Rationale and design of an integrated bio-behavioral approach to improve adherence to pre-exposure prophylaxis and HIV risk reduction among opioid-dependent people who use drugs: The CHRP-BB study

Abstract

Background: Few primary HIV prevention strategies have successfully integrated both behavioral and biomedical components, with modest HIV risk reduction outcomes among opioiddependent people who use drugs (PWUD). In response to this unmet need, we developed a brief, bio-behavioral intervention to simultaneously promote PrEP adherence and reduce HIV risk among opioid-dependent PWUD. Methods: Using a Hybrid Type I implementation science design, we will examine the efficacy of the integrated bio-behavioral, Community-friendly Health Recovery Program (CHRP-BB) compared to a time-and-attention matched control condition among HIV-negative, opioiddependent PWUD who are prescribed PrEP and enrolled in a methadone maintenance program (MMP) using a randomized controlled trial (RCT). Participants are assessed at baseline, immediately post-intervention (8 weeks) and follow-ups at weeks 20, 32, and 44 post-intervention. The primary outcome is biomedical (PrEP adherence), with secondary outcomes including behavioral (self-reported drug-and sex-related HIV risk behaviors), ongoing drug use (confirmed with urine drug testing), and related domains of the theoretical information-motivation-behavioral skills (IMB) model of behavior change related to PrEP adherence and HIV-transmission-risk reduction. Additionally, we will conduct a process evaluation of delivery/implementation of the intervention to collect valuable information to be used in future implementation.

Coordinating Systems of Care for HIV and Opioid Use Disorder: A Systematic Review of Enablers and Barriers to Integrated Service Access, and Systems and Tools Required for Implementation

“…Other OUD treatment programs with integrated HIV services that were limited in scope included recruiting participants from an urban comprehensive MMT program to deliver weekly group meetings and text messages for clients to reduce sex and drug use behaviors that increase HIV risk and to enhance PrEP adherence. The program sought to overcome challenges associated with neurocognitive impairment, which is common among people who use drugs and contributes to poor treatment adherence ( Shrestha et al, 2019 ). Three other studies described integration of HIV prevention (including risk assessment, education, and testing) into OTPs ( Jessop et al, 2017 ; Knudsen et al, 2017 ; Peavy et al, 2020 ).…”

“…Two studies explored potential interest of clients seeking OUD treatment to engage in integrated HIV services: integrating PrEP into a prison MAT program and the potential of health information technology to optimize HIV treatment for clients enrolled in an inpatient detoxification program ( Peterson et al, 2019 ; Tofighi et al, 2019 ). Client acceptability of PrEP integration into MMT was also examined within the program described above ( Shrestha & Copenhaver, 2018 ; Shrestha et al, 2019 ).…”

“…Open-access models that did not require an appointment and allowed clients to walk in whenever it was convenient also facilitated service access. On-site HIV testing at MMT facilities enabled HIV service access via referrals ( Gardner et al, 2016 ; Jessop et al, 2017 ; Oldfield et al, 2019a ; Shrestha et al, 2019 ).…”

“…Both model types referred to developing integrated referral systems to ensure that clients were able to move between services effectively ( Aggarwal et al, 2019 ; Irvine et al, 2017 ; Oldfield et al, 2019a ). Both models also introduced integrated risk assessment tools to identify clients with HIV who may require OUD treatment, and to identify clients with OUD who may be at risk for HIV ( Gardner et al, 2016 ; Irvine et al, 2017 ; Oldfield et al, 2019a ; Shrestha et al, 2018 , 2019 ). Both models developed intake, clinical monitoring, and reporting tools for clients accessing HIV and/or OUD services ( Gardner et al, 2016 ; Jessop et al, 2017 ).…”

“…Another OUD Service Integration program, wherein outpatient OUD treatment was the entry point, integrated HIV risk counseling and PrEP adherence-trained graduate-level facilitators delivered the intervention in person and followed up with clients between sessions via adherence reminder text messages ( Shrestha & Copenhaver, 2018 ; Shrestha et al, 2018 ). A similar intervention was also implemented within the New Haven MAT prison program and five surrounding MAT facilities ( Shrestha et al, 2019 ). The Opioid Outpatient Treatment program (in which outpatient methadone treatment was the service entry point that provides integrated HIV testing and treatment) uses primary care clinicians, psychiatrists, and medical and social case managers to deliver comprehensive services ( Simeone et al, 2017 ).…”