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

Date Published: April 2, 2018

Publisher: BioMed Central

Author(s): Kasey Claborn, Sara Becker, Don Operario, Steve Safren, Josiah D. Rich, Susan Ramsey.


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. 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.

This 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.

This 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.

Partial Text

Illicit drug use remains a common and significant problem among people living with HIV (PLWH). Drug use is one of the most significant barriers to antiretroviral therapy (ART) adherence, contributing to suboptimal treatment outcomes and increased transmission of HIV. As suggested by the syndemics model [1], multiple morbidities such as drug use and HIV act synergistically to produce poorer health outcomes. Over 81% of persons living with HIV report a history of illicit drug use and nearly one in four meet diagnostic criteria for a severe substance use disorder [2]. Drug use remains prevalent among PLWH enrolled in primary care with one study showing that 24% report marijuana use, 9% report amphetamine use, 8.5% report crack cocaine use, 10% report polydrug use, and almost 3% report injection drug use in the preceding 3 months [3]. This study was conducted using the CFAR Network of Integrated Clinical Systems (CNICS) data which consisted of academically affiliated HIV clinics; thus, 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 continue to experience poorer rates of ART adherence, lapses in treatment retention, and increased morbidity and mortality [7, 8]. Existing adherence interventions have yet to prove effective among this high-risk population. This protocol seeks to improve ART adherence and promote linkage to substance use treatment by developing an adherence intervention tailored to HIV-infected PWUD. This behavioral intervention will utilize the syndemics framework to address critical factors aimed at improving adherence and reducing substance use. This study will use a pilot type 1 hybrid effectiveness-implementation design [19] given that Life Steps and BMI have both proven efficacious. In order to speed the translation of research to practice, we test the effectiveness of these interventions delivered in a real-world clinical setting, while simultaneously examining potential barriers and facilitators to implementation.




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