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| ID | Type | Description | Link |
|---|---|---|---|
| 323-NJU-TRIAL | Other Grant/Funding Number | International AIDS Society |
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| Name | Class |
|---|---|
| Kenyatta National Hospital | OTHER_GOV |
| University of Nairobi | OTHER |
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The purpose of this study is to determine whether giving small financial incentives will motivate parents to test their children for HIV.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No incentive | No Intervention | No incentive | |
| KES financial incentive 1 | Experimental | Kenyan Shillings conditional cash transfer upon HIV testing |
|
| KES financial incentive 2 | Experimental | Kenyan Shillings conditional cash transfer upon HIV testing |
|
| KES financial incentive 3 | Experimental | Kenyan Shillings conditional cash transfer upon HIV testing |
|
| KES financial incentive 4 | Experimental | Kenyan Shillings conditional cash transfer upon HIV testing |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Financial incentive | Behavioral | Conditional cash transfer upon HIV testing |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
None
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer A Slyker, PhD | University of Washington | Principal Investigator |
| Irene N Njugna, MBChB, Msc | University of Washington/Kenyatta National Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kisumu County Hospital | Kisumu | Kenya |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30287676 | Background | 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. | |
| 29596217 |
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| ID | Type | URL | Comment |
|---|---|---|---|
| Current FIT Protocol | Study Protocol | View IPD |
Open to collaboration. Please contact the study PIs for requests for data sharing.
January 2019
Contact PIs for more info
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| ID | Title | Description |
|---|---|---|
| FG000 | No Incentive | KES financial incentive = $0 |
| FG001 | KES Financial Incentive 1 | KES financial incentive 1= $1.25 |
| FG002 | KES Financial Incentive 2 | KES financial incentive 2= $2.50 |
| FG003 | KES Financial Incentive 3 | KES financial incentive 3= $5 |
| FG004 | KES Financial Incentive 4 | KES financial incentive 4= $10 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | No Incentive | KES financial incentive= $0 |
| BG001 | KES Financial Incentive 1 | KES financial incentive 1= $1.25 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Count of Participants | Participants | 2 months |
|
2 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | No Incentive | KES financial incentive = $0 | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. | University of Washington | 206-422-5564 | jsyker@uw.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 18, 2018 | May 17, 2021 | Prot_SAP_000.pdf |
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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 |
| 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. |
| 32049774 | Background | 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. |
| 33048877 | Derived | 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. |
| BG002 |
| KES Financial Incentive 2 |
KES financial incentive 2= $2.50 |
| BG003 | KES Financial Incentive 3 | KES financial incentive 3= $5 |
| BG004 | KES Financial Incentive 4 | KES financial incentive 4= $10 |
| BG005 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Inter-Quartile Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Overall number of baseline participants | Count of Participants | Participants |
|
KES financial incentive 2=$2.50
| OG003 | KES Financial Incentive 3 | KES financial incentive 3=$5 |
| OG004 | KES Financial Incentive 4 | KES financial incentive 4=$10 |
|
|
| 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 | Posted | Median | Inter-Quartile Range | days | 2 months |
|
|
|
| Secondary | Number of Female Participants Who Present Children for HIV Testing (Females) | HIV testing [primary outcome 1] stratified by caregiver sex (females) | Posted | Count of Participants | Participants | 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) | Posted | Count of Participants | Participants | 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) | Posted | Count of Participants | Participants | 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 | Posted | Count of Participants | Participants | 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) | Posted | Count of Participants | Participants | 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) | Posted | Count of Participants | Participants | 2 months |
|
|
|
| 90 |
| 0 |
| 90 |
| 0 |
| 90 |
| EG001 | KES Financial Incentive 1 | KES financial incentive 1= $1.25 | 0 | 89 | 0 | 89 | 0 | 89 |
| EG002 | KES Financial Incentive 2 | KES financial incentive 2= $2.50 | 0 | 93 | 0 | 93 | 0 | 93 |
| EG003 | KES Financial Incentive 3 | KES financial incentive 3= $5 | 0 | 92 | 0 | 92 | 0 | 92 |
| EG004 | KES Financial Incentive 4 | KES financial incentive 4= $10 | 0 | 88 | 0 | 88 | 0 | 88 |
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