Funding for this research was provided by:
Schweizerischer Nationalfonds zur Förderung der Wissenschaftlichen Forschung (323530_177576, IZ07Z0_160876/1, PCEFP3_181355)
Stiftung Infektiologie beider Basel (N/A)
CIPHER grant - International AIDS Society (N/A)
Text and Data Mining valid from 2019-08-13
Received: 5 January 2019
Accepted: 24 May 2019
First Online: 13 August 2019
Ethics approval and consent to participate
: Before cluster-randomization and trial start, the study team obtains verbal consent from all involved village chiefs by attending the village chiefs’ councils and presenting the project. On the day of the HIV-testing campaign, the counselors obtain a written consent from the household head (or representative aged 18 years or older), to collect household data and to propose HIV-testing to all household members. Allocation to cluster arm is concealed at the household level in order to keep the risk of selection bias as low as possible. IIliterate participants will provide a thumb print and a witness (independent to the trial and aged > 21 years old), chosen by the participant, will co-sign the form. The informed consent is provided in the local language, Sesotho, and the participant will receive a copy of the consent forms. The household head has the right to withdraw consent at any time without giving reasons. In case of withdrawal, only data collected until the time of withdrawal will be used for research purposes (fully anonymized, identifier removed).If the household consents to participate, then the counselors obtain from each household member written informed consent for HIV-testing, following national HIV-testing guidelines and using the national HIV-testing form [CitationRef removed]. According to national guidelines individuals aged 12 years or older can consent to HIV-testing. For younger individuals a witness has to sign the national testing form. For HIVST no written consent will be obtained as the act of self-testing itself represents consent. Individual consent for interventions/screenings other than HIV-testing, such as referral for VMMC, is obtained using standard procedures according to national guidelines as these are considered part of the routine delivery of HIV-prevention services and not specifically study-related.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).Results of this research project will be shared at three levels: at district level, national level, and on an international level, by presenting at conferences and publication in peer-reviewed journals. The current version of the International Committee of Medical Journal Editors (ICMJE) recommendations [CitationRef removed] is applicable regarding authorship eligibility and the use of professional writers is not intended.
: 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.