Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03196492
Recruitment Status : Recruiting
First Posted : June 22, 2017
Last Update Posted : July 5, 2019
Sponsor:
Collaborator:
University of Maryland, College Park
Information provided by (Responsible Party):
Johns Hopkins University

Brief Summary:

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.


Condition or disease Intervention/treatment
Microbial Colonization Other: No intervention

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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effect of Injectable Contraceptives on Inflammation, Vaginal Microbiota, and STI/HIV Risk Among Adolescent Girls and Young Women
Actual Study Start Date : June 14, 2017
Estimated Primary Completion Date : June 14, 2021
Estimated Study Completion Date : June 14, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

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).



Primary Outcome Measures :
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   13 Years to 24 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy 13-24 Adolescent Girls and Young Women
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03196492


Contacts
Layout table for location contacts
Contact: Obianuju Okonkwo, BS 410-955-0646 AimsStudy@jhu.edu

Locations
Layout table for location information
United States, Maryland
Johns Hopkins Hospital Recruiting
Baltimore, Maryland, United States, 21205
Contact: Okonkwo         
Sponsors and Collaborators
Johns Hopkins University
University of Maryland, College Park
Investigators
Layout table for investigator information
Principal Investigator: Jenell Coleman Fennell, MD Johns Hopkins University

Layout table for additonal information
Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT03196492    
Other Study ID Numbers: IRB00126504
First Posted: June 22, 2017    Key Record Dates
Last Update Posted: July 5, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Communicable Diseases
Infection
Medroxyprogesterone Acetate
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptive Agents, Male
Antineoplastic Agents, Hormonal
Antineoplastic Agents