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

CompletedOBSERVATIONAL
Enrollment

150

Participants

Timeline

Start Date

December 8, 2016

Primary Completion Date

December 8, 2022

Study Completion Date

February 10, 2023

Conditions
HIV
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"

Trial Locations (2)

10240

Rainbow Sky Association of Thailand (RSAT), Bangkok

10500

Service Worker IN Group (SWING), Bang Rak

All Listed Sponsors
collaborator

Alere, Inc.

INDUSTRY

lead

Thai Red Cross AIDS Research Centre

OTHER

NCT03194880 - Alere COMBO and Alere q Detect in an HIV PrEP Program in Thailand | Biotech Hunter | Biotech Hunter