Positive Health Check evaluation: A type 1 hybrid design randomized trial to decrease HIV viral loads in patients seen in HIV primary care

Abstract

For people with HIV, important transmission prevention strategies include early initiation and adherence to antiretroviral therapy and retention in clinical care with the goal of reducing viral loads as quickly as possible. Consequently, at this point in the HIV epidemic, innovative and effective strategies are urgently needed to engage and retain people in health care to support medication adherence. To address this gap, the Positive Health Check Evaluation Trial uses a type 1 hybrid randomized trial design to test whether the use of a highly tailored video doctor intervention will reduce HIV viral load and retain people with HIV in health care. Eligible and consenting patients from four HIV primary care clinical sites are randomly assigned to receive either the Positive Health Check intervention in addition to the standard of care or the standard of care only. The primary aim is to determine the effectiveness of the intervention. A second aim is to understand the implementation potential of the intervention in clinic workflows, and a third aim is to assess the costs of intervention implementation. The trial findings will have important real-world applicability for understanding how digital interventions that take the form of video doctors can be used to decrease viral load and to support retention in care among diverse patients attending HIV primary care clinics. in clinical care are important transmission prevention strategies because people with HIV (PWH) who are treated with ART and maintain VL suppression have effectively no risk of sexually transmitting HIV [2-5], and they experience a life expectancy similar to people not infected with HIV [6]. In 2017, of all PWH in the United States, 85.8% knew they were diagnosed and 62.7% were virally suppressed [1]. Consequently, to decrease sexual transmission of HIV, effective interventions are needed to engage PWH in regular health care that supports ART adherence and retention in medical care [4].

Challenges of and Solutions for Developing Tailored Video Interventions That Integrate Multiple Digital Assets to Promote Engagement and Improve Health Outcomes: Tutorial

“…We are currently conducting a pragmatic type 1 hybrid trial [ 42 ] to test the effectiveness of PHC in improving health outcomes for patients with HIV engaged in clinical care, as well as to test the feasibility of implementing PHC in HIV clinics. The study also includes collecting data on the costs associated with implementing PHC in clinical settings [ 43 ].…”

Challenges of and Solutions for Developing Tailored Video Interventions That Integrate Multiple Digital Assets to Promote Engagement and Improve Health Outcomes: Tutorial (Preprint)

“…We believe that the return on investment of developing this highly interactive and tailored intervention can be considered beneficial if the intervention is shown to be effective and scaled up and implemented at a low cost by HIV clinics. We are currently conducting a pragmatic type 1 hybrid trial [42] to test the effectiveness of PHC in improving health outcomes for patients with HIV engaged in clinical care, as well as to test the feasibility of implementing [43].…”

Effectiveness of an Interactive, Highly Tailored “Video Doctor” Intervention to Suppress Viral Load and Retain Patients With HIV in Clinical Care: A Randomized Clinical Trial

“…This study was designed to achieve 80% power for comparisons between the intervention and control arms on the primary endpoint (VL suppression), assuming rates of 62% and 50%, respectively, at the 5% significance level and accounting for 25% annual attrition; details of the power analysis are provided in the study by Lewis et al 18 Analyses were conducted using SAS software, version 9.4. 29 Statistical tests were performed at the 5% significance level.…”