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Financial Incentives to Increase Pediatric HIV Testing (FIT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03049917
Recruitment Status : Completed
First Posted : February 10, 2017
Last Update Posted : November 15, 2018
Sponsor:
Collaborators:
Kenyatta National Hospital
University of Nairobi
Information provided by (Responsible Party):
Jennifer Slyker, University of Washington

Brief Summary:
The purpose of this study is to determine whether giving small financial incentives will motivate parents to test their children for HIV.

Condition or disease Intervention/treatment Phase
HIV Behavioral: Financial incentive Not Applicable

Detailed Description:
The study will be a randomized controlled trial (RCT) with 5 arms with equal allocation to each arm: no incentive, or one of 4 different levels of financial incentive. We will randomize 800 parents with children of unknown status at HIV treatment clinics in Western Kenya.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 449 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Financial Incentives to Increase Pediatric HIV Testing
Actual Study Start Date : January 31, 2017
Actual Primary Completion Date : October 1, 2018
Actual Study Completion Date : October 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
No Intervention: No incentive
No incentive
Experimental: KES financial incentive 1
Kenyan Shillings conditional cash transfer upon HIV testing
Behavioral: Financial incentive
Conditional cash transfer upon HIV testing

Experimental: KES financial incentive 2
Kenyan Shillings conditional cash transfer upon HIV testing
Behavioral: Financial incentive
Conditional cash transfer upon HIV testing

Experimental: KES financial incentive 3
Kenyan Shillings conditional cash transfer upon HIV testing
Behavioral: Financial incentive
Conditional cash transfer upon HIV testing

Experimental: KES financial incentive 4
Kenyan Shillings conditional cash transfer upon HIV testing
Behavioral: Financial incentive
Conditional cash transfer upon HIV testing




Primary Outcome Measures :
  1. HIV testing [ Time Frame: 2 months ]
    Presents with child(ren) to complete HIV testing at the study clinic within 2 months of recruitment; test results will be recorded in a study questionnaire


Secondary Outcome Measures :
  1. Cost effectiveness of incentives [ Time Frame: 2 years ]
    A study questionnaire will be used to collect participant and program costs, and data used to calculate cost effectiveness



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Parent/caregiver receiving HIV care
  • Parent/caregiver has one or more children <13 years old
  • Child is HIV exposed (parent/caregiver report or clinic confirmation)
  • Caregiver reports child's HIV status is unknown

Exclusion Criteria:

  • None

    • The investigators reserve the right to exclude any potential enrollee who is deemed to be at high personal risk, or whose children are at high personal risk, of interpersonal violence, by study participation .

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): NCT03049917


Locations
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Kenya
Kisumu County Hospital
Kisumu, Kenya
Sponsors and Collaborators
University of Washington
Kenyatta National Hospital
University of Nairobi
Investigators
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Principal Investigator: Jennifer A Slyker, PhD University of Washington
Principal Investigator: Irene N Njugna, MBChB, Msc University of Washington/Kenyatta National Hospital

Study Data/Documents: Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: Current FIT Protocol

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jennifer Slyker, Assistant Professor, Department of Global Health, University of Washington
ClinicalTrials.gov Identifier: NCT03049917     History of Changes
Other Study ID Numbers: STUDY00000599
323-NJU-TRIAL ( Other Grant/Funding Number: International AIDS Society )
First Posted: February 10, 2017    Key Record Dates
Last Update Posted: November 15, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Open to collaboration. Please contact the study PIs for requests for data sharing.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Analytic Code
Time Frame: January 2019
Access Criteria: Contact PIs for more info

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jennifer Slyker, University of Washington:
financial incentive
pediatric HIV testing