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

Community-based Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03343158
• Other study ID #: EG0174
• Status: Terminated
• Start date: October 17, 2017
• Est. completion date: March 31, 2018

Study information

• Verified date: February 2021
• Source: Elizabeth Glaser Pediatric AIDS Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2260
• Est. completion date: March 31, 2018
• Est. primary completion date: February 28, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
Zimbabwe	EGPAF Zimbabwe	Harare

Sponsors (5)

Lead Sponsor	Collaborator
Elizabeth Glaser Pediatric AIDS Foundation	Biomedical Research and Training Institute, Zimbabwe, JSI Research & Training Institute, Inc., United States Agency for International Development (USAID), World Education, Inc.

Country where clinical trial is conducted

Zimbabwe, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Four weeks
Primary	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	Six weeks
Secondary	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	Two weeks