Adolescent BV - Impact of the vaginal microbiome on topical HIV pre-exposure prophylaxis (PrEP)

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Updated on 16 February 2023
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sexually transmitted infections

Summary

Through this study, we hope to learn how healthy bacteria and bacteria associated with a vaginal infection called bacterial vaginosis (BV) affect how PrEP works in women. BV is a common infection in young women that causes itching, odor, vaginal discharge, and inflammation. Women with BV may be at increased risk to become infected with sexually transmitted infections, including HIV. This is why it is important to reduce the number of vaginal infections that people experience and to study how to make PrEP more effective for women.

Description

The study consists of two, three, or four visits, depending on the group they have been assigned, over the course of four to five weeks. Participation involves answering questions about your medical and sexual history, a blood draw, vaginal swabs, HIV and pregnancy testing, and pelvic exams.
For more information, email microbicide@einsteinmed.edu and/or text the study team at 347-835-7842.

Details
Condition Women's Health, Bacterial Infections
Clinical Study IdentifierTX250741
Last Modified on16 February 2023

Eligibility

 Yes No Not Sure

Inclusion Criteria

Female
Between the ages of 16-50
Have a diagnosis of BV and have been prescribed treatment OR Have no symptoms of BV – no vaginal discharge, vaginal itching, or odor
Sexually active
Healthy
Not pregnant or breastfeeding
Do not have HIV or a sexually transmitted infection
Not menopausal
Have previously had a speculum exam

Exclusion Criteria

Inability to undergo speculum examination or never had a speculum exam
Never been sexually active
Pregnancy
Currently breastfeeding
HIV or other active sexually transmitted infection (STI) (Neisseria gonorrhoeae, Chlamydia trachomatis, Trichomonas vaginalis, genital herpes simplex virus (HSV) or human papillomavirus (HPV) lesion)
Immunocompromised conditions (active cancer, lupus, inflammatory bowel disease, multiple sclerosis, chronic steroid use)
Menopausal
Known bleeding disorder
Unexplained vaginal bleeding
Allergy to both silver nitrate and Monsel’s solution
Healthy women with any of the above or vaginal symptoms (itching, discharge, bleeding, lesion) will be excluded
Clear my responses
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What happens next?
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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