Positive Connections: COPA2
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Miami
- Enrollment
- 360
- Locations
- 2
- Primary Endpoint
- HIV viral Load (VL)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Outcomes
Primary Outcomes
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: Self-report
Time Frame: 2 years
Proportion of self-reported adherent participants over time
Medication adherence: Hair sample
Time Frame: 2 years
Adherence by hair sample to estimate an average concentration of ARV medication exposure
Secondary Outcomes
No secondary outcomes reported
Investigators
DEBORAH JONES
Professor of Psychiatry & Behavioral Sciences
University of Miami