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Alere COMBO and Alere q Detect in an HIV PrEP Program in Thailand

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03194880
Recruitment Status : Recruiting
First Posted : June 21, 2017
Last Update Posted : January 4, 2019
Alere, Inc.
Information provided by (Responsible Party):
Thai Red Cross AIDS Research Centre

Brief 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 (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%).

Condition or disease Intervention/treatment
HIV Device: AlereCOMBO and Alere q Detect

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.

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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Performance Characteristics of AlereCOMBO and Alere q Detect in an HIV PrEP Program in Thailand
Actual Study Start Date : December 8, 2016
Estimated Primary Completion Date : December 8, 2020
Estimated Study Completion Date : December 10, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Group/Cohort Intervention/treatment
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'.
Device: AlereCOMBO and Alere q Detect

The 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

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Participants visiting either the RSAT or SWING drop in centers in Bangkok to access PrEP will be asked to join the study.

Inclusion Criteria:

  • Will start receiving PrEP at one of the participating clinics
  • 18 years or older
  • Willing to provide informed consent

Exclusion Criteria:

  • Not receiving PrEP at one of the participating clinics
  • HIV-infected

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03194880

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Contact: Reshmie Ramautarsing 662 253 0996
Contact: Jureeporn Jantarapakde, RN, MSc 662 253 0996

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Service Worker IN Group (SWING) Recruiting
Bang Rak, Bangkok, Thailand, 10500
Contact: Surang Janyam, MA    +662 632 9501   
Rainbow Sky Association of Thailand (RSAT) Recruiting
Bangkapi, Bangkok, Thailand, 10240
Contact: Danai Linjongrut, B,Eng    +6685 139 3688   
Sponsors and Collaborators
Thai Red Cross AIDS Research Centre
Alere, Inc.
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Principal Investigator: Nittaya Phanuphak, MD, PhD Thai Red Cross AIDS Research Centre (TRCARC)

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Responsible Party: Thai Red Cross AIDS Research Centre Identifier: NCT03194880     History of Changes
Other Study ID Numbers: Alere COMBO & Alere q Detect
First Posted: June 21, 2017    Key Record Dates
Last Update Posted: January 4, 2019
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No