An Evaluation of a Rapid Test for HIV

NCT01733927 | Completed Phase 3

• 1 other identifier: DIEECII #3
• Study Type: interventional
• Target: 497
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study, conducted in Santiago-Chile, was to:

1. 1.Evaluate the sensitivity and specificity of OraQuick Advance oral rapid test (OQA)when compared to ELISA;
2. 2.Track the number of people in the study who returned for their ELISA test HIV results; and
3. 3.Analyze the perception among participants of the use of OQA compared to ELISA testing for HIV screening.

Conditions

HIV Seropositivity

Keywords

HIV screening; Rapid test for HIV

Outcome Measures

Primary Outcomes (1)

• The sensitivity and specificity of a rapid test in oral fluid (OraQuick Advance)compare to the ELISA test for HIV.

  OraQuick Advance rapid oral test (OQA) was administered to people living with HIV (PLWH) who were not under Anti-retroviral treatment. The PLWH had a previous positive ELISA test and confirmed diagnose with a Western-blot. People who didn't know their HIV diagnose, and who had come to the clinic for an ELISA test for HIV were also administered OQA test after they had completed their ELISA test.

  1 day (Immediately after the participants had taken their ELISA test for HIV or when recruited in case of people living with HIV.)

Secondary Outcomes (1)

• The number of people who received their result from the ELISA for HIV test, versus the number of people who receives their OQA results.

  Clinic staff notified patient of their ELISA test results for up to three weeks after their clinic visit.

Other Outcomes (1)

• Perceptions among study participants of the use of OQA compared to ELISA testing for HIV screening.

  Within 3 months after they were administered their OQA test, the participants were either interviewed or participated in a focus group.

Study Arms (1)

Rapid testing for HIV

EXPERIMENTAL

The intervention consisted in administer an oral rapid test for HIV (OQA) to people that also had taken an ELISA test to compare their tests results. Group 1 consisted of 344 participants who did not know their HIV status; Group 2 consisted of 153 participants who were previously confirmed to be HIV positive. The participants were instructed to obtain their own oral fluid sample using the testing devices provide by the OQA rapid test kits. Project team members, certified to interpret OQA results, registered each test outcome on a data form using the same code number that the participant was assigned for the ELISA test.

Device: Rapid testing for HIV

Interventions

Rapid testing for HIV DEVICE

The research team members were trained and certified in administering the OQA testing through the AIDS International Consortium in Philadelphia (WHCI), USA. During the recruitment process, participants were informed about the nature of the test, the length of time for results, and what procedures would be involved in self-administering the OQA test. After providing informed consent, including the release of information for research use, participants demonstrated their ability to properly take an OQA sample using a popsicle stick as a proxy for the testing device.

Also known as: OraQuick Advance rapid test

Rapid testing for HIV

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old or older
• Seeking ELISA testing to learn their HIV status (group 1) or
• Having been confirmed HIV positive through Western Blot testing (Group 2)

You may not qualify if:

• HIV positive currently under antiretroviral medication

Sponsors & Collaborators

• Pontificia Universidad Catolica de Chile: lead

Study Sites (1)

School of Nursing, Pontificia Universidad Catolica de Chile

Macul, Santiago Metropolitan, 7810000, Chile

Location

Related Publications (1)

• Irarrazabal LP, Ferrer L, Cianelli R, Lara L, Reed R, Levy J, Perez C. Oral rapid test: an alternative to traditional HIV screening in Chile. Rev Panam Salud Publica. 2013 Jun;33(6):427-32.

  PMID: 23939368 DERIVED

MeSH Terms

Conditions

HIV Seropositivity

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; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Lisette P Irarrazabal, PhD ©

  Pontificia Universidad Catolica de Chile / University of Illinois at Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2012
• First Posted: November 27, 2012
• Study Start: May 1, 2010
• Primary Completion: November 1, 2010
• Study Completion: March 1, 2011
• Last Updated: November 27, 2012

Record last verified: 2012-11

Locations

CL (1)