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

Not Applicable

Completed

• Conditions: HIV
• Interventions: Device: Point of care CD4 device (Alere PIMA)

• Registration Number: NCT02515149
• Lead Sponsor: Centers for Disease Control and Prevention

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07
• Primary Completion: 2014-09
• Study Completion: 2014-12
• Study First Submitted: 2015-08-03
• Study First Submitted QC: 2015-08-03
• Study First Posted: 2015-08-04
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-07
• Last Update Posted: 2025-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 770

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Point of care	Point of care CD4 device (Alere PIMA)	POC CD4 testing after home-based HIV testing

Primary Outcome Measures

Name	Time	Method
Linkage to HIV care	Within six months from date of study enrollment	As ascertained from clinic charts
ART initiation	Within six months from date of study enrollment	As ascertained from clinic charts

Trial Locations

Locations (1)

CDC - KEMRI Field Research Station; 🇰🇪 Kisumu, Nyanza, Kenya