HIV InfectionNCT01716299
Comparison of HIV Testing Algorithms
An observational study of HIV Infection, run by Medecins Sans Frontieres, Netherlands at 2 sites in Ethiopia.
Trial summary
The primary objective of the study is to assess whether an improved MSF HIV diagnostic algorithm which includes a simple and easy to perform confirmation test has significantly better positive predictive value than WHO recommended RDT testing algorithms that do not include confirmatory testing. Read more about this study
- Who is it for?
- Ages 5 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV Infection
- What is being tested?
- application of a confirmation test
- How many people
- 495 participants
- Where
- 2 sitesEthiopia
- Study dates
- Dec 2010to Dec 2013
- Phase
- Observational
- 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 5 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients presenting the Counseling and Testing centres in the two study sites
Who may be able to join
- • Age >= 59 months (to help ensure success of venepuncture)
- Informed consent from the individual or guardian to participate in study
Who cannot join
- • Inability to obtain venous blood sample
- Withdrawal of consent to test or to participate in the study
Trial locations and contacts
2 sites in 1 country.
Ethiopia2 sites
Abdurafi Health Center
Ābderafī, Amhara Regional State
Humera Hospital
Humera, Tigray
About this study
Official title: Comparison of HIV Testing Algorithms in Two Sites in Ethiopia
The primary objective of the study is to assess whether an improved MSF HIV diagnostic algorithm which includes a simple and easy to perform confirmation test has significantly better positive predictive value than WHO recommended RDT testing algorithms that do not include confirmatory testing.
Read the detailed description
Rapid Diagnostic Tests (RDT's) are essential tools in antiretroviral treatment (ART) scale up. An important drawback to RDTs is the risk of false positive results. In 2005, MSF-Holland has therefore changed the testing algorithm to introduce a confirmation test. This proposal outlines an evaluation study of the results of the new confirmatory testing algorithm. It aims to compare the confirmatory algorithm employed by MSF-OCA to the MoH serial algorithm which is based on WHO recommendations. A secondary objective of the study is to determine if there is a correlation between kala-azar infection and risk of false positive HIV RDT results as clinicians in the projects suspect such a correlation. Furthermore, the study will look at the positive predictive value of weak test lines, which have been associated with higher risk of false positive results. Finally, the study aims to evaluate the results of a new simplified confirmation test, the dilution testing. Clients for the study will be recruited at two counseling and testing sites in Abdurafi and Humera, aiming to reach a sample size of 200 serial-algorithm positive and 200 negative samples in each site.
- Conditions
- HIV Infection
- Being tested
- application of a confirmation test
- Keywords
- HIV, Diagnostics
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
application of a confirmation testOther
Addition of confirmation test to serial testing algorithm, including dilution test
application of a confirmation testOther
use of rapid confirmation test
What is being measured
The primary outcome is the main question the study is designed to answer.
HIV result by Western Blot
Measured: one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2012 (estimated)
- Study startDec 2010
- Primary completionJul 2011
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionStudies of the same condition, open and under way.
- 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 495 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medecins Sans Frontieres, Netherlands
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leslie Shanks, Medecins Sans Frontieres, Netherlands
- Investigators
- Leslie Shanks, MD, Principal investigator, Medecins Sans Frontieres, Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01716299
- Sponsor's protocol ID
- msf09
- Status last verified
- Jan 2014
- First submitted
- 25 Oct 2012
- Last updated
- 22 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Shanks L, Siddiqui MR, Abebe A, Piriou E, Pearce N, Ariti C, Masiga J, Muluneh L, Wazome J, Ritmeijer K, Klarkowski D. Dilution testing using rapid diagnostic tests in a HIV diagnostic algorithm: a novel alternative for confirmation testing in resource limited settings. Virol J. 2015 May 14;12:75. doi: 10.1186/s12985-015-0306-4.
