Positive Connections: COPA2

This study proposes to assess the impact of a provider-based intervention to enhance re-engagement and improve retention, adherence, persistence and viral load among challenging patients in Argentina

Study Overview

• Status: Completed
• Conditions: Human Immunodeficiency Virus
• Intervention / Treatment: Behavioral: Motivational Interviewing

Detailed Description

Motivational Interviewing (MI) has primarily been utilized as a counseling strategy by therapists to counter addiction and improve lifestyle behaviors.

This application proposes to train physicians to utilize MI to promote re-engagement in HIV care and to sustain retention and adherence. The study will increase the reach of the original pilot study and increase its generalizability, expanding the patient population to a wide variety of public and private clinic and hospital patients, including transgender women, drug users, men who have sex with men (MSM), and heterosexual men and women.

• Study Type: Interventional
• Enrollment (Actual): 360
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina
    • Fundación Huésped
  • Buenos Aires, Argentina
    • Helios Salud

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• HIV seropositive
• At least 18 years of age (there will be no upper age range)
• "Challenging" HIV-infected patients, defined as 1) diagnosed for > 6 months and having detectable viral load > 500 copies/mL at last assessment following 6 months of ART prescription, AND 2) not retained in care, i.e., 3 missed pharmacy pick-ups in the last 6 consecutive months, or not attending a physician visit in the last 12 months or more

Exclusion Criteria:

• Participants with delirium and/or psychosis will be excluded.

There are no exclusions based on literacy as all materials will be administered using an audio computer assisted self-interview system (ACASI) supervised by assessors.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Experimental condition; The proposed intervention training utilizes a structured, sustainable MI training and supervision program designed to improve retention, adherence and persistence in challenging patients.	Behavioral: Motivational Interviewing; The training will include MI skills and elements identified as most effective, MI spirit (collaboration, evoking patient motivation, honoring patient autonomy, recognizing and reinforcing change talk, and "rolling" with (not fighting) resistance. Physicians utilizing MI will learn to engage with patients in an empathic, nonjudgmental manner and to pose simple but strategic questions to motivate change; when patients resist change, the physician learns to ''roll'' with resistance instead of confronting it. If and when the patient is ready to initiate a change, the physician will be prepared to support their decision
NO_INTERVENTION: Standard of Care (SOC); Physicians providing SOC will attend 3 time-matched video presentations over 2 years on research on optimizing entry into and retention in care and adherence, from materials available at the International Association for Providers of AIDS Care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HIV viral Load (VL)	VL will be assessed by blood sampling. Viral suppression (HIV VL <200 copies/mL) will be the primary dichotomous outcome; a secondary dichotomization will be made among detectable patients with VL <1000 and those with VL >1000.	Less than 6 months detectable VL
Retention in care	Defined as the number of missed clinic appointments (i.e., "no shows" not cancelled in advance by patients or clinic staff) in the 6 months preceding assessment.	2 years
Medication persistence	Medication persistence is the time to treatment discontinuation, with a permissible gap of < 30 days, participants will be considered to have discontinued the regimen if a therapy gap = > 30 days occurs.	2 years
Medication adherence: Hair sample	Adherence by hair sample to estimate an average concentration of ARV medication exposure	2 years
Medication adherence: Self-report	Proportion of self-reported adherent participants over time	2 years

Collaborators and Investigators

• Sponsor: University of Miami
• Collaborators: National Institute of Mental Health (NIMH); Fundacion Huesped, Buenos Aires, Argentina; Fundacion Helios Salud, Buenos Aires, Argentina

Publications and helpful links

General Publications

• Sued O, Cecchini D, Rolon MJ, Calanni L, David D, Lupo S, Cahn P, Cassetti I, Weiss SM, Alcaide ML, Rodriguez VJ, Mantero A, Jones DL. A small cluster randomised clinical trial to improve health outcomes among Argentine patients disengaged from HIV care. Lancet Reg Health Am. 2022 Sep;13:100307. doi: 10.1016/j.lana.2022.100307. Epub 2022 Jun 23.
• Sued O, Cassetti I, Cecchini D, Cahn P, de Murillo LB, Weiss SM, Mandell LN, Soni M, Jones DL. 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. Trials. 2018 Jul 24;19(1):396. doi: 10.1186/s13063-018-2758-5.

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 1, 2016
• Primary Completion (ACTUAL): November 30, 2020
• Study Completion (ACTUAL): November 30, 2020

Study Registration Dates

• First Submitted: July 1, 2016
• First Submitted That Met QC Criteria: July 22, 2016
• First Posted (ESTIMATE): July 27, 2016

Study Record Updates

• Last Update Posted (ACTUAL): June 29, 2022
• Last Update Submitted That Met QC Criteria: June 22, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: HIV, Motivational Interviewing, Retention in Care
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases; HIV Infections; Acquired Immunodeficiency Syndrome
• Other Study ID Numbers: 20160313; R01MH095539 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No