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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04517760
Enrollment
21080
Registered
2020-08-18
Start date
2018-02-22
Completion date
2019-09-30
Last updated
2020-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pediatric HIV Infection

Keywords

HIV Screen tool, orphans and vulnerable children, Tanzania

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.

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.

Interventions

None listed

Sponsors

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

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
2 Years to 19 Years
Healthy volunteers
No

Inclusion 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

Design outcomes

Primary

MeasureTime frameDescription
Sensitivity of HIV risk screening toolWithin four weeksChildren/adolescents testing HIV positive on the tool who are truly HIV positive
Specificity of HIV risk screening toolWithin four weeksChildren/adolescents testing HIV negative on the tool who are truly HIV negative
Positive predictive valueWithin four weeksProportion of children/adolescents testing positive on the tool who actually have HIV
Negative predictive valueWithin four weeksProportion of children/adolescents testing negative on the tool who do not actually have HIV
Acceptability of HIV risk screening toolWithin six weeksExamining the extent of reception of the screening tool by the OVC caregivers and the community case workers using a semi-structured questionnaire
Feasibility of HIV risk screening toolWithin six weeksExploring the practicality of use of HIV risk screening tool through focus group discussions with community case workers

Countries

Tanzania

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026