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

NCT04517760 | Completed

• 1 other identifier: EG0216
• Study Type: observational
• Target: 21,080
• Locations: 1 country
• Sites: 1

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.

Conditions

Pediatric HIV Infection

Keywords

HIV Screen tool; orphans and vulnerable children; Tanzania

Outcome Measures

Primary Outcomes (6)

• 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

Eligibility Criteria

• Age: 2 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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:
• 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
• unwilling to consent to the study

Sponsors & Collaborators

• Elizabeth Glaser Pediatric AIDS Foundation: lead
• Tanzania Ministry of Health, Community Development, Gender, Elderly and Children: collaborator
• PACT International: collaborator

Study Sites (1)

Elizabeth Glaser Pediatric AIDS Foundation

Dar es Salaam, Tanzania

Location

Study Officials

• Gretchen Antelman, PhD

  E. Glaser Pediatric AIDS Found

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2020
• First Posted: August 18, 2020
• Study Start: February 22, 2018
• Primary Completion: September 30, 2019
• Study Completion: September 30, 2019
• Last Updated: August 18, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: End 2020
• Access Criteria: Dataverse repository

Locations

TA (1)