Microbial ColonizationAIMSNCT03196492
Vaginal Microbiota, and STI/HIV Risk Among Adolescent Girls and Young Women
An observational study of Microbial Colonization, run by Johns Hopkins University at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 13 to 24 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Microbial Colonization
- Type of treatment
- Injection or infusion
- How many people
- 234 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jun 2017to 14 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 24 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: Healthy 13-24 Adolescent Girls and Young Women
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Injectable Contraceptives on Inflammation, Vaginal Microbiota, and STI/HIV Risk Among Adolescent Girls and Young Women
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.
Read the 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.
- Conditions
- Microbial Colonization
- Being tested
- No intervention
- Medical subject headings
- Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| No hormone | Half of the cohort (n=40) will have opted to forgo hormonal contraception (HC). Receives: Other: No intervention | |
| Depo-provera | Half of the cohort (n=40) will have opted to initiate injectable depo-provera (DMPA). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2017
- Study start14 Jun 2017
- Primary completion14 Jun 2021
- Study completion14 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Microbial ColonizationStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 234 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Maryland, College Park, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Jenell Coleman Fennell, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03196492
- Sponsor's protocol ID
- IRB00126504
- Other IDs
- 1R01HD092013
- Acronym
- AIMS
- Status last verified
- Jun 2021
- First submitted
- 19 Jun 2017
- Last updated
- 18 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Injectable Contraceptives on Inflammation, Vaginal Microbiota, and STI/HIV Risk Among Adolescent Girls and Young Women
- ClinicalTrials.gov ID
- NCT03196492
- Acronym / sponsor ID
- AIMS / IRB00126504
- Conditions
- Microbial Colonization
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 234 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- University of Maryland, College Park, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 14 Jun 2017 (actual)
- Primary completion
- 14 Jun 2021 (actual)
- Study completion
- 14 Jun 2021 (actual)
- First posted
- 22 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No hormone | – | Other: No interventionHalf of the cohort (n=40) will have opted to forgo hormonal contraception (HC). |
| Depo-provera | – | –Half of the cohort (n=40) will have opted to initiate injectable depo-provera (DMPA). |
Who may qualify
- Ages
- 13 to 24 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Healthy 13-24 Adolescent Girls and Young Women
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Other | No hormone |
Primary outcome
Association between lactobacillus-dominant microbiota and sexually transmitted infections (STI)
Time frame: 6 months
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jenell Coleman Fennell, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Microbial Colonization, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association between lactobacillus-dominant microbiota and sexually transmitted infections (STI) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2021.