Positive Connections: COPA2

University of Miami360 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

360

Conditions

Human Immunodeficiency Virus

Interventions

Motivational InterviewingBEHAVIORAL

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (2)

Fundacion Huesped

Buenos Aires, Argentina

Helios Salud

Buenos Aires, Argentina

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 2 years

Medication adherence: Hair sample

Adherence by hair sample to estimate an average concentration of ARV medication exposure

Time frame: 2 years

Medication adherence: Self-report

Proportion of self-reported adherent participants over time

Time frame: 2 years

Data from ClinicalTrials.gov

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