Vaginal Microbiota, and STI/HIV Risk Among Adolescent Girls and Young Women

Completed

Conditions studied: Microbial Colonization

In brief

The investigators are doing a study on the bacteria that normally live in the vagina and what effect, if any, Depo-Provera has on the bacteria. 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.

Key facts

Study ID

NCT03196492

Run by

Johns Hopkins University

People needed

234

Starts

2017-06-14

Expected to finish

2021-06-14

Last updated by the study team

2021-06-18

Who can join

Age: 13 and older, up to 24. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Age 13-24
• 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.

You may not qualify if…

• Any other immunodeficiency (e.g. organ transplant recipient)
• 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

Where it is running

• Johns Hopkins Hospital — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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