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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

February 3, 2017
February 10, 2017
November 15, 2018
January 31, 2017
October 1, 2018   (Final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT03049917 on ClinicalTrials.gov Archive Site
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
Same as current
Not Provided
Not Provided
 
Financial Incentives to Increase Pediatric HIV Testing
Financial Incentives to Increase Pediatric HIV Testing
The purpose of this study is to determine whether giving small financial incentives will motivate parents to test their children for HIV.
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.
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
HIV
Behavioral: Financial incentive
Conditional cash transfer upon HIV testing
  • 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
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.
 
Completed
449
800
October 1, 2018
October 1, 2018   (Final data collection date for primary outcome measure)

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:

    • 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 .
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Kenya
 
 
NCT03049917
STUDY00000599
323-NJU-TRIAL ( Other Grant/Funding Number: International AIDS Society )
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
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
Jennifer Slyker, University of Washington
University of Washington
  • Kenyatta National Hospital
  • University of Nairobi
Principal Investigator: Jennifer A Slyker, PhD University of Washington
Principal Investigator: Irene N Njugna, MBChB, Msc University of Washington/Kenyatta National Hospital
University of Washington
November 2018

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