Status:
COMPLETED
Caregiver-Assisted Oral Fluid-based HIV Screening in Children: Uganda
Lead Sponsor:
Catholic Relief Services
Collaborating Sponsors:
Centers for Disease Control and Prevention
Conditions:
HIV Testing
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of this study is to evaluate the acceptability, feasibility and effectiveness of a caregiver-assisted oral fluid-based HIV test to screen children for HIV. The results of this study are in...
Detailed Description
Rationale: Globally, there are 1.8 million children living with HIV (CLHIV), however, despite great progress over the past 15 years, only 52% are receiving antiretroviral therapy (ART), leaving approx...
Eligibility Criteria
Inclusion
- Inclusion Criteria for Index parent/caregivers:
- HIV-positive diagnosis
- 18 years old or older
- Emancipated minors (15-17 years of age) with eligible children
- Inclusion Criteria for eligible children:
- Biological children (of an index parent/caregiver) 18 months - 14 years of age with an unknown HIV status
- Non-biological children living in the same household as the index parent/caregivers where the child has a history of HIV exposure (where the mother is HIV-positive, of unknown status, unavailable for testing, or who is deceased)
- Biological children (of an index parent/caregiver) 18 months - 14 years of age, as well as non-biological children living in the same household as the index parent/caregiver where the child has a history of HIV exposure (where the mother is HIV-positive, of unknown status, unavailable for testing, or who is deceased), with a known previous HIV-negative status completed less than three months following the cessation of breastfeeding and whose parent/caregiver states that there is reason to suspect a new exposure
- Inclusion criteria for participation in survey after completion of care giver-assisted oral fluid-based HIV screening:
- • Adult index parents who complete the oral-based HIV screening with at least one eligible child, regardless of screening result.
- Exclusion Criteria for Index parent/caregivers:
- Adults answering "yes" to any of the first three intimate partner violence (IPV) risk assessment questions
- Adults answering "yes", "maybe" or I don't know" to the fourth IPV question
- Those unable to provide independent informed consent due to mental disability or other limitations (as deemed by study staff)
- Exclusion Criteria for eligible children:
- Children \<18 months of age
- Children 18 months - 14 years of age with a known HIV-positive status
- Biological children (of an index parent/caregiver) 18 months - 14 years of age where the child has a history of HIV exposure (where the mother is HIV-positive, of unknown status, unavailable for testing, or who is deceased), with previous known HIV-negative status completed less than three months following the cessation of breastfeeding and whose parent/caregiver states that they have no reason to suspect a new exposure
- Non-biological children living in the same household as the index parent/caregiver age where the child has a history of HIV exposure (where the mother is HIV-positive, of unknown status, unavailable for testing, or who is deceased), with previous known HIV-negative status completed less than three months following the cessation of breastfeeding and whose parent/caregiver states that they have no reason to suspect a new exposure
- Children still breastfeeding
- Children with cessation of breastfeeding \< 3 months
- Exclusion criteria for participation in survey after completion of oral-based HIV screening:
- • Adult index parent/caregivers who do not complete the oral-based HIV screening with at least one eligible child
Exclusion
Key Trial Info
Start Date :
April 19 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 8 2021
Estimated Enrollment :
4865 Patients enrolled
Trial Details
Trial ID
NCT04774666
Start Date
April 19 2021
End Date
October 8 2021
Last Update
March 11 2022
Active Locations (32)
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1
Bugiri Hospital
Bugiri, Bugiri District, Uganda
2
Nankoma HC IV
Bugiri, Bugiri District, Uganda
3
Kabuyanda HC IV
Kabuyanda, Isingiro District, Uganda
4
Rwekubo HC IV
Kahirimbi, Isingiro District, Uganda