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

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.