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

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03343158

Enrollment

2260

Registered

2017-11-17

Start date

2017-10-17

Completion date

2018-03-31

Last updated

2021-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

2 Years to 18 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Phase 1: Validity of various questions in predicting the probability of HIV among OVC (Screening tool)	Four weeks	Sensitivity and specificity of eleven questions in predicting HIV among OVC
Phase 2: Validation of combined questions in predicting HIV among OVC (Validating Screen tool)	Six weeks	Validation of combined questions assessed from Phase 1 in predicting HIV among OVC

Secondary

Measure	Time frame	Description
Usability of screening tool	Two weeks	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

Countries

Zimbabwe

Outcome results