HIV
Conditions
Keywords
financial incentive, pediatric HIV testing
Brief summary
The purpose of this study is to determine whether giving small financial incentives will motivate parents to test their children for HIV.
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.
Interventions
BEHAVIORALFinancial incentive
Conditional cash transfer upon HIV testing
Sponsors
Kenyatta National Hospital
University of Nairobi
University of Washington
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 .
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Present Children for HIV Testing | 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 | 2 months | Number of days it took between randomization and caregiver presenting the child for HIV testing |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Caregivers With One Child Who Present Children for HIV Testing | 2 months | HIV testing \[primary outcome 1\] stratified by number of children (one child) |
| Number of Participants With More Than 1 Child Who Present Children for HIV Testing | 2 months | Number of participants presenting children for HIV testing among caregivers with more than child |
| Number of Female Participants Who Present Children for HIV Testing (Females) | 2 months | HIV testing \[primary outcome 1\] stratified by caregiver sex (females) |
| Number of Caregivers With Age More Than Median Presenting Children for HIV Testing | 2 months | Number of caregivers presenting children for HIV testing stratified by caregiver age (caregiver \>38 years) |
| Number of Caregivers With Age Less Than Median Presenting Children for HIV Testing | 2 months | Number of participants presenting for HIV testing stratified by caregiver age (caregiver \<=38 years) |
| Number of Male Participants Who Present Children for HIV Testing | 2 months | Time to HIV testing \[primary outcome 1\] stratified by caregiver sex (males) |
Countries
Kenya
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| No Incentive KES financial incentive= $0 | 90 |
| KES Financial Incentive 1 KES financial incentive 1= $1.25 | 89 |
| KES Financial Incentive 2 KES financial incentive 2= $2.50 | 93 |
| KES Financial Incentive 3 KES financial incentive 3= $5 | 92 |
| KES Financial Incentive 4 KES financial incentive 4= $10 | 88 |
| Total | 452 |
Baseline characteristics
| Characteristic | Total | No Incentive | KES Financial Incentive 4 | KES Financial Incentive 1 | KES Financial Incentive 3 | KES Financial Incentive 2 |
|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 452 Participants | 90 Participants | 88 Participants | 89 Participants | 92 Participants | 93 Participants |
| Age, Continuous | 38 years | 37.5 years | 39.5 years | 37 years | 38 years | 38 years |
| Overall number of baseline participants | 452 Participants | 90 Participants | 88 Participants | 89 Participants | 92 Participants | 93 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 452 Participants | 90 Participants | 88 Participants | 89 Participants | 92 Participants | 93 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 305 Participants | 64 Participants | 59 Participants | 62 Participants | 55 Participants | 65 Participants |
| Sex: Female, Male Male | 147 Participants | 26 Participants | 29 Participants | 27 Participants | 37 Participants | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 90 | 0 / 89 | 0 / 93 | 0 / 92 | 0 / 88 |
| other Total, other adverse events | 0 / 90 | 0 / 89 | 0 / 93 | 0 / 92 | 0 / 88 |
| serious Total, serious adverse events | 0 / 90 | 0 / 89 | 0 / 93 | 0 / 92 | 0 / 88 |
Outcome results
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
Time frame: 2 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| No Incentive | Number of Days Participants Take to Bring Children for HIV Testing | 8 days |
| KES Financial Incentive 1 | Number of Days Participants Take to Bring Children for HIV Testing | 7 days |
| KES Financial Incentive 2 | Number of Days Participants Take to Bring Children for HIV Testing | 4 days |
| KES Financial Incentive 3 | Number of Days Participants Take to Bring Children for HIV Testing | 5 days |
| KES Financial Incentive 4 | Number of Days Participants Take to Bring Children for HIV Testing | 5 days |
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
Time frame: 2 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| No Incentive | Number of Participants Who Present Children for HIV Testing | 31 Participants |
| KES Financial Incentive 1 | Number of Participants Who Present Children for HIV Testing | 31 Participants |
| KES Financial Incentive 2 | Number of Participants Who Present Children for HIV Testing | 44 Participants |
| KES Financial Incentive 3 | Number of Participants Who Present Children for HIV Testing | 51 Participants |
| KES Financial Incentive 4 | Number of Participants Who Present Children for HIV Testing | 54 Participants |
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)
Time frame: 2 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| No Incentive | Number of Caregivers With Age Less Than Median Presenting Children for HIV Testing | 15 Participants |
