Positive Connections: COPA2

Not Applicable

Completed

• Conditions: Human Immunodeficiency Virus
• Interventions: Behavioral: Motivational Interviewing

• Registration Number: NCT02846350
• Lead Sponsor: University of Miami

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2016-07
• Study First Submitted: 2016-07-01
• Study First Submitted QC: 2016-07-22
• Study First Posted: 2016-07-27
• Primary Completion: 2020-11-30
• Study Completion: 2020-11-30
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-22
• Last Update Posted: 2022-06-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 360

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Experimental condition	Motivational Interviewing	The proposed intervention training utilizes a structured, sustainable MI training and supervision program designed to improve retention, adherence and persistence in challenging patients.

Primary Outcome Measures

Name	Time	Method
HIV viral Load (VL)	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.
Retention in care	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.
Medication persistence	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.
Medication adherence: Self-report	2 years	Proportion of self-reported adherent participants over time
Medication adherence: Hair sample	2 years	Adherence by hair sample to estimate an average concentration of ARV medication exposure

Trial Locations

Locations (2)

Helios Salud; 🇦🇷 Buenos Aires, Argentina

Fundacion Huesped; 🇦🇷 Buenos Aires, Argentina