDEA Miami SSP’s current client flow (Figure 2) and was used as a foundational piece to discuss barriers and facilitators to implementation in the second focus group with community stakeholders. A list of community stakeholders engaged in the second focus group can be found in Table 1. System and organizational level barriers to implementation uncovered between the second focus group and individual interviews were aggregated into three broader themes: Intra-organizational, inter-organizational, and system-wide education. Solutions across multiple representative organizations on how to overcome these system-level barriers were elucidated and addressed. An overview of the emergent barriers and suggested resolutions can be found in Table 2.

Figure 2.

Figure 2.

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Ideal patient flow for entering HIV care via Tele-Harm Reduction

Table 2.

Themes from focus group discussions with identified community-level stakeholders

Theme Barrier Identified Solution to overcome barrier PRISM Domain
Inter-organizational communication and collaboration Various electronic health records across partners Scanning/uploading documents across electronic health records Organizational Perspective; Implementation and Sustainability Infrastructure
Waiting time to enroll in Ryan White HIV/AIDS Program and see a physician (same day) Enroll in Ryan White Program using Telehealth Implementation and Sustainability Infrastructure
SSP staff accompanying client for appointment to mitigate stigma was not sustainable Enroll in Ryan White Program using Telehealth Implementation and Sustainability Infrastructure
Case management experience varied regarding the target population, and staff turnover is common Two culturally sensitive case managers were designated to receive alerts (text and email) when a new PLHIV was identified External Environment; Implementation and Sustainability Infrastructure
Enrollment into the AIDS Drug Assistance Program (ADAP) requires inperson, onsite paperwork and limited medication to a 30-day supply Department of Health can have someone complete enrollment onsite at SSP; ADAP enrollment options using Telehealth technology; 90-day supply of medication is permitted; SSP staff can pick up medication on behalf of IDEA clients Organizational Perspective; External Environment; Implementation and Sustainability Infrastructure
Intra-organizational barriers IDEA was authorized to operate only as a pilot under the initial legislation Stakeholders successfully advocated for Senate Bill 366 allowing SSPs to operate pending county opt-in throughout the state. Miami-Dade County opted in. Organizational Perspective
IDEA SSP is a part of University of Miami Health System and uses an electronic health record to document which automatically generates a bill The electronic health record was updated to not automatically generate a bill under the unique IDEA Wellness Clinic department code. Organizational Perspective
System-wide education and stigma reduction Not all Ryan White service providers had cultural sensitivity around working with vulnerable/disenfranchised communities University of Miami and SSP identified case managers with previous experience working with PWID living with HIV to develop training materials. External Environment
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3.2. Patient Perspective

Twenty-five PWID living with HIV enrolled at the SSP participated in the in-depth interviews; of those, 17 participants were enrolled in the THR pilot. Participants overwhelmingly expressed that receiving HIV care onsite at the SSP was acceptable, and a preferred delivery model, for a multitude of reasons. First, participants expressed that the SSP staff and HIV care providers create a comfortable, confidential environment by delivering non-stigmatizing services. As one participant stated:

“We get treated with respect. We get treated like normal human beings. You know?... They don’t see us – you guys don’t judge us. You guys don’t talk bad about us. You guys don’t mistreat us, don’t call us names. You know?...Feels like human beings with respect, love, and care…Genuine”. Female, 35 years old

Participants noted that previous experiences with stigma and discrimination in the traditional healthcare setting related to their HIV status and substance use were pervasive barriers and reasons for prior HIV treatment disengagement. Second, multiple participants expressed the convenience of having access to multiple PWID-specific services all in one location (i.e. SSP). As one participant explained:

“I think it covers basic(s) – you come here to get syringes because you need to use. Then, of course, they help with HIV…it’s all one place, one-stop shop”. Female, 27 years old

Participants also expressed remaining barriers to initiating HIV care for intervention consideration, such as competing priorities (i.e. continued substance use, mental health disorders), transportation, and expanding SSP hours of operation to include weekends and afternoons.

When provided information about the THR intervention, most participants expressed willingness and comfort with accessing an HIV provider via telehealth at the SSP. In addition, participants validated the importance of offering flexible medication management protocols, including onsite medication storage via pill lockers at the exchange and in-the-field medication deliveries so patient had multiple options of engagement. One participant stated:

“…Also, the fact that we have med lockers in – a lot of people that we deal with are homeless, so medication is very expensive, and it’s either stolen or sold, so the lockers cut that out of the equation”. Male, 61 years old

However, a small minority of participants expressed concerns regarding confidentiality and security of the HIPAA compliant videoconferencing system in addition to their perceived ability to navigate the telehealth technology. Participants also provided insights into intervention design improvements, including the desire to have peers (i.e. persons with lived experience) integrated into the delivery of the intervention. In addition, participants expressed the need to integrate and expand this intervention at the mobile SSP site to increase intervention reach and patient accessibility.

