Clinical trial NCT03343158: Orphans and Vulnerable Children Risk Screening Tool Research Study (Zimbabwe)
Official title: Orphans and Vulnerable Children Risk Screening Tool Research Study (Zimbabwe)
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Orphans, Children, Adolescents
Vulnerable Children, Adolescents
Community-based
Lead sponsor: Elizabeth Glaser Pediatric AIDS Foundation
Sponsor class: OTHER
Collaborators: name: JSI Research & Training Institute, Inc.
name: Biomedical Research and Training Institute, Zimbabwe
name: United States Agency for International Development (USAID)
name: World Education, Inc.
First posted: 2017-11-17
Enrollment: 2260
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: 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

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.

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.

Primary outcomes:
measure: Phase 1: Validity of various questions in predicting the probability of HIV among OVC (Screening tool)
timeFrame: Four weeks
measure: Phase 2: Validation of combined questions in predicting HIV among OVC (Validating Screen tool)
timeFrame: Six weeks
Secondary outcomes:
measure: Usability of screening tool
timeFrame: Two weeks
Other outcomes:
Locations:
city: Harare
country: Zimbabwe
facility: EGPAF Zimbabwe
Study officials:
affiliation: Elizabeth Glaser Pediatric AIDS Foundation
name: Agnes Mahomva, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Elizabeth Glaser Pediatric AIDS Foundation
name: Godfrey Woelk, PhD
role: PRINCIPAL_INVESTIGATOR
References: