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Financial Incentives to Increase Pediatric HIV Testing (FIT)

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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

Tracking Information
First Submitted Date  ICMJE February 3, 2017
First Posted Date  ICMJE February 10, 2017
Last Update Posted Date November 15, 2018
Actual Study Start Date  ICMJE January 31, 2017
Actual Primary Completion Date October 1, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 9, 2017)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03049917 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 9, 2017)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Financial Incentives to Increase Pediatric HIV Testing
Official Title  ICMJE Financial Incentives to Increase Pediatric HIV Testing
Brief Summary The purpose of this study is to determine whether giving small financial incentives will motivate parents to test their children for HIV.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE HIV
Intervention  ICMJE Behavioral: Financial incentive
Conditional cash transfer upon HIV testing
Study Arms  ICMJE
  • No Intervention: No incentive
    No incentive
  • Experimental: KES financial incentive 1
    Kenyan Shillings conditional cash transfer upon HIV testing
    Intervention: Behavioral: Financial incentive
  • Experimental: KES financial incentive 2
    Kenyan Shillings conditional cash transfer upon HIV testing
    Intervention: Behavioral: Financial incentive
  • Experimental: KES financial incentive 3
    Kenyan Shillings conditional cash transfer upon HIV testing
    Intervention: Behavioral: Financial incentive
  • Experimental: KES financial incentive 4
    Kenyan Shillings conditional cash transfer upon HIV testing
    Intervention: Behavioral: Financial incentive
Publications * Wagner AD, Njuguna IN, Neary J, Omondi VO, Otieno VA, Babigumira J, Maleche-Obimbo E, Wamalwa DC, John-Stewart GC, Slyker JA. Financial Incentives to Increase Uptake of Pediatric HIV Testing (FIT): study protocol for a randomised controlled trial in Kenya. BMJ Open. 2018 Oct 3;8(10):e024310. doi: 10.1136/bmjopen-2018-024310.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 13, 2018)
449
Original Estimated Enrollment  ICMJE
 (submitted: February 9, 2017)
800
Actual Study Completion Date  ICMJE October 1, 2018
Actual Primary Completion Date October 1, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 .
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Kenya
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03049917
Other Study ID Numbers  ICMJE STUDY00000599
323-NJU-TRIAL ( Other Grant/Funding Number: International AIDS Society )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Open to collaboration. Please contact the study PIs for requests for data sharing.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Analytic Code
Time Frame: January 2019
Access Criteria: Contact PIs for more info
Responsible Party Jennifer Slyker, University of Washington
Study Sponsor  ICMJE University of Washington
Collaborators  ICMJE
  • Kenyatta National Hospital
  • University of Nairobi
Investigators  ICMJE
Principal Investigator: Jennifer A Slyker, PhD University of Washington
Principal Investigator: Irene N Njugna, MBChB, Msc University of Washington/Kenyatta National Hospital
PRS Account University of Washington
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP