HIVFIT-PilotNCT02931422
Financial Incentives to Increase Pediatric HIV Testing Pilot Study (FIT-Pilot)
A study testing Financial incentive in people with HIV, run by University of Washington at 1 site in Kenya.
Trial summary
The aim of the pilot study is to evaluate the feasibility, acceptability and costs of a financial incentive intervention to motivate pediatric HIV testing in Western Kenya. The study will evaluate 3 cash incentive values and determine percent uptake of testing. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- 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
- 60 participants
- Where
- 1 siteKenya
- Study dates
- Sep 2016to 31 Jan 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Parent/caregiver receiving HIV care
- Parent/caregiver is female
- 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 a 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.
About this study
Official title: Financial Incentives to Increase Pediatric HIV Testing Pilot Study
The aim of the pilot study is to evaluate the feasibility, acceptability and costs of a financial incentive intervention to motivate pediatric HIV testing in Western Kenya. The study will evaluate 3 cash incentive values and determine percent uptake of testing. A post-test questionnaire will explore parental satisfaction, mechanisms of incentive effectiveness and the impact of testing on emotional health and pediatric healthcare utilization.
Read the detailed description
The study will be a randomized trial with 3 arms (1:1:1 allocation) with small, medium, and large cash incentive. The investigators will randomize 60 parents with children of unknown status at Kisumu County Hospital in Western Kenya.
- Conditions
- HIV
- Being tested
- Financial incentive
- Keywords
- HIV, 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 group | Role | What they receive |
|---|---|---|
| Low Financial Incentive | Experimental | Conditional cash transfer upon HIV testing Receives: Behavioral: Financial incentive |
| Medium Financial Incentive | Experimental | Conditional cash transfer upon HIV testing Receives: Behavioral: Financial incentive |
| High Financial Incentive | Experimental | 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.
HIV testing
% of parents completing pediatric HIV testing within 2 months will be compared between arms.
Measured: Testing within 2 months of recruitment
Secondary outcomes (4)
Parental satisfaction with incentives
A post-test questionnaire will assess parental satisfaction with the incentive, including the value provided, other preferred formats (vouchers, agricultural items, etc)
Measured: 2 months of recruitment
Motivational mechanism
A post-test questionnaire will assess mechanisms by which incentives motivate behavioral change. Questions will assess potential for coercion, parental previous intention to test, and whether incentives overcame economic and/or emotional barriers to testing
Measured: 2 months
Care seeking
A post-test questionnaire will assess whether learning the child's HIV status will affect the likelihood of seeking future medical services for the child
Measured: 2 months
Emotional impact
A post-test questionnaire will assess impact of testing on caregiver, child, and family emotional well-being
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2016 (estimated)
- Study startSep 2016
- Primary completion31 Jan 2017
- Study completion31 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Kenyatta National Hospital, University of Nairobi
- Responsible party
- Principal investigator, Jennifer Slyker, University of Washington
- Investigators
- Jennifer A Slyker, PhD, MSc, Principal investigator, University of WashingtonIrene N Njuguna, MBChB, Msc, Principal investigator, University of Washington/Kenyatta National Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02931422
- Sponsor's protocol ID
- 50526-J
- Acronym
- FIT-Pilot
- Status last verified
- Feb 2017
- First submitted
- 7 Oct 2016
- Last updated
- 3 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Financial Incentives to Increase Pediatric HIV Testing Pilot Study
- ClinicalTrials.gov ID
- NCT02931422
- Acronym / sponsor ID
- FIT-Pilot / 50526-J
- Conditions
- HIV
- Keywords
- HIV, financial incentive, pediatric HIV testing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Kenyatta National Hospital, University of Nairobi
- Study start
- Sep 2016
- Primary completion
- 31 Jan 2017 (actual)
- Study completion
- 31 Jan 2017 (actual)
- First posted
- 13 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the pilot study is to evaluate the feasibility, acceptability and costs of a financial incentive intervention to motivate pediatric HIV testing in Western Kenya. The study will evaluate 3 cash incentive values and determine percent uptake of testing. A post-test questionnaire will explore parental satisfaction, mechanisms of incentive effectiveness and the impact of testing on emotional health and pediatric healthcare utilization.
Detailed description
The study will be a randomized trial with 3 arms (1:1:1 allocation) with small, medium, and large cash incentive. The investigators will randomize 60 parents with children of unknown status at Kisumu County Hospital in Western Kenya.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low Financial Incentive | Experimental | Behavioral: Financial incentiveConditional cash transfer upon HIV testing |
| Medium Financial Incentive | Experimental | Behavioral: Financial incentiveConditional cash transfer upon HIV testing |
| High Financial Incentive | Experimental | Behavioral: Financial incentiveConditional cash transfer upon HIV testing |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Parent/caregiver receiving HIV care
- Parent/caregiver is female
- 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
- The investigators reserve the right to exclude any potential enrollee who is deemed to be a high personal risk, or whose children are at high personal risk, of interpersonal violence, by study participation.
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 | High Financial Incentive, Low Financial Incentive, Medium Financial Incentive |
Primary outcome
HIV testing
Time frame: Testing within 2 months of recruitment
% of parents completing pediatric HIV testing within 2 months will be compared between arms.
4 secondary outcomes
Parental satisfaction with incentives
Time frame: 2 months of recruitment
Motivational mechanism
Time frame: 2 months
Care seeking
Time frame: 2 months
Emotional impact
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2017.
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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, MSc principal investigator
University of Washington
Irene N Njuguna, 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 5 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 3 Feb 2017. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
HIV testing (time frame: Testing within 2 months of recruitment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Feb 2017.