PubMed 25972188Shanks L, Siddiqui MR, Kliescikova J, Pearce N, Ariti C, Muluneh L, Pirou E, Ritmeijer K, Masiga J, Abebe A. Evaluation of HIV testing algorithms in Ethiopia: the role of the tie-breaker algorithm and weakly reacting test lines in contributing to a high rate of false positive HIV diagnoses. BMC Infect Dis. 2015 Feb 3;15:39. doi: 10.1186/s12879-015-0769-3.
PubMed 25645240
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of HIV Testing Algorithms in Two Sites in Ethiopia
- ClinicalTrials.gov ID
- NCT01716299
- Acronym / sponsor ID
- msf09
- Conditions
- HIV Infection
- Keywords
- HIV, Diagnostics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 495 participants (actual)
- Lead sponsor
- Medecins Sans Frontieres, NetherlandsUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- Jul 2011 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 29 Oct 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 primary objective of the study is to assess whether an improved MSF HIV diagnostic algorithm which includes a simple and easy to perform confirmation test has significantly better positive predictive value than WHO recommended RDT testing algorithms that do not include confirmatory testing.
Detailed description
Rapid Diagnostic Tests (RDT's) are essential tools in antiretroviral treatment (ART) scale up. An important drawback to RDTs is the risk of false positive results. In 2005, MSF-Holland has therefore changed the testing algorithm to introduce a confirmation test. This proposal outlines an evaluation study of the results of the new confirmatory testing algorithm. It aims to compare the confirmatory algorithm employed by MSF-OCA to the MoH serial algorithm which is based on WHO recommendations. A secondary objective of the study is to determine if there is a correlation between kala-azar infection and risk of false positive HIV RDT results as clinicians in the projects suspect such a correlation. Furthermore, the study will look at the positive predictive value of weak test lines, which have been associated with higher risk of false positive results. Finally, the study aims to evaluate the results of a new simplified confirmation test, the dilution testing. Clients for the study will be recruited at two counseling and testing sites in Abdurafi and Humera, aiming to reach a sample size of 200 serial-algorithm positive and 200 negative samples in each site.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients presenting the Counseling and Testing centres in the two study sites
Key inclusion criteria (2 listed)
- • Age >= 59 months (to help ensure success of venepuncture)
Key exclusion criteria (2 listed)
- • Inability to obtain venous blood sample
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 |
|---|---|---|
| application of a confirmation testAddition of confirmation test to serial testing algorithm, including dilution test | Other | – |
| application of a confirmation testuse of rapid confirmation test | Other | – |
Primary outcome
HIV result by Western Blot
Time frame: one week
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 22 Jan 2014.
- Derived from this study: PubMed 25972188Shanks L, Siddiqui MR, Abebe A, Piriou E, Pearce N, Ariti C, Masiga J, Muluneh L, Wazome J, Ritmeijer K, Klarkowski D. Dilution testing using rapid diagnostic tests in a HIV diagnostic algorithm: a novel alternative for confirmation testing in resource limited settings. Virol J. 2015 May 14;12:75. doi: 10.1186/s12985-015-0306-4.
- Derived from this study: PubMed 25645240Shanks L, Siddiqui MR, Kliescikova J, Pearce N, Ariti C, Muluneh L, Pirou E, Ritmeijer K, Masiga J, Abebe A. Evaluation of HIV testing algorithms in Ethiopia: the role of the tie-breaker algorithm and weakly reacting test lines in contributing to a high rate of false positive HIV diagnoses. BMC Infect Dis. 2015 Feb 3;15:39. doi: 10.1186/s12879-015-0769-3.
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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.
Leslie Shanks, MD principal investigator
Medecins Sans Frontieres, Netherlands
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infection, run by Medecins Sans Frontieres, Netherlands at 2 sites in Ethiopia.
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 2 inclusion and 2 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 22 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Ethiopia. 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.
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?
HIV result by Western Blot (time frame: one week). 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 NCT01716299, which also lists 2 linked publications.
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 22 Jan 2014; AzTrials last refreshed its copy on 27 Oct 2026.