NCT02515149

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
770

participants targeted

Target at P75+ for not_applicable hiv

Timeline
Completed

Started Jul 2013

Shorter than P25 for not_applicable hiv

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2013

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 3, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 4, 2015

Completed
Last Updated

April 8, 2025

Status Verified

April 1, 2025

Enrollment Period

1.2 years

First QC Date

August 3, 2015

Last Update Submit

April 7, 2025

Conditions

HIV

Keywords

linkage to carepoint of care diagnosticspoint of care CD4HIV care cascadeKenya

Outcome Measures

Primary Outcomes (2)

  • Linkage to HIV care

    As ascertained from clinic charts

    Within six months from date of study enrollment

  • ART initiation

    As ascertained from clinic charts

    Within six months from date of study enrollment

Study Arms (2)

Standard of care

NO INTERVENTION

Referral laboratory based CD4 measurement after home-based HIV testing

Point of care

EXPERIMENTAL

POC CD4 testing after home-based HIV testing

Device: Point of care CD4 device (Alere PIMA)

Interventions

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

Also known as: Alere Pima
Point of care

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • current HIV care or HIV care within last six months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CDC - KEMRI Field Research Station

Kisumu, Nyanza, Kenya

Location

Related Publications (1)

  • Desai MA, Okal DO, Rose CE, Ndivo R, Oyaro B, Otieno FO, Williams T, Chen RT, Zeh C, Samandari T. Effect of point-of-care CD4 cell count results on linkage to care and antiretroviral initiation during a home-based HIV testing campaign: a non-blinded, cluster-randomised trial. Lancet HIV. 2017 Sep;4(9):e393-e401. doi: 10.1016/S2352-3018(17)30091-7. Epub 2017 May 31.

    PMID: 28579225DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 3, 2015

First Posted

August 4, 2015

Study Start

July 1, 2013

Primary Completion

September 1, 2014

Study Completion

December 1, 2014

Last Updated

April 8, 2025

Record last verified: 2025-04

Locations

KE(1)