HIVFITNCT03049917

Financial Incentives to Increase Pediatric HIV Testing

A study testing Financial incentive in people with HIV, run by University of Washington at 1 site in Kenya.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

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

Who is it for?: Ages 18 years and older
Conditions the study is for: HIV
What is being tested?: Financial incentive
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 452 participants
Where: 1 siteKenya
Study dates: 6 Feb 2017to 1 Oct 2018
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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 .

Trial locations and contacts

1 site in 1 country.

Kenya1 site

Kisumu County Hospital
Kisumu

Other trials in Kenya

About this study

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

Read the 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.

Conditions: HIV
Being tested: Financial incentive
Keywords: financial incentive, pediatric HIV testing

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Financial incentiveBehavioural
Conditional cash transfer upon HIV testing

Study groups in NCT03049917
Study group	Role	What they receive
No incentive	No intervention	No incentive
KES financial incentive 1	Experimental	Kenyan Shillings conditional cash transfer upon HIV testing Receives: Behavioral: Financial incentive
KES financial incentive 2	Experimental	Kenyan Shillings conditional cash transfer upon HIV testing Receives: Behavioral: Financial incentive
KES financial incentive 3	Experimental	Kenyan Shillings conditional cash transfer upon HIV testing Receives: Behavioral: Financial incentive
KES financial incentive 4	Experimental	Kenyan Shillings conditional cash transfer upon HIV testing Receives: Behavioral: Financial incentive

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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
Measured: 2 months

Secondary outcomes (6)

Number of Female Participants Who Present Children for HIV Testing (Females)
HIV testing [primary outcome 1] stratified by caregiver sex (females)
Measured: 2 months
Number of Male Participants Who Present Children for HIV Testing
Time to HIV testing [primary outcome 1] stratified by caregiver sex (males)
Measured: 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)
Measured: 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
Measured: 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)
Measured: 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)
Measured: 2 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Feb 20171 Oct 2018

First posted10 Feb 2017
Study start6 Feb 2017
Primary completion1 Oct 2018
Study completion1 Oct 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (4)Papers the sponsor has linked to this study.
Other trials for HIVStudies of the same condition, open and under way.
More trials run by University of WashingtonThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 452 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03049917
Sponsor's protocol ID: STUDY00000599
Other IDs: 323-NJU-TRIAL
Acronym: FIT
Status last verified: Jun 2021
First submitted: 3 Feb 2017
Last updated: 25 Jun 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Open to collaboration. Please contact the study PIs for requests for data sharing.

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.
PubMed 30287676
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.
PubMed 29596217
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.
PubMed 32049774
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.
PubMed 33048877

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All HIV trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Financial Incentives to Increase Pediatric HIV Testing
ClinicalTrials.gov ID: NCT03049917
Acronym / sponsor ID: FIT / STUDY00000599
Conditions: HIV
Keywords: financial incentive, pediatric HIV testing
Study type: Interventional
Recruitment status: Completed
Enrolment: 452 participants (actual)
Lead sponsor: University of WashingtonUniversity, hospital or other
Collaborators: Kenyatta National Hospital, University of Nairobi
Study start: 6 Feb 2017 (actual)
Primary completion: 1 Oct 2018 (actual)
Study completion: 1 Oct 2018 (actual)
First posted: 10 Feb 2017 (actual)
Results: Posted 25 Jun 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 5

Arm	Type	Receives
No incentive	No intervention	–No incentive
KES financial incentive 1	Experimental	Behavioral: Financial incentiveKenyan Shillings conditional cash transfer upon HIV testing
KES financial incentive 2	Experimental	Behavioral: Financial incentiveKenyan Shillings conditional cash transfer upon HIV testing
KES financial incentive 3	Experimental	Behavioral: Financial incentiveKenyan Shillings conditional cash transfer upon HIV testing
KES financial incentive 4	Experimental	Behavioral: Financial incentiveKenyan Shillings conditional cash transfer upon HIV testing

