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Trial record 50 of 640 for:    test AND point-of-care

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

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ClinicalTrials.gov Identifier: NCT02515149
Recruitment Status : Completed
First Posted : August 4, 2015
Last Update Posted : August 4, 2015
Sponsor:
Collaborators:
Kenya Medical Research Institute
United States President's Emergency Plan for AIDS Relief
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
HIV Device: Point of care CD4 device (Alere PIMA) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 770 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official 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
Study Start Date : July 2013
Actual Primary Completion Date : September 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
No Intervention: Standard of care
Referral laboratory based CD4 measurement after home-based HIV testing
Experimental: Point of care
POC CD4 testing after home-based HIV testing
Device: Point 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
Other Name: Alere Pima




Primary Outcome Measures :
  1. Linkage to HIV care [ Time Frame: Within six months from date of study enrollment ]
    As ascertained from clinic charts

  2. ART initiation [ Time Frame: Within six months from date of study enrollment ]
    As ascertained from clinic charts



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02515149


Locations
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Kenya
CDC - KEMRI Field Research Station
Kisumu, Nyanza, Kenya
Sponsors and Collaborators
Centers for Disease Control and Prevention
Kenya Medical Research Institute
United States President's Emergency Plan for AIDS Relief

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier: NCT02515149     History of Changes
Other Study ID Numbers: CDC - NCHHSTP - 6382
First Posted: August 4, 2015    Key Record Dates
Last Update Posted: August 4, 2015
Last Verified: August 2015

Keywords provided by Centers for Disease Control and Prevention:
linkage to care
point of care diagnostics
point of care CD4
HIV care cascade
Kenya