3.3. Pilot Study Outcomes

Between January 2020 and June 2021, 35 PWID living with HIV were enrolled in the THR pilot study with at least 6 months of follow up per participant. Demographics and drug use patterns are presented in Table 3. The majority were male (57.1%), experiencing unstable housing (59.4%), and injected heroin (77.1%), cocaine (37.1%), speedball (25.7%) or fentanyl (14.3%). We conducted 35 THR visits for Ryan White case management and initial visit with a physician, and 35 initiations of care (Figure 3). Supported by 94 physician visits, 652 medication drops by CET, and continuous engagement at syringe exchanges, 25 (78.1%) were virally suppressed (i.e. HIV RNA <200) at six months, the end of the pilot period. In THR, 2 participants were not engaged in medication delivery services, 15 received medications at the fixed site via 270 drops, and 18 received medications in the field via 382 drops. Thirty-four participants had a diagnosis of OUD by Diagnostic and Statistical Manual of Mental Disorders (DSM-5) (Asken, Grossman, & Christensen, 2007) and 27 were prescribed MOUD during the pilot period. Five were prescribed DAA for HCV.

Table 3.

Descriptive statistics of patients enrolled in the Tele-Harm Reduction pilot, stratified by 6-month viral suppression status

Characteristic Enrolled in THR Pilot (N=35) Virally Suppressed at 6 months (n=25) Nonsuppressed at 6 months (n=10)
Age (median, IQR) 42 (36–55) 41 (36–54) 49 (38–59)
Biological Sex (n, %)
 Male 20 (57.1) 13 (65.0) 7 (35.0)
 Female 15 (42.9) 12 (80.0) 3 (20.0)
Race/Ethnicity (n, %)
 Non-Hispanic White 12 (36.4) 10 (83.3) 2 (16.7)
 Non-Hispanic Black 7 (21.2) 5 (71.4) 2 (28.6)
 Hispanic 14 (42.4) 8 (57.1) 6 (42.9)
Educational Attainment (n, %)
 <High School/GED 23 (67.7) 14 (60.9) 9 (39.1)
 >High School/GED 11 (32.4) 11 (100.0) 0 (0.0)
Annual Income (n, %)
 <$14,999 20 (66.7) 14 (70.0) 6 (30.0)
 >$15,000 10 (33.3) 9 (90.0) 1 (10.0)
Housing Status (n, %)
 Currently experiencing unstable housing 19 (59.4) 13 (68.4) 6 (31.6)
 Not experiencing unstable housing 13 (40.6) 10 (76.9) 3 (23.1)
Sexual Orientation (n, %)
 Gay/Bisexual 6 (18.2) 6 (100.0) 0 (0.0)
 Heterosexual 27 (81.8) 18 (66.7) 9 (33.3)
Substances Injected (n, %)
 Heroin 27 (77.1) 19 (70.4) 8 (29.6)
 Cocaine 13 (37.1) 10 (76.9) 3 (23.1)
 Methamphetamine 3 (8.8) 3 (100.0) 0 (0.0)
 Speedball 9 (25.7) 7 (77.8) 2 (22.2)
 Fentanyl 5 (14.3) 4 (80.0) 1 (20.0)
Type of Medication Management (n, %)
 Accessed at SSP fixed site 15 (45.5) 12 (80.0) 3 (20.0)
 In-field medication drop 18 (54.5) 11 (61.1) 7 (38.9)
Prescribed HCV Treatment (n, %)
 Yes 5 (14.3) 3 (60.0) 2 (40.0)
 No 30 (85.7) 22 (73.3) 8 (26.7)
Prescribed MOUD (n, %)
 Yes 27 (77.1) 18 (66.7) 9 (33.3)
 No 8 (22.9) 7 (87.5) 1 (12.5)
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Figure 3.

Figure 3.

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Tele-Harm Reduction intervention pilot outcomes

4. DISCUSSION

In this study we showed that the THR intervention delivered through an SSP was acceptable, feasible, and preliminarily promising in achieving virologic suppression in a vulnerable population of PWID living with HIV in one of the highest HIV-incidence metropolitan areas in the United States. Recent increasing HIV incidence among PWID adds an urgency as well as a complexity in pursuit of an approach to achieve viral suppression and prevent incident infections (Alpren et al., 2020; Cranston et al., 2019; Peters et al., 2016; Tookes et al., 2019). The traditional healthcare system is not well designed to engage marginalized communities into care (Eaton, 2020)—EHE plans will require HIV care delivery, at least initially, to meet PWID outside of the often-stigmatizing care environment. Instead, we must meet patients where they are—both physically and mentally—with no judgment to facilitate later engagement into the healthcare system.

EHE is unique relative to past federal government HIV initiatives in that it specifically identifies SSPs as part of the strategy, and programs are currently being scaled in places where they have not previously been available. Previous studies have attempted to integrate care for patients with HIV/OUD by bringing addiction treatment with MOUD into HIV primary care settings (Lucas et al., 2010; Sullivan et al., 2006). While these programs have shown success, the populations evaluated were already established in HIV care and treatment-seeking for their OUD. Our new THR approach expands upon current models of care (Rodriguez et al., 2019; Tookes et al., 2020) and uses technology to bring HIV care out of the traditional medical system to serve and treat a marginalized population with uncontrolled HIV. Centering the delivery of the THR intervention at an SSP allows patients to transition between MOUD and clean syringes and is situated in an authentic harm reduction approach that respects patient autonomy.

We were able, through focus groups and qualitative interviews, to assess the feasibility and acceptability of telehealth case management for PWID who utilize our SSP in coordination with our Miami-Dade County Ryan White Program. This formative work led to a pilot of this service delivery system, in which we have successfully enrolled 35 PWID into Ryan White (via 2 culturally sensitive case managers who had both experience and desire to work with PWID) and ADAP (or verified insurance) via THR from the comfort of the non-stigmatizing SSP. We were also able to assess the feasibility and acceptability of using THR for rapid initiation of ART for newly and previously diagnosed individuals living with HIV in Miami. We established a Test and Treat site at the Miami IDEA SSP in partnership with the Florida Department of Health, offering a safe, de-stigmatizing place for individuals to enter care.

Participant feedback allowed us to refine the intervention throughout the pilot period. Our patients expressed satisfaction with the THR pilot, particularly when we added phlebotomy to our services at the SSP or on the mobile unit, completely removing any need to interact with the traditional healthcare system. Participants can come to the SSP for scheduled or on-demand THR visits in a dynamic, adaptive approach based on need; alternatively, outreach staff takes iPads, WiFi hotspots, and disposable headphones out to find participants. In addition to fundamental compassionate delivery of care enhanced via mobile SSP, partnerships with safety-net hospitals, Ryan White programs, substance use disorder treatment programs and shelters further tailored our intervention to patient need. Our THR Model is innovative in the delivery of enhanced access to specialty care for this vulnerable community who has been traditionally left behind in the advance of HIV prevention and treatment. Leveraging the SSP framework for initiation of ART, MOUD, and DAA has great promise as an adaptable model for low threshold care in the South and in resource limited settings in general, using SSPs to bring HIV care out of a traditional healthcare clinic, a critical step to any comprehensive EHE plans.

The THR pilot is especially timely in the COVID-19 era where PWID continue to experience extensive barriers to engagement in HIV care (Beima-Sofie et al., 2020; Rogers et al., 2020) with current estimates that less than half of PWID living with HIV in the US are virally suppressed (Karch et al., 2016; Kim et al., 2019). Early diagnosis and immediate ART initiation are essential to rapidly decrease viral transmission, reduce the impact of HIV outbreaks, and improve quality of life among PWID. After implementation of routine HIV and HCV testing at IDEA in 2018, a transmission network of seven incident HIV cases among PWID was identified by IDEA Miami SSP and found to be epidemiologically and socially linked to a larger network in need of HIV care. Alignment of resources led to early viral suppression (mean time = 70 days) after reactive rapid HIV test (Lyss et al., 2020; Tookes et al., 2020). However, the public health investigation and response revealed significant barriers to care for PWID that required a reexamination and shift in the way HIV care was delivered in Miami to people living with SUD and inspired the development of THR.

There are limitations to this this study. Specifically, this process included qualitative data collection from two focus groups and seven key stakeholder interviews. While key stakeholders represented leadership from various organizations involved in HIV care and treatment, there is a possibility that key representation at the individual or organizational level is absent. Likewise, it is possible that the PWID living with HIV interviewed were not representative of other demographics of PWID such as the large group of MSM who inject stimulants. However, based on demographics of individuals enrolled in the THR pilot, we were successful in enrolling PWID from communities of higher risk such as PWID experiencing unstable housing. Finally, while we were able to show high rates of viral suppression in our pilot, a randomized controlled trial will be necessary to determine the efficacy of the intervention versus the standard-of-care, generalizability to other locales, and cost effectiveness analysis for sustainability of the intervention.

5. CONCLUSION

The traditional healthcare system has fallen short for PWID. Without a change, we will not be able to get to zero HIV infections in the US. PWID often experience discrimination and considerable social disadvantage, that can be exacerbated by an HIV diagnosis. Rooted in harm reduction, the THR intervention shows promise in facilitating engagement in HIV care and viral suppression among PWID.

Supplementary Material

1

Highlights.

  • Tele-Harm Reduction is a peer driven, telehealth enhanced, harm reduction intervention

  • Tele-Harm Reduction overcomes stigma and meets persons who inject drugs where they are

  • Tele-Harm Reduction is promising in supporting HIV viral suppression

ACKNOWLEDGEMENTS

The team would like to express heartfelt thanks to the late Margo Lawson for her key role in execution of this study, as well as being an eternal inspiration for all of our work at IDEA. Thank you to our partners at the Florida Department of Health: Emma Spencer, PhD and Kira Villamizar, MPH. Finally, we would like to thank all of our IDEA participants for your trust in us to be your harm reduction home base.

FUNDING SOURCES

This work was supported by the National Institutes of Health 1 DP2 DA053720-01, 3P30MH116867-01A1S1, P30AI073961 and P30CA240139. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

Footnotes

Conflicts of interest: Dr. Tookes reports receiving funding from Gilead Sciences

Author Disclosure: none

Declaration of interests

The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

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