Positive Connections: COPA2

Human Immunodeficiency Virus Clinical Trial

Official title:

Positive Connections: COPA2

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02846350
• Other study ID #: 20160313
• Secondary ID: R01MH095539
• Status: Completed
• Phase: N/A
• Start date: July 2016
• Est. completion date: November 30, 2020

Study information

• Verified date: June 2022
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 360
• Est. completion date: November 30, 2020
• Est. primary completion date: November 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Human Immunodeficiency Virus

Intervention

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

Locations

Country	Name	City	State
Argentina	Fundacion Huesped	Buenos Aires
Argentina	Helios Salud	Buenos Aires

Sponsors (4)

Lead Sponsor	Collaborator
University of Miami	Fundacion Helios Salud, Buenos Aires, Argentina, Fundacion Huesped, Buenos Aires, Argentina, National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

Argentina, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	Medication adherence: Hair sample	Adherence by hair sample to estimate an average concentration of ARV medication exposure	2 years
Primary	Medication adherence: Self-report	Proportion of self-reported adherent participants over time	2 years