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

N/ACompletedNCT03196492

Johns Hopkins University234 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

234

Conditions

Microbial Colonization

Interventions

No interventionOTHER

No intervention

Eligibility

Sex: FEMALEMin age: 13 YearsMax age: 24 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * 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. Exclusion Criteria: * 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

Locations (1)

Johns Hopkins Hospital

Baltimore, Maryland, United States

Outcomes

Primary Outcomes

Association between lactobacillus-dominant microbiota and sexually transmitted infections (STI)

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.

Time frame: 6 months

Data from ClinicalTrials.gov

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