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

NCT ID: NCT04517760

Last Updated: 2020-08-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 21080 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-02-22
• Study Completion Date: 2019-09-30

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.

Conditions

Pediatric HIV Infection

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: CROSS_SECTIONAL

Eligibility Criteria

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

• 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

• 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:

• unwilling to consent to the study

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tanzania Ministry of Health, Community Development, Gender, Elderly and Children

UNKNOWN

Sponsor Role: collaborator

PACT International

UNKNOWN

Sponsor Role: collaborator

Elizabeth Glaser Pediatric AIDS Foundation

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gretchen Antelman, PhD

Role: PRINCIPAL_INVESTIGATOR

E. Glaser Pediatric AIDS Found

Locations

Elizabeth Glaser Pediatric AIDS Foundation

Dar es Salaam, , Tanzania

Countries

Tanzania

Other Identifiers

EG0216

Identifier Type: -

Identifier Source: org_study_id