| KES Financial Incentive 1 | Number of Caregivers With Age Less Than Median Presenting Children for HIV Testing | 19 Participants |
| KES Financial Incentive 2 | Number of Caregivers With Age Less Than Median Presenting Children for HIV Testing | 22 Participants |
| KES Financial Incentive 3 | Number of Caregivers With Age Less Than Median Presenting Children for HIV Testing | 26 Participants |
| KES Financial Incentive 4 | Number of Caregivers With Age Less Than Median Presenting Children for HIV Testing | 26 Participants |
| All Females | Number of Caregivers With Age Less Than Median Presenting Children for HIV Testing | 108 Participants |
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)
Time frame: 2 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| No Incentive | Number of Caregivers With Age More Than Median Presenting Children for HIV Testing | 16 Participants |
| KES Financial Incentive 1 | Number of Caregivers With Age More Than Median Presenting Children for HIV Testing | 12 Participants |
| KES Financial Incentive 2 | Number of Caregivers With Age More Than Median Presenting Children for HIV Testing | 22 Participants |
| KES Financial Incentive 3 | Number of Caregivers With Age More Than Median Presenting Children for HIV Testing | 25 Participants |
| KES Financial Incentive 4 | Number of Caregivers With Age More Than Median Presenting Children for HIV Testing | 28 Participants |
| All Females | Number of Caregivers With Age More Than Median Presenting Children for HIV Testing | 103 Participants |
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)
Time frame: 2 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| No Incentive | Number of Caregivers With One Child Who Present Children for HIV Testing | 15 Participants |
| KES Financial Incentive 1 | Number of Caregivers With One Child Who Present Children for HIV Testing | 14 Participants |
| KES Financial Incentive 2 | Number of Caregivers With One Child Who Present Children for HIV Testing | 26 Participants |
| KES Financial Incentive 3 | Number of Caregivers With One Child Who Present Children for HIV Testing | 29 Participants |
| KES Financial Incentive 4 | Number of Caregivers With One Child Who Present Children for HIV Testing | 32 Participants |
| All Females | Number of Caregivers With One Child Who Present Children for HIV Testing | 90 Participants |
Secondary
Number of Female Participants Who Present Children for HIV Testing (Females)
HIV testing \[primary outcome 1\] stratified by caregiver sex (females)
Time frame: 2 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| No Incentive | Number of Female Participants Who Present Children for HIV Testing (Females) | 25 Participants |
| KES Financial Incentive 1 | Number of Female Participants Who Present Children for HIV Testing (Females) | 22 Participants |
| KES Financial Incentive 2 | Number of Female Participants Who Present Children for HIV Testing (Females) | 34 Participants |
| KES Financial Incentive 3 | Number of Female Participants Who Present Children for HIV Testing (Females) | 29 Participants |
| KES Financial Incentive 4 | Number of Female Participants Who Present Children for HIV Testing (Females) | 38 Participants |
| All Females | Number of Female Participants Who Present Children for HIV Testing (Females) | 156 Participants |
Secondary
Number of Male Participants Who Present Children for HIV Testing
Time to HIV testing \[primary outcome 1\] stratified by caregiver sex (males)
Time frame: 2 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| No Incentive | Number of Male Participants Who Present Children for HIV Testing | 6 Participants |
| KES Financial Incentive 1 | Number of Male Participants Who Present Children for HIV Testing | 9 Participants |
| KES Financial Incentive 2 | Number of Male Participants Who Present Children for HIV Testing | 10 Participants |
| KES Financial Incentive 3 | Number of Male Participants Who Present Children for HIV Testing | 22 Participants |
| KES Financial Incentive 4 | Number of Male Participants Who Present Children for HIV Testing | 16 Participants |
| All Females | Number of Male Participants Who Present Children for HIV Testing | 55 Participants |
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
Time frame: 2 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| No Incentive | Number of Participants With More Than 1 Child Who Present Children for HIV Testing | 15 Participants |
| KES Financial Incentive 1 | Number of Participants With More Than 1 Child Who Present Children for HIV Testing | 17 Participants |
| KES Financial Incentive 2 | Number of Participants With More Than 1 Child Who Present Children for HIV Testing | 16 Participants |
| KES Financial Incentive 3 | Number of Participants With More Than 1 Child Who Present Children for HIV Testing | 21 Participants |
| KES Financial Incentive 4 | Number of Participants With More Than 1 Child Who Present Children for HIV Testing | 21 Participants |
| All Females | Number of Participants With More Than 1 Child Who Present Children for HIV Testing | 116 Participants |