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

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.

Completed

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Key information

Conditions

HIV

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CDC - KEMRI Field Research Station

Kisumu, Nyanza, Kenya

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Point of care CD4 device (Alere PIMA)

Device

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

Other names: Alere Pima

Primary outcomes

Linkage to HIV care

Time frame: Within six months from date of study enrollment

As ascertained from clinic charts
ART initiation

Time frame: Within six months from date of study enrollment

As ascertained from clinic charts

Sponsors and collaborators

Lead sponsor

Centers for Disease Control and Prevention

Fed

Collaborators

Kenya Medical Research Institute
United States President's Emergency Plan for AIDS Relief

Registry information

Official study title

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

Acronym: CD4-POC

Important dates

Study start: 2013
Primary completion: 2014
Study completion: 2014
First posted: Aug 4, 2015
Registry last updated: Apr 8, 2025

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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Completed