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Positive Connections: COPA2

Positive Connections: COPA2

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02846350
Enrollment
360
Registered
2016-07-27
Start date
2016-07-31
Completion date
2020-11-30
Last updated
2022-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Human Immunodeficiency Virus

Keywords

HIV, Motivational Interviewing, Retention in Care

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.

Interventions

BEHAVIORALMotivational 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

Sponsors

Fundacion Huesped, Buenos Aires, Argentina
CollaboratorUNKNOWN
Fundacion Helios Salud, Buenos Aires, Argentina
CollaboratorUNKNOWN
National Institute of Mental Health (NIMH)
CollaboratorNIH
University of Miami
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
HIV viral Load (VL)Less than 6 months detectable VLVL 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 care2 yearsDefined 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 persistence2 yearsMedication 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: Hair sample2 yearsAdherence by hair sample to estimate an average concentration of ARV medication exposure
Medication adherence: Self-report2 yearsProportion of self-reported adherent participants over time

Countries

Argentina

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 23, 2026