A non-inferiority trial of an evidence-based secondary HIV prevention behavioral intervention compared to an adapted, abbreviated version: Rationale and intervention description

Roman Shrestha; Archana Krishnan; Frederick L Altice; Michael Copenhaver

doi:10.1016/j.cct.2015.08.002

A non-inferiority trial of an evidence-based secondary HIV prevention behavioral intervention compared to an adapted, abbreviated version: Rationale and intervention description

Contemp Clin Trials. 2015 Sep:44:95-102. doi: 10.1016/j.cct.2015.08.002. Epub 2015 Aug 5.

Authors

Roman Shrestha¹, Archana Krishnan², Frederick L Altice³, Michael Copenhaver⁴

Affiliations

¹ Department of Community Medicine & Health Care, University of Connecticut Health Center, Farmington, CT, USA; Center for Health, Intervention, & Prevention (CHIP), University of Connecticut, Storrs, CT, USA.
² Center for Health, Intervention, & Prevention (CHIP), University of Connecticut, Storrs, CT, USA; Section of Infectious Diseases, AIDS Program, Yale University School of Medicine, New Haven, CT, USA.
³ Center for Health, Intervention, & Prevention (CHIP), University of Connecticut, Storrs, CT, USA; 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.
⁴ Center for Health, Intervention, & Prevention (CHIP), University of Connecticut, Storrs, CT, USA; Department of Allied Health Sciences, University of Connecticut, Storrs, CT, USA. Electronic address: Michael.Copenhaver@UConn.edu.

Abstract

Background: Real-world clinical settings like addiction treatment programs are ill-equipped to deploy and sustain the existing resource-demanding evidence-based interventions (EBIs) that target HIV-infected people who use drugs (PWUDs), and this has left a critical void in current HIV prevention efforts. In response to this unmet need, we have conducted formative research in addiction treatment settings that has resulted in Holistic Health for HIV (3H+) - an empirically adapted, substantially abbreviated version of Holistic Health Recovery Program (HHRP+), a CDC-recommended EBI targeting HIV-infected PWUDs.

Methods: Using a non-inferiority randomized controlled trial design, we will determine whether the abbreviated 3H+ intervention is comparable (i.e., within a 10% margin) and cost-effective relative to the original HHRP+ intervention in terms of reducing HIV risk behaviors and improving antiretroviral therapy (ART) adherence among HIV-infected PWUDs in addiction treatment who report drug- or sex-related HIV risk behaviors.

Conclusions: This article provides a description of the development and adaptation of the 3H+ intervention, the innovative non-inferiority comparative experimental design for testing the 3H+ to the HHRP+. Furthermore, it provides empirical evidence from a formal cost-effectiveness analysis justifying the cost-effectiveness of the 3H+ intervention when compared to the HHRP+ intervention. If confirmed to be comparable and more cost-effective, as hypothesized, the 3H+ intervention has the potential to be readily and immediately integrated within common clinical settings where large numbers of HIV-infected PWUDs receive clinical services.

Keywords: Antiretroviral adherence; Drug users; HIV risk reduction; Intervention adaptation; Non-inferiority prospective trial; Secondary HIV prevention.

Abstract

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