Vaginal Microbiota, and STI/HIV Risk Among Adolescent Girls and Young Women
NCT ID: NCT03196492
Last Updated: 2021-06-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
234 participants
OBSERVATIONAL
2017-06-14
2021-06-14
Brief Summary
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Women 13-24 years of age, who are HIV negative, being seen in a clinic for birth control or sexually transmitted disease (STD) check-up, or have a child and are planning to receive a Depo-Provera shot for contraception or have declined the use of hormonal contraception may join.
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Detailed Description
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Women 13-24 years of age, who are HIV negative, being seen in a clinic for birth control or STD check-up, or have a child and are planning to receive a Depo-Provera shot for contraception or have declined the use of hormonal contraception may join.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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No hormone
Half of the cohort (n=40) will have opted to forgo hormonal contraception (HC).
No intervention
No intervention
Depo-provera
Half of the cohort (n=40) will have opted to initiate injectable depo-provera (DMPA).
No interventions assigned to this group
Interventions
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No intervention
No intervention
Eligibility Criteria
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Inclusion Criteria
* Female sex
* Seeking contraceptive/ STI services OR has had a child OR is legally married
* Has had consensual vaginal sex
* Two years have passed since menses started
* HIV negative by self-report
* Willing to refrain from using douches, washes, or other similar feminine hygiene products. (Tampons are allowed)
* Planning to receive the Depo-Provera shot, -OR- Have regular menstrual cycles with at least 21 - 45 days between menses and plans to use no hormonal birth control.
Exclusion Criteria
* Recently pregnant (within 4 weeks), currently pregnant, or planning to become pregnant within the next 12 months
* Currently breastfeeding
* Hysterectomy or a known genital tract anomaly
* Amenorrhea (except if caused by contraceptive method like the implant)
* Antibiotic or antifungal use within past 30 days
13 Years
24 Years
FEMALE
Yes
Sponsors
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University of Maryland, College Park
OTHER
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
Johns Hopkins University
OTHER
Responsible Party
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Principal Investigators
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Jenell Coleman Fennell, MD
Role: PRINCIPAL_INVESTIGATOR
Johns Hopkins University
Locations
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Johns Hopkins Hospital
Baltimore, Maryland, United States
Countries
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Other Identifiers
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IRB00126504
Identifier Type: -
Identifier Source: org_study_id
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