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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02845284 |
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Date of registration:
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20/07/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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'HI-4-TU' Study: Health Improvement for Teen Ugandans Study
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Scientific title:
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Enhanced HIV/Sexually Transmitted Infections and Pregnancy Prevention Study to Improve Adolescent Reproductive Health Services in Uganda |
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Date of first enrolment:
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March 30, 2016 |
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Target sample size:
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486 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02845284 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Uganda
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Contacts
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Name:
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Florence Mirembe, MMED, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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MU-JHU Care Ltd |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Pregnant at =28 weeks of gestation
- Agreeing to provide written informed consent to be screened for and take part in the
study
- Agreeing to provide adequate locator information with residence within 30 km
- Agreeing to a home visit
- Agreeing to come for follow up visits and to receive study follow up phone calls
Exclusion Criteria:
- Serious illness or social conditions that would prevent adherence to study
requirements
- High risk pregnancy or fetal death in utero (with the exception of risk defined only
by maternal age)
Age minimum:
15 Years
Age maximum:
19 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Pregnancy
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Sexually Transmitted Diseases
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Human Immunodeficiency Virus
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Intervention(s)
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Behavioral: enhanced group support
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Behavioral: enhanced individual support
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Primary Outcome(s)
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Composite measure of consistent condom-use and use of an effective family planning method method
[Time Frame: A comparison of this binary outcome will be conducted at one year.]
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Incidence of any Sexually Transmitted Infection
[Time Frame: at one year]
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Secondary ID(s)
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IRB00061475
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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