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OpenTrials
Completed

NCT Number: NCT02846350

Positive Connections: COPA2

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

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Key information

Conditions

Human Immunodeficiency Virus Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fundacion Huesped, Buenos Aires, Argentina

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Motivational Interviewing

Behavioral

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

Primary outcomes

  1. HIV viral Load (VL)

    Time frame: 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.

  2. Retention in care

    Time frame: 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.

  3. Medication persistence

    Time frame: 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.

  4. Medication adherence: Hair sample

    Time frame: 2 years

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

  5. Medication adherence: Self-report

    Time frame: 2 years

    Proportion of self-reported adherent participants over time

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Collaborators

  • Fundacion Helios Salud, Buenos Aires, Argentina
  • Fundacion Huesped, Buenos Aires, Argentina
  • National Institute of Mental Health (NIMH)

Registry information

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Jul 27, 2016
Registry last updated
Jun 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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