Clincosm LogoSign in Get a demo

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

Sponsor
University of Washington (Other)
Overall Status
Completed
CT.gov ID
NCT02445989
Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (NIH)
120
Enrollment
1
Location
2
Arms
31
Actual Duration (Months)
3.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

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 Design

Study Type:
Interventional
Actual Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Effects of Contraceptive Ring on Vaginal Microbiota, HIV Shedding and Local Immunity
Actual Study Start Date :
May 1, 2016
Actual Primary Completion Date :
Nov 1, 2018
Actual Study Completion Date :
Dec 1, 2018

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Cyclic NuvaRing CVR Use

CVR use for 3 weeks, remove for 1 week, then replace

Drug: NuvaRing
Provide NuvaRing to women seeking contraception
Other Names:
  • Contraceptive vaginal ring

    		•
    Experimental: Continuous NuvaRing CVR Use

    CVR use for 4 weeks, then replace

    Drug: NuvaRing
    Provide NuvaRing to women seeking contraception
    Other Names:
  • Contraceptive vaginal ring

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Quantity of L. crispatus determined by species-specific qPCR assay [Up to 8 months]

    Secondary Outcome Measures

    1. Rates of bacterial vaginosis during contraceptive ring uses [Up to 8 months]

    2. Number of adverse events with CVR use [Up to 8 months]

    3. Acceptability of CVR to male sex partners of study participants assessed by questionnaire [Up to 1 month]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 40 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Thika Clinic Thika Kenya

    Sponsors and Collaborators

    • University of Washington
    • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    Investigators

    • Principal Investigator: Jeanne M Marrazzo, MD, MPH, University of Washington

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Jeanne Marrazzo, Professor of Medicine, University of Washington
    ClinicalTrials.gov Identifier:
    NCT02445989
    Other Study ID Numbers:
    • 48663
    • R01HD077872
    First Posted:
    May 15, 2015
    Last Update Posted:
    Dec 10, 2018
    Last Verified:
    Dec 1, 2018
    Keywords provided by Jeanne Marrazzo, Professor of Medicine, University of Washington
    HIV
    Contraceptive Vaginal Ring
    Bacterial Vaginosis
    Additional relevant MeSH terms:
    Vaginosis, Bacterial
    Vaginal Diseases
    Contraceptive Agents
    NuvaRing

    Study Results

    No Results Posted as of Dec 10, 2018