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Positive Connections: COPA2

Primary Purpose

Human Immunodeficiency Virus

Status
Completed
Phase
Not Applicable
Locations
Argentina
Study Type
Interventional
Intervention
Motivational Interviewing
Sponsored by
University of Miami
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Human Immunodeficiency Virus focused on measuring HIV, Motivational Interviewing, Retention in Care

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Fundacion Huesped
  • Helios Salud

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Experimental condition

Standard of Care (SOC)

Arm Description

The proposed intervention training utilizes a structured, sustainable MI training and supervision program designed to improve retention, adherence and persistence in challenging patients.

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

Outcomes

Primary Outcome Measures

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.
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.
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.
Medication adherence: Hair sample
Adherence by hair sample to estimate an average concentration of ARV medication exposure
Medication adherence: Self-report
Proportion of self-reported adherent participants over time

Secondary Outcome Measures

Full Information

First Posted
July 1, 2016
Last Updated
June 22, 2022
Sponsor
University of Miami
Collaborators
Fundacion Huesped, Buenos Aires, Argentina, Fundacion Helios Salud, Buenos Aires, Argentina, National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT02846350
Brief Title
Positive Connections: COPA2
Official Title
Positive Connections: COPA2
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
July 2016 (Actual)
Primary Completion Date
November 30, 2020 (Actual)
Study Completion Date
November 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
Collaborators
Fundacion Huesped, Buenos Aires, Argentina, Fundacion Helios Salud, Buenos Aires, Argentina, National Institute of Mental Health (NIMH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Human Immunodeficiency Virus
Keywords
HIV, Motivational Interviewing, Retention in Care

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
360 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental condition
Arm Type
Active Comparator
Arm Description
The proposed intervention training utilizes a structured, sustainable MI training and supervision program designed to improve retention, adherence and persistence in challenging patients.
Arm Title
Standard of Care (SOC)
Arm Type
No Intervention
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
Motivational Interviewing
Intervention Description
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
Primary Outcome Measure Information:
Title
HIV viral Load (VL)
Description
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.
Time Frame
Less than 6 months detectable VL
Title
Retention in care
Description
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.
Time Frame
2 years
Title
Medication persistence
Description
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.
Time Frame
2 years
Title
Medication adherence: Hair sample
Description
Adherence by hair sample to estimate an average concentration of ARV medication exposure
Time Frame
2 years
Title
Medication adherence: Self-report
Description
Proportion of self-reported adherent participants over time
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deborah L Jones, PhD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fundacion Huesped
City
Buenos Aires
Country
Argentina
Facility Name
Helios Salud
City
Buenos Aires
Country
Argentina

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36210799
Citation
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.
Results Reference
derived
PubMed Identifier
30041703
Citation
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.
Results Reference
derived

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Positive Connections: COPA2

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