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NCT02740998 · ClinicalTrials.gov registry record
Long-Acting Progestin Contraception and the Vaginal Microbiome
A clinical trial, sponsored by Boston Medical Center.
- Completed
- Registry status
- 28
- Enrollment target
NCT02740998: Completed study, sponsored by Boston Medical Center.
NCT02740998 is a clinical trial that has completed, run by Boston Medical Center. The registered enrollment target is 28 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02740998 has completed, sponsored by Boston Medical Center.
- COMPLETED
- Registry status
- 28 participants
- Enrollment target
Study Summary
Despite many years of research, controversy persists as to whether hormonal contraception promotes HIV acquisition. A number of observational studies on depot medroxyprogesterone acetate (DMPA) injection showed an increase in HIV risk and no evidence of increased risk with oral contraceptive pills. There are no human studies currently published on the impact of the levonorgestrel intrauterine device (LNG IUD) on HIV transmission risk and minimal data on the effects of the etonogestrel subdermal implant (ESI) on risk of HIV acquisition. Establishing whether any of these highly effective contraceptives increases the risk of HIV infection would have far-reaching public health implications, particularly in areas of high HIV prevalence such as sub-Saharan Africa, where injectable contraception accounts for nearly half of contraceptive use. Perturbations in the normal vaginal microbiota, or community of microorganisms inhabiting the vaginal body niche, have long been known to affect the risk of transmission of HIV. Studies have shown altered vaginal microbiota with DMPA injection and preserved vaginal microbiota with the LNG IUD, but no studies have compared these methods head-to-head or used culture-independent sequencing methodology. The investigators propose a prospective pilot study to evaluate the impact of different long-acting progestin contraceptive formulations on the vaginal microbiome. Specifically, the investigators aim to identify and compare metagenomics profiles associated with DMPA, LNG IUD, and ESI contraceptive use by community analysis of vaginal swab samples from women collected longitudinally after contraceptive method initiation. The investigators hypothesize that DMPA will increase community diversity in the vaginal microbiota, whereas the LNG IUD and ESI will not affect the balance of microorganisms in the vagina. Women who are planning to initiate DMPA, LNG IUD, and ESI contraception as well as controls not seeking contraception will be recruited
Primary Outcome
Use of the following two approaches will provide preliminary data for future larger studies from this limited pilot study. If the hypothesis of a vaginal microbial shift with Depo Provera (DMPA) use is confirmed (our PRIMARY analysis), these tools will enable visualization of the differences. The tables of relative abundance of either taxonomic groups or metabolic pathways will be used to identify differential bacterial biomarkers present among patient and sample classes. Two bioinformatics tool
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2016-03 |
| Est. Completion | 2018-06-01 |
What the finished NCT02740998 record still lists
NCT02740998 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 28 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT02740998 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02740998 about?
NCT02740998 is a clinical study titled "Long-Acting Progestin Contraception and the Vaginal Microbiome". Despite many years of research, controversy persists as to whether hormonal contraception promotes HIV acquisition. A number of observational studies on depot medroxyprogesterone acetate (DMPA) injection showed an increase in HIV risk and no evidence of increased risk with oral contraceptive pills. ...
What is the current status of trial NCT02740998?
This trial is currently completed. The enrollment target is 28 participants. The study started on 2016-03. Estimated completion is 2018-06-01.
Who is sponsoring clinical trial NCT02740998?
This trial is sponsored by Boston Medical Center, which has 253 total clinical trials registered on ClinicalTrials.gov.
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