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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03196492
Acronym
AIMS
Enrollment
234
Registered
2017-06-22
Start date
2017-06-14
Completion date
2021-06-14
Last updated
2021-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Microbial Colonization

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.

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.

Interventions

OTHERNo intervention

No intervention

Sponsors

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

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
13 Years to 24 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Association between lactobacillus-dominant microbiota and sexually transmitted infections (STI)6 monthsThe 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026