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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02931422
Other study ID # 50526-J
Secondary ID
Status Completed
Phase N/A
First received October 7, 2016
Last updated February 2, 2017
Start date September 2016
Est. completion date January 31, 2017

Study information

Verified date February 2017
Source University of Washington
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. A post-test questionnaire will explore parental satisfaction, mechanisms of incentive effectiveness and the impact of testing on emotional health and pediatric healthcare utilization.


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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date January 31, 2017
Est. primary completion date January 31, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

*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.

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, 

Outcome

Type Measure Description Time frame Safety issue
Primary HIV testing % of parents completing pediatric HIV testing within 2 months will be compared between arms. Testing within 2 months of recruitment
Secondary 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) 2 months of recruitment
Secondary 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 2 months
Secondary 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 2 months
Secondary Emotional impact A post-test questionnaire will assess impact of testing on caregiver, child, and family emotional well-being 2 months
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