Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201908919241847 Date of Approval: 20/08/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title An Investigation to Evaluate the Performance of the Cepheid Xpert® HIV-1 VL XC Test
Official scientific title An Investigation to Evaluate the Performance of the Cepheid Xpert® HIV-1 VL XC Test
Brief summary describing the background and objectives of the trial Quantitative measurement of HIV levels in peripheral blood has greatly contributed to the understanding of the pathogenesis of HIV infection, and has been shown to be an essential parameter in prognosis and management of HIV infected individuals. Plasma viral load levels (PVL) are the single biggest predictor of clinical outcome and are therefore used when considering ART initiation, monitoring response to therapy, and instituting a change in drug regimen. More recently it has also been used for specific applications of HIV diagnosis as well. Given the high genetic diversity of HIV, it is importance to use viral load assays that span the genetic diversity. Comparative studies of the main viral load assays continue to show both under quantitation and over quantitation of the different forms of the virus; and as new groups continue to appear this will continue to challenge the performance of the different test kits. HIV RNA viral load is the most useful diagnostic marker for acute HIV infection. It has sensitivity close to 100 percent and specificity from 95% to 98%, depending on the type of assay. The aim of this study is to evaluate the performance of the CepheidExpert HIV-1XC Test in detecting and quantifying HIV-1 RNA in human plasma
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied HIV/AIDS
Purpose of the trial Early detection /Screening
Anticipated trial start date 15/09/2019
Actual trial start date
Anticipated date of last follow up 21/02/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 800
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Crossover: all participants receive all interventions in different sequence during study Non-randomised Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Measurement of HIV1 RNA in Human Plasma Not Applicable Not Applicable Plasma specimens collected from participants will be used to evaluate the performance of the Xpert® HIV-1 Viral Load XC test for detection and quantitation of HIV-1 RNA in human plasma. 0 Uncontrolled
Experimental Group Measurement of HIV1 RNA in Human Plasma Not Applicable Not Applicable Using the Cepheid Xpert® HIV-1 VL XC Test to measure HIV1 RNA in Human Plasma 800
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• 18 years of age or older • Able and willing to provide the required amount of blood without compromising their well being • Able to understand the study and sign the informed consent • Adults at risk for HIV infection as defined by WHO guidelines 5 and/or the individual is from a region with known high incidence of HIV infection • Adults who have not been previously screened for HIV or that have been previously screened for HIV and were negative for HIV infection. • Study participant previously tested positive for HIV infection • Previously enrolled in this study. • The Investigator does not feel the study participant is suitable to participate in this study. Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 70 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
No 08/07/2019 Ghana health Service Ethics Review Committee
Ethics Committee Address
Street address City Postal code Country
Adabraka Accra 00190 Ghana
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Performance of the Xpert® HIV-1 Viral Load XC test for detection and quantitation of HIV-1 RNA in human plasma End of assay test
Secondary Outcome Performance of the Expert HIV-1 Viral Load XC Test for the detection of and quantification of HIV-1 RNA in human plasma End of assay test
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Atua Government Hospital Atua Atua Ghana
Volta River Authority Hospital VRA Hospital Grounds Akosombo Ghana
St Martin de Pores Hospital St Martin de Pores ospital Grounds Agomanya Ghana
FUNDING SOURCES
Name of source Street address City Postal code Country
Cerba Xpert 7-11 Lequerre Street Paris 95310 France
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Cepheid 904 Caribbean Drive Sunnyvale California 94089 United States of America Commercial Sector/Industry
COLLABORATORS
Name Street address City Postal code Country
Dr Ebenezar Narteh Volta River Authority Hospital Grounds Akosombo Ghana
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Jacob PlangeRhule jprhule@gmail.com +233244458455 27 Maseru Avenue, East Legon Accra, Ghana
City Postal code Country Position/Affiliation
Accra 00000 Ghana West Africa Clinical Research Company Limited
Role Name Email Phone Street address
Scientific Enquiries Pamela Johnson pamela.johnson@cepheid.com +16502451169 904 Caribbean Drive, Sunnyvale, CA 94089
City Postal code Country Position/Affiliation
California 94089 United States of America Cepheid
Role Name Email Phone Street address
Public Enquiries Paul Sekyere Nyantakyi psn@wacrec.com +233504101151 27 Maseru Avenue, East Legon
City Postal code Country Position/Affiliation
Accra 00500 Ghana West Africa Clinical Research Company Limited
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Participants anonymised data and summary study results Clinical Study Report Within 12 months of completion date of study Access granted to any party interested in the study summary results
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information