Project Khanya: a randomized, hybrid effectiveness-implementation trial of a peer-delivered behavioral intervention for ART adherence and substance use in Cape Town, South Africa

Abstract Background Substance use is prevalent in South Africa and associated with poor HIV treatment outcomes, yet, it is largely unaddressed in HIV care. Implementing an evidence-based, task-shared intervention for antiretroviral therapy (ART) adherence and substance use integrated into HIV care m...

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Main Authors: Jessica F. Magidson, John A. Joska, Bronwyn Myers, Jennifer M. Belus, Kristen S. Regenauer, Lena S. Andersen, Sybil Majokweni, Conall O’Cleirigh, Steven A. Safren
Format: Article
Language:English
Published: BMC 2020-03-01
Series:Implementation Science Communications
Subjects:
Online Access:https://doi.org/10.1186/s43058-020-00004-w
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author Jessica F. Magidson
John A. Joska
Bronwyn Myers
Jennifer M. Belus
Kristen S. Regenauer
Lena S. Andersen
Sybil Majokweni
Conall O’Cleirigh
Steven A. Safren
author_facet Jessica F. Magidson
John A. Joska
Bronwyn Myers
Jennifer M. Belus
Kristen S. Regenauer
Lena S. Andersen
Sybil Majokweni
Conall O’Cleirigh
Steven A. Safren
author_sort Jessica F. Magidson
collection DOAJ
description Abstract Background Substance use is prevalent in South Africa and associated with poor HIV treatment outcomes, yet, it is largely unaddressed in HIV care. Implementing an evidence-based, task-shared intervention for antiretroviral therapy (ART) adherence and substance use integrated into HIV care may be a feasible and effective way to improve HIV treatment outcomes and reduce substance use in this population. Methods Guided by the RE-AIM framework, a randomized, hybrid type 1 effectiveness-implementation trial (n = 60) is being used to evaluate a peer-delivered intervention that integrates evidence-based intervention components, including Life-Steps (problem solving and motivational skills for HIV medication adherence), behavioral activation to increase alternative, substance-free rewarding activities in one’s environment, and relapse prevention skills, including mindfulness. The comparison condition is enhanced standard of care, which includes facilitating a referral to a local substance use treatment clinic (Matrix). Participants are followed for a period of 6 months. Implementation outcomes are defined by Proctor’s model for implementation and include mixed methods evaluations of feasibility, acceptability, and fidelity, and barriers and facilitators to implementation. Primary patient-level effectiveness outcomes are ART adherence (Wisepill) and substance use (WHO-ASSIST and urinalysis); viral load is an exploratory outcome. Discussion Results of this trial will provide important evidence as to whether peer delivery of an integrated intervention for ART adherence and substance use is feasible, acceptable, and effective. Implementation outcomes will provide important insight into using peers as an implementation strategy to extend task sharing models for behavioral health in resource-limited settings globally. Trial registration ClinicalTrials.gov identifier: NCT03529409 . Trial registered on May 18, 2018.
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spelling doaj.art-1733e0984e374e529882c44b4b6741b52022-12-21T23:27:11ZengBMCImplementation Science Communications2662-22112020-03-011111210.1186/s43058-020-00004-wProject Khanya: a randomized, hybrid effectiveness-implementation trial of a peer-delivered behavioral intervention for ART adherence and substance use in Cape Town, South AfricaJessica F. Magidson0John A. Joska1Bronwyn Myers2Jennifer M. Belus3Kristen S. Regenauer4Lena S. Andersen5Sybil Majokweni6Conall O’Cleirigh7Steven A. Safren8Department of Psychology, University of MarylandHIV Mental Health Research Unit, Division of Neuropsychiatry, Department of Psychiatry and Mental Health, University of Cape TownAlcohol, Tobacco and Other Drug Research Unit, South African Medical Research CouncilDepartment of Psychology, University of MarylandDepartment of Psychology, University of MarylandHIV Mental Health Research Unit, Division of Neuropsychiatry, Department of Psychiatry and Mental Health, University of Cape TownHIV Mental Health Research Unit, Division of Neuropsychiatry, Department of Psychiatry and Mental Health, University of Cape TownDepartment of Psychiatry, Massachusetts General Hospital/Harvard Medical SchoolDepartment of Psychology, University of MiamiAbstract Background Substance use is prevalent in South Africa and associated with poor HIV treatment outcomes, yet, it is largely unaddressed in HIV care. Implementing an evidence-based, task-shared intervention for antiretroviral therapy (ART) adherence and substance use integrated into HIV care may be a feasible and effective way to improve HIV treatment outcomes and reduce substance use in this population. Methods Guided by the RE-AIM framework, a randomized, hybrid type 1 effectiveness-implementation trial (n = 60) is being used to evaluate a peer-delivered intervention that integrates evidence-based intervention components, including Life-Steps (problem solving and motivational skills for HIV medication adherence), behavioral activation to increase alternative, substance-free rewarding activities in one’s environment, and relapse prevention skills, including mindfulness. The comparison condition is enhanced standard of care, which includes facilitating a referral to a local substance use treatment clinic (Matrix). Participants are followed for a period of 6 months. Implementation outcomes are defined by Proctor’s model for implementation and include mixed methods evaluations of feasibility, acceptability, and fidelity, and barriers and facilitators to implementation. Primary patient-level effectiveness outcomes are ART adherence (Wisepill) and substance use (WHO-ASSIST and urinalysis); viral load is an exploratory outcome. Discussion Results of this trial will provide important evidence as to whether peer delivery of an integrated intervention for ART adherence and substance use is feasible, acceptable, and effective. Implementation outcomes will provide important insight into using peers as an implementation strategy to extend task sharing models for behavioral health in resource-limited settings globally. Trial registration ClinicalTrials.gov identifier: NCT03529409 . Trial registered on May 18, 2018.https://doi.org/10.1186/s43058-020-00004-wRE-AIMHybrid designGlobal mental healthHIVSubstance useAntiretroviral therapy (ART) adherence
spellingShingle Jessica F. Magidson
John A. Joska
Bronwyn Myers
Jennifer M. Belus
Kristen S. Regenauer
Lena S. Andersen
Sybil Majokweni
Conall O’Cleirigh
Steven A. Safren
Project Khanya: a randomized, hybrid effectiveness-implementation trial of a peer-delivered behavioral intervention for ART adherence and substance use in Cape Town, South Africa
Implementation Science Communications
RE-AIM
Hybrid design
Global mental health
HIV
Substance use
Antiretroviral therapy (ART) adherence
title Project Khanya: a randomized, hybrid effectiveness-implementation trial of a peer-delivered behavioral intervention for ART adherence and substance use in Cape Town, South Africa
title_full Project Khanya: a randomized, hybrid effectiveness-implementation trial of a peer-delivered behavioral intervention for ART adherence and substance use in Cape Town, South Africa
title_fullStr Project Khanya: a randomized, hybrid effectiveness-implementation trial of a peer-delivered behavioral intervention for ART adherence and substance use in Cape Town, South Africa
title_full_unstemmed Project Khanya: a randomized, hybrid effectiveness-implementation trial of a peer-delivered behavioral intervention for ART adherence and substance use in Cape Town, South Africa
title_short Project Khanya: a randomized, hybrid effectiveness-implementation trial of a peer-delivered behavioral intervention for ART adherence and substance use in Cape Town, South Africa
title_sort project khanya a randomized hybrid effectiveness implementation trial of a peer delivered behavioral intervention for art adherence and substance use in cape town south africa
topic RE-AIM
Hybrid design
Global mental health
HIV
Substance use
Antiretroviral therapy (ART) adherence
url https://doi.org/10.1186/s43058-020-00004-w
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