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Usability Study of a Self-test Prototype for Human Immunodeficiency Virus (HIV) Screening

NCT03979144 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 113

Last updated 2019-06-07

No results posted yet for this study

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.

Conditions

  • Mass Screening

Interventions

BEHAVIORAL

Observational study

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.

Sponsors & Collaborators

  • The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)

    lead OTHER

Principal Investigators

  • Tatiana J Fernandes, DSD, MSc · Assessoria Clinica / Bio-Manguinhos / Fiocruz

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-06-19
Primary Completion
2019-01-26
Completion
2019-03-11

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03979144 on ClinicalTrials.gov