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

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.

Study Overview

• Status: Terminated
• Conditions: Orphans, Children, Adolescents; Vulnerable Children, Adolescents; Community-based

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.

• Study Type: Observational
• Enrollment (Actual): 2260

Contacts and Locations

Study Locations

• Zimbabwe
  • Harare, Zimbabwe
    • EGPAF Zimbabwe

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Elizabeth Glaser Pediatric AIDS Foundation
• Collaborators: United States Agency for International Development (USAID); Biomedical Research and Training Institute, Zimbabwe; World Education, Inc.; JSI Research & Training Institute, Inc.
• Investigators: Principal Investigator: Godfrey Woelk, PhD, Elizabeth Glaser Pediatric AIDS Foundation; Principal Investigator: Agnes Mahomva, MD, Elizabeth Glaser Pediatric AIDS Foundation

Study record dates

Study Major Dates

• Study Start (Actual): October 17, 2017
• Primary Completion (Actual): February 28, 2018
• Study Completion (Actual): March 31, 2018

Study Registration Dates

• First Submitted: November 10, 2017
• First Submitted That Met QC Criteria: November 14, 2017
• First Posted (Actual): November 17, 2017

Study Record Updates

• Last Update Posted (Actual): February 5, 2021
• Last Update Submitted That Met QC Criteria: February 3, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: EG0174

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No