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

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ClinicalTrials.gov Identifier: NCT03598686
Recruitment Status : Recruiting
First Posted : July 25, 2018
Last Update Posted : June 7, 2019
Sponsor:
Collaborators:
SolidarMed
Ministry of Health, Lesotho
University of Basel
University Hospital, Basel, Switzerland
Information provided by (Responsible Party):
Tracy Glass, Swiss Tropical & Public Health Institute

Brief 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

Condition or disease Intervention/treatment Phase
HIV HIV/AIDS Diagnostic Test: OraQuick Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

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 reasons for this interlinked design are: a) potential study participants for VIBRA trial (HIV-positive individuals not on ART) are recruited during the HOSENG study, b) this design allows us to assess the entire HIV/AIDS care cascade in one larger project, and c) both trials rely on interventions involving VHWs, who need to be randomized and specifically trained. Therefore, it is more efficient and feasible to run both trials parallel and randomize at one time point.

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.

Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Home-based Plus Self-testing to Improve HIV Testing Coverage in Rural Lesotho - a Cluster Randomized Controlled Trial in Rural Lesotho.
Actual Study Start Date : July 26, 2018
Actual Primary Completion Date : May 31, 2019
Estimated Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
No Intervention: 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
Experimental: 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.
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.




Primary Outcome Measures :
  1. HIV testing coverage [ Time Frame: within 120 days after enrolment (i.e. HTS campaign) ]
    HIV testing coverage among individuals aged 12 years or older in the surveyed area within 120 days after the HIV testing and service (HTS) campaign, 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


Secondary Outcome Measures :
  1. HIV testing coverage among adolescents and young adults (ADORE nested study outcome) [ Time Frame: within 120 days after enrolment (i.e. HTS campaign) ]
    HIV testing coverage among 12-24 years old individuals in the surveyed area within 120 days after the HTS campaign, defined as the proportion of all 15-24 years old individuals living in a household of the surveyed area with a confirmed HIV test result.

  2. Blood-based HIV testing uptake [ Time Frame: at enrolment (i.e. HTS campaign) ]
    Blood-based HIV testing uptake, defined as the proportion of all individuals living in a household of the surveyed area, being eligible for blood-based HIV testing and accepting to be tested using blood-based point-of-care HIV test during the home-visit.

  3. Oral HIVST uptake using OraQuick [ Time Frame: at enrolment (i.e. HTS campaign) and within 120 days after enrolment (i.e. HTS campaign) ]
    Oral HIVST uptake among absent individuals, defined as the proportion of all individuals living in a household of the surveyed area for whom an oral HIVST was left behind and who accepted to be self-tested using the oral HIVST.

  4. Overall HIV testing coverage [ Time Frame: within 120 days after enrolment (i.e. HTS campaign) ]
    HIV testing coverage irrespective of age, defined as the proportion of all individuals living in a household of the surveyed area with a confirmed HIV test result



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Eligibility - clusters

Inclusion criteria:

  1. the cluster is rural and clearly confined to the catchment area of one of the study clinics i. one cluster usually consists of one village, but could include several small villages serviced by the same VHW
  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)

Exclusion criteria:

  1. village authority (=village chief) opposed to trial participation (verbal assent)
  2. VHW opposed to trial participation or not fulfilling the minimum requirements mentioned above (=inclusion criteria, point b) i. Note: if a cluster entails several VHWs, then the cluster can still participate if there is at least one VHW in the cluster who is willing to trial participation and fulfills the minimum requirements.

Eligibility - household

Inclusion criteria:

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03598686


Contacts
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Contact: Tracy Glass, PhD 79 415 72 37 ext +41 tracy.glass@swisstph.ch
Contact: Alain Amstutz, MD 5860 4300 ext +266 alain.amstutz@swisstph.ch

Locations
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Lesotho
District of Butha-Buthe Recruiting
Butha-Buthe, Lesotho
Contact: Thabo Lejone, MIH    62000584 ext +266    t.lejone@solidarmed.ch   
Contact: Alain Amstutz, MD    58604300 ext +266    alain.amstutz@swisstph.ch   
District of Mokhotlong Recruiting
Mokhotlong, Lesotho
Contact: Lefu Khesa, RN    56425205 ext +266    l.khesa@solidarmed.ch   
Contact: Alain Amstutz, MD    58604300 ext +266    alain.amstutz@swisstph.ch   
Sponsors and Collaborators
Tracy Glass
SolidarMed
Ministry of Health, Lesotho
University of Basel
University Hospital, Basel, Switzerland
Investigators
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Study Director: Niklaus Labhardt, MD Swiss TPH
Study Chair: Manuel Battegay, MD University Hospital, Basel, Switzerland
Study Chair: Josephine Muhairwe, MD SolidarMed Lesotho
Principal Investigator: Tracy R Glass, PhD Swiss TPH

Additional Information:
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Responsible Party: Tracy Glass, Head of Statistics, Principal Investigator, Swiss Tropical & Public Health Institute
ClinicalTrials.gov Identifier: NCT03598686     History of Changes
Other Study ID Numbers: P002-18-3.0
First Posted: July 25, 2018    Key Record Dates
Last Update Posted: June 7, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Tracy Glass, Swiss Tropical & Public Health Institute:
HIV
HIV/AIDS
self-testing
HIVST
home-based
community-based
lesotho
oraquick
testing coverage
htc campaign