Orphans, Children, AdolescentsNCT03343158
Orphans and Vulnerable Children Risk Screening Tool Research Study (Zimbabwe)
An observational study of Orphans, Children, Adolescents and Vulnerable Children, Adolescents, run by Elizabeth Glaser Pediatric AIDS Foundation at 1 site in Zimbabwe.
Trial summary
Investigators propose to assess the sensitivity, specificity, positive and negative predictive value of an HIV Risk Screening Tool in identifying the risk of being HIV-infected among Orphans and Vulnerable Children (OVC) aged 2-18 years in a community setting. Read more about this study
- Who is it for?
- Ages 2 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Orphans, Children, Adolescents, Vulnerable Children, Adolescents, Community-based
- How many people
- 2,260 participants
- Where
- 1 siteZimbabwe
- Study dates
- 17 Oct 2017to 31 Mar 2018
- 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 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: OVC aged 2-18 years, living in households which are registered on a database developed by World Education Institute, a Non-Government Organization which provides services for orphans and vulnerable children in the community
Who may be able to join
- Children/adolescents ages 2 up to 18 years living in a household and enrolled in WEI/Zimbabwe and/or partners program;
- Children/adolescents ages 2 up to 18 years with HIV status unknown, or who tested negative three or more months ago;
- Children/adolescents ages 2 up to 18 years who are healthy or ill (unless they are ill enough to require immediate hospitalization).
Who cannot join
- Children/adolescents aged 2 up to 18 years tested HIV positive
- Children/adolescents ages 2 up to 18 years who require immediate hospitalization;
- Children/adolescents ages 2 up to 18 years who refuse/are refused participation.
Trial locations and contacts
1 site in 1 country.
About this study
Investigators propose to assess the sensitivity, specificity, positive and negative predictive value of an HIV Risk Screening Tool in identifying the risk of being HIV-infected among Orphans and Vulnerable Children (OVC) aged 2-18 years in a community setting.
Read the detailed description
In the first phase of the study, investigators will identify an optimal set of screening questions with acceptable sensitivity and false positive rate, based on the draft 11-question pilot tool. Using the identified questions, investigators will develop a composite screening tool and determine criteria that should be used for identifying children for testing with minimally acceptable sensitivity and false positive rates. In the second phase of the study, investigators will select optimal questions to create a composite screening tool and validate it in a similar study population. Investigators anticipate the accuracy of the tool will be much improved compared to the individual questions. Investigators will also assess the usability of the HIV Risk Screening Tool as measured by the time taken to administer the tool, and perceptions of its ease and simplicity.
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1: Validity of various questions in predicting the probability of HIV among OVC (Screening tool)
Sensitivity and specificity of eleven questions in predicting HIV among OVC
Measured: Four weeks
Phase 2: Validation of combined questions in predicting HIV among OVC (Validating Screen tool)
Validation of combined questions assessed from Phase 1 in predicting HIV among OVC
Measured: Six weeks
Secondary outcomes (1)
Usability of screening tool
CHWs who participate in the screening will be invited to participate in a short survey, offered in either Shona or English (depending on participant choice), on the ease, simplicity, and usability of the screening tool, as well as perceptions of the process
Measured: Two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study start17 Oct 2017
- Primary completion28 Feb 2018
- Study completion31 Mar 2018
Why it stopped: Significantly more resources would have been necessary to complete the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orphans, Children, AdolescentsStudies 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
- 2,260 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elizabeth Glaser Pediatric AIDS Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- JSI Research & Training Institute, Inc., Biomedical Research and Training Institute, Zimbabwe, United States Agency for International Development (USAID), World Education, Inc.
- Responsible party
- Sponsor
- Investigators
- Agnes Mahomva, MD, Principal investigator, Elizabeth Glaser Pediatric AIDS FoundationGodfrey Woelk, PhD, Principal investigator, Elizabeth Glaser Pediatric AIDS Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03343158
- Sponsor's protocol ID
- EG0174
- Status last verified
- Feb 2021
- First submitted
- 10 Nov 2017
- Last updated
- 5 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Orphans and Vulnerable Children Risk Screening Tool Research Study (Zimbabwe)
- ClinicalTrials.gov ID
- NCT03343158
- Acronym / sponsor ID
- EG0174
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Significantly more resources would have been necessary to complete the study.
