Positive Health Check Evaluation Trial

Research Triangle Institute, Durham NC

Investigators

Linked publications & trials

Abstract

? DESCRIPTION (provided by applicant): This application seeks to evaluate the impact of Positive Health Check (PHC) on clinical outcomes of HIV- positive patients > 18 years. The specific aims of the study are to 1) test the impact of PHC on achieving better clinical outcomes (i.e., viral load suppression, ART prescription refills, clinic appointment attendance) and reducing HIV risk (sexually transmitted disease [STD] screening and treatment, pregnancy tests, emergency contraception [EC]); 2) examine PHC implementation longitudinally to assess change over time in the perceived fit of PHC, the context for PHC implementation, the feasibility of PHC implementation, and patient-provider communication; 3) document costs associated with PHC implementation; and 4) describe the standards of care used in each clinic that related to risk reduction, adherence, and retention in care. The PHC intervention is a web-based application to facilitate patient-provider communication. Effective patient-provider communication can improve ART adherence, retention in care, and self-management. Because PHC is an Internet-based, video counseling intervention, staff burden and dissemination costs are expected to be low, and it eliminates variability in implementation fidelity. Proven effective, the PHC intervention will be prime for wide-scale dissemination. The trial will be a prospective randomized-controlled trial using a Type 1 hybrid trial approach. Using this approach, we will conduct a randomized controlled trial (RCT) of the PHC intervention and a robust process evaluation to document implementation context, barriers, and facilitators at the organizational level as well and data to characterize the cost of the PHC intervention and standard of care at each clinic. Patients will be recruited from four HIV primary care clinics located in Washington DC; Newark, NJ; Tampa, FL; and San Francisco, CA. The sites were selected because they serve a representative patient population, collect all required clinical indicators through electronic medical records (EMRs), have access to a sufficient number of patients to enroll at least 580 patients in the RCT, and are located in an MSA with high HIV prevalence. A total of 2,320 patients (580 patients from each site) will be enrolled. Of these, 1,160 patients (290 per site) will be randomized to the intervention arm and will complete the PHC intervention at scheduled HIV primary care appointments up to three times over the 2-year implementation period. The remaining 1,160 patients (290 per site) will be randomized to the control condition and receive usual care. Clinical outcomes will be extracted from EMRs at baseline and regular intervals. We hypothesize that exposure to the PHC intervention will be associated with improved clinical outcomes.