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

NCT03196492 | Completed

• 2 other identifiers: IRB001265041R01HD092013
• Study Type: observational
• Target: 234
• Locations: 1 country
• Sites: 1

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.

Conditions

Microbial Colonization

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

No hormone

Half of the cohort (n=40) will have opted to forgo hormonal contraception (HC).

Other: No intervention

Depo-provera

Half of the cohort (n=40) will have opted to initiate injectable depo-provera (DMPA).

Interventions

No intervention OTHER

No intervention

No hormone

Eligibility Criteria

• Age: 13 Years - 24 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Healthy 13-24 Adolescent Girls and Young Women

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21205, United States

Location

MeSH Terms

Conditions

Communicable Diseases

Condition Hierarchy (Ancestors)

Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jenell Coleman Fennell, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2017
• First Posted: June 22, 2017
• Study Start: June 14, 2017
• Primary Completion: June 14, 2021
• Study Completion: June 14, 2021
• Last Updated: June 18, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)