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

Microbial Colonization Clinical Trial

— AIMS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03196492
• Other study ID #: IRB00126504
• Secondary ID: 1R01HD092013
• Status: Completed
• Start date: June 14, 2017
• Est. completion date: June 14, 2021

Study information

• Verified date: June 2021
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 234
• Est. completion date: June 14, 2021
• Est. primary completion date: June 14, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 13 Years to 24 Years

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Microbial Colonization

Intervention

Other:
• No intervention
No intervention

Locations

Country	Name	City	State
United States	Johns Hopkins Hospital	Baltimore	Maryland

Sponsors (3)

Lead Sponsor	Collaborator
Johns Hopkins University	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), University of Maryland, College Park

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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