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Published in: Trials 1/2018

Open Access 01-12-2018 | Study protocol

Physician-delivered motivational interviewing to improve adherence and retention in care among challenging HIV-infected patients in Argentina (COPA2): study protocol for a cluster randomized controlled trial

Authors: Omar Sued, Isabel Cassetti, Diego Cecchini, Pedro Cahn, Lina Bofill de Murillo, Stephen M. Weiss, Lissa N. Mandell, Manasi Soni, Deborah L. Jones

Published in: Trials | Issue 1/2018

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Abstract

Background

“Challenging” HIV-infected patients, those not retained in treatment, represent a critical focus for positive prevention, as linkage to care, early initiation of antiretroviral therapy, adherence and retention in treatment facilitate viral suppression, thus optimizing health and reducing HIV transmission. Argentina was one of the first Latin American countries to guarantee HIV prevention, diagnosis and comprehensive care services, including antiretroviral medication, which removed cost and access as barriers. Yet, dropout occurs at every stage of the HIV continuum. An estimated 110,000 individuals are HIV-infected in Argentina; of these, 70% have been diagnosed and 54% were linked to care. However, only 36% have achieved viral suppression and 31% of those diagnosed delayed entry to care. To achieve meaningful reductions in HIV infection at the community level, innovative strategies must be developed to re-engage patients. Motivational Interviewing (MI) is a patient-centered approach and has been used by therapists in Central and South America to enhance motivation and commitment in substance use and risk reduction. Our pilot feasibility study utilized culturally tailored MI in physicians to target patients not retained in treatment in public and private clinics in Buenos Aires, Argentina. Results demonstrated that a physician-based MI intervention was feasible and effective in enhanced and sustained patient adherence, viral suppression, and patient-physician communication and attitudes about treatment among these patients at 6 and 9 months post baseline.

Methods/design

This clinical trial seeks to extend these findings in public and private clinics in four urban population centers in Argentina, in which clinics (n = 6 clinics, six MDs per clinic site) are randomized to experimental (physician MI Intervention) (n = 3) or control (physician Standard of Care) (n = 3) conditions in a 3:3 ratio. Using a cluster randomized clinical trial design, the study will test the effectiveness of a physician-based MI intervention to improve and sustain retention, adherence, persistence, and viral suppression among “challenging” patients (n = 420) over 24 months.

Discussion

Results are anticipated to have significant public health implications for the implementation of MI to re-engage and retain patients in HIV treatment and care and improve viral suppression through high levels of medication adherence.

Trial registration

ClinicalTrials.gov, ID: NCT02846350. Registered on 1 July 2016.
Appendix
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Metadata
Title
Physician-delivered motivational interviewing to improve adherence and retention in care among challenging HIV-infected patients in Argentina (COPA2): study protocol for a cluster randomized controlled trial
Authors
Omar Sued
Isabel Cassetti
Diego Cecchini
Pedro Cahn
Lina Bofill de Murillo
Stephen M. Weiss
Lissa N. Mandell
Manasi Soni
Deborah L. Jones
Publication date
01-12-2018
Publisher
BioMed Central
Published in
Trials / Issue 1/2018
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-018-2758-5

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