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Effects of Contraceptive Ring on Vaginal Microbiota, HIV Shedding and Local Immunity

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ClinicalTrials.gov Identifier: NCT02445989
Recruitment Status : Completed
First Posted : May 15, 2015
Last Update Posted : December 10, 2018
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Jeanne Marrazzo, University of Washington

Tracking Information
First Submitted Date  ICMJE April 20, 2015
First Posted Date  ICMJE May 15, 2015
Last Update Posted Date December 10, 2018
Actual Study Start Date  ICMJE May 2016
Actual Primary Completion Date November 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 12, 2015)
Quantity of L. crispatus determined by species-specific qPCR assay [ Time Frame: Up to 8 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02445989 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 12, 2015)
  • Rates of bacterial vaginosis during contraceptive ring uses [ Time Frame: Up to 8 months ]
  • Number of adverse events with CVR use [ Time Frame: Up to 8 months ]
  • Acceptability of CVR to male sex partners of study participants assessed by questionnaire [ Time Frame: Up to 1 month ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Contraceptive Ring on Vaginal Microbiota, HIV Shedding and Local Immunity
Official Title  ICMJE Effects of Contraceptive Ring on Vaginal Microbiota, HIV Shedding and Local Immunity
Brief Summary The investigators propose to explore the hypothesis—supported by limited data—that a contraceptive vaginal ring (CVR) that is commonly used in the United States, the NuvaRing, will enhance women's genital and reproductive health. The investigators propose that this CVR will increase the bacteria that help the vaginal environment protect against infection by HIV and other STIs, and that in women who already have HIV, use of the CVR will lower the quantity of HIV that is shed in the female genital tract.
Detailed Description

The investigators objective is to study effects of a contraceptive vaginal ring (CVR) containing estrogen and progesterone (NuvaRing) on vaginal bacteria, HIV shedding, and local immunity in women. The investigators will build on data that support a favorable effect of CVR on vaginal bacteria. Bacterial vaginosis (BV) is found in >50% of women in sub-Saharan Africa. BV significantly increases risk of HIV acquisition in, and HIV transmission to male partners from, HIV-infected women, genital HIV shedding, and viral set point in infected male partners. Pregnancy is also an independent risk for HIV acquisition and transmission. Contraception comprises critical biomedical prevention for women with or at risk for HIV. Systemic depot progesterone—commonly used throughout Africa—may independently increase risk of HIV acquisition and transmission. Hormonal interventions preventing unintended pregnancy and promoting a protective vaginal microenvironment could synergistically reduce HIV risk especially combined with topical antiretrovirals (ARV). The investigators propose NuvaRing use may contribute to reduction in BV, pregnancy prevention, and decreased rates of HIV shedding in HIV-infected women. Sustained vaginal delivery of contraceptive and ARV PrEP as "multicomponent prevention" is a major focus for scientists but effects on the vaginal environment need careful definition before broad implementation.

Total duration of follow up is no more than 8 months, with 5 months of CVR usage.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Bacterial Vaginosis
  • HIV
Intervention  ICMJE Drug: NuvaRing
Provide NuvaRing to women seeking contraception
Other Name: Contraceptive vaginal ring
Study Arms  ICMJE
  • Active Comparator: Cyclic NuvaRing CVR Use
    CVR use for 3 weeks, remove for 1 week, then replace
    Intervention: Drug: NuvaRing
  • Experimental: Continuous NuvaRing CVR Use
    CVR use for 4 weeks, then replace
    Intervention: Drug: NuvaRing
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 12, 2015)
120
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2018
Actual Primary Completion Date November 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • BV+ by Amsel Criteria
  • Not intending to become pregnant over the course of the study
  • If HIV infected, not taking ART
  • Capable of providing written informed consent

Exclusion Criteria:

  • Current pregnancy
  • Desire/intent to become pregnant over the course of the study
  • Contraindications to hormonal contraceptive use
  • Current cigarette smoking if age is older than 35 years
  • Unable to comprehend consent material because of language barrier or psychological difficulty
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Kenya
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02445989
Other Study ID Numbers  ICMJE 48663
R01HD077872 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jeanne Marrazzo, University of Washington
Study Sponsor  ICMJE University of Washington
Collaborators  ICMJE Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators  ICMJE
Principal Investigator: Jeanne M Marrazzo, MD, MPH University of Washington
PRS Account University of Washington
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP