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

December 16, 2019 updated by: Tracy Glass

Home-based Plus Self-testing to Improve HIV Testing Coverage in Rural Lesotho - a Cluster Randomized Controlled Trial in Rural Lesotho.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

By launching the 90-90-90 strategy UNAIDS has shown a way forward in controlling and finally eradicating the deadly AIDS epidemic. Recent global data shows that progress towards the first UNAIDS target, i.e. to ensure that 90% of HIV-positive individuals are aware of their status, is lower than progress in other areas of the HIV care cascade. It is estimated that still approximately 2.7 million HIV-positive people do not know their HIV status.

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/

Study Type

Interventional

Enrollment (Actual)

10000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Lesotho
      • Butha-Buthe, Lesotho
        • District of Butha-Buthe
      • Mokhotlong, Lesotho
        • District of Mokhotlong

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
within 120 days after enrolment (i.e. HTS campaign)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
within 120 days after enrolment (i.e. HTS campaign)
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.
at enrolment (i.e. HTS campaign)
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.
at enrolment (i.e. HTS campaign) and within 120 days after enrolment (i.e. HTS campaign)
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
within 120 days after enrolment (i.e. HTS campaign)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tracy Glass

Collaborators

University Hospital, Basel, Switzerland
University of Basel
Ministry of Health, Lesotho
SolidarMed

Investigators

  • Study Director: Niklaus Labhardt, MD, Swiss TPH
  • Study Chair: Josephine Muhairwe, MD, SolidarMed Lesotho

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 26, 2018

Primary Completion (ACTUAL)

May 31, 2019

Study Completion (ACTUAL)

September 9, 2019

Study Registration Dates

First Submitted

July 16, 2018

First Submitted That Met QC Criteria

July 16, 2018

First Posted (ACTUAL)

July 26, 2018

Study Record Updates

Last Update Posted (ACTUAL)

December 17, 2019

Last Update Submitted That Met QC Criteria

December 16, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P002-18-3.0

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on HIV/AIDS

Clinical Trials on OraQuick

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Norway

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe