Pediatric HIV InfectionNCT04517760
Evaluating an HIV Risk Screening Tool for Orphans and Vulnerable Children in Tanzania
An observational study of Pediatric HIV Infection, run by Elizabeth Glaser Pediatric AIDS Foundation at 1 site in Tanzania.
Trial 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… Read more about this study
- Who is it for?
- Ages 2 to 19 years
- Conditions the study is for
- Pediatric HIV Infection
- How many people
- 21,080 participants
- Where
- 1 siteTanzania
- Study dates
- 22 Feb 2018to 30 Sep 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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
- 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
Who cannot join
- 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:
- unwilling to consent to the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- 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.
- Conditions
- Pediatric HIV Infection
- Keywords
- HIV Screen tool, orphans and vulnerable children, Tanzania
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of HIV risk screening tool
Children/adolescents testing HIV positive on the tool who are truly HIV positive
Measured: Within four weeks
Specificity of HIV risk screening tool
Children/adolescents testing HIV negative on the tool who are truly HIV negative
Measured: Within four weeks
Positive predictive value
Proportion of children/adolescents testing positive on the tool who actually have HIV
Measured: Within four weeks
Negative predictive value
Proportion of children/adolescents testing negative on the tool who do not actually have HIV
Measured: 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
Measured: 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
Measured: Within six weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2020
- Study start22 Feb 2018
- Primary completion30 Sep 2019
- Study completion30 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric HIV InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 21,080 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elizabeth Glaser Pediatric AIDS Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Tanzania Ministry of Health, Community Development, Gender, Elderly and Children, PACT International
- Responsible party
- Sponsor
- Investigators
- Gretchen Antelman, PhD, Principal investigator, E. Glaser Pediatric AIDS Found
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04517760
- Sponsor's protocol ID
- EG0216
- Status last verified
- Aug 2020
- First submitted
- 12 Aug 2020
- Last updated
- 18 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating an HIV Risk Screening Tool for Use in a Population of Orphans and Other Vulnerable Children in Tanzania
- ClinicalTrials.gov ID
- NCT04517760
- Acronym / sponsor ID
- EG0216
- Conditions
- Pediatric HIV Infection
- Keywords
- HIV Screen tool, orphans and vulnerable children, Tanzania
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21,080 participants (actual)
- Lead sponsor
- Elizabeth Glaser Pediatric AIDS FoundationUniversity, hospital or other
- Collaborators
- Tanzania Ministry of Health, Community Development, Gender, Elderly and Children, PACT International
- Study start
- 22 Feb 2018 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 18 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 2 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (4 listed)
- 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
- 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
Key exclusion criteria (6 listed)
- 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.
- unwilling to consent to the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sensitivity of HIV risk screening tool
Time frame: Within four weeks
Children/adolescents testing HIV positive on the tool who are truly HIV positive
Specificity of HIV risk screening tool
Time frame: Within four weeks
Children/adolescents testing HIV negative on the tool who are truly HIV negative
Positive predictive value
Time frame: Within four weeks
Proportion of children/adolescents testing positive on the tool who actually have HIV
Negative predictive value
Time frame: Within four weeks
Proportion of children/adolescents testing negative on the tool who do not actually have HIV
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2020.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gretchen Antelman, PhD principal investigator
E. Glaser Pediatric AIDS Found
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pediatric HIV Infection, run by Elizabeth Glaser Pediatric AIDS Foundation at 1 site in Tanzania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tanzania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of HIV risk screening tool (time frame: Within four weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2020; AzTrials last refreshed its copy on 31 Oct 2026.