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Impact on Linkage to HIV Care With Point of Care CD4 Testing and Home-based HIV Testing in Kenya

Randomized 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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02515149
Acronym
CD4-POC
Enrollment
770
Registered
2015-08-04
Start date
2013-07-31
Completion date
2014-12-31
Last updated
2025-04-08

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

Conditions

HIV

Keywords

linkage to care, point of care diagnostics, point of care CD4, HIV care cascade, Kenya

Brief summary

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.

Interventions

DEVICEPoint 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

Sponsors

Kenya Medical Research Institute
CollaboratorOTHER
United States President's Emergency Plan for AIDS Relief
CollaboratorFED
Centers for Disease Control and Prevention
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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 * Not having received HIV care in prior 6 months if known HIV+

Exclusion criteria

* current HIV care or HIV care within last six months

Design outcomes

Primary

MeasureTime frameDescription
Linkage to HIV careWithin six months from date of study enrollmentAs ascertained from clinic charts
ART initiationWithin six months from date of study enrollmentAs ascertained from clinic charts

Countries

Kenya

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026