HIVNCT03194880
Alere COMBO and Alere q Detect in an HIV PrEP Program in Thailand
An observational study of HIV, run by Thai Red Cross AIDS Research Centre at 2 sites in Thailand.
Trial summary
Two new rapid HIV tests by Alere™ have the potential to substantially decrease the window period for rapid tests. First, the Alere™ HIV Combo is a rapid fourth generation test. The performance in a laboratory based setting was recently assessed at the Thai Red Cross Anonymous Clinic Laboratory in Bangkok, Thailand… Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- HIV
- What is being tested?
- AlereCOMBO and Alere q Detect
- Type of treatment
- Medical device
- How many people
- 150 participants
- Where
- 2 sitesThailand
- Study dates
- 8 Dec 2016to 10 Feb 2023
- 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 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants visiting either the RSAT or SWING drop in centers in Bangkok to access PrEP will be asked to join the study.
Who may be able to join
- Will start receiving PrEP at one of the participating clinics
- 18 years or older
- Willing to provide informed consent
Who cannot join
- Not receiving PrEP at one of the participating clinics
- HIV-infected
Trial locations and contacts
2 sites in 1 country.
Thailand2 sites
Service Worker IN Group (SWING)
Bang Rak, Bangkok, 10500
Rainbow Sky Association of Thailand (RSAT)
Bangkok, 10240
About this study
Official title: Performance Characteristics of AlereCOMBO and Alere q Detect in an HIV PrEP Program in Thailand
Two new rapid HIV tests by Alere™ have the potential to substantially decrease the window period for rapid tests. First, the Alere™ HIV Combo is a rapid fourth generation test. The performance in a laboratory based setting was recently assessed at the Thai Red Cross Anonymous Clinic Laboratory in Bangkok, Thailand (personal communication). Of 50 confirmed acute HIV samples, Alere™ HIV Combo could detect 37 (74%), while none of these 50 cases could be identified by the currently used third generation tests. These data have not yet been published, but the preliminary results indicate a very favorable performance of the Alere™ HIV Combo in a facility-based laboratory setting.
Second, the Alere™ q HIV-1/2 Detect is a qualitative, cartridge based, nucleic acid amplification test designed for Point of Care use. Data from several early infant diagnosis studies in Sub-Saharan African countries have assessed the performance of the Alere™ q HIV-1/2 Detect. The test was performed in the field, by a range of health professionals, from nurses and laboratory technicians to medical doctors. The pooled analysis showed a sensitivity of 99.07% (95%CI 95.48 - 99.95%) and a specificity of 99.94% (99.72-100%).
Read the detailed description
This will be a prospective study, collecting blood samples from individuals receiving PrEP at one of two drop-in centers in Bangkok, Thailand:
Rainbow Sky Association of Thailand (RSAT) and Service Worker IN Group (SWING). RSAT is a community-based organization for people with sexual diversity (MSM, gay, transgender, lesbians, and bisexual), and has specific programs for MSM, transgender and lesbian health. SWING promotes HIV prevention among male and female sex workers and provides both community outreach and clinical services at their center. Both locations offer PrEP as part of their service.
Participants who visit the DICs seeking to receive PrEP will undergo HIV testing at several time points: before receiving PrEP (Month 0), one month after starting PrEP (Month 1), three months after starting PrEP (Month 3), and every three months thereafter.
The routine HIV testing algorithm in the DIC is as follows:
- Determine® HIV-1/2 (Alere Medical Co., Ltd.), if reactive followed by two other rapid 3rd generation immunochromatography anti-HIV tests. These are all rapid tests on whole blood as collected by finger prick, performed by trained community health workers in the DIC.
For the purpose of this study, two additional blood samples will be taken by phlebotomy to perform:
- The Anonymous Clinic HIV-testing algorithm (see Annex 1): Architect® HIV-1/2 Combo (Abbott), if reactive followed by Determine® HIV-1/2 (Alere) and Elecsys® HIV combi PT (Roche). Samples that are non-reactive by Architect® HIV-1/2 Combo will be tested by pooled NAAT using Aptima HIV-1 RNA qualitative assay (Hologic®) to screen for acute HIV infection. Samples that are positive by Architect®, Determine® and Elecsys® will be tested by second generation EIA (which detects IgG Ab) to identify acute HIV infection (i.e. 4th generation reactive and 2nd generation negative). This is the standard HIV testing algorithm performed at the Thai Red Cross Anonymous Clinic Laboratory and will identify acute HIV infections.
- Alere™ HIV Combo Alere™ q HIV-1/2 Detect Both the regular DIC algorithm and the Anonymous Clinic algorithm will be used as comparator methods.
