Evaluating an HIV Risk Screening Tool for Orphans and Vul... | NCT04517760

Studies
Evaluating an HIV Risk Screening Tool for Orphans and Vulnerable Children in Tanzania

NCT04517760

Sponsor

Elizabeth Glaser Pediatric AIDS Foundation

Status

Completed

Last Update Posted

Aug 18, 2020Actual

Enrollment

21,080Actual

Phase

Not provided

Conditions

Pediatric HIV Infection

Interventions

Not provided

Countries

Tanzania

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

Aug 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 22, 2018Actual

Primary Completion Date

Sep 30, 2019Actual

Completion Date

Sep 30, 2019Actual

First Submitted Date

Aug 12, 2020

First Submission Date that Met QC Criteria

Aug 17, 2020

First Posted Date

Aug 18, 2020Actual

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

Aug 17, 2020

Last Update Posted Date

Aug 18, 2020Actual

Name	Class
Tanzania Ministry of Health, Community Development, Gender, Elderly and Children	UNKNOWN
PACT International	UNKNOWN

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

The goal of the research was to evaluate the performance of items within the Kizazi Kipya (K2) Orphan and Vulnerable Children (OVC) HIV risk screening tool in identifying HIV-positive children, to optimize an HIV screening tool for OVC and children and adolescents in facility settings and to assess the feasibility and acceptability of home-based HIV risk screening and testing.

Detailed Description

Under the ongoing community-based Kizazi Kipya (K2) OVC project, program staff currently administer a 13-item HIV risk screening tool to all K2 program beneficiaries, and refers those who screen positive to facility-based HIV testing. A subset of this 13-item tool is a module of four items that had previously been used as a standalone four-question screening tool in facilities in Zimbabwe.

The primary objectives of this study are as follows.

To evaluate the performance of a lay cadre-administered four-item subset of the K2 HIV risk screening tool that matches the Zimbabwe evidence-based tool in predicting the HIV status of vulnerable children/adolescents represented by two populations: (a) K2 OVC beneficiaries and (b) children/adolescents attending health facilities.
To identify additional items in the K2 HIV risk screening tool that could be added to the four-question subset to improve the tool's performance.
To assess fidelity to the administration of the OVC HIV screening tool items through structured observations of community case workers in the K2 program.
To assess the acceptability of OVC HIV risk screening and testing implemented in the community among OVC beneficiaries in the K2 program.
To assess the acceptability and feasibility of integrating the OVC HIV screening tool with HIV testing among OVC community case workers in the K2 program.

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

21,080Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Sensitivity of HIV risk screening tool	Children/adolescents testing HIV positive on the tool who are truly HIV positive	Within four weeks
Specificity of HIV risk screening tool	Children/adolescents testing HIV negative on the tool who are truly HIV negative	Within four weeks
Positive predictive value	Proportion of children/adolescents testing positive on the tool who actually have HIV	Within four weeks
Negative predictive value	Proportion of children/adolescents testing negative on the tool who do not actually have HIV	Within four weeks
Acceptability of HIV risk screening tool	Examining the extent of reception of the screening tool by the OVC caregivers and the community case workers using a semi-structured questionnaire	Within six weeks
Feasibility of HIV risk screening tool	Exploring the practicality of use of HIV risk screening tool through focus group discussions with community case workers	Within six weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Children and adolescents and their caregivers:

Inclusion Criteria:

Living in a household deemed to be at elevated HIV risk based on previously identified risk criteria
Attending a study health facility in two regions of Tanzania
Age 2-19 years

Exclusion Criteria:

Previously tested HIV-positive
History of antiretroviral treatment (ART)
Unable or unwilling to be consented
Age 5-19 years old, tested negative in past 6 months, and having no reported exposure to HIV through sexual contact (consensual, abuse) or through blood transfusion/needle injury.

Community care workers:

Inclusion criteria:

conducting HIV risk screening in OVC households as part of their role in the Kizazi Kipya project in the subset of study districts where structured observations and focus group discussions were conducted

Exclusion criteria:

unwilling to consent to the study

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Years

Maximum Age

19 Years

Standard Ages

ChildAdult

Study Population

Children and adolescents (and their caregivers as applicable) participating in an orphans and vulnerable children (OVC) program or presenting for services at a study facility. Community care workers (CCWs) who have been conducting HIV risk screening in OVC households as part of their role in the OVC program.

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Gretchen Antelman, PhD	E. Glaser Pediatric AIDS Found	Principal Investigator

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

The IPD sharing plan will include the final quantitative datasets, tools, data dictionaries and analytic code will be made publicly available through a Dataverse repository.

Types

Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Analytic Code

Time Frame

End 2020

Access Criteria

Dataverse repository

URL

Not provided