- Enrolment
- 2,260 participants (actual)
- Lead sponsor
- Elizabeth Glaser Pediatric AIDS FoundationUniversity, hospital or other
- Collaborators
- JSI Research & Training Institute, Inc., Biomedical Research and Training Institute, Zimbabwe, United States Agency for International Development (USAID), World Education, Inc.
- Study start
- 17 Oct 2017 (actual)
- Primary completion
- 28 Feb 2018 (actual)
- Study completion
- 31 Mar 2018 (actual)
- First posted
- 17 Nov 2017 (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.
Investigators propose to assess the sensitivity, specificity, positive and negative predictive value of an HIV Risk Screening Tool in identifying the risk of being HIV-infected among Orphans and Vulnerable Children (OVC) aged 2-18 years in a community setting.
Detailed description
In the first phase of the study, investigators will identify an optimal set of screening questions with acceptable sensitivity and false positive rate, based on the draft 11-question pilot tool. Using the identified questions, investigators will develop a composite screening tool and determine criteria that should be used for identifying children for testing with minimally acceptable sensitivity and false positive rates. In the second phase of the study, investigators will select optimal questions to create a composite screening tool and validate it in a similar study population. Investigators anticipate the accuracy of the tool will be much improved compared to the individual questions. Investigators will also assess the usability of the HIV Risk Screening Tool as measured by the time taken to administer the tool, and perceptions of its ease and simplicity.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- OVC aged 2-18 years, living in households which are registered on a database developed by World Education Institute, a Non-Government Organization which provides services for orphans and vulnerable children in the community
Key inclusion criteria (3 listed)
- Children/adolescents ages 2 up to 18 years living in a household and enrolled in WEI/Zimbabwe and/or partners program;
- Children/adolescents ages 2 up to 18 years with HIV status unknown, or who tested negative three or more months ago;
- Children/adolescents ages 2 up to 18 years who are healthy or ill (unless they are ill enough to require immediate hospitalization).
Key exclusion criteria (3 listed)
- Children/adolescents aged 2 up to 18 years tested HIV positive
- Children/adolescents ages 2 up to 18 years who require immediate hospitalization;
- Children/adolescents ages 2 up to 18 years who refuse/are refused participation.
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
Phase 1: Validity of various questions in predicting the probability of HIV among OVC (Screening tool)
Time frame: Four weeks
Sensitivity and specificity of eleven questions in predicting HIV among OVC
Phase 2: Validation of combined questions in predicting HIV among OVC (Validating Screen tool)
Time frame: Six weeks
Validation of combined questions assessed from Phase 1 in predicting HIV among OVC
1 secondary outcome
Usability of screening tool
Time frame: Two weeks
Results and safety
The study was stopped early (reason given: Significantly more resources would have been necessary to complete the study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2021.
- Individual participant dataSharing planned: No
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.
Agnes Mahomva, MD principal investigator
Elizabeth Glaser Pediatric AIDS Foundation
Godfrey Woelk, PhD principal investigator
Elizabeth Glaser Pediatric AIDS Foundation
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 Orphans, Children, Adolescents and Vulnerable Children, Adolescents, run by Elizabeth Glaser Pediatric AIDS Foundation at 1 site in Zimbabwe.
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 3 inclusion and 3 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: stopped early, as of the sponsor's last update on 5 Feb 2021. 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 Zimbabwe. 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 was stopped early (reason given: Significantly more resources would have been necessary to complete the study.). Results are not available in the source record.
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?
Phase 1: Validity of various questions in predicting the probability of HIV among OVC (Screening tool) (time frame: Four weeks). The study lists 2 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 5 Feb 2021.