HOme-based SElf-testiNG - a Cluster Randomized Controlled Trial in Rural Lesotho (HOSENG)
NCT ID: NCT03598686
Last Updated: 2019-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
10000 participants
INTERVENTIONAL
2018-07-26
2019-09-09
Brief Summary
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Detailed Description
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Home- or community-based HIV testing has been proven to be very effective in resource-limited settings and therefore is a key strategy endorsed by WHO. Although acceptance of testing during such campaigns is usually very high, coverage remains low due to absent household members. And usually these absent people are men and young adults - both of which have a disproportionately high risk of HIV acquisition and poorer clinical outcomes once infected.
Oral HIV self-testing (HIVST) has shown to be an accurate diagnostic tool with a high acceptance and feasibility in sub-Saharan Africa. Experiences from the sub-Saharan region suggest that when HIV self-testing is provided as part of a home-based HIV testing campaigns, it can increase uptake of testing and facilitate linkage to care, especially among individuals who are at high risk of HIV infection.
The HOSENG study is linked to a follow-up trial, the VIBRA study. Together they are called the GET ON ("GETing tOwards Ninety") research project. The HOSENG study with its home-based HIV testing campaign provides the platform for the VIBRA study.
The HOSENG study is a cluster randomized, parallel-group (1:1:1:1 allocation), open-label, superiority, prospective clinical trial. Clusters are stratified by district, size of village, and village access to the nearest health facility.
The primary endpoint is HIV testing coverage among individuals aged 12 years or older in the surveyed area within 120 days after the home visit, defined as the proportion of all individuals 12 years or older living in a household of the surveyed area with a confirmed HIV test result. The secondary enpoints are listed below.
For the entire GET ON project we will collect cost data. Specifically for 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 ART service). These data will provide the average cost per participant achieving the primary endpoint within 120 days in each cluster arm ('per participant tested cost'). Secondly, a cost-effectiveness analysis will be performed with respect to the primary endpoint. Da-ta to assess patient level costs will be collected from a randomly selected sub-sample of study participants from each cluster arm. Costs will be reported as means (incl. SD) and medians (incl. IQRs) in local currencies and US dollars and International Dollars.
A nested study (ADORE study: "ADolescent ORal sElf-testing") will explore the acceptability of oral HIVST among adolescents and young adults with quantitative methods (see secondary endpoint) and qualitative methods: A qualitative case-control study. Cases are those who refused testing through oral HIVST and controls are those who accepted testing through oral HIVST. We plan to conduct at least 10 interviews per group, stratified by two pre-defined factors (male vs female; age 12-15 vs age 16-24), following the concept of saturation. Data will be collected by a trained study member, who was part of the HIV testing campaign, using a piloted interview questionnaire (KoboToolbox; www.kobotoolbox.org), conducted in the local language (Sesotho). Qualitative data will be recorded, transcribed, translated into English and coded and analyzed using the Framework Method.
More, detailed information:
* https://getonproject.wordpress.com
* https://www.swisstph.ch/en/topics/hiv-aids/
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
The HOSENG study is a cluster randomized, parallel-group (1:1:1:1 allocation), open-label, superiority, prospective clinical trial. Clusters are stratified by district, size of village, and village access to the nearest health facility.
DIAGNOSTIC
NONE
Study Groups
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HOSENG Control
Standard of care during a door-to-door HIV testing campaign:
1. For present household members: blood-based HIV testing
2. For absent household members or household members who refuse testing: They are encouraged to get tested by the Village Health Worker (VHW) or the nearby health facility
No interventions assigned to this group
HOSENG Intervention
HOSENG Intervention during a door-to-door HIV testing campaign:
1. For present household members: blood-based HIV testing
a) If any absent person in the household: One of the present household members is tested and trained using the oral HIVST (OraQuick©)
2. For absent household members or household members who refuse testing: One oral HIVST (OraQuick©) is left behind and has to be brought back to the VHW after usage. Otherwise it will be collected by the VHW after two weeks.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
2. the cluster has at least one registered VHW who is willing to participate and fulfills the following criteria: i. is at least 18 years of age ii. has adequate reading and writing skills iii. successfully passes the training assessment, assessed by a local person independent to GET ON research project and GET ON research team. Two criteria have to be fulfilled: a. is able to fill in the assessment (tick boxes, write in correct fields) b. is able to give an adequate answer regarding open question (in order to see if VHW is able to read and write and has a basic logic thinking)
Eligibility - household
a) signed informed consent form from household head or representative aged 18 years or older
Exclusion Criteria
a) no signed informed consent form from household head or representative
ALL
No
Sponsors
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SolidarMed
OTHER
Ministry of Health, Lesotho
OTHER_GOV
University of Basel
OTHER
University Hospital, Basel, Switzerland
OTHER
Tracy Glass
OTHER
Responsible Party
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Tracy Glass
Head of Statistics, Principal Investigator
Principal Investigators
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Niklaus Labhardt, MD
Role: STUDY_DIRECTOR
Swiss TPH
Manuel Battegay, MD
Role: STUDY_CHAIR
University Hospital, Basel, Switzerland
Josephine Muhairwe, MD
Role: STUDY_CHAIR
SolidarMed
Tracy R Glass, PhD
Role: PRINCIPAL_INVESTIGATOR
Swiss TPH
Locations
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District of Butha-Buthe
Butha-Buthe, , Lesotho
District of Mokhotlong
Mokhotlong, , Lesotho
Countries
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References
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Amstutz A, Matsela L, Lejone TI, Kopo M, Glass TR, Labhardt ND. Reaching Absent and Refusing Individuals During Home-Based HIV Testing Through Self-Testing-at What Cost? Front Med (Lausanne). 2021 Jun 29;8:653677. doi: 10.3389/fmed.2021.653677. eCollection 2021.
Amstutz A, Lejone TI, Khesa L, Muhairwe J, Bresser M, Vanobberghen F, Kopo M, Kao M, Nsakala BL, Tlali K, Klimkait T, Battegay M, Labhardt ND, Glass TR. Home-based oral self-testing for absent and declining individuals during a door-to-door HIV testing campaign in rural Lesotho (HOSENG): a cluster-randomised trial. Lancet HIV. 2020 Nov;7(11):e752-e761. doi: 10.1016/S2352-3018(20)30233-2. Epub 2020 Oct 9.
Amstutz A, Kopo M, Lejone TI, Khesa L, Kao M, Muhairwe J, Glass TR, Labhardt ND. "If it is left, it becomes easy for me to get tested": Use of oral self-tests and community health workers to maximize the potential of home-based HIV testing among adolescents in Lesotho. J Int AIDS Soc. 2020 Sep;23 Suppl 5(Suppl 5):e25563. doi: 10.1002/jia2.25563.
Amstutz A, Lejone TI, Khesa L, Muhairwe J, Nsakala BL, Tlali K, Bresser M, Vanobberghen F, Kopo M, Kao M, Klimkait T, Battegay M, Labhardt ND, Glass TR. The 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. Trials. 2019 Aug 13;20(1):496. doi: 10.1186/s13063-019-3469-2.
Related Links
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Official Project Homepage
Other Identifiers
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P002-18-3.0
Identifier Type: -
Identifier Source: org_study_id