Abstract
BackgroundThere is a need for evaluating community-based antiretroviral therapy (ART) delivery models to improve overall performance of HIV programs, specifically in populations that may have difficulties to access continuous care. This cluster-randomized clinical trial aims to evaluate the effectiveness of a multicomponent differentiated ART delivery model (VIBRA model) after home-based same-day ART initiation in remote villages in Lesotho, southern Africa.Methods/designThe VIBRA trial (VIllage-Based Refill of ART) is a cluster-randomized parallel-group superiority clinical trial conducted in two districts in Lesotho, southern Africa. Clusters (i.e., villages) are randomly assigned to either the VIBRA model or standard care. The clusters are stratified by district, village size, and village access to the nearest health facility. Eligible individuals (HIV-positive, aged 10 years or older, and not taking ART) identified during community-based HIV testing campaigns are offered same-day home-based ART initiation. The intervention clusters offer a differentiated ART delivery package with two features: (1) drug refills and follow-ups by trained and supervised village health workers (VHWs) and (2) the option of receiving individually tailored adherence reminders and notifications of viral load results via SMS. The control clusters will continue to receive standard care, i.e., collecting ART refills from a clinic and no SMS notifications. The primary endpoint is viral suppression 12 months after enrolment. Secondary endpoints include linkage to and engagement in care. Furthermore, safety and cost-effectiveness analyses plus qualitative research are planned. The minimum target sample size is 262 participants. The statistical analyses will follow the CONSORT guidelines. The VIBRA trial is linked to another trial, the HOSENG (HOme-based SElf-testiNG) trial, both of which are within the GET ON (GETing tOwards Ninety) research project.DiscussionThe VIBRA trial is among the first to evaluate the delivery of ART by VHWs immediately after ART initiation. It assesses the entire HIV care cascade from testing to viral suppression. As most countries in sub-Saharan Africa have cadres like the VHW program in Lesotho, this model—if shown to be effective—has the potential to be scaled up. The system impact evaluation will provide valuable cost estimations, and the qualitative research will suggest how the model could be further modified to optimize its impact.Trial registrationClinicaltrials.gov, NCT03630549. Registered on 15 August 2018.
Highlights
Multiple studies conducted in sub-Saharan Africa (SSA) report high attrition from Human immunodeficiency virus (HIV) testing to linkage to care and suboptimal engagement in care [1,2,3,4,5,6,7]
The Village-based Refill of ART (VIBRA) trial is among the first to evaluate the delivery of antiretroviral therapy (ART) by Village health worker (VHW) immediately after ART initiation
We describe the protocol for a cluster-randomized clinical trial that aims to evaluate the effectiveness of the VIBRA model following same-day home-based ART initiation in rural communities in Lesotho
Summary
Effective and differentiated strategies are needed to improve the HIV care cascade, especially in rural settings. The VIBRA model entails a second feature, SMS reminders and notifications These have been studied widely in sub-Saharan Africa and lead to increased adherence and engagement in care [68,69,70,71,72,73,74]. While most studies use standardized messages reminding the patient about their drug intake or clinic visits, the SMS intervention in the VIBRA model will go one step further. It will automatically generate and send notifications that are individually tailored according to the VL level, indicating the steps of action for the patient.
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