Offering ART Refill Through Community Health Workers Versus Clinic-Based Follow-Up After Home-Based Same-Day ART Initiation: The VIBRA Cluster-Randomised Clinical Trial

Background: Community-based antiretroviral treatment (ART) dispensing by lay workers is an important differentiated service delivery model in sub-Sahara Africa. However, patients new in care are generally excluded from such models. Home-based same-day ART initiation is becoming widespread practice, but linkage to the clinic is challenging. The pragmatic VIBRA (Village-based refill of ART) cluster-randomised trial in rural Lesotho compared the option of ART refill by existing lay village health workers (VHW) versus clinic-based refill after home-based same-day ART initiation. Methods: In village-clusters randomised to intervention, individuals found HIV-positive during a door-to-door HIV-testing campaign were offered same-day ART initiation with the option of refill by VHWs. The trained VHWs dispensed drugs and scheduled clinic-visits for viral load measurement at 6- and 12-months. In control-villages, participants were offered same-day ART initiation with clinic-based ART refill. The primary outcome was 12-month viral suppression. Secondary endpoints comprised linkage and 12-month engagement in care. Analyses were intention-to-treat. Clinicaltrials.gov/NCT03630549 Findings: From August 16 th , 2018, until May 28 th , 2019, 118 individuals from 108 households in 57 clusters from intervention arm, and 139 individuals from 130 households in 60 clusters in control were enrolled (150 [58%] female, median age 36 years (interquartile range 30-48), 200 [78%] newly diagnosed). 48/118 (41%) opted for VHW-based refill. At 12 months, 46/118 (39%) and 64/139 (46%) participants in the intervention and control arm achieved viral suppression (adjusted difference -0·07[95%CI -0·20-0·06];p=0·256). Arms were similar in linkage, but engagement in care tended to be lower in intervention. Zero and seven deaths occurred in control and intervention arm. Interpretation: The offer of village-based ART refill did not amplify the effect of home-based same-day ART initiation alone. Our trial rather raises concerns regarding engagement in care and safety if follow-up is provided by existing lay health cadres for patients newly initiated on ART. Trial Registration: Clinicaltrials.gov/NCT03630549 Funding: Swiss National Science Foundation; Janggen-Pohn Foundation Declaration of Interest: The authors declare that they have no competing interests. Ethical Approval: This trial was approved by the National Health Research and Ethics Committee of the Ministry of Health of Lesotho (ID06-2018) and the Ethics committee in Switzerland (Ethikkomission Nordwest- und Zentralschweiz; 2018-00283) and registered with Clinicaltrials.gov (NCT03630549).