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 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202608906122652 Date of Registration: 14/08/2026
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title R2D2 HIVPlus
Official scientific title Rapid Research In Diagnostics Development for HIV+ (R2D2 HIVPLUS) Study
Brief summary describing the background and objectives of the trial Over 30 million people living with HIV (PLHIV) are on antiretroviral therapy (ART), mostly in low- and middle-income countries (LMICs). ART aims to suppress HIV viral load (VL) to improve health outcomes and reduce transmission, while CD4 testing remains essential for assessing immune status, particularly in advanced HIV disease. Routine monitoring of VL and CD4 count is necessary to detect adherence issues, treatment failure and guide clinical decisions. Despite global recommendations for routine VL and CD4 testing, major diagnostic gaps persist in LMICs due to limited laboratory capacity, especially in rural or underserved areas. These challenges are compounded by reagent shortages, equipment downtime, and high costs, resulting in delayed or infrequent testing. There is an urgent need for scalable, accurate, and affordable diagnostic solutions that support both point-of-care (POC) and centralized testing using easily transportable sample types. This study will systematically evaluate novel HIV VL and/or CD4 testing tools (“novel HIV tests”), including POC and open-platform PCR-based formats for disease monitoring, focusing on prototypes or design-locked products with potential to overcome technical and operational limitations of currently available diagnostic tools
Type of trial Non-Randomised
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 Treatment: Devices
Anticipated trial start date 05/08/2026
Actual trial start date
Anticipated date of last follow up 05/08/2029
Actual Last follow-up date
Anticipated target sample size (number of participants) 1500
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
Single Group Non-randomised Allocation Sequence/Code was not concealed Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Novel HIV Viral Load and or CD4 Diagnostic Tests Once at enrollment Participants will undergo evaluation using prototype and design-locked novel HIV viral load (VL) and/or CD4 diagnostic tests, including point-of-care (POC) and open-platform PCR-based testing platforms. Blood samples collected by fingerstick and/or venipuncture will be tested using both the novel HIV tests and WHO-endorsed reference assays. Novel point-of-care sample preparation devices may also be evaluated. Results from the WHO-endorsed reference tests will be used for clinical management, while results from the novel HIV tests will be used solely for research and will not be returned to participants or clinicians 1500
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Diagnostic Evaluation Component (DEC) Inclusion criteria: Individuals aged 10 years and older. Confirmed HIV infection (documented medical record); irrespective of CD4 count or ART status. Receiving care at participating study sites. Usability Assessment Component (UAC) Inclusion criteria: Individuals aged 18 years and older Healthcare workers or laboratory personnel involved in HIV VL and/or CD4 testing at participating sites. Diagnostic Evaluation Component (DEC) Exclusion criteria: Unable or unwilling to provide informed consent/assent. Any condition that, in the opinion of the investigator, would preclude provision of appropriate samples. Usability Assessment Component (UAC) Unwilling or unable to provide informed consent 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),Infant: 13 Month(s)-24 Month(s),Middle Aged: 45 Year(s)-64 Year(s) 10 Year(s) 80 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 12/06/2026 University of Zambia Biomedical Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Nationalist Road Lusaka 10101 Zambia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Point estimates of sensitivity and specificity of novel HIV tests, with 95% confidence intervals, using WHO-endorsed reference standards. During the course of the study – it is a rolling protocol and depends on the tech that is available and has been onboarded for the duration of the 2 years. Data is collected in various Case Report Forms at screening and enrolment, at sample collection, at sample processing, when results are available, in the form of surveys for usability ad acceptability surveys for the tech involved and usability evaluations for test information, direct observations and think aloud protocols. REDCap will be the primary data collection tool. During the course of the study
