Positive Connections: COPA2

NCT02846350 | Completed

• 2 other identifiers: 20160313R01MH095539
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Human Immunodeficiency Virus

Keywords

HIV, Motivational Interviewing, Retention in Care

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (2)

Experimental condition

ACTIVE COMPARATOR

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

Standard of Care (SOC)

NO INTERVENTION

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

Interventions

Motivational Interviewing BEHAVIORAL

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

Experimental condition

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (2)

Fundacion Huesped

Buenos Aires, Argentina

Location

Helios Salud

Buenos Aires, Argentina

Location

Related Publications (2)

• 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.

  PMID: 36210799 DERIVED

• 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.

  PMID: 30041703 DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Directive Counseling; Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Deborah L Jones, PhD

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry & Behavioral Sciences

Study Record Dates

• First Submitted: July 1, 2016
• First Posted: July 27, 2016
• Study Start: July 1, 2016
• Primary Completion: November 30, 2020
• Study Completion: November 30, 2020
• Last Updated: June 29, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

AR (2)