Status:
COMPLETED
Caregiver-Assisted Oral Fluid-based HIV Screening in Children: Zambia
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 in Zambia. The results of this st...
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 adult index parent/caregivers:
- All HIV-positive adults
- 18 years old or older with eligible children
- Inclusion Criteria for Eligible children:
- • All biological children (of an adult index case) 18 months - 14 years of age with an unknown HIV status
- Exclusion Criteria for adult index parent/caregivers:
- Adults answering "yes" to any of the four intimate partner violence risk assessment questions
- Adults previously diagnosed as mentally disabled
- Adults currently in prison are excluded from this study.
- Adult partners of index parent/caregivers
- Exclusion Criteria for Children:
- Children \<18 months of age
- All biological children (of an index case) 18 months - 14 years of age with a documented HIV-negative status after cessation of breastfeeding
- All biological children (of an index case) 18 months - 14 years of age with a documented HIV-positive status
- Children still breastfeeding or with cessation of breastfeeding \< 3 months
- Non-biological children of the index parent/caregiver
Exclusion
Key Trial Info
Start Date :
February 8 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 8 2021
Estimated Enrollment :
2730 Patients enrolled
Trial Details
Trial ID
NCT04754386
Start Date
February 8 2021
End Date
December 8 2021
Last Update
February 28 2022
Active Locations (15)
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1
Mutendere Clinic
Mutendere, Lusaka Province, Zambia
2
Chitope Rural Health Centre
Mwavi, Lusaka Province, Zambia
3
Nadezwe Rural Health Center
Chikankata, Southern Province, Zambia
4
Chivuna Rural Health Centre
Livingstone, Southern Province, Zambia