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

December 6, 2018 updated by: Jeanne Marrazzo, University of Washington
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

120

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Kenya
      • Thika, Kenya
        • Thika Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 36 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Quantity of L. crispatus determined by species-specific qPCR assay
Time Frame: Up to 8 months
Up to 8 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Rates of bacterial vaginosis during contraceptive ring uses
Time Frame: Up to 8 months
Up to 8 months
Number of adverse events with CVR use
Time Frame: Up to 8 months
Up to 8 months
Acceptability of CVR to male sex partners of study participants assessed by questionnaire
Time Frame: Up to 1 month
Up to 1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Washington

Collaborators

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

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2016

Primary Completion (Actual)

November 1, 2018

Study Completion (Actual)

December 1, 2018

Study Registration Dates

First Submitted

April 20, 2015

First Submitted That Met QC Criteria

May 12, 2015

First Posted (Estimate)

May 15, 2015

Study Record Updates

Last Update Posted (Actual)

December 10, 2018

Last Update Submitted That Met QC Criteria

December 6, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 48663
  • R01HD077872 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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