Effect of Injectable Contraceptives on Inflammation, Vaginal Microbiota, and STI/HIV Risk Among Adolescent Girls and Young Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 234
- 试验地点
- 1
- 主要终点
- Association between lactobacillus-dominant microbiota and sexually transmitted infections (STI)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 13 Years 至 24 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Association between lactobacillus-dominant microbiota and sexually transmitted infections (STI)
时间窗: 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.
次要结局
未报告次要终点