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

Johns Hopkins University

Status: Completed

Conditions: Microbial Colonization

Treatments: Other: No intervention

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT03196492

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

IRB00126504

Details and patient eligibility

About

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.

Full 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.

Enrollment: 234 patients

Sex: Female

Ages: 13 to 24 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

234 participants in 2 patient groups

No hormone

Description:

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

Treatment:

Other: No intervention

Depo-provera

Description:

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