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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03049917
Other study ID # STUDY00000599
Secondary ID 323-NJU-TRIAL
Status Completed
Phase N/A
First received
Last updated
Start date February 6, 2017
Est. completion date October 1, 2018

Study information

Verified date June 2021
Source University of Washington
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 452
Est. completion date October 1, 2018
Est. primary completion date October 1, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Financial incentive
Conditional cash transfer upon HIV testing

Locations

Country Name City State
Kenya Kisumu County Hospital Kisumu

Sponsors (3)

Lead Sponsor Collaborator
University of Washington Kenyatta National Hospital, University of Nairobi

Country where clinical trial is conducted

Kenya, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 Number of Female Participants Who Present Children for HIV Testing (Females) HIV testing [primary outcome 1] stratified by caregiver sex (females) 2 months
Secondary Number of Male Participants Who Present Children for HIV Testing Time to HIV testing [primary outcome 1] stratified by caregiver sex (males) 2 months
Secondary 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
Secondary 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
Secondary 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
Secondary 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
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