HIVHOSENGNCT03598686
HOme-based SElf-testiNG - a Cluster Randomized Controlled Trial in Rural Lesotho (HOSENG)
A study testing OraQuick in people with HIV and HIV/AIDS, run by Tracy Glass at 2 sites in Lesotho.
Trial 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 Read more about this study
- Who is it for?
- Any age
- What is being tested?
- OraQuick
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10,000 participants
- Where
- 2 sitesLesotho
- Study dates
- 26 Jul 2018to 9 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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)
- signed informed consent form from household head or representative aged 18 years or older
Who cannot join
- village authority (=village chief) opposed to trial participation (verbal assent)
- 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
- no signed informed consent form from household head or representative
Trial locations and contacts
2 sites in 1 country.
Lesotho2 sites
District of Butha-Buthe
Butha-Buthe
District of Mokhotlong
Mokhotlong
About this study
Official title: 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
Read the 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/
- Being tested
- OraQuick
- Keywords
- HIV, HIV/AIDS, self-testing, HIVST, home-based, community-based, lesotho, oraquick, testing coverage, htc campaign
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OraQuickDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: OraQuick |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: within 120 days after enrolment (i.e. HTS campaign)
Secondary outcomes (4)
HIV testing coverage among adolescents and young adults (ADORE nested study outcome)
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.
Measured: within 120 days after enrolment (i.e. HTS campaign)
Blood-based HIV testing uptake
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.
Measured: at enrolment (i.e. HTS campaign)
Oral HIVST uptake using OraQuick
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.
Measured: at enrolment (i.e. HTS campaign) and within 120 days after enrolment (i.e. HTS campaign)
Overall HIV testing coverage
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
Measured: within 120 days after enrolment (i.e. HTS campaign)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study start26 Jul 2018
- Primary completion31 May 2019
- Study completion9 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 10,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tracy Glass
- Sponsor type
- University, hospital or other
- Collaborators
- SolidarMed, Ministry of Health, Lesotho, University of Basel, University Hospital, Basel, Switzerland
- Responsible party
- Sponsor-investigator, Tracy Glass, Swiss Tropical & Public Health Institute
- Investigators
- Niklaus Labhardt, MD, Study director, Swiss TPHManuel Battegay, MD, Study chair, University Hospital, Basel, SwitzerlandJosephine Muhairwe, MD, Study chair, SolidarMedTracy R Glass, PhD, Principal investigator, Swiss TPH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03598686
- Sponsor's protocol ID
- P002-18-3.0
- Acronym
- HOSENG
- Status last verified
- Dec 2019
- First submitted
- 16 Jul 2018
- Last updated
- 17 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34268321Amstutz 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.
PubMed 33045193Amstutz 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.
PubMed 32869527Amstutz 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.
PubMed 31409421
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home-based Plus Self-testing to Improve HIV Testing Coverage in Rural Lesotho - a Cluster Randomized Controlled Trial in Rural Lesotho.
- ClinicalTrials.gov ID
- NCT03598686
- Acronym / sponsor ID
- HOSENG / P002-18-3.0
- Keywords
- HIV, HIV/AIDS, self-testing, HIVST, home-based, community-based, lesotho, oraquick
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10,000 participants (actual)
- Lead sponsor
- Tracy GlassUniversity, hospital or other
- Collaborators
- SolidarMed, Ministry of Health, Lesotho, University of Basel, University Hospital, Basel, Switzerland
- Study start
- 26 Jul 2018 (actual)
- Primary completion
- 31 May 2019 (actual)
- Study completion
- 9 Sep 2019 (actual)
- First posted
- 26 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 | Diagnostic Test: OraQuickHOSENG 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
- signed informed consent form from household head or representative aged 18 years or older
Key exclusion criteria (4 listed)
- village authority (=village chief) opposed to trial participation (verbal assent)
- 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
- no signed informed consent form from household head or representative
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OraQuickMost 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. | Diagnostic test | HOSENG Intervention |
Primary outcome
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
4 secondary outcomes
HIV testing coverage among adolescents and young adults (ADORE nested study outcome)
Time frame: within 120 days after enrolment (i.e. HTS campaign)
Blood-based HIV testing uptake
Time frame: 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)
Overall HIV testing coverage
Time frame: within 120 days after enrolment (i.e. HTS campaign)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2019.
- Derived from this study: PubMed 34268321Amstutz 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.
- Derived from this study: PubMed 33045193Amstutz 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.
- Derived from this study: PubMed 32869527Amstutz 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.
- Derived from this study: PubMed 31409421Amstutz 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.
- Official Project HomepageLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Niklaus Labhardt, MD study director
Swiss TPH
Manuel Battegay, MD study chair
University Hospital, Basel, Switzerland
Josephine Muhairwe, MD study chair
SolidarMed
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OraQuick in people with HIV and HIV/AIDS, run by Tracy Glass at 2 sites in Lesotho.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Lesotho. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HIV testing coverage (time frame: within 120 days after enrolment (i.e. HTS campaign)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03598686, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2019.