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

Pediatric HIV Infection Clinical Trial

Official title:

Evaluating an HIV Risk Screening Tool for Use in a Population of Orphans and Other Vulnerable Children in Tanzania

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04517760
• Other study ID #: EG0216
• Status: Completed
• Start date: February 22, 2018
• Est. completion date: September 30, 2019

Study information

• Verified date: August 2020
• Source: Elizabeth Glaser Pediatric AIDS Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21080
• Est. completion date: September 30, 2019
• Est. primary completion date: September 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 19 Years

Eligibility

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

Related Conditions & MeSH terms

• HIV Infections
• Pediatric HIV Infection

Locations

Country	Name	City	State
Tanzania	Elizabeth Glaser Pediatric AIDS Foundation	Dar es Salaam

Sponsors (3)

Lead Sponsor	Collaborator
Elizabeth Glaser Pediatric AIDS Foundation	PACT International, Tanzania Ministry of Health, Community Development, Gender, Elderly and Children

Country where clinical trial is conducted

Tanzania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity of HIV risk screening tool	Children/adolescents testing HIV positive on the tool who are truly HIV positive	Within four weeks
Primary	Specificity of HIV risk screening tool	Children/adolescents testing HIV negative on the tool who are truly HIV negative	Within four weeks
Primary	Positive predictive value	Proportion of children/adolescents testing positive on the tool who actually have HIV	Within four weeks
Primary	Negative predictive value	Proportion of children/adolescents testing negative on the tool who do not actually have HIV	Within four weeks
Primary	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
Primary	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