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Completed

NCT Number: NCT04517760

Evaluating an HIV Risk Screening Tool for Orphans and 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.

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Key information

Conditions

Pediatric HIV Infection

Age range

2 year–19 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Elizabeth Glaser Pediatric AIDS Foundation

Dar es Salaam, Tanzania

About this study

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.

  • 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.
  • 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.
  • To assess fidelity to the administration of the OVC HIV screening tool items through structured observations of community case workers in the K2 program.
  • To assess the acceptability of OVC HIV risk screening and testing implemented in the community among OVC beneficiaries in the K2 program.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Sensitivity of HIV risk screening tool

    Time frame: Within four weeks

    Children/adolescents testing HIV positive on the tool who are truly HIV positive

  2. Specificity of HIV risk screening tool

    Time frame: Within four weeks

    Children/adolescents testing HIV negative on the tool who are truly HIV negative

  3. Positive predictive value

    Time frame: Within four weeks

    Proportion of children/adolescents testing positive on the tool who actually have HIV

  4. Negative predictive value

    Time frame: Within four weeks

    Proportion of children/adolescents testing negative on the tool who do not actually have HIV

  5. Acceptability of HIV risk screening tool

    Time frame: Within six weeks

    Examining the extent of reception of the screening tool by the OVC caregivers and the community case workers using a semi-structured questionnaire

  6. Feasibility of HIV risk screening tool

    Time frame: Within six weeks

    Exploring the practicality of use of HIV risk screening tool through focus group discussions with community case workers

Sponsors and collaborators

Lead sponsor

Elizabeth Glaser Pediatric AIDS Foundation

Other

Collaborators

  • PACT International
  • Tanzania Ministry of Health, Community Development, Gender, Elderly and Children

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Aug 18, 2020
Registry last updated
Aug 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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