CTN-0067: Comparing Treatments for HIV-Infected Opioid Users in an Integrated Care Effectiveness Study (CHOICES) Scale Up

Grants and Contracts Details


CTN-0067: Comparing Treatments for HIV-Infected Opioid Users in an Integrated Care Effectiveness Study (CHOICES) Scale Up STUDY SYNOPSIS AND SCHEMA Substance use disorders are common in HIV-infected individuals [1-5]. Untreated substance use disorders are associated with increased HIV risk behaviors [6-8], decreased receipt of antiretroviral therapy (ART) Andersen, 2000 #87; Cook, 2001 #88; Miguez, 2003 #89; Korthuis, 2004 #90}, decreased ART adherence [7, 9-12], decreased HIV viral suppression [9, 13-16], greater HIV-related symptoms [17, 18], and higher hospitalization rates [19, 20]. Compared to other HIV risk groups, people who inject drugs (PWID) are less likely to engage in HIV care and achieve HIV viral suppression [9, 13, 21] or sustained viral suppression [22, 23]. Treatment of substance use disorders can increase engagement in HIV care [24, 25]. Opioid replacement therapy (ORT) with methadone [26] and sublingual buprenorphine/naloxone (BUP/NX) [27] decrease HIV transmission risk behaviors and improve HIV outcomes, yet access to these medication-assisted therapies is limited and requires adherence to daily dosing. HIV providers are well-positioned to integrate pharmacotherapy for substance use disorders into HIV treatment settings, but thus far only BUP/NX has been adopted in HIV practice. In the Buprenorphine-HIV Evaluation and Support (BHIVES) Collaborative (a demonstration of integrated care for HIV and opioid dependence), HIV-infected individuals with opioid dependence who received office-based BUP/NX from an HIV clinic provider decreased opioid use [28], increased ART use [25], experienced higher quality of HIV care [29] and reported better quality of life [30]. HIV treatment guidelines now recommend opioid agonist therapy as a key treatment strategy for engaging PWID in HIV treatment [31]. Retention on agonist therapy remains limited, however, due to daily dosing requirements, and some patients would prefer alternatives to agonist treatment. Long-acting antagonist treatment may provide an alternative to daily agonist therapy for patients with opioid use disorder, though its ability to facilitate closing gaps in HIV treatment retention and outcomes is unknown. Extended-release naltrexone (XR-NTX), a deep muscle injection that lasts 28 days, eliminates the need for daily dosing. XR-NTX improves alcohol dependence treatment adherence and retention when integrated into primary care clinics [32, 33], but has not been tested in people living with HIV and having difficulty engaging in HIV treatment. XRNTX may also be preferred by some HIV-infected patients seeking a non-narcotic treatment option or once a month dosing. The CTN-0055 CHOICES pilot study demonstrated the feasibility of extended-release naltrexone (XR-NTX) for treatment of opioid use disorder in HIV primary care at two HIV clinic pilot sites. The CTN-0067 CHOICES scale-up study builds on lessons learned from the pilot and uses the Consolidated Framework for Implementation Research to advance understanding of XR-NTX adoption in HIV primary care settings. CTN-0067 CHOICES scale-up study is conducted in 8 HIV primary care clinics. It is an open-label, randomized, comparative effectiveness trial of officebased XR-NTX for 24 weeks (6 monthly injections) (n = 175) versus TAU (n = 175) in HIV-infected participants with untreated opioid use disorder and at risk for or presenting with HIV viral nonsuppression (Figure 1). The primary outcome is HIV viral suppression (HIV RNA pcr < 200 copies/mL) at 24 weeks. Secondary outcomes include VACS Index, CD4 count, HIV care engagement, and ART adherence mediation. The trial will be powered as a non-inferiority trial because the overall goal of the research is to add to rather than supplant currently available effective treatments. An implementation assessement documents best practices. Each participant will be engaged in the overall study for 25 to 26 weeks, depending on the speed of screening and enrollment procedures. Specific Aim: The specific aim is to compare the effect of office-based extended-release naltrexone (XR-NTX) versus treatment as usual (TAU) on HIV viral suppression at 24 weeks for HIV-infected participants with untreated opioid use disorder and at risk for or presenting HIV viral non-suppression at baseline. Secondary Specific Aims: Secondary aims compare the effectiveness of XR-NTX versus TAU in 1) other HIV outcomes (VACS Index, CD4 count), 2) engagement in HIV care (receipt of ART, ART adherence, retention in HIV care, HIV risk behaviors), 3) ART adherence as mediated by number of opioid use days at 24 weeks, and 4) qualitative interviews with patients, providers, and staff to document the HIV primary care treatment environment and describe XR-NTX formative implementation strategies, challenges, and best practices.
Effective start/end date6/1/175/31/18


  • University of Cincinnati


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