Orphans and Vulnerable Children Risk Screening Tool Resea... | NCT03343158

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

NCT03343158

Sponsor

Elizabeth Glaser Pediatric AIDS Foundation

Status

Terminated

Last Update Posted

Feb 5, 2021Actual

Enrollment

2,260Actual

Phase

Not provided

Conditions

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

Interventions

Not provided

Countries

Zimbabwe

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2021

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Significantly more resources would have been necessary to complete the study.

Expanded Access Info

Start Date

Oct 17, 2017Actual

Primary Completion Date

Feb 28, 2018Actual

Completion Date

Mar 31, 2018Actual

First Submitted Date

Nov 10, 2017

First Submission Date that Met QC Criteria

Nov 14, 2017

First Posted Date

Nov 17, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 3, 2021

Last Update Posted Date

Feb 5, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sponsor

Lead Sponsor

Elizabeth Glaser Pediatric AIDS FoundationOTHER

Collaborators

Name	Class
JSI Research & Training Institute, Inc.	OTHER
Biomedical Research and Training Institute, Zimbabwe	OTHER
United States Agency for International Development (USAID)	FED

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2,260Actual

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Agnes Mahomva, MD	Elizabeth Glaser Pediatric AIDS Foundation	Principal Investigator
Godfrey Woelk, PhD	Elizabeth Glaser Pediatric AIDS Foundation	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
EGPAF Zimbabwe		Harare			Zimbabwe

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided