VIBRA trial – Effect of village-based refill of ART following home-based same-day ART initiation vs clinic-based ART refill on viral suppression among individuals living with HIV: protocol of a cluster-randomized clinical trial in rural Lesotho

Abstract

Background There 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/design The 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. Discussion The 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 registration Clinicaltrials.gov, NCT03630549 . Registered on 15 August 2018. Electronic supplementary material The online version of this article (10.1186/s13063-019-3510-5) contains supplementary material, which is available to authorized users.

HOSENG trial – Effect of the provision of oral self-testing for absent and refusing individuals during a door-to-door HIV testing campaign on testing coverage: protocol of a cluster randomized clinical trial in rural Lesotho

“…Once the HIV test is done, the counselor documents the result in the patient's health booklet and provides post-test counseling. If the HIV test is confirmed positive, the counselor contacts the study nurse, who then provides further counseling and assesses the participant for enrollment into the inter-linked follow-up study (VIBRA trial [22])…”

“…The rationale for a cluster-randomized design at village level is (1) the reliance of the trial on the village health workers (VHWs) and (2) the high risk of cross-contamination between the study arms if randomization would be done at the individual or household level. The HOSENG trial, with its home-based HIV-testing campaign, provides a recruitment platform for another trial, the VIBRA (Village-Based Refill of ART) trial [22], and thus they are based on the same cluster-randomization and run in parallel. Together, HOSENG and VIBRA [22] constitute the GET ON (GETting tOwards Ninety) research project.…”

“…The HOSENG trial, with its home-based HIV-testing campaign, provides a recruitment platform for another trial, the VIBRA (Village-Based Refill of ART) trial [22], and thus they are based on the same cluster-randomization and run in parallel. Together, HOSENG and VIBRA [22] constitute the GET ON (GETting tOwards Ninety) research project. To ensure a balance in the exposure to the HOSENG intervention in the two arms, the clusters (villages) will be randomized into four potential groups in a 1:1:1:1 allocation.…”

“…For the entire GET ON project we will collect cost data, see more details in the VIBRA trial protocol [22] published elsewhere. Specifically, for the HOSENG trial, first, direct costs of the intervention will be assessed: Staff costs (campaign team, VHWs, clinic staff), personnel training costs (VHWs), cost of equipment (HIV tests, consumables, logistics), as well as non-medical costs to the participant (i.e., cost of transportation to the ART service).…”

“…The sample size is driven by the VIBRA trial [22]. We assume that to achieve the VIBRA trial [22] sample size (minimum 262 HIV-positive individuals not on ART) by testing about 10,000 individuals in 100 villages, based on a previous trial [32]. According to a previous home-based HIV-testing campaign [33], we estimate an HIV-testing coverage rate of individuals aged 12 years or older in rural villages of 63%.…”