Roman Shrestha1, Frederick L Altice2, Brian Sibilio3, Jude Ssenyonjo3, Michael M Copenhaver3. 1. Section of Infectious Diseases, AIDS Program, Yale University School of Medicine, New Haven, CT, USA. Electronic address: roman.shrestha@yale.edu. 2. Section of Infectious Diseases, AIDS Program, Yale University School of Medicine, New Haven, CT, USA; Division of Epidemiology of Microbial Diseases, Yale University School of Public Health, New Haven, CT, USA. 3. Department of Allied Health Sciences, University of Connecticut, Storrs, CT, USA.
Abstract
BACKGROUND: Few primary HIV prevention strategies have successfully integrated both behavioral and biomedical components, with modest HIV risk reduction outcomes among opioid-dependent 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, opioid-dependent PWUD who are prescribed PrEP and enrolled in amethadone 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. CONCLUSIONS: This study will be among the first prospective trial to test an integrated bio-behavioral intervention to improve adherence to PrEP and HIV risk reduction among opioid-dependent PWUD.
RCT Entities:
BACKGROUND: Few primary HIV prevention strategies have successfully integrated both behavioral and biomedical components, with modest HIV risk reduction outcomes among opioid-dependent 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, opioid-dependent 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. CONCLUSIONS: This study will be among the first prospective trial to test an integrated bio-behavioral intervention to improve adherence to PrEP and HIV risk reduction among opioid-dependent PWUD.
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