Orphans and Vulnerable Children Risk Screening Tool Research Study (Zimbabwe)

Elizabeth Glaser Pediatric AIDS Foundation

Status: Terminated

Conditions: Community-based; Orphans, Children, Adolescents; Vulnerable Children, Adolescents

Study type: Observational

Funder types: Other; Other U.S. Federal agency; Industry

Identifiers

NCT03343158

EG0174

Details and patient eligibility

About

Investigators propose to assess the sensitivity, specificity, positive and negative predictive value of an HIV Risk Screening Tool in identifying the risk of being HIV-infected among Orphans and Vulnerable Children (OVC) aged 2-18 years in a community setting.

Full description

In the first phase of the study, investigators will identify an optimal set of screening questions with acceptable sensitivity and false positive rate, based on the draft 11-question pilot tool. Using the identified questions, investigators will develop a composite screening tool and determine criteria that should be used for identifying children for testing with minimally acceptable sensitivity and false positive rates. In the second phase of the study, investigators will select optimal questions to create a composite screening tool and validate it in a similar study population. Investigators anticipate the accuracy of the tool will be much improved compared to the individual questions. Investigators will also assess the usability of the HIV Risk Screening Tool as measured by the time taken to administer the tool, and perceptions of its ease and simplicity.

Enrollment: 2,260 patients

Sex: All

Ages: 2 to 18 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Children/adolescents ages 2 up to 18 years living in a household and enrolled in WEI/Zimbabwe and/or partners program;
• Children/adolescents ages 2 up to 18 years with HIV status unknown, or who tested negative three or more months ago;
• Children/adolescents ages 2 up to 18 years who are healthy or ill (unless they are ill enough to require immediate hospitalization).

Exclusion criteria

• Children/adolescents aged 2 up to 18 years tested HIV positive
• Children/adolescents ages 2 up to 18 years who require immediate hospitalization;
• Children/adolescents ages 2 up to 18 years who refuse/are refused participation.