Clinical Trial: An Evaluation of a Rapid Test for HIV

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: An Evaluation of an Oral Rapid Test for HIV

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 Summary:

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 qui
Sponsor: Pontificia Universidad Catolica de Chile

Current Primary Outcome: The sensitivity and specificity of a rapid test in oral fluid (OraQuick Advance)compare to the ELISA test for HIV. [ Time Frame: 1 day (Immediately after the participants had taken their ELISA test for HIV or when recruited in case of people living with 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.


Original Primary Outcome: Same as current

Current Secondary Outcome: The number of people who received their result from the ELISA for HIV test, versus the number of people who receives their OQA results. [ Time Frame: Clinic staff notified patient of their ELISA test results for up to three weeks after their clinic visit. ]

Ones the results of the ELISA test came back from the laboratory, the responsible party at the clinic had to notify the patient and the research team about their ELISA for HIV result and if they had been successfully notifying the HIV status. The patient had authorized the clinic staff to disclosure their HIV result to the research team in the consent form when enrolled in the research. This results were compared with the number of people that would have received their result in the same visit (after 20 minutes) if administered OQA instead of the ELISA.


Original Secondary Outcome: Same as current

Information By: Pontificia Universidad Catolica de Chile

Dates:
Date Received: November 21, 2012
Date Started: May 2010
Date Completion:
Last Updated: November 26, 2012
Last Verified: November 2012