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Article History

Received: 5 January 2019

Accepted: 10 June 2019

First Online: 22 August 2019

Ethics approval and consent to participate

: This trial has been 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).Details of the consent process of the testing campaign are provided in the HOSENG study protocol. If a household member is eligible for inclusion into the VIBRA trial, the study nurse will obtain separate written informed consent and then collect the participant’s data and draw blood for storage and additional analyses. The informed consent forms for the control and intervention clusters are different but do not indicate the cluster allocation. Allocation to the cluster arm is concealed to minimize the risk of selection bias. Illiterate participants provide a thumb-print and a witness (independent of the trial and > 21 years old), chosen by the participant, will co-sign the informed consent form. For participants aged < 18 years, a literate caregiver (someone who takes care of them and > 21 years old) provides consent. The informed consent form is in the local language, Sesotho, and each participant is given a copy. Study participants have the right to withdraw their consent at any time without giving reasons. If a participant does withdraw, only data collected until the time of withdrawal will be used for research purposes (fully anonymized with the identifier removed).Participation in this study is not anticipated to cause any substantial additional risk or cost to the participants. Therefore, we will not pay compensation to them. Free AirTime (local prepaid money for cellphone usage) will be provided to the VHWs for their duties within the study. The VHWs have a central role in this new differentiated ART care and delivery model. Besides providing the basic supplies required for their work (i.e., a lockable drawer or cabinet to store medication and patient documents), we will support them with money for transportation to make sure the link between VHWs and the health facility is guaranteed. All VHWs who do not have a cellphone will receive a cellphone to stay in close contact with their responsible CAN. We will consider implementing stepwise remuneration for nurses at the health facilities for the clinic-based ART visits by our study participants during the follow-up.The results of this research project will be shared at three levels: (1) district level, during meetings headed by the district health management team, (2) national level, at the national research symposium of the Ministry of Health, and (3) international level through presentations at conferences and publication in peer-reviewed journals. The current version of the recommendations of the International Committee of Medical Journal Editors [] will be followed regarding the eligibility of authorship and we do not intend to use a professional writer.

: Not applicable.

: The Division of Infectious Diseases and Hospital Epidemiology, University Hospital Basel, under the lead of MB, receives unrestricted education and research grants from Gilead, MSD, Janssen, and ViiV. All other authors declare that they have no competing interests.