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Positive Connections: COPA2

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02846350
Recruitment Status : Completed
First Posted : July 27, 2016
Last Update Posted : June 29, 2022
Sponsor:
Collaborators:
Fundacion Huesped, Buenos Aires, Argentina
Fundacion Helios Salud, Buenos Aires, Argentina
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
DEBORAH JONES, University of Miami

Study Description
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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

Condition or disease Intervention/treatment Phase
Human Immunodeficiency Virus Behavioral: Motivational Interviewing Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 360 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Positive Connections: COPA2
Actual Study Start Date : July 2016
Actual Primary Completion Date : November 30, 2020
Actual Study Completion Date : November 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. HIV viral Load (VL) [ Time Frame: Less than 6 months detectable 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.

  2. Retention in care [ Time Frame: 2 years ]
    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.

  3. Medication persistence [ Time Frame: 2 years ]
    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.

  4. Medication adherence: Hair sample [ Time Frame: 2 years ]
    Adherence by hair sample to estimate an average concentration of ARV medication exposure

  5. Medication adherence: Self-report [ Time Frame: 2 years ]
    Proportion of self-reported adherent participants over time


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02846350


Locations
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Argentina
Fundacion Huesped
Buenos Aires, Argentina
Helios Salud
Buenos Aires, Argentina
Sponsors and Collaborators
University of Miami
Fundacion Huesped, Buenos Aires, Argentina
Fundacion Helios Salud, Buenos Aires, Argentina
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Deborah L Jones, PhD University of Miami
  Study Documents (Full-Text)

Documents provided by DEBORAH JONES, University of Miami:
Informed Consent Form  [PDF] October 22, 2018

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: DEBORAH JONES, Professor of Psychiatry & Behavioral Sciences, University of Miami
ClinicalTrials.gov Identifier: NCT02846350    
Other Study ID Numbers: 20160313
R01MH095539 ( U.S. NIH Grant/Contract )
First Posted: July 27, 2016    Key Record Dates
Last Update Posted: June 29, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by DEBORAH JONES, University of Miami:
HIV, Motivational Interviewing, Retention in Care
Additional relevant MeSH terms:
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Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Immune System Diseases
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