NCT03343158

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

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 2,260 (actual)
• Sponsor: Elizabeth Glaser Pediatric AIDS Foundation · Academic / Other
• Sex: All
• Age: 2 Years – 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed 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.

Conditions

• Orphans, Children, Adolescents
• Vulnerable Children, Adolescents
• Community-based

Timeline

• Start date: 2017-10-17
• Primary completion: 2018-02-28
• Completion: 2018-03-31
• First posted: 2017-11-17
• Last updated: 2021-02-05

Locations

1 site across 1 country: Zimbabwe