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Performance Characteristics of Alere COMBO and Alere q Detect in an HIV PrEP Program in Thailand

Tue 20 Mar 2018 Implementation Sciences
Study period: December 8, 2016 – December 10, 2020

Two new rapid HIV tests by Alere™ have the potential to substantially decrease the window period for rapid tests. The Alere™ HIV Combo or a rapid fourth generation test, has recently been assessed at the Thai Red Cross Anonymous Clinic Laboratory in Bangkok, Thailand. 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.

Moreover, 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%).

This prospective observational cohort study collects blood samples from individuals receiving PrEP at one of two drop-in centers (DICs) in Bangkok, Thailand –Rainbow Sky Association of Thailand (RSAT) and Service Worker IN Group (SWING) Foundation. 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.

Study Flow:
The routine HIV testing algorithm in the DICs include using Determine® HIV-1/2, a rapid test collected by finger prick. If found reactive, the algorithm will be followed by two other 3 rd generation immunochromatography anti-HIV tests. In addition to the routine algorithm, two additional blood samples will be taken by phlebotomy to perform at the Thai Red Cross Anonymous Clinic. If found non- reactive via Architect® HIV-1/2 Combo (Abbott), the sample will be tested by pooled NAAT to screen for acute HIV infection. On the other hand, if found reactive, the samples will be tested by 2 nd generation enzyme immunoassay (EIA) to detect HIV antibodies and identify acute HIV infection. The Alere™ HIV Combo Alere™ q HIV-1/2 Detect used at the DICs and Anonymous Clinic will be used as comparator methods.

Study Population
A total of 150 participants visiting either the RSAT or SWIN drop in centers in Bangkok to access PrEP will be enrolled.

Implementation Sciences