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

Elizabeth Glaser Pediatric AIDS Foundation

Status: Completed

Conditions: Pediatric HIV Infection

Study type: Observational

Funder types: Other

Identifiers

NCT04517760

EG0216

Details and patient eligibility

About

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.

Full 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.

Enrollment: 21,080 patients

Sex: All

Ages: 2 to 19 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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