Efficacy of CHAMPS for Improving Viral Suppression: A Randomised Clinical Trial.

Abstract

Given the fragmented condition of the United States healthcare system and the challenges inherent in the lives of poor, stigmatized, and minoritized groups, our study team conducted a multi-site randomized (1:1) controlled efficacy trial of Community Health Workers And MHealth to ImProve Viral Suppression (CHAMPS), a combination intervention comprised of both the WiseApp and community health worker delivered health information, among adults with HIV in New York City and Birmingham, Alabama. Data analysis used an intention-to-treat approach. Enrollment for this study was from May 2021-May 2023 with follow-up completed at 6- and 12-months following study enrollment. In the analytic sample of 300 study participants, the mean age was 48.1 years; 219 (73.2%) participants identified as Non-Hispanic Black, 28 (9.4%) as Non-Hispanic White, 39 (13.0%) as Hispanic, and 10 (3.3%) as Other Non-Hispanic. From baseline to six months, the proportion of participants who were virally suppressed increased for both study arms, with OR = 1.16 (SE = 0.26, p = 0.52, 95%CI 0.75-1.79) for standard of care and OR = 1.66 (SE = 0.33, p = 0.010, 95%CI 1.13-2.44) for CHAMPS. However, there was no statistically significant difference in changes between the two study arms (p = 0.28). The CHAMPS intervention did not have a significant effect on HIV viral suppression relative to non-suppression at 12-months compared with the standard of care arm. Nonetheless, these findings should be interpreted in the context of the COVID-19 and Monkeypox pandemic with persistent concerns related to exposure to the viruses and limited access to healthcare and other social services. Trial Registration: ClinicalTrials.gov Identifier: NCT04562649.