Abstract

BackgroundHIV-testing coverage remains below the targeted 90% despite efforts and resources invested. Home-based HIV-testing is a key approach endorsed by the World Health Organization (WHO), especially to reach individuals who might not seek testing otherwise. Although acceptance of testing during such campaigns is high, coverage remains low due to absent household members. This cluster-randomized trial aims to assess increase in testing coverage using oral HIV self-testing (HIVST) among individuals who are absent or decline testing during home-based HIV-testing.MethodsThe HOSENG (HOme-based SElf-testiNG) trial is a cluster-randomized, parallel-group, superiority trial in two districts of Lesotho, Southern Africa. Clusters are stratified by district, village size, and village access to the nearest health facility. Cluster eligibility criteria include: village is in catchment area of one of the study facilities, village authority provides consent, and village has a registered, capable, and consenting village health worker (VHW). In intervention clusters, HIV self-tests are provided for eligible household members who are absent or decline HIV-testing in the presence of the campaign team. In control clusters, standard of care for absent and refusing individuals applies, i.e., referral to a health facility. The primary outcome is HIV-testing coverage among individuals aged 12 years or older within 120 days after enrollment. Secondary objectives include HIV-testing coverage among other age groups, and uptake of the different testing modalities. Statistical analyses will be conducted and reported in line with CONSORT guidelines. The HOSENG trial is linked to the VIBRA (Village-Based Refill of ART) trial. Together, they constitute the GET ON (GETting tOwards Ninety) research project.DiscussionThe HOSENG trial tests whether oral HIVST may be an add-on during door-to-door testing campaigns towards achieving optimal testing coverage. The provision of oral self-test kits, followed up by VHWs, requires little additional human resources, finances and logistics. If cost-effective, this approach should inform home-based HIV-testing policies not only in Lesotho, but in similar high-prevalence settings.Trial registrationClinicalTrials.gov, (ID: NCT03598686). Registered on 25 July 2018. More information is available at www.getonproject.wordpress.com.

Highlights

  • human immune deficiency virus (HIV)-testing coverage remains below the targeted 90% despite efforts and resources invested

  • The HOme-based SElftestiNG (HOSENG) trial tests whether oral HIV self-testing (HIVST) may be an add-on during door-to-door testing campaigns towards achieving optimal testing coverage

  • The most recent data from Eastern and Southern Africa show that the percentage of people living with HIV who know their HIV status has steadily improved in the last few years, currently at a level of 81% (64–95%), but still leaving a gap of approximately 1.7 million HIV-positive people to reach the target of 90% knowing their HIV status [3, 4]

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Summary

Methods

Setting The HOSENG (HOme-based SElf-testiNG) trial will be conducted in the districts of Butha-Buthe and Mokhotlong, in Northern Lesotho, Southern Africa, in the catchment areas of 22 health facilities. 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). These data will provide the cost per participant achieving. A nested study (ADORE study: “ADolescent ORal sElf-testing”) will explore the effectiveness acceptability of oral HIVST among adolescents and young adults with quantitative methods

Discussion
Background
Blood-based HIVtesting uptake
Findings
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