HOme-based SElf-testiNG - a Cluster Randomized Controlled Trial in Rural Lesotho (HOSENG)

Summary

This cluster-randomized trial aims to evaluate the efficacy of the use of oral HIV self-testing (HIVST) among individuals who are absent or who decline HIV testing during home-based HIV testing

Conditions

• HIV
• HIV/AIDS

Interventions

DIAGNOSTIC_TEST

OraQuick

Most trials assessing oral HIVST make use of OraQuick® (OraQuick ADVANCE HIV I/II test kits, packaged for self-use), an oral-fluid rapid self-test. OraQuick® is a 2nd generation serology assay with a sensitivity of 99.3% (95%CI; 98.4%, 99.7%) and a specificity of 99.8% (95%CI; 99.6%, 99.9%). In a pilot study with 59 participants conducted in Lesotho in 2015 more than 90% of the participants found utilization of OraQuick® easy, and trusted the results of the self-test kit. The WHO recently has announced that OraQuick becomes the first prequalified HIV self-test, in order to improve diagnosis in low-resourced health systems and in countries where stigma prevents people from getting tested. Therefore, OraQuick® is now available in Lesotho for as little as 2 USD per test kit.

Sponsors & Collaborators

• SolidarMed

  collaborator OTHER

• Ministry of Health, Lesotho

  collaborator OTHER_GOV

• University of Basel

  collaborator OTHER

• University Hospital, Basel, Switzerland

  collaborator OTHER

• Tracy Glass

  lead OTHER

Principal Investigators

• Niklaus Labhardt, MD · Swiss TPH

• Manuel Battegay, MD · University Hospital, Basel, Switzerland

• Josephine Muhairwe, MD · SolidarMed

• Tracy R Glass, PhD · Swiss TPH

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Model

PARALLEL

Eligibility

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-07-26

Primary Completion

2019-05-31

Completion

2019-09-09

Countries

• Lesotho

Study Locations