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

Centers for Disease Control and Prevention (CDC)

Status: Completed

Conditions: HIV

Treatments: Device: Point of care CD4 device (Alere PIMA)

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT02515149

CDC - NCHHSTP - 6382

Details and patient eligibility

About

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.

Enrollment: 770 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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770 participants in 2 patient groups

Standard of care

No Intervention group

Description:

Referral laboratory based CD4 measurement after home-based HIV testing

Point of care

Experimental group

Description:

POC CD4 testing after home-based HIV testing

Treatment:

Device: Point of care CD4 device (Alere PIMA)