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

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.

PMID: 26253181
PMCID: PMC4744142
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

Roman Shrestha et al. Contemp Clin Trials. 2015 Sep.

. 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.

PMID: 26253181
PMCID: PMC4744142
DOI: 10.1016/j.cct.2015.08.002

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.

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Figures

**Figure 1**
Overview of study design Note: T measured in weeks

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References

1. Centers for Disease Control and P. HIV Surveillance Report, 2012. Vol. 24. Centers for Disease Control and Prevention; 2014. p. 83.
1. Avants SK, Margolin A, Usubiaga MH, Doebrick C. Targeting HIV-related outcomes with intravenous drug users maintained on methadone: a randomized clinical trial of a harm reduction group therapy. Journal of substance abuse treatment. 2004;26:67–78. - PubMed
1. Volkow ND, Montaner J. The urgency of providing comprehensive and integrated treatment for substance abusers with HIV. Health affairs (Project Hope) 2011;30:1411–9. - PMC - PubMed
1. Strathdee SA, Hallett TB, Bobrova N, Rhodes T, Booth R, Abdool R, et al. HIV and risk environment for injecting drug users: the past, present, and future. The Lancet. 376:268–84. - PMC - PubMed
1. Noar S. Behavioral Interventions to Reduce HIV-related Sexual Risk Behavior: Review and Synthesis of Meta-Analytic Evidence. AIDS and Behavior. 2008;12:335–53. - PubMed

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

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

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