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

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

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.

Study Overview

• Status: Completed
• Conditions: Pediatric HIV Infection

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.

• Study Type: Observational
• Enrollment (Actual): 21080

Contacts and Locations

Study Locations

• Tanzania
  • Dar es Salaam, Tanzania
    • Elizabeth Glaser Pediatric AIDS Foundation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 19 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Elizabeth Glaser Pediatric AIDS Foundation
• Collaborators: Tanzania Ministry of Health, Community Development, Gender, Elderly and Children; PACT International
• Investigators: Principal Investigator: Gretchen Antelman, PhD, E. Glaser Pediatric AIDS Found

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 22, 2018
• Primary Completion (ACTUAL): September 30, 2019
• Study Completion (ACTUAL): September 30, 2019

Study Registration Dates

• First Submitted: August 12, 2020
• First Submitted That Met QC Criteria: August 17, 2020
• First Posted (ACTUAL): August 18, 2020

Study Record Updates

• Last Update Posted (ACTUAL): August 18, 2020
• Last Update Submitted That Met QC Criteria: August 17, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: Tanzania; orphans and vulnerable children; HIV Screen tool
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; HIV Infections
• Other Study ID Numbers: EG0216

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan 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.
• IPD Sharing Time Frame: End 2020
• IPD Sharing Access Criteria: Dataverse repository
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No