An observational study in Orphans, Children, Adolescents, Vulnerable Children, Adolescents and Community-based, sponsored by Elizabeth Glaser Pediatric AIDS Foundation. Terminated at 1 site in Zimbabwe. Open to participants aged 2 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-02-05.
Sponsored by Elizabeth Glaser Pediatric AIDS Foundation · Observational
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.
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.
OVC aged 2-18 years, living in households which are registered on a database developed by World Education Institute, a Non-Government Organization which provides services for orphans and vulnerable children in the community
Exclusion Criteria:
Phase 1: Validity of various questions in predicting the probability of HIV among OVC (Screening tool)
Sensitivity and specificity of eleven questions in predicting HIV among OVC
Time frame: Four weeks
Phase 2: Validation of combined questions in predicting HIV among OVC (Validating Screen tool)
Validation of combined questions assessed from Phase 1 in predicting HIV among OVC
Time frame: Six weeks
Usability of screening tool
CHWs who participate in the screening will be invited to participate in a short survey, offered in either Shona or English (depending on participant choice), on the ease, simplicity, and usability of the screening tool, as well as perceptions of the process
Time frame: Two weeks
Plan to share: No
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This study is terminated, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
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Elizabeth Glaser Pediatric AIDS Foundation