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (2 listed)

None

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Financial incentiveConditional cash transfer upon HIV testing	Behavioural	KES financial incentive 1, KES financial incentive 2, KES financial incentive 3, KES financial incentive 4

Primary outcome

Number of Participants Who Present Children for HIV Testing
Time frame: 2 months
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
Number of Days Participants Take to Bring Children for HIV Testing
Time frame: 2 months
Number of days it took between randomization and caregiver presenting the child for HIV testing

6 secondary outcomes

Number of Female Participants Who Present Children for HIV Testing (Females)
Time frame: 2 months
Number of Male Participants Who Present Children for HIV Testing
Time frame: 2 months
Number of Caregivers With One Child Who Present Children for HIV Testing
Time frame: 2 months
Number of Participants With More Than 1 Child Who Present Children for HIV Testing
Time frame: 2 months
Number of Caregivers With Age Less Than Median Presenting Children for HIV Testing
Time frame: 2 months
Number of Caregivers With Age More Than Median Presenting Children for HIV Testing
Time frame: 2 months

Results and safety

Results posted to the registry on 25 Jun 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
No Incentive	90	31
KES Financial Incentive 1	89	31
KES Financial Incentive 2	93	44
KES Financial Incentive 3	92	51
KES Financial Incentive 4	88	54

Primary outcome: Number of Participants Who Present Children for HIV Testing

Time frame: 2 months. Count of participants. Unit: Participants

Measure	No Incentive n = 90	KES Financial Incentive 1 n = 89	KES Financial Incentive 2 n = 93	KES Financial Incentive 3 n = 92	KES Financial Incentive 4 n = 88
Value	31	31	44	51	54

Primary outcome: Number of Days Participants Take to Bring Children for HIV Testing

Time frame: 2 months. Median (Inter-Quartile Range). Unit: days

Measure	No Incentive n = 90	KES Financial Incentive 1 n = 89	KES Financial Incentive 2 n = 93	KES Financial Incentive 3 n = 92	KES Financial Incentive 4 n = 88
Value	8 (3 to 23)	7 (4 to 14)	4 (1 to 11)	5 (2 to 14)	5 (2 to 8)

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: 2 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
No Incentive	0 of 90 (0%)	0 of 90 (0%)	0 of 90
KES Financial Incentive 1	0 of 89 (0%)	0 of 89 (0%)	0 of 89
KES Financial Incentive 2	0 of 93 (0%)	0 of 93 (0%)	0 of 93
KES Financial Incentive 3	0 of 92 (0%)	0 of 92 (0%)	0 of 92
KES Financial Incentive 4	0 of 88 (0%)	0 of 88 (0%)	0 of 88

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 30287676Wagner 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.
Background: PubMed 29596217Njuguna 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.
Background: PubMed 32049774Atkins 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.
Derived from this study: PubMed 33048877Njuguna 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.
Individual participant dataSharing planned: Yes. Open to collaboration. Please contact the study PIs for requests for data sharing.

Related trials for HIV

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Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
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Not yet recruiting
Adapting the ESTEEM Intervention to Improve Mental Health and PrEP Uptake Among Men at Risk of HIV
PrEP Use
RecruitingPhase 2
Evaluating the Safety and Immunogenicity of MTBVAC
HIV I Infection, Tuberculosis
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Evaluating the Effectiveness of a Mobile HIV Prevention App to Increase HIV and Sexually Transmitted Infections (STI) Testing and PrEP Initiation Among Rural Men Who Have Sex With Men
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Not yet recruiting
PNF RCT to Decrease Alcohol Use and Increase HIV Prevention
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jennifer A Slyker, PhD principal investigator

University of Washington

Irene N Njugna, MBChB, Msc principal investigator

University of Washington/Kenyatta National Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Financial incentive in people with HIV, run by University of Washington at 1 site in Kenya.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Who Present Children for HIV Testing (time frame: 2 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03049917, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2021.