NCT03049917

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
452

participants targeted

Target at P50-P75 for not_applicable hiv

Timeline
Completed

Started Feb 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 3, 2017

Completed
3 days until next milestone

Study Start

First participant enrolled

February 6, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 10, 2017

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed
2.7 years until next milestone

Results Posted

Study results publicly available

June 25, 2021

Completed
Last Updated

June 25, 2021

Status Verified

June 1, 2021

Enrollment Period

1.6 years

First QC Date

February 3, 2017

Results QC Date

April 8, 2021

Last Update Submit

June 3, 2021

Conditions

Keywords

financial incentivepediatric HIV testing

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (6)

  • Number of Female Participants Who Present Children for HIV Testing (Females)

    2 months

  • Number of Male Participants Who Present Children for HIV Testing

    2 months

  • Number of Caregivers With One Child Who Present Children for HIV Testing

    2 months

  • Number of Participants With More Than 1 Child Who Present Children for HIV Testing

    2 months

  • Number of Caregivers With Age Less Than Median Presenting Children for HIV Testing

    2 months

  • +1 more secondary outcomes

Study Arms (5)

No incentive

NO INTERVENTION

No incentive

KES financial incentive 1

EXPERIMENTAL

Kenyan Shillings conditional cash transfer upon HIV testing

Behavioral: Financial incentive

KES financial incentive 2

EXPERIMENTAL

Kenyan Shillings conditional cash transfer upon HIV testing

Behavioral: Financial incentive

KES financial incentive 3

EXPERIMENTAL

Kenyan Shillings conditional cash transfer upon HIV testing

Behavioral: Financial incentive

KES financial incentive 4

EXPERIMENTAL

Kenyan Shillings conditional cash transfer upon HIV testing

Behavioral: Financial incentive

Interventions

Conditional cash transfer upon HIV testing

KES financial incentive 1KES financial incentive 2KES financial incentive 3KES financial incentive 4

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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 .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kisumu County Hospital

Kisumu, Kenya

Location

Related Publications (4)

  • 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.

    PMID: 30287676BACKGROUND
  • 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.

    PMID: 29596217BACKGROUND
  • 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.

    PMID: 32049774BACKGROUND
  • 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.

Results Point of Contact

Title
Dr.
Organization
University of Washington

Study Officials

  • Jennifer A Slyker, PhD

    University of Washington

    PRINCIPAL INVESTIGATOR
  • Irene N Njugna, MBChB, Msc

    University of Washington/Kenyatta National Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, Department of Global Health

Study Record Dates

First Submitted

February 3, 2017

First Posted

February 10, 2017

Study Start

February 6, 2017

Primary Completion

October 1, 2018

Study Completion

October 1, 2018

Last Updated

June 25, 2021

Results First Posted

June 25, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will share

Open to collaboration. Please contact the study PIs for requests for data sharing.

Shared Documents
STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
Time Frame
January 2019
Access Criteria
Contact PIs for more info

Available IPD Datasets

Study Protocol (Current FIT Protocol)Access

Locations