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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of Injectable Contraceptives on Inflammation, Vaginal Microbiota, and STI/HIV Risk Among Adolescent Girls and Young Women

Conditions
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Microbial Colonization

Intervention / Treatment
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* Other: No intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 24 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No hormone<br>Half of the cohort (n=40) will have opted to forgo hormonal contraception (HC). | Other: No intervention<br>* No intervention<br>|
| Depo-provera<br>Half of the cohort (n=40) will have opted to initiate injectable depo-provera (DMPA). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 6 months |