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

NCT03194880 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 150

Last updated 2023-02-17

No results posted yet for this study

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%).

Conditions

Interventions

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

Sponsors & Collaborators

  • Alere, Inc.

    collaborator INDUSTRY

  • Thai Red Cross AIDS Research Centre

    lead OTHER

Principal Investigators

  • Nittaya Phanuphak, MD, PhD · Thai Red Cross AIDS Research Centre (TRCARC)

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-12-08
Primary Completion
2022-12-08
Completion
2023-02-10

Countries

  • Thailand

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03194880 on ClinicalTrials.gov