HIV SeropositivityPhase 3NCT01733927
An Evaluation of a Rapid Test for HIV
A Phase 3 study testing Rapid testing for HIV in people with HIV Seropositivity, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV Seropositivity
- What is being tested?
- Rapid testing for HIV
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 497 participants
- Where
- 1 siteChile
- Study dates
- May 2010to Mar 2011
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- HIV positive currently under antiretroviral medication
Trial locations and contacts
1 site in 1 country.
Chile1 site
School of Nursing, Pontificia Universidad Catolica de Chile
Macul, Santiago Metropolitan, 7810000
About this study
Official title: An Evaluation of an Oral Rapid Test for HIV
The purpose of this study, conducted in Santiago-Chile, was to:
- Evaluate the sensitivity and specificity of OraQuick Advance oral rapid test (OQA)when compared to ELISA;
- Track the number of people in the study who returned for their ELISA test HIV results; and
- Analyze the perception among participants of the use of OQA compared to ELISA testing for HIV screening.
Read the 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
- Being tested
- Rapid testing for HIV
- Keywords
- HIV screening, Rapid test for HIV
- Medical subject headings
- HIV Seropositivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rapid testing for HIVDevice
Also called OraQuick Advance rapid test
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Rapid testing for HIV |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: Clinic staff notified patient of their ELISA test results for up to three weeks after their clinic visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2012 (estimated)
- Study startMay 2010
- Primary completionNov 2010
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV SeropositivityStudies of the same condition, open and under way.
- More trials run by Pontificia Universidad Catolica de ChileThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 497 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pontificia Universidad Catolica de Chile
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lisette P Irarrazabal, PhD ©, Principal investigator, Pontificia Universidad Catolica de Chile / University of Illinois at Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01733927
- Sponsor's protocol ID
- DIEECII #3
- Status last verified
- Nov 2012
- First submitted
- 21 Nov 2012
- Last updated
- 27 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23939368
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of an Oral Rapid Test for HIV
- ClinicalTrials.gov ID
- NCT01733927
- Acronym / sponsor ID
- DIEECII #3
- Conditions
- HIV Seropositivity
- Keywords
- HIV screening, Rapid test for HIV
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 497 participants (actual)
- Lead sponsor
- Pontificia Universidad Catolica de ChileUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Nov 2010 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 27 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study, conducted in Santiago-Chile, was to:
- Evaluate the sensitivity and specificity of OraQuick Advance oral rapid test (OQA)when compared to ELISA;
- Track the number of people in the study who returned for their ELISA test HIV results; and
- 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.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rapid testing for HIV | Experimental | Device: Rapid testing for HIVThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (1 listed)
- HIV positive currently under antiretroviral medication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rapid testing for HIVAlso: OraQuick Advance rapid testThe 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. | Device | Rapid testing for HIV |
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.
1 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2012.
- Derived from this study: PubMed 23939368Irarrazabal 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lisette P Irarrazabal, PhD © principal investigator
Pontificia Universidad Catolica de Chile / University of Illinois at Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Rapid testing for HIV in people with HIV Seropositivity, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01733927, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2012.