Study Title:
Evaluation of SAMBA Semi-Quantitative Point-of-Care (POC) Viral load test for Antiretroviral therapy Monitoring in Moshi, Municipal Tanzania (SAMBA-01).
Sponsor Name: DANIDA Building Stronger Universities (BSU3) Centre for Medical Parasitology Department of Immunology and Microbiology University of Copenhagen Faculty of Health and Medical Sciences Blegdamsvej 3B, Building 07-11-50, 2200 Copenhagen N
Application Number: TFDA0018/CTR/007/5, Date Received: 20/3/2018
Principal Investigator: Dr Ireen Kiwelu, Kilimanjaro Christian Medical Centre (KCMC), Pasua and Majengo Health Clinics, P.O. Box 2236, KILIMANJARO.
Intervention Medicinal Product Status of IMP
SAMBA II Semi Q-HIV Point Of Care Viral Load assay Unregistered
Primary Disease: HIV Infection
Trial Site: KCMC, Majengo and Pasua Health Centres in Moshi town.
Start / Approval Date: 24/09/2018, Status / Approval Remark: Approved
Primary Purpose: To assess the performance of the SAMBA semi-Q point of care viral load test in HIV-1 infected adults compared to gold standard COBAS? TaqMan? before ART initiation and during treatment in Moshi, Municipal.
Study Phase: Phase III
Study Type: Interventional
Expected Completion Date: 12th September 2020
Target Sample Size: 350
Recruitment Status: Not yet recruiting
Outcome: Samples with plasma HIV-1 RNA above or below 1000 copies/ml will be dectected by the SAMBA assay. Additionally, Viral load results from POC(SAMBA) is expected within 2 hours. Time to results from sample collection to results ready will be compared within current standard of care.