An interventional study of Point of care CD4 device (Alere PIMA) in HIV, sponsored by Centers for Disease Control and Prevention. Completed at 1 site in Kenya. Per ClinicalTrials.gov, last updated 2025-04-08.
Sponsored by Centers for Disease Control and Prevention · Not applicable, Interventional, and Health services research
Randomised Controlled Trial to Assess Accuracy, Feasibility, Acceptability, Cost Effectiveness and Impact of Point of Care CD4 Testing on HIV Diagnosis, Linkage to Care and Time to Antiretroviral Therapy Initiation among HIV Infected Patients in Rural Western Kenya.
Centers for Disease Control and Prevention is the lead sponsor of 273 studies on the registry; 2 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 8 (73%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria: adults living in the study catchment area (Gem Village, Nyanza province Western Kenya) served by one of 23 HIV clinics and 3 referral labs
Exclusion Criteria:
Referral laboratory based CD4 measurement after home-based HIV testing
POC CD4 testing after home-based HIV testing
Device: Point of care CD4 device (Alere PIMA)
for persons testing + with home-based HIV testing using Kenya's two rapid test algorithm, intervention arm participants received point of care CD4 testing followed by counseling on results which included their treatment eligibility
Also known as: Alere Pima
Linkage to HIV care
As ascertained from clinic charts
Time frame: Within six months from date of study enrollment
ART initiation
As ascertained from clinic charts
Time frame: Within six months from date of study enrollment
This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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Centers for Disease Control and Prevention