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

Summary

Participation Requirements

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,...

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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