Vaginal Microbiota, and STI/HIV Risk Among Adolescent Gir... | NCT03196492

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

NCT03196492

Sponsor

Johns Hopkins University

Status

Completed

Last Update Posted

Jun 18, 2021Actual

Enrollment

234Actual

Phase

Not provided

Conditions

Microbial Colonization

Interventions

No intervention

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
1R01HD092013	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Jun 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 14, 2017Actual

Primary Completion Date

Jun 14, 2021Actual

Completion Date

Jun 14, 2021Actual

First Submitted Date

Jun 19, 2017

First Submission Date that Met QC Criteria

Jun 20, 2017

First Posted Date

Jun 22, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 14, 2021

Last Update Posted Date

Jun 18, 2021Actual

Name	Class
University of Maryland, College Park	OTHER
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

234Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
No intervention	Other	No intervention	No hormone

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

13 Years

Maximum Age

24 Years

Standard Ages

ChildAdult

Study Population

Healthy 13-24 Adolescent Girls and Young Women

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jenell Coleman Fennell, MD	Johns Hopkins University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Johns Hopkins Hospital		Baltimore	Maryland	21205	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003141	Communicable Diseases

Ancestor Terms

ID	Term
D007239	Infections
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided