Cepheid Xpert HIV-1 Viral Load Assay
Diagnostic TestRapid, on-site molecular HIV-1 viral load testing used in accordance with cleared/approved labeling
NCT Number: NCT04517825
This is a two-phase study designed to assess measures of feasibility, sustainability, acceptability, penetration, and fidelity before and after implementation of a rapid molecular HIV-1 viral load testing infrastructure at a level III health center in rural western Uganda.
The central hypothesis is that implementation of PoC HIV-1 testing without accompanying modifications to clinic triage and flow, laboratory processes, and existing protocols guiding adherence counseling and regimen change, will not result in significant improvement in clinical outcomes in PLWH.
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Notify Me18 year and older
All sexes
Observational
Bugoye Level III Health Centre, Bugoye, Kasese, Uganda
This is a two-phase study designed to assess measures of feasibility, sustainability, acceptability, penetration, and fidelity before and after implementation of a rapid molecular HIV-1 viral load testing infrastructure at a level III health center in rural western Uganda.
In Phase 1, the study team will perform/record the following:
In Phase 2, the study team will perform/record the following:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Rapid, on-site molecular HIV-1 viral load testing used in accordance with cleared/approved labeling
Time frame: Each clinic day for up to six months
HIV viral load tests performed at peripheral health center
Time frame: Each month for up to six months
HIV viral load tests performed at peripheral health center
Time frame: Each clinic day for up to six months
Acceptability of rapid HIV viral load results
Time frame: Each month for up to six months
Acceptability of rapid HIV viral load results
Time frame: Each clinic day for up to 9 months
Impact on routine ART Clinic flow
Time frame: Pre- and post-intervention (approximately 6 months apart)
Perceived time spent conducting on-site testing vs send-out testing
Time frame: Up to 90 days after blood draw, after which considered not returned
Mean and median number of days from blood draw to client receiving viral load result either from current standard of care or on-site testing
Time frame: Each clinic day (i.e. weekly) during the 6 months of Phase 2 when the Xpert is operational
Total number of hours spent in maintenance, trouble-shooting, or repair
University of North Carolina, Chapel Hill
Other
IGHID 11920 - More Than a Machine: Exploring the Ancillary Systems and Processes Required to Make Point-of-care HIV-1 Viral Load Testing Effective in Rural Western Uganda
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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