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.: PACTR202001785886049 Date of Approval: 23/01/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title POwER
Official scientific title POwER: Point Of care HIV viral load testing to Enhance Re-suppression
Brief summary describing the background and objectives of the trial Background: Access to HIV viral load testing remains a challenge for many people on antiretroviral therapy (ART) in low- and middle-income countries, where HIV care is provided mainly in primary care clinics. Weak laboratory and clinic systems often delay the detection and management of viremia, which can lead to morbidity, HIV drug resistance and HIV transmission. Point-of-care viral testing could become an important strategy to overcome these challenges, but we do not know whether point of care tests can be successfully implemented in primary care clinics to manage viraemia. Study design: This will be a dual-site, open-label, individually randomized feasibility study amongst people with recent HIV viraemia >1000 copies/ml, comparing point-of-care viral load testing with standard laboratory viral load testing. At 12 weeks after enrolment, patients will have a repeat viral load using point-of-care testing in the intervention arm, or standard laboratory testing in the standard care arm. Those with persistent viraemia >1000 copies/ml will be considered for switching to second-line ART. The primary outcome is viral suppression at 24 weeks. We will also assess implementation of point-of-care viral load testing using process evaluation data, interviews and focus groups. Primary objective of the study: To estimate the effect of implementing point-of-care viral load testing versus standard laboratory viral load testing on the proportion of HIV positive participants with viraemia who subsequently achieve viral resuppression Secondary objectives: To assess whether it is feasible to perform a randomised implementation trial of point-of-care viral load testing to manage viraemia in a routine South African clinic, by determining: a) What proportion of people with HIV viraemia is feasible to enrol? b) What proportion of those enrolled is feasible to follow up? c) What proportion of point-of-care viral load results are received and acted on in the same day?
Type of trial RCT
Acronym (If the trial has an acronym then please provide) POwER
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied HIV/AIDS
Purpose of the trial Diagnosis / Prognosis
Anticipated trial start date 24/02/2020
Actual trial start date 20/08/2020
Anticipated date of last follow up 24/05/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 100
Actual target sample size (number of participants) 125
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
OxTREC 66 19 University of Oxford Tropical Research Ethics Committee OxTREC
BREC 836 2019 University of KwaZulu-Natal Biomedical Research Ethics Committee
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
Parallel: different groups receive different interventions at same time during study Randomised Permuted block randomization Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Point of care HIV viral load testing Once Once At approximately 12 weeks after enrolment, participants in the intervention arm will have HIV viral load testing performed using a point-of-care assay 50
Control Group Standard of care laboratory viral load testing Once Once After approximately 12 weeks in the study, participants in the standard of care arm will have viral load testing performed using the standard laboratory based viral load assay 50 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Participant is willing and able to give informed consent for participation in the study. HIV positive adult, Male or Female, aged ≥18 years. Receiving first-line ART Latest viral load in the past 10 weeks ≥1000 copies/mL Has already received enhanced adherence counselling Requires hospital admission Pregnant 80 and over: 80+ Year,Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 150 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
Yes 20/12/2019 University of KwaZuluNatal Biomedical Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
University of KwaZulu-Natal, Private Bag X54001 Durban 4000 South Africa
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 11/10/2019 Oxford Tropical Research Ethics Committee OxTREC
Ethics Committee Address
Street address City Postal code Country
University of Oxford Research Services, University Offices Wellington Square, OX1 2JD Oxford 0000 United Kingdom
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The proportion of participants in each arm with viral load <50 copies/mL measured on laboratory reference assay 24 weeks after enrolment
Secondary Outcome Proportion of patients with viraemia at the study clinic who are successfully enrolled in the study During study enrolment period
Secondary Outcome Proportion of enrolled participants who attend the study exit visit 24 weeks after enrolment
Secondary Outcome The proportion of point-of-care viral load tests that are communicated to participants on the same day 24 weeks after enrolment
Secondary Outcome The proportion of point-of-care viral load tests ≥1000 copies/mL that result in same day enhanced adherence counselling 24 weeks after enrolment
Secondary Outcome The proportion of point-of-care viral load tests ≥1000 copies/mL that result in same day switch to second-line ART 24 weeks after enrolment
Secondary Outcome To determine staff perspectives regarding implementation of point-of-care viral load testing in a routine clinic During enrolment when point-of-care testing is being implemented, and after study conclusion
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Prince Cyril Zulu Clinic University Avenue, Berea Durban 4001 South Africa
Mafakathini Clinic Mafakathini Howick Umgungundlovu South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
University of Oxford Internal Research England Global Challenges Research Fund 0007365 University of Oxford University Offices, Wellington Square Oxford United Kingdom
Africa Oxford Initiative AfiOx 119 Centre for Tropical Medicine and Global Health, The Peter Medawar Building for Pathogen Research, University of Oxford, South Parks Road Oxford United Kingdom
Wellcome Trust PhD Programme for Primary Care Clinicians 216421 Z 19 Z Gibbs Building 215 Euston Road London United Kingdom
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor University of Oxford University of Oxford Research Services, University Offices Wellington Square, Oxford United Kingdom University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Jienchi Dorward jienchi.dorward@phc.ox.ac.uk 00441865289300 Nuffield Department of Primary Care Health Sciences, University of Oxford Radcliffe Observatory Quarter, Woodstock Road, OX2 6GG
City Postal code Country Position/Affiliation
Oxford United Kingdom Clinical Research Fellow
Role Name Email Phone Street address
Principal Investigator Nigel Garrett nigel.garrett@caprisa.org 0027316550617 CAPRISA, 2nd Floor, Doris Duke Medical Research Institute, Private Bag X7, 719 Umbilo Road, Congella,
City Postal code Country Position/Affiliation
Durban 4013 South Africa Head of Vaccines and Pathogenesis
Role Name Email Phone Street address
Public Enquiries Jienchi Dorward jienchi.dorward@phc.ox.ac.uk 00441865289300 Nuffield Department of Primary Care Health Sciences, University of Oxford Radcliffe Observatory Quarter, Woodstock Road, OX2 6GG
City Postal code Country Position/Affiliation
Oxford United Kingdom Clinical Research Fellow
Role Name Email Phone Street address
Scientific Enquiries Jienchi Dorward jienchi.dorward@phc.ox.ac.uk 00441865289300 Nuffield Department of Primary Care Health Sciences, University of Oxford Radcliffe Observatory Quarter, Woodstock Road, OX2 6GG
City Postal code Country Position/Affiliation
Oxford United Kingdom Clinical Research Fellow
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The final anonymised dataset can be requested by any bona fide researcher through a request lodged to the Principal Investigators or thorugh the CAPRISA website: https://www.caprisa.org/Pages/CAPRISAStudies Study Protocol Data will be made available after not longer than 6 months after first publication of results. Any bona fide researcher or research organisation may request access to the final anonymised dataset. Requests will be reviewed by the CAPRISA Scientific Review Committee within 30 business days. Requests will be assessed on the quality of the request and the scientific merit of the planned analysis.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 31/10/2023 15/08/2023
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 31/10/2023
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks https://www.caprisa.org/DBFile/Files/3546351b-5c74-4159-85f7-e8ee991bacc4/POwER_POC_VL_Viraemia_Protocol_Version2.0_24Jun20clean.pdf
Changes to trial information