Mass ScreeningNCT03979144
Usability Study of a Self-test Prototype for Human Immunodeficiency Virus (HIV) Screening
An observational study of Mass Screening, run by The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz) at 1 site in Brazil.
Trial summary
It concerns a study to evaluate the usability of an HIV self-test prototype developed from TR DPP® HIV - 1/2 Oral Fluid. The study followed the recommendations of Technical Note No. 20/2016 / GEVIT / GGTPS / ANVISA. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mass Screening
- What is being tested?
- Observational study
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 113 participants
- Where
- 1 siteBrazil
- Study dates
- 19 Jun 2018to 11 Mar 2019
- How long will I take part?
- 7 Months
- Phase
- Observational
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Lay people, that is, individuals without formal technical or scientific training, with different degrees of education, genres and age groups. The user profile included information about the academic / professional training and city / state, of both sexes, selected from characteristics distributed in 4 different groups, including regional variations: Group 1: participants with a grade of schooling up to elementary school, in the age group of 18 to 29 years; Group 2: participants with a high school education level, between the ages of 18 and 29; Group 3: participants with educational level up to elementary school, in the age group from 30 years; Group 4: participants with a high school education, in the age group from 30 years of age
Who may be able to join
- Individuals aged ≥ 18 years, of both sexes, who agree to participate in the study, after reading, understanding and signing the ICF;
- Individuals who authorized filming during the test.
Who cannot join
- Illiterates;
- Participants who have already performed any other HIV self-test;
- Health professionals with complete higher education;
- Colorblind individuals.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Assessoria Clinica / Bio-Manguinhos / Fiocruz
Rio de Janeiro, 21.040-360
About this study
It concerns a study to evaluate the usability of an HIV self-test prototype developed from TR DPP® HIV - 1/2 Oral Fluid. The study followed the recommendations of Technical Note No. 20/2016 / GEVIT / GGTPS / ANVISA.
Read the detailed description
It concerns a study with a mixed method approach to evaluate the usability of a prototype of HIV self-test among lay users. Data collection techniques were performed through observation through videos of lay users conducting self-testing without supervision, a qualitative checklist by participant observation, pre-test and post-test interviews, and closure form. There was no randomization in this study.
The study was conducted by four clinical research sites, distributed in four different states of Brazil in other to obtain a geographic representation: Unidade de Ensaios Clínicos para Imunobiológicos (UECI) at Rio de Janeiro; Centro de Ciências da Saúde da Universidade Federal da Paraíba (UFPB) at Paraíba, Faculdade de Medicina de Botucatu (UNESP) at São Paulo and Centro de Ciências Biológicas e da Saúde da Universidade Estadual do Pará (UEPA) at Pará.
- Conditions
- Mass Screening
- Being tested
- Observational study
- Keywords
- Usability, HIV self-test, Prototype
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational studyBehavioural
This was an observational study of a medical device, through the usability assessment, for the registration of a self-test for the immunodeficiency virus (HIV) screening.
What is being measured
The primary outcome is the main question the study is designed to answer.
Compliance with self-test execution
Percentage of participants who followed all the steps correctly
Measured: Day 1
Compliance with results interpretation
Percentage of participants who misinterpreted the test result
Measured: Day 1
Compliance with self-test result
Percentage of positive results interpreted as negative
Measured: Day 1
Compliance with self-test steps
Percentage of participants who made mistakes in each of the steps
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2019
- Study start19 Jun 2018
- Primary completion26 Jan 2019
- Study completion11 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mass ScreeningStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 113 participants (actual)
- Target duration
- 7 Months
Sponsor and investigators
- Lead sponsor
- The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tatiana J Fernandes, DSD, MSc, Principal investigator, Assessoria Clinica / Bio-Manguinhos / Fiocruz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03979144
- Sponsor's protocol ID
- ASCLIN 003/2017
- Status last verified
- Jun 2019
- First submitted
- 20 May 2019
- Last updated
- 7 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Usability Study of a Self-test Prototype for Human Immunodeficiency Virus (HIV) Screening
- ClinicalTrials.gov ID
- NCT03979144
- Acronym / sponsor ID
- ASCLIN 003/2017
- Conditions
- Mass Screening
- Keywords
- Usability, HIV self-test, Prototype
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)University, hospital or other
- Study start
- 19 Jun 2018 (actual)
- Primary completion
- 26 Jan 2019 (actual)
- Study completion
- 11 Mar 2019 (actual)
- First posted
- 7 Jun 2019 (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.
It concerns a study to evaluate the usability of an HIV self-test prototype developed from TR DPP® HIV - 1/2 Oral Fluid. The study followed the recommendations of Technical Note No. 20/2016 / GEVIT / GGTPS / ANVISA.
Detailed description
It concerns a study with a mixed method approach to evaluate the usability of a prototype of HIV self-test among lay users. Data collection techniques were performed through observation through videos of lay users conducting self-testing without supervision, a qualitative checklist by participant observation, pre-test and post-test interviews, and closure form. There was no randomization in this study.
The study was conducted by four clinical research sites, distributed in four different states of Brazil in other to obtain a geographic representation: Unidade de Ensaios Clínicos para Imunobiológicos (UECI) at Rio de Janeiro; Centro de Ciências da Saúde da Universidade Federal da Paraíba (UFPB) at Paraíba, Faculdade de Medicina de Botucatu (UNESP) at São Paulo and Centro de Ciências Biológicas e da Saúde da Universidade Estadual do Pará (UEPA) at Pará.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 7 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Lay people, that is, individuals without formal technical or scientific training, with different degrees of education, genres and age groups. The user profile included information about the academic / professional training and city / state, of both sexes, selected from characteristics distributed in 4 different groups, including regional variations: Group 1: participants with a grade of schooling up to elementary school, in the age group of 18 to 29 years; Group 2: participants with a high school education level, between the ages of 18 and 29; Group 3: participants with educational level up to elementary school, in the age group from 30 years; Group 4: participants with a high school education, in the age group from 30 years of age
Key inclusion criteria (2 listed)
- Individuals aged ≥ 18 years, of both sexes, who agree to participate in the study, after reading, understanding and signing the ICF;
- Individuals who authorized filming during the test.
Key exclusion criteria (4 listed)
- Illiterates;
- Participants who have already performed any other HIV self-test;
- Health professionals with complete higher education;
- Colorblind individuals.
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 |
|---|---|---|
| Observational studyThis was an observational study of a medical device, through the usability assessment, for the registration of a self-test for the immunodeficiency virus (HIV) screening. | Behavioural | – |
Primary outcome
Compliance with self-test execution
Time frame: Day 1
Percentage of participants who followed all the steps correctly
Compliance with results interpretation
Time frame: Day 1
Percentage of participants who misinterpreted the test result
Compliance with self-test result
Time frame: Day 1
Percentage of positive results interpreted as negative
Compliance with self-test steps
Time frame: Day 1
Percentage of participants who made mistakes in each of the steps
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 7 Jun 2019.
- 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.
Tatiana J Fernandes, DSD, MSc principal investigator
Assessoria Clinica / Bio-Manguinhos / Fiocruz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mass Screening, run by The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz) at 1 site in Brazil.
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 2 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 7 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. 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?
Compliance with self-test execution (time frame: Day 1). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Jun 2019.