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.: PACTR202002785960123 Date of Registration: 12/02/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title PHILA
Official scientific title PHILA: Point of care HIV viral Load testing in a community ART programme
Brief summary describing the background and objectives of the trial Background: The South African government’s Centralised Chronic Medication Dispensing and Distribution (CCMDD) programme allows quicker, more convenient antiretroviral therapy (ART) collection at pick-up points in the community. However, only people with a suppressed HIV viral load are eligible to be referred from their clinic into CCMDD. Currently, taking blood and reviewing the viral load result requires two clinic visits as samples are sent away for testing in central laboratories. Point-of-care viral load testing, where patients receive their viral load results in one clinic visit, could remove this bottleneck and improve CCMDD. Study design: PHILA will be a single-site, individually randomised, implementation trial comparing point-of-care viral load testing with standard laboratory based viral load testing within CCMDD. We will enrol 200 HIV positive adults in CCMDD who are due a repeat viral load test, and randomize them 1:1 to receive point-of-care viral load testing or standard laboratory testing. Patients with a suppressed viral load will be eligible to have their CCMDD prescription renewed. The research team will monitor routine clinical data to record the primary outcome of CCMDD prescription renewal at 3 weeks post-enrolment. Point-of-care viral load implementation processes will be assessed using staff interviews and focus groups. Primary objective of the study: To compare the effect of point-of-care viral load testing versus standard laboratory viral load testing on the proportion of participants who have their CCMDD prescription renewed Secondary objectives: To compare the effect of point-of-care viral load testing versus standard laboratory viral load testing on a) Time to receiving viral load results, renewal of CCMDD prescriptions and first ART collection in CCMDD b) The proportion of participants retained in all HIV services (clinic and/or CCMDD) c) The number of clinic visits required for CCMDD renewal
Type of trial RCT
Acronym (If the trial has an acronym then please provide) PHILA
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 01/04/2022
Actual trial start date 15/08/2022
Anticipated date of last follow up 15/02/2023
Actual Last follow-up date 22/12/2023
Anticipated target sample size (number of participants) 200
Actual target sample size (number of participants) 200
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
OxTREC 64 19 University of Oxford Tropical Research Ethics Committee OxTREC
BREC 837 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 and creatinine testing Once Once At enrolment participants in the intervention arm will have HIV viral load and creatinine testing performed using a point-of-care assay 100
Control Group Standard of care laboratory viral load and creatinine testing Once Once At enrolment participants in the standard of care arm will have viral load and creatinine testing performed using the standard laboratory based viral load assay 100 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 ART in CCMDD and willing to continue in CCMDD Due a renewal of their prescription in CCMDD Requires an HIV viral load test for renewal of their CCMDD prescription Not eligible for CCMDD as per South African Department of Health criteria (Pregnant or breast feeding, current tuberculosis, known to have diabetes and with blood glucose >7.0mmol/L, known to have hypertension with blood pressure ≥140/90 mmHg, other medical condition requiring regular clinical consultations) 80 and over: 80+ Year,Adolescent: 13 Year(s)-17 Year(s),Adult: 18 Year(s)-44 Year(s),Aged: 65 Year(s)-79 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 11/11/2019 Oxford Tropical Research Ethics Committee OxTREC
Ethics Committee Address
Street address City Postal code Country
University of Oxford Research Services, University Offices Wellington Square, Oxford 0000 United Kingdom
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Proportion of participants in each arm with renewal of CCMDD prescription 3 weeks after enrolment
Secondary Outcome Days from enrolment to renewal of prescription in CCMDD database Up to 16 weeks after enrolment
Secondary Outcome Proportion of participants in each arm with ART collection recorded in clinic notes or CCMDD system 6-16 weeks post enrolment
Secondary Outcome Days from enrolment until consultation when viral load results recorded in chart Up to 16 weeks post enrolment
Secondary Outcome Number of clinic visits from enrolment until CCMDD renewal Up to 16 weeks post enrolment
Secondary Outcome Total cost for the patient (including costs such as transport, time, childcare) to have their CCMDD prescription renewed At enrolment and subsequent visits up to and including CCMDD renewal
Secondary Outcome Days from enrolment to first ART collection recorded in CCMDD database Up to 16 weeks post enrolment
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Prince Cyril Zulu Clinic University Avenue, Berea Durban 4001 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
Dowager Countess Eleanor Peel Trust 280 The Secretary, Dowager Countess Eleanor Peel Trust, Hill Dickinson LLP, 50 Fountain Street Manchester M2 2AS 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 0000 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 00447707859373 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
Public Enquiries Jienchi Dorward jienchi.dorward@phc.ox.ac.uk 00447707859373 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 00447707859373 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
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 21/12/2024
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 21/12/2024
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks https://www.caprisa.org/DBFile/Files/9d8b9f1b-27fa-4556-baf2-78984968853d/PHILA_POC_VL_CCMDD_Protocol_Version_2.0_10Nov21_clean.pdf
Changes to trial information