Clinical trial NCT02846350: Positive Connections: COPA2
Official title: Positive Connections: COPA2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Human Immunodeficiency Virus
Keywords: HIV, Motivational Interviewing, Retention in Care
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: Fundacion Huesped, Buenos Aires, Argentina
name: Fundacion Helios Salud, Buenos Aires, Argentina
name: National Institute of Mental Health (NIMH)
First posted: 2016-07-27
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Primary outcomes:
measure: HIV viral Load (VL)
timeFrame: Less than 6 months detectable VL
measure: Retention in care
timeFrame: 2 years
measure: Medication persistence
timeFrame: 2 years
measure: Medication adherence: Hair sample
timeFrame: 2 years
measure: Medication adherence: Self-report
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Fundacion Huesped
city: Buenos Aires
country: Argentina
facility: Helios Salud
Study officials:
affiliation: University of Miami
name: Deborah L Jones, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.