TY - JOUR
T1 - Adherence intervention for HIV-infected persons who use drugs
T2 - Adaptation, open trial, and pilot randomized hybrid type 1 trial protocol
AU - Claborn, Kasey
AU - Becker, Sara
AU - Operario, Don
AU - Safren, Steve
AU - Rich, Josiah D.
AU - Ramsey, Susan
N1 - Funding Information:
The current protocol was funded by a Grant from NIDA (K23DA039037) awarded to the first author. Dr Rich’s involvement has been supported by NIDA (K24DA022112) and NIAID (P30 AI42853). Dr. Safren was supported by NIDA (K24DA040489). The content is solely the responsibility of the authors and does not necessarily represent the official views of NIDA or the National Institutes of Health.
Publisher Copyright:
© 2018 The Author(s).
PY - 2018/12/27
Y1 - 2018/12/27
N2 - Background: 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. Methods: 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. Discussion: 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. Trial registration NCT02907697
AB - Background: 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. Methods: 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. Discussion: 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. Trial registration NCT02907697
KW - Adherence
KW - HIV/AIDS
KW - Mixed methods
KW - Motivational interview
KW - Protocol
KW - Substance use
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U2 - 10.1186/s13722-018-0113-5
DO - 10.1186/s13722-018-0113-5
M3 - Article
C2 - 29606129
AN - SCOPUS:85051962854
VL - 13
JO - Addiction science & clinical practice
JF - Addiction science & clinical practice
SN - 1940-0632
IS - 1
M1 - 12
ER -