Financial Incentives to Increase Pediatric HIV Testing (FIT)

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

Study Overview

• Status: Completed
• Conditions: HIV
• Intervention / Treatment: Behavioral: Financial incentive

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: Interventional
• Enrollment (Actual): 452
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Kenya
  • Kisumu, Kenya
    • Kisumu County Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 .

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Who Present Children for HIV Testing	Number of caregivers who present child(ren) to complete HIV testing at the study clinic within 2 months of recruitment; test results will be recorded in a study questionnaire	2 months
Number of Days Participants Take to Bring Children for HIV Testing	Number of days it took between randomization and caregiver presenting the child for HIV testing	2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Female Participants Who Present Children for HIV Testing (Females)	HIV testing [primary outcome 1] stratified by caregiver sex (females)	2 months
Number of Male Participants Who Present Children for HIV Testing	Time to HIV testing [primary outcome 1] stratified by caregiver sex (males)	2 months
Number of Caregivers With One Child Who Present Children for HIV Testing	HIV testing [primary outcome 1] stratified by number of children (one child)	2 months
Number of Participants With More Than 1 Child Who Present Children for HIV Testing	Number of participants presenting children for HIV testing among caregivers with more than child	2 months
Number of Caregivers With Age Less Than Median Presenting Children for HIV Testing	Number of participants presenting for HIV testing stratified by caregiver age (caregiver <=38 years)	2 months
Number of Caregivers With Age More Than Median Presenting Children for HIV Testing	Number of caregivers presenting children for HIV testing stratified by caregiver age (caregiver >38 years)	2 months

Collaborators and Investigators

• Sponsor: University of Washington
• Collaborators: University of Nairobi; Kenyatta National Hospital
• Investigators: Principal Investigator: Jennifer A Slyker, PhD, University of Washington; Principal Investigator: Irene N Njugna, MBChB, Msc, University of Washington/Kenyatta National Hospital

Publications and helpful links

General 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.
• Njuguna IN, Wagner AD, Omondi VO, Otieno VA, Neary J, Bosire R, Babigumira JB, Levin C, Maleche-Obimbo E, Wamalwa DC, John-Stewart G, Slyker J. Financial Incentives for Pediatric HIV Testing in Kenya. Pediatr Infect Dis J. 2018 Nov;37(11):1142-1144. doi: 10.1097/INF.0000000000002035.
• Atkins DL, Wagner AD, Zhang J, Njuguna IN, Neary J, Omondi VO, Otieno VA, Ondeng'e K, Wamalwa DC, John-Stewart G, Slyker JA, Beima-Sofie K. Brief Report: Use of the Consolidated Framework for Implementation Research (CFIR) to Characterize Health Care Workers' Perspectives on Financial Incentives to Increase Pediatric HIV Testing. J Acquir Immune Defic Syndr. 2020 May 1;84(1):e1-e6. doi: 10.1097/QAI.0000000000002323.
• Njuguna IN, Wagner AD, Neary J, Omondi VO, Otieno VA, Orimba A, Mugo C, Babigumira JB, Levin C, Richardson BA, Maleche-Obimbo E, Wamalwa DC, John-Stewart G, Slyker J. Financial incentives to increase pediatric HIV testing: a randomized trial. AIDS. 2021 Jan 1;35(1):125-130. doi: 10.1097/QAD.0000000000002720.

Study record dates

Study Major Dates

• Study Start (Actual): February 6, 2017
• Primary Completion (Actual): October 1, 2018
• Study Completion (Actual): October 1, 2018

Study Registration Dates

• First Submitted: February 3, 2017
• First Submitted That Met QC Criteria: February 9, 2017
• First Posted (Actual): February 10, 2017

Study Record Updates

• Last Update Posted (Actual): June 25, 2021
• Last Update Submitted That Met QC Criteria: June 3, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: financial incentive; pediatric HIV testing
• Other Study ID Numbers: STUDY00000599; 323-NJU-TRIAL (Other Grant/Funding Number: International AIDS Society)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Open to collaboration. Please contact the study PIs for requests for data sharing.
• IPD Sharing Time Frame: January 2019
• IPD Sharing Access Criteria: Contact PIs for more info
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Analytic Code

Study Data/Documents

1. Study Protocol
   Information identifier: Current FIT Protocol

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No