Vaginal Microbiota, and STI/HIV Risk Among Adolescent Girls and Young Women
- Conditions
- Microbial Colonization
- Registration Number
- NCT03196492
- Lead Sponsor
- Johns Hopkins University
- Brief Summary
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.
- Detailed Description
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 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 234
- 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.
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Association between lactobacillus-dominant microbiota and sexually transmitted infections (STI) 6 months The investigators will determine if there is an association between lactobacillus-dominant microbiota and STIs. The investigators will report the prevalence of each vaginal community state types (CST) and STIs.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Johns Hopkins Hospital
🇺🇸Baltimore, Maryland, United States
Johns Hopkins Hospital🇺🇸Baltimore, Maryland, United States