Positive Connections: COPA2
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02846350|
Recruitment Status : Completed
First Posted : July 27, 2016
Last Update Posted : June 29, 2022
- Study Details
- Tabular View
- No Results Posted
- How to Read a Study Record
|Condition or disease||Intervention/treatment||Phase|
|Human Immunodeficiency Virus||Behavioral: Motivational Interviewing||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||360 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Positive Connections: COPA2|
|Actual Study Start Date :||July 2016|
|Actual Primary Completion Date :||November 30, 2020|
|Actual Study Completion Date :||November 30, 2020|
Active Comparator: Experimental condition
The proposed intervention training utilizes a structured, sustainable MI training and supervision program designed to improve retention, adherence and persistence in challenging patients.
Behavioral: Motivational 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
No Intervention: Standard of Care (SOC)
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
- 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.
- 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.
- 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.
- Medication adherence: Hair sample [ Time Frame: 2 years ]Adherence by hair sample to estimate an average concentration of ARV medication exposure
- Medication adherence: Self-report [ Time Frame: 2 years ]Proportion of self-reported adherent participants over time
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02846350
|Buenos Aires, Argentina|
|Buenos Aires, Argentina|
|Principal Investigator:||Deborah L Jones, PhD||University of Miami|
Documents provided by DEBORAH JONES, University of Miami:
|Responsible Party:||DEBORAH JONES, Professor of Psychiatry & Behavioral Sciences, University of Miami|
|Other Study ID Numbers:||
R01MH095539 ( U.S. NIH Grant/Contract )
|First Posted:||July 27, 2016 Key Record Dates|
|Last Update Posted:||June 29, 2022|
|Last Verified:||June 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
HIV, Motivational Interviewing, Retention in Care
Acquired Immunodeficiency Syndrome
Immunologic Deficiency Syndromes
Immune System Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
RNA Virus Infections
Slow Virus Diseases