Clinical trial NCT01733927: An Evaluation of a Rapid Test for HIV
Official title: An Evaluation of an Oral Rapid Test for HIV
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: HIV Seropositivity
Keywords: HIV screening
Rapid test for HIV
Lead sponsor: Pontificia Universidad Catolica de Chile
Sponsor class: OTHER
First posted: 2012-11-27
Enrollment: 497
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

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.

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

Primary outcomes:
measure: The sensitivity and specificity of a rapid test in oral fluid (OraQuick Advance)compare to the ELISA test for HIV.
timeFrame: 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:
measure: The number of people who received their result from the ELISA for HIV test, versus the number of people who receives their OQA results.
timeFrame: Clinic staff notified patient of their ELISA test results for up to three weeks after their clinic visit.
Other outcomes:
measure: Perceptions among study participants of the use of OQA compared to ELISA testing for HIV screening.
timeFrame: Within 3 months after they were administered their OQA test, the participants were either interviewed or participated in a focus group.
Locations:
city: Macul
country: Chile
facility: School of Nursing, Pontificia Universidad Catolica de Chile
state: Santiago
Study officials:
affiliation: Pontificia Universidad Catolica de Chile / University of Illinois at Chicago
name: Lisette P Irarrazabal, PhD ©
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.