HIV SeropositivityNCT03777371
Anti-HIV False Positivity Rate in Pregnant Women; and Investigating the Factors Affecting This Situation
An observational study of HIV Seropositivity and Acquired Immunodeficiency Syndrome, run by Kanuni Sultan Suleyman Training and Research Hospital.
Trial summary
HIV virus is an etiologic agent of ( AIDS ) immunodeficiency syndrome . It is known that the estimated rate of transfer from mother to baby is 25% to 45%, pregnancy rate is 5-10%, pregnancy rate is 15-20% and in lactation period is 5-10%. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- HIV Seropositivity, Acquired Immunodeficiency Syndrome, Pregnancy, High Risk
- What is being tested?
- Anti HIV Seropositive Pregnant Women
- How many people
- 128 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2014to 1 Dec 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Pregnant women between 8 and 40 weeks of gestation
Who may be able to join
- Anti HIV seropositive Pregnant Women
Who cannot join
- Anti HIV seronegative Pregnant Women
About this study
HIV virus is an etiologic agent of ( AIDS ) immunodeficiency syndrome . It is known that the estimated rate of transfer from mother to baby is 25% to 45%, pregnancy rate is 5-10%, pregnancy rate is 15-20% and in lactation period is 5-10%. Risk factors; maternal viral load, breastfeeding, vaginal birth, and prematurity. Although there is a high rate of false positivity in prenatal screening in our country, one of the factors affecting this is the number of pregnancies.
- Being tested
- Anti HIV Seropositive Pregnant Women
- Medical subject headings
- HIV Seropositivity, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti HIV Seropositive Pregnant WomenOther
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect of the number of pregnancies on Anti HIV false positivity rate
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2018
- Study start1 Jan 2014
- Primary completion1 Dec 2018
- Study completion1 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV SeropositivityStudies 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
- Retrospective
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pınar Yalcin bahat, Kanuni Sultan Suleyman Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03777371
- Sponsor's protocol ID
- HIVinPregnancies
- Status last verified
- Dec 2018
- First submitted
- 13 Dec 2018
- Last updated
- 17 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anti-HIV False Positivity Rate in Pregnant Women; and Investigating the Factors Affecting This Situation
- ClinicalTrials.gov ID
- NCT03777371
- Acronym / sponsor ID
- HIVinPregnancies
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 1 Dec 2018 (actual)
- Study completion
- 1 Dec 2018 (actual)
- First posted
- 17 Dec 2018 (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.
HIV virus is an etiologic agent of ( AIDS ) immunodeficiency syndrome . It is known that the estimated rate of transfer from mother to baby is 25% to 45%, pregnancy rate is 5-10%, pregnancy rate is 15-20% and in lactation period is 5-10%. Risk factors; maternal viral load, breastfeeding, vaginal birth, and prematurity. Although there is a high rate of false positivity in prenatal screening in our country, one of the factors affecting this is the number of pregnancies.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Pregnant women between 8 and 40 weeks of gestation
Key inclusion criteria (1 listed)
- Anti HIV seropositive Pregnant Women
Key exclusion criteria (1 listed)
- Anti HIV seronegative Pregnant Women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anti HIV Seropositive Pregnant Women | Other | – |
Primary outcome
The effect of the number of pregnancies on Anti HIV false positivity rate
Time frame: 5 years
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 17 Dec 2018.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Seropositivity and Acquired Immunodeficiency Syndrome, run by Kanuni Sultan Suleyman Training and Research Hospital.
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 1 inclusion and 1 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 17 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
The effect of the number of pregnancies on Anti HIV false positivity rate (time frame: 5 years). 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 17 Dec 2018.