Adherence intervention for HIV-infected persons who use drugs: adaptation, open trial, and pilot randomized hybrid type 1 trial protocol

Kasey Claborn,Don Operario,Susan Ramsey,Sara Becker,Josiah D Rich,Steve Safren

doi:10.1186/s13722-018-0113-5

Abstract

BackgroundHIV-infected people who use drugs (PWUD) exhibit the highest rates of non-adherence to antiretroviral therapy (ART) among people living with HIV. This contributes to poor treatment outcomes, increased morbidity and mortality, and HIV transmission. However, current interventions fail to address the unique barriers to adherence faced by this population. Life Steps is a brief, single session intervention that demonstrated increased ART adherence among HIV-infected individuals. This study protocol seeks to improve clinical practice by adapting Life Steps for HIV-infected PWUD and adding a brief motivational intervention addressing drug use. This intervention will incorporate educational, motivational, and behavioral skills components specifically aimed at improving adherence and linkage to substance use treatment among HIV-infected PWUD.MethodsThis project will consist of three phases using a mixed-methods approach. In Phase 1, qualitative interviews with HIV-infected PWUD and community providers, coupled with feedback from an expert review panel, will be used to enhance the existing Life Steps manual and interventionist training protocol. In Phase 2, the prototype will be pilot tested and qualitative exit interviews with HPWUD will identify the strengths and limitations of the intervention. Data regarding feasibility, acceptability, and barriers to delivery will guide modifications to finalize a modified Life Steps-Drug Use (LS-DU) protocol. In Phase 3, a pilot type 1 hybrid effectiveness-implementation trial will examine the effectiveness of LS-DU relative to a health education intervention control condition on ART adherence and viral load data at 1-, 3-, and 6-months. Data regarding clinic readiness for implementation and intervention sustainability potential will be collected.DiscussionThis protocol will adapt and evaluate an intervention to improve adherence among HIV-infected PWUD. Results of this study will provide significant data on the acceptability, initial effectiveness, and sustainability potential of an adherence intervention for a high risk and underserved population.Trial registration NCT02907697

Highlights

human immunodeficiency virus (HIV)-infected people who use drugs (PWUD) exhibit the highest rates of non-adherence to antiretroviral therapy (ART) among people living with HIV
Illicit drug use remains a common and significant problem among people living with HIV (PLWH)
Only one study to date has evaluated Life Steps among a drug using population and this study focused on depressed injection drug users who are unlikely to be representative of the full range of HIV-infected PWUD [13]

Summary

Introduction

HIV-infected people who use drugs (PWUD) exhibit the highest rates of non-adherence to antiretroviral therapy (ART) among people living with HIV This contributes to poor treatment outcomes, increased morbidity and mortality, and HIV transmission. This study protocol seeks to improve clinical practice by adapting Life Steps for HIVinfected PWUD and adding a brief motivational intervention addressing drug use This intervention will incorporate educational, motivational, and behavioral skills components aimed at improving adherence and linkage to substance use treatment among HIV-infected PWUD. This study was conducted using the CFAR Network of Integrated Clinical Systems (CNICS) data which consisted of academically affiliated HIV clinics; it is possible that these are underestimates of active illicit drug use These data demonstrate that sustainable interventions and risk reduction programs addressing substance use are needed within the HIV clinical setting. HIV-infected PWUD are more likely to have medical (e.g., hepatitis C, tuberculosis) and psychiatric (e.g., depression, anxiety) comorbidity, neurocognitive impairment, and increased risk for drug overdose, which contribute to reduced adherence and poorer health outcomes [8]

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