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

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%).

Study Overview

• Status: Completed
• Conditions: HIV
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Actual): 150

Contacts and Locations

Study Locations

• Thailand
  • Bangkok, Thailand, 10240
    • Rainbow Sky Association of Thailand (RSAT)
  • Bangkok
    • Bang Rak, Bangkok, Thailand, 10500
      • Service Worker IN Group (SWING)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

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: 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 completedThe 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 correctlyInvalid controlResults could not be interpretedOthers

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	5 years

Collaborators and Investigators

• Sponsor: Thai Red Cross AIDS Research Centre
• Collaborators: Alere, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): December 8, 2016
• Primary Completion (Actual): December 8, 2022
• Study Completion (Actual): February 10, 2023

Study Registration Dates

• First Submitted: June 19, 2017
• First Submitted That Met QC Criteria: June 19, 2017
• First Posted (Actual): June 21, 2017

Study Record Updates

• Last Update Posted (Actual): February 17, 2023
• Last Update Submitted That Met QC Criteria: February 15, 2023
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: Alere COMBO & Alere q Detect

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No