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

June 14, 2021 updated by: Johns Hopkins University

Effect of Injectable Contraceptives on Inflammation, 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

234

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Johns Hopkins Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years to 24 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Healthy 13-24 Adolescent Girls and Young Women

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Collaborators

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

Investigators

  • Principal Investigator: Jenell Coleman Fennell, MD, Johns Hopkins University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 14, 2017

Primary Completion (Actual)

June 14, 2021

Study Completion (Actual)

June 14, 2021

Study Registration Dates

First Submitted

June 19, 2017

First Submitted That Met QC Criteria

June 20, 2017

First Posted (Actual)

June 22, 2017

Study Record Updates

Last Update Posted (Actual)

June 18, 2021

Last Update Submitted That Met QC Criteria

June 14, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00126504
  • 1R01HD092013 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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