- Conditions
- HIV
- Being tested
- AlereCOMBO and Alere q Detect
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlereCOMBO and Alere q DetectDevice
The feasibility assessment will comprise of two components:
- User's perspective: A questionnaire will be developed and used to assess the level of satisfaction among community health workers performing the two new tests, using a 5 point Likert scale. We will assess the training and manual, the use of the test, the user's confidence, troubleshooting and technical support components and resolving problems.
- The laboratory component: For each test we will evaluate:
- The percentage of assays completed
- The percentage of assays incomplete (i.e. invalid result on two attempts)
- Reasons for incomplete assays, e.g.
- The sample could not be delivered to the strip or cartridge correctly
- Invalid control
- Results could not be interpreted
- Others
| Study group | Role | What they receive |
|---|---|---|
| HIV testing | At each visit, the DIC HIV testing algorithm will be performed, and additionally, HIV testing by the Anonymous Clinic Algorithm, the Alere™ HIV Combo and the Alere™ q HIV-1/2 Detect. The latter two tests will be performed at the DICs. In case of an invalid result for the Alere™ HIV Combo or the Alere™ q HIV-1/2 Detect, the test will be repeated. If the repeated test is invalid after the second attempt, it is recorded as 'invalid result'. Receives: Device: AlereCOMBO and Alere q Detect |
What is being measured
The primary outcome is the main question the study is designed to answer.
HIV test results
The HIV test results will be reported by number and proportions for Alere™ HIV Combo, Alere™ q HIV-1/2 Detect and the standard HIV testing algorithms; the number of acute HIV infections detected by Alere™ HIV Combo and Alere™ q HIV-1/2 Detect will be calculated as the proportion of the total number of participants who have confirmed acute HIV infection. The reliability and validity assessment of Alere™ HIV Combo and Alere™ q HIV-1/2 Detect will be compared with the standard HIV testing and we will present the results as the sensitivity, specificity, number of false positives and number of false negatives. The measuring agreement of HIV test results will be compared between the standard HIV testing algorithms and Alere™ HIV Combo, the standard HIV testing algorithms and Alere™ q HIV-1/2 Detect.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2017
- Study start8 Dec 2016
- Primary completion8 Dec 2022
- Study completion10 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thai Red Cross AIDS Research Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Alere, Inc.
- Responsible party
- Sponsor
- Investigators
- Nittaya Phanuphak, MD, PhD, Principal investigator, Thai Red Cross AIDS Research Centre (TRCARC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03194880
- Sponsor's protocol ID
- Alere COMBO & Alere q Detect
- Status last verified
- Apr 2022
- First submitted
- 19 Jun 2017
- Last updated
- 17 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance Characteristics of AlereCOMBO and Alere q Detect in an HIV PrEP Program in Thailand
- ClinicalTrials.gov ID
- NCT03194880
- Acronym / sponsor ID
- Alere COMBO & Alere q Detect
- Conditions
- HIV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Thai Red Cross AIDS Research CentreUniversity, hospital or other
- Collaborators
- Alere, Inc.
- Study start
- 8 Dec 2016 (actual)
- Primary completion
- 8 Dec 2022 (actual)
- Study completion
- 10 Feb 2023 (actual)
- First posted
- 21 Jun 2017 (actual)
- 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.
Two new rapid HIV tests by Alere™ have the potential to substantially decrease the window period for rapid tests. First, the Alere™ HIV Combo is a rapid fourth generation test. The performance in a laboratory based setting was recently assessed at the Thai Red Cross Anonymous Clinic Laboratory in Bangkok, Thailand (personal communication). Of 50 confirmed acute HIV samples, Alere™ HIV Combo could detect 37 (74%), while none of these 50 cases could be identified by the currently used third generation tests. These data have not yet been published, but the preliminary results indicate a very favorable performance of the Alere™ HIV Combo in a facility-based laboratory setting.
Second, the Alere™ q HIV-1/2 Detect is a qualitative, cartridge based, nucleic acid amplification test designed for Point of Care use. Data from several early infant diagnosis studies in Sub-Saharan African countries have assessed the performance of the Alere™ q HIV-1/2 Detect. The test was performed in the field, by a range of health professionals, from nurses and laboratory technicians to medical doctors. The pooled analysis showed a sensitivity of 99.07% (95%CI 95.48 - 99.95%) and a specificity of 99.94% (99.72-100%).
Detailed description
This will be a prospective study, collecting blood samples from individuals receiving PrEP at one of two drop-in centers in Bangkok, Thailand:
Rainbow Sky Association of Thailand (RSAT) and Service Worker IN Group (SWING). RSAT is a community-based organization for people with sexual diversity (MSM, gay, transgender, lesbians, and bisexual), and has specific programs for MSM, transgender and lesbian health. SWING promotes HIV prevention among male and female sex workers and provides both community outreach and clinical services at their center. Both locations offer PrEP as part of their service.
Participants who visit the DICs seeking to receive PrEP will undergo HIV testing at several time points: before receiving PrEP (Month 0), one month after starting PrEP (Month 1), three months after starting PrEP (Month 3), and every three months thereafter.
The routine HIV testing algorithm in the DIC is as follows:
- Determine® HIV-1/2 (Alere Medical Co., Ltd.), if reactive followed by two other rapid 3rd generation immunochromatography anti-HIV tests. These are all rapid tests on whole blood as collected by finger prick, performed by trained community health workers in the DIC.
For the purpose of this study, two additional blood samples will be taken by phlebotomy to perform:
- The Anonymous Clinic HIV-testing algorithm (see Annex 1): Architect® HIV-1/2 Combo (Abbott), if reactive followed by Determine® HIV-1/2 (Alere) and Elecsys® HIV combi PT (Roche). Samples that are non-reactive by Architect® HIV-1/2 Combo will be tested by pooled NAAT using Aptima HIV-1 RNA qualitative assay (Hologic®) to screen for acute HIV infection. Samples that are positive by Architect®, Determine® and Elecsys® will be tested by second generation EIA (which detects IgG Ab) to identify acute HIV infection (i.e. 4th generation reactive and 2nd generation negative). This is the standard HIV testing algorithm performed at the Thai Red Cross Anonymous Clinic Laboratory and will identify acute HIV infections.
- Alere™ HIV Combo Alere™ q HIV-1/2 Detect Both the regular DIC algorithm and the Anonymous Clinic algorithm will be used as comparator methods.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HIV testing | – | Device: AlereCOMBO and Alere q DetectAt each visit, the DIC HIV testing algorithm will be performed, and additionally, HIV testing by the Anonymous Clinic Algorithm, the Alere™ HIV Combo and the Alere™ q HIV-1/2 Detect. The latter two tests will be performed at the DICs. In case of an invalid result for the Alere™ HIV Combo or the Alere™ q HIV-1/2 Detect, the test will be repeated. If the repeated test is invalid after the second attempt, it is recorded as 'invalid result'. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants visiting either the RSAT or SWING drop in centers in Bangkok to access PrEP will be asked to join the study.
Key inclusion criteria (3 listed)
- Will start receiving PrEP at one of the participating clinics
- 18 years or older
- Willing to provide informed consent
Key exclusion criteria (2 listed)
- Not receiving PrEP at one of the participating clinics
- HIV-infected
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 |
|---|---|---|
| AlereCOMBO and Alere q DetectThe feasibility assessment will comprise of two components: 1. User's perspective: A questionnaire will be developed and used to assess the level of satisfaction among community health workers performing the two new tests, using a 5 point Likert scale. We will assess the training and manual, the use of the test, the user's confidence, troubleshooting and technical support components and resolving problems. 2. The laboratory component: For each test we will evaluate: * The percentage of assays completed * The percentage of assays incomplete (i.e. invalid result on two attempts) * Reasons for incomplete assays, e.g. * The sample could not be delivered to the strip or cartridge correctly * Invalid control * Results could not be interpreted * Others | Device | HIV testing |
Primary outcome
HIV test results
Time frame: 5 years
The HIV test results will be reported by number and proportions for Alere™ HIV Combo, Alere™ q HIV-1/2 Detect and the standard HIV testing algorithms; the number of acute HIV infections detected by Alere™ HIV Combo and Alere™ q HIV-1/2 Detect will be calculated as the proportion of the total number of participants who have confirmed acute HIV infection. The reliability and validity assessment of Alere™ HIV Combo and Alere™ q HIV-1/2 Detect will be compared with the standard HIV testing and we will present the results as the sensitivity, specificity, number of false positives and number of false negatives. The measuring agreement of HIV test results will be compared between the standard HIV testing algorithms and Alere™ HIV Combo, the standard HIV testing algorithms and Alere™ q HIV-1/2 Detect.
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 17 Feb 2023.
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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.
Nittaya Phanuphak, MD, PhD principal investigator
Thai Red Cross AIDS Research Centre (TRCARC)
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, run by Thai Red Cross AIDS Research Centre at 2 sites in Thailand.
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 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 17 Feb 2023. 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 Thailand. 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 test results (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Feb 2023.