Secondary Outcome 2.1 Point estimates of sensitivity and specificity of novel HIV tests, with 95% confidence intervals, using WHO-endorsed reference standards. at clinically relevant cutoffs: - HIV VL: 50, 200, and 1,000 copies/mL - CD4: ≤200 and ≤350 cells/µL 2.2 Point estimates of sensitivity and specificity of novel HIV tests, with 95% confidence intervals, using novel POC sample preparation methods against WHO-endorsed reference standards. 2.3 Agreement analysis for novel HIV tests: Quantitative agreement (e.g. Bland-Altman bias, limits of agreement Categorical agreement at clinical thresholds 2.4 Agreement analysis of reference testing with samples prepared by the novel POC device and currently recommended preparation device: - Quantitative agreement (e.g. Bland-Altman bias, limits of agreement) - Categorical agreement at clinical thresholds 2.5 Usability metrics, including task performance metrics (e.g., proportion of invalid/error results, user error rates, time to result) and analysis of survey responses using descriptive parameters (e.g., proportions and Likert scale averages). During the course of the study
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Centre for Infectious Disease Research in Zambia Stand 378A/15 Main Street Ibex Lusaka 10101 Zambia
FUNDING SOURCES
Name of source Street address City Postal code Country
Gates Foundation 500 Fifth Avenue North Seattle 98109 United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Heidelberg University Hospital Im Neuenheimer Feld 672 Heidelberg 69120 Germany University
COLLABORATORS
Name Street address City Postal code Country
Zankli Research Center Bingham University Teaching Hospital KM 26 Abuja Keffi Expressway karu Nasarawa State 961105 Nigeria
Stellenbosch University Francie van Zijl Drive Cape Town 7505 South Africa
De La Salle Medical and Health Sciences Institute Gov D Mangubat Avenue Dasmarinas 4114 Philippines
Infectious Diseases Research Collaboration IDRC Plot 2C Nakasero Hill Road Kampala 7475 Uganda
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Monde Muyoyeta monde.muyoyeta@cidrz.org +260966765615 Stand 378A 15 Main Street
City Postal code Country Position/Affiliation
Lusaka 34681 Zambia Cheif scientific Officer
Role Name Email Phone Street address
Scientific Enquiries Mutumwa Muyangana mutumwa.muyangana@cidrz.org +260978890009 Stand 378A 15 Main Street
City Postal code Country Position/Affiliation
Lusaka 34681 Zambia Research Medical Officer
Role Name Email Phone Street address
Public Enquiries Kachimba Shamaoma kachimba.shamaoma@cidrz.org +260969754597 Stand 378A15 Main Street
City Postal code Country Position/Affiliation
Lusaka 34681 Zambia Research Coordinator
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Data Sharing and Transfer Agreements will have to be drafted by requesting parties using a standardized data sharing and transfer template. Will individual participants data be available: Yes What data in particular will be shared: Individual participant data that underlline the results reported in teh manuscript after deidentificaation. Refer to below. What other documents will be available: Study Protocol When will data be available (start and end dates): Beginning 1 year following publication; no end dates With whom: Investigators whose proposed use of data has been approved by an Independent Review Committee identified for this purpose For what types of analyses: For individual participant data meta-analyses By what mechanism will data be made available? Proposals should be directed to idtm.tech@uni-heidelberg.de. To gain access, data requestors will need to sign a dat sharing and transfer agreement with the University Hospital of Heidelberg. Clinical Study Report,Informed Consent Form,Study Protocol During and after the study completion De-identified individual participant data will be made available to qualified researchers upon reasonable request, subject to Sponsor approval, ethical requirements, and execution of an appropriate data-sharing agreement.
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
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 07/08/2026 This was an error Experimental Group, Novel HIV Viral Load and or CD4 Diagnostic Tests, , Once at enrollment, Participants will undergo evaluation using prototype and design-locked novel HIV viral load (VL) and/or CD4 diagnostic tests, including point-of-care (POC) and open-platform PCR-based testing platforms. Blood samples collected by fingerstick and/or venipuncture will be tested using both the novel HIV tests and WHO-endorsed reference assays. Novel point-of-care sample preparation devices may also be evaluated. Results from the WHO-endorsed reference tests will be used for clinical management, while results from the novel HIV tests will be used solely for research and will not be returned to participants or clinicians, 350, Experimental Group, Novel HIV Viral Load and or CD4 Diagnostic Tests, , Once at enrollment, Participants will undergo evaluation using prototype and design-locked novel HIV viral load (VL) and/or CD4 diagnostic tests, including point-of-care (POC) and open-platform PCR-based testing platforms. Blood samples collected by fingerstick and/or venipuncture will be tested using both the novel HIV tests and WHO-endorsed reference assays. Novel point-of-care sample preparation devices may also be evaluated. Results from the WHO-endorsed reference tests will be used for clinical management, while results from the novel HIV tests will be used solely for research and will not be returned to participants or clinicians, 1500,