Positive Connections: COPA2

University of Miami

Status: Completed

Conditions: Human Immunodeficiency Virus

Treatments: Behavioral: Motivational Interviewing

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02846350

R01MH095539 (U.S. NIH Grant/Contract)

20160313

Details and patient eligibility

About

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

Full 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.

Enrollment: 360 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

360 participants in 2 patient groups

Experimental condition

Active Comparator group

Description:

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

Treatment:

Behavioral: Motivational Interviewing

Standard of Care (SOC)

No Intervention group

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