Rapid Research In Diagnostics Development for HIV+ (R2D2 HIVPLUS) Study

Rapid Research In Diagnostics Development for HIV+ (R2D2 HIVPLUS) Study - R2D2 HIVPlus

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00040753

Enrollment

1500

Registered

2026-06-25

Start date

2026-09-30

Completion date

Unknown

Last updated

2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV

Interventions

Group 1: New tests can provide a practical and reliable alternative to currently available methods and help address existing gaps in access to HIV testing. Design-locked novel HIV VL tests will meet

Eligibility

Sex/Gender

All

Age

10 Years to No maximum

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Secondary

Measure	Time frame
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).	—

Measure

Time frame

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).

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Countries

Nigeria, Philippines, South Africa, Uganda, Zambia

Contacts

Public ContactSeda Yerlikaya

Universitätsklinikum Heidelberg

seda.yerlikaya@uni-heidelberg.de+49 6221 56-36838

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Sep 19, 2026