Skip to main content
OpenTrials
Completed

NCT Number: NCT03196492

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Microbial Colonization Communicable Diseases Disease Attributes Infections Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

13 year–24 year

Sex eligibility

Female

Study type

Observational

Primary location

Johns Hopkins Hospital

Baltimore, Maryland, 21205, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention

Other

No intervention

Primary outcomes

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • University of Maryland, College Park

Registry information

Official study title

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

Acronym: AIMS

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Jun 22, 2017
Registry last updated
Jun 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.