Clinical trial NCT04517760: Evaluating an HIV Risk Screening Tool for Orphans and Vulnerable Children in Tanzania
Official title: Evaluating an HIV Risk Screening Tool for Use in a Population of Orphans and Other Vulnerable Children in Tanzania
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pediatric HIV Infection
Keywords: HIV Screen tool
orphans and vulnerable children
Tanzania
Lead sponsor: Elizabeth Glaser Pediatric AIDS Foundation
Sponsor class: OTHER
Collaborators: name: Tanzania Ministry of Health, Community Development, Gender, Elderly and Children
name: PACT International
First posted: 2020-08-18
Enrollment: 21080
Sex: ALL
Minimum age (years): 2
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
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.

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.

Eligibility 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

Exclusion criteria:

* unwilling to consent to the study

Primary outcomes:
measure: Sensitivity of HIV risk screening tool
timeFrame: Within four weeks
measure: Specificity of HIV risk screening tool
timeFrame: Within four weeks
measure: Positive predictive value
timeFrame: Within four weeks
measure: Negative predictive value
timeFrame: Within four weeks
measure: Acceptability of HIV risk screening tool
timeFrame: Within six weeks
measure: Feasibility of HIV risk screening tool
timeFrame: Within six weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Dar es Salaam
country: Tanzania
facility: Elizabeth Glaser Pediatric AIDS Foundation
Study officials:
affiliation: E. Glaser Pediatric AIDS Found
name: Gretchen Antelman, PhD
role: PRINCIPAL_INVESTIGATOR
References: