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

NCT03194880 | Completed DMC

• 1 other identifier: Alere COMBO & Alere q Detect
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 2

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%).

Conditions

HIV

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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

Interventions

AlereCOMBO and Alere q Detect DEVICE

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

HIV testing

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Thai Red Cross AIDS Research Centre: lead
• Alere, Inc.: collaborator

Study Sites (2)

Service Worker IN Group (SWING)

Bang Rak, Bangkok, 10500, Thailand

Location

Rainbow Sky Association of Thailand (RSAT)

Bangkok, 10240, Thailand

Location

Study Officials

• Nittaya Phanuphak, MD, PhD

  Thai Red Cross AIDS Research Centre (TRCARC)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2017
• First Posted: June 21, 2017
• Study Start: December 8, 2016
• Primary Completion: December 8, 2022
• Study Completion: February 10, 2023
• Last Updated: February 17, 2023

Record last verified: 2022-04

Locations

TH (2)