Ignite Creation Date:
2025-12-25 @ 2:04 AM
Ignite Modification Date:
2025-12-28 @ 12:14 AM
Study NCT ID:
NCT04517760
Status:
COMPLETED
Last Update Posted:
2020-08-18
First Post:
2020-08-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluating an HIV Risk Screening Tool for Orphans and Vulnerable Children in Tanzania
Sponsor:
Elizabeth Glaser Pediatric AIDS Foundation
Organization:
Study Overview
Official Title:
Evaluating an HIV Risk Screening Tool for Use in a Population of Orphans and Other Vulnerable Children in Tanzania
Status:
COMPLETED
Status Verified Date:
2020-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
1. 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.
2. 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.
3. To assess fidelity to the administration of the OVC HIV screening tool items through structured observations of community case workers in the K2 program.
4. To assess the acceptability of OVC HIV risk screening and testing implemented in the community among OVC beneficiaries in the K2 program.
5. 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.
The primary objectives of this study are as follows.
1. 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.
2. 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.
3. To assess fidelity to the administration of the OVC HIV screening tool items through structured observations of community case workers in the K2 program.
4. To assess the acceptability of OVC HIV risk screening and testing implemented in the community among OVC beneficiaries in the K2 program.
5. 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: