An Evaluation of a Rapid Test for HIV

NCT ID: NCT01733927

Last Updated: 2012-11-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 497 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-05-31
• Study Completion Date: 2011-03-31

Brief Summary

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

1. Evaluate the sensitivity and specificity of OraQuick Advance oral rapid test (OQA)when compared to ELISA;

2. Track the number of people in the study who returned for their ELISA test HIV results; and

3. Analyze the perception among participants of the use of OQA compared to ELISA testing for HIV screening.

Detailed Description

Human Immunodeficiency Virus /Acquired Immunodeficiency Syndrome (HIV/AIDS) continues to be one of the most devastating worldwide pandemics. In response to the HIV/AIDS epidemic, the Joint United Nations Programme on HIV/AIDS in 2010, urged countries to improve access to HIV/AIDS testing and counseling in an effort to increase the number of people who know their HIV status, thereby attempting to decrease transmission and increase treatment. Thus, an effective country response is to increase voluntary testing and counseling, particularly among at-risk populations. Ensuring patients receive their test results is an essential component of these efforts.

Chile, since 1991, has seen an increase of notified cases of HIV/ AIDS among certain regions of the country. The Chilean government offers free screening for HIV using only the ELISA test. In addition, many Chileans fail to return to receive their test results, as do many other individuals worldwide. In the United States, the Center for Disease Control reported that when using the "gold standard of HIV testing" (the ELISA) 30% of people with negative results and 39% of people with positive results do not return for their test results.

In Western counties, as well as several Latin American countries, the use of rapid testing technology to identify HIV 1 and 2 has increased the percentage of people who learn their serological status when compared with those who are tested using the traditional ELISA method. Neither the rapid test nor ELISA yield a definitive diagnosis, so further confirmation testing is required using the Western Blot to rule out the possibility of a false positive result. Nonetheless, by providing quick turn-around, rapid testing helps to facilitate individuals receiving their initial test results, thereby increasing the their probability of being quickly referred to appropriate health services for confirmatory testing and treatment.

Although the Food and Drug Administration (FDA) currently has approved six different rapid tests for clinical use to detect HIV 1 and 2, the OraQuick Advance Rapid Assessment (OQA) is the only one that is administered orally.

OQA testing can be conducted in geographical locations where laboratory facilities capable of performing ELISA assays are unavailable. Thus, HIV screening programs that adopt OQA can extend their reach far beyond previous locations.

Despite OQA's growing success and popularity in many different settings globally, Chile has yet to accept OQA or any rapid testing as a viable alternative to ELISA testing. The Chilean government has delayed approval for the adoption of OQA pending additional evidence among Chileans that it offers a more advantageous alternative to ELISA testing with equal specificity.

Conditions

HIV Seropositivity

Keywords

HIV screening; Rapid test for HIV

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: NONE

Study Groups

Rapid testing for HIV

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.

Group Type: EXPERIMENTAL

Rapid testing for HIV

Intervention Type: 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.

Interventions

Rapid testing for HIV

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.

Intervention Type: DEVICE

Other Intervention Names

OraQuick Advance rapid test

Eligibility Criteria

Inclusion Criteria

• 18 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)

Exclusion Criteria

• HIV positive currently under antiretroviral medication

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Pontificia Universidad Catolica de Chile

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lisette P Irarrazabal, PhD ©

Role: PRINCIPAL_INVESTIGATOR

Pontificia Universidad Catolica de Chile / University of Illinois at Chicago

Locations

School of Nursing, Pontificia Universidad Catolica de Chile

Macul, Santiago Metropolitan, Chile

Countries

Chile

References

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.

Reference Type: DERIVED

PMID: 23939368 (View on PubMed)

Other Identifiers

DIEECII #3

Identifier Type: -

Identifier Source: org_study_id