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

NCT03598686 | Completed

• 1 other identifier: P002-18-3.0
• Study Type: interventional
• Target: 10,000
• Locations: 1 country
• Sites: 2

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

Conditions

HIV; HIV/AIDS

Keywords

HIV; HIV/AIDS; self-testing; HIVST; home-based; community-based; lesotho; oraquick; testing coverage; htc campaign

Outcome Measures

Primary Outcomes (1)

• HIV testing coverage

  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

  within 120 days after enrolment (i.e. HTS campaign)

Secondary Outcomes (4)

• HIV testing coverage among adolescents and young adults (ADORE nested study outcome)

  within 120 days after enrolment (i.e. HTS campaign)

• Blood-based HIV testing uptake

  at enrolment (i.e. HTS campaign)

• Oral HIVST uptake using OraQuick

  at enrolment (i.e. HTS campaign) and within 120 days after enrolment (i.e. HTS campaign)

• Overall HIV testing coverage

  within 120 days after enrolment (i.e. HTS campaign)

Study Arms (2)

HOSENG Control

NO INTERVENTION

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

HOSENG Intervention

EXPERIMENTAL

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

Interventions

OraQuick DIAGNOSTIC_TEST

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.

HOSENG Intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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)

You may not qualify if:

• village authority (=village chief) opposed to trial participation (verbal assent)
• Eligibility - household
• a) signed informed consent form from household head or representative aged 18 years or older
• a) no signed informed consent form from household head or representative

Sponsors & Collaborators

• Tracy Glass: lead
• SolidarMed: collaborator
• Ministry of Health, Lesotho: collaborator
• University of Basel: collaborator
• University Hospital, Basel, Switzerland: collaborator

Study Sites (2)

District of Butha-Buthe

Butha-Buthe, Lesotho

Location

District of Mokhotlong

Mokhotlong, Lesotho

Location

Related Publications (4)

• 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.

  PMID: 34268321 DERIVED

• 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.

  PMID: 33045193 DERIVED

• 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.

  PMID: 32869527 DERIVED

• 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.

  PMID: 31409421 DERIVED

Related Links

• Official Project Homepage

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Niklaus Labhardt, MD

  Swiss TPH

  STUDY DIRECTOR

• Manuel Battegay, MD

  University Hospital, Basel, Switzerland

  STUDY CHAIR

• Josephine Muhairwe, MD

  SolidarMed

  STUDY CHAIR

• Tracy R Glass, PhD

  Swiss TPH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of Statistics, Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: July 16, 2018
• First Posted: July 26, 2018
• Study Start: July 26, 2018
• Primary Completion: May 31, 2019
• Study Completion: September 9, 2019
• Last Updated: December 17, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

LE (2)