Orphans and Vulnerable Children Risk Screening Tool Research Study (Zimbabwe)
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Orphans, Children, Adolescents
- Sponsor
- Elizabeth Glaser Pediatric AIDS Foundation
- Enrollment
- 2260
- Locations
- 1
- Primary Endpoint
- Phase 2: Validation of combined questions in predicting HIV among OVC (Validating Screen tool)
- Status
- Terminated
- Last Updated
- 5 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Phase 2: Validation of combined questions in predicting HIV among OVC (Validating Screen tool)
Time Frame: Six weeks
Validation of combined questions assessed from Phase 1 in predicting HIV among OVC
Phase 1: Validity of various questions in predicting the probability of HIV among OVC (Screening tool)
Time Frame: Four weeks
Sensitivity and specificity of eleven questions in predicting HIV among OVC
Secondary Outcomes
- Usability of screening tool(Two weeks)