An Investigation to Evaluate the Performance of the Cepheid Xpert® HIV-1 VL XC Test

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

PACTR

Registry ID

PACTR201908919241847

Enrollment

800

Registered

2019-08-20

Start date

2019-09-15

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/AIDS

Interventions

Measurement of HIV1 RNA in Human Plasma

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • 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.

Exclusion criteria

Exclusion criteria: • 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.

Design outcomes

Primary

Measure	Time frame
Performance of the Xpert® HIV-1 Viral Load XC test for detection and quantitation of HIV-1 RNA in human plasma	—

Secondary

Measure	Time frame
Performance of the Expert HIV-1 Viral Load XC Test for the detection of and quantification of HIV-1 RNA in human plasma	—

Countries

Ghana

Contacts

Public ContactPaul Sekyere Nyantakyi

West Africa Clinical Research Company Limited

psn@wacrec.com+233504101151

Outcome results

None listed

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