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

Primary Purpose

Bacterial Vaginosis, HIV

Status
Completed
Phase
Phase 4
Locations
Kenya
Study Type
Interventional
Intervention
NuvaRing
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Bacterial Vaginosis focused on measuring HIV, Contraceptive Vaginal Ring, Bacterial Vaginosis

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Thika Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Cyclic NuvaRing CVR Use

Continuous NuvaRing CVR Use

Arm Description

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

CVR use for 4 weeks, then replace

Outcomes

Primary Outcome Measures

Quantity of L. crispatus determined by species-specific qPCR assay

Secondary Outcome Measures

Rates of bacterial vaginosis during contraceptive ring uses
Number of adverse events with CVR use
Acceptability of CVR to male sex partners of study participants assessed by questionnaire

Full Information

First Posted
April 20, 2015
Last Updated
December 6, 2018
Sponsor
University of Washington
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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1. Study Identification

Unique Protocol Identification Number
NCT02445989
Brief Title
Effects of Contraceptive Ring on Vaginal Microbiota, HIV Shedding and Local Immunity
Official Title
Effects of Contraceptive Ring on Vaginal Microbiota, HIV Shedding and Local Immunity
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
May 2016 (Actual)
Primary Completion Date
November 2018 (Actual)
Study Completion Date
December 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bacterial Vaginosis, HIV
Keywords
HIV, Contraceptive Vaginal Ring, Bacterial Vaginosis

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cyclic NuvaRing CVR Use
Arm Type
Active Comparator
Arm Description
CVR use for 3 weeks, remove for 1 week, then replace
Arm Title
Continuous NuvaRing CVR Use
Arm Type
Experimental
Arm Description
CVR use for 4 weeks, then replace
Intervention Type
Drug
Intervention Name(s)
NuvaRing
Other Intervention Name(s)
Contraceptive vaginal ring
Intervention Description
Provide NuvaRing to women seeking contraception
Primary Outcome Measure Information:
Title
Quantity of L. crispatus determined by species-specific qPCR assay
Time Frame
Up to 8 months
Secondary Outcome Measure Information:
Title
Rates of bacterial vaginosis during contraceptive ring uses
Time Frame
Up to 8 months
Title
Number of adverse events with CVR use
Time Frame
Up to 8 months
Title
Acceptability of CVR to male sex partners of study participants assessed by questionnaire
Time Frame
Up to 1 month

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeanne M Marrazzo, MD, MPH
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
Thika Clinic
City
Thika
Country
Kenya

12. IPD Sharing Statement

Citations:
PubMed Identifier
23871397
Citation
Polis CB, Curtis KM. Use of hormonal contraceptives and HIV acquisition in women: a systematic review of the epidemiological evidence. Lancet Infect Dis. 2013 Sep;13(9):797-808. doi: 10.1016/S1473-3099(13)70155-5. Epub 2013 Jul 19.
Results Reference
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PubMed Identifier
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Citation
van der Straten A, Montgomery ET, Cheng H, Wegner L, Masenga G, von Mollendorf C, Bekker L, Ganesh S, Young K, Romano J, Nel A, Woodsong C. High acceptability of a vaginal ring intended as a microbicide delivery method for HIV prevention in African women. AIDS Behav. 2012 Oct;16(7):1775-86. doi: 10.1007/s10461-012-0215-0.
Results Reference
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PubMed Identifier
22297505
Citation
Kiser PF, Johnson TJ, Clark JT. State of the art in intravaginal ring technology for topical prophylaxis of HIV infection. AIDS Rev. 2012 Jan-Mar;14(1):62-77.
Results Reference
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PubMed Identifier
21068695
Citation
Marrazzo JM, Martin DH, Watts DH, Schulte J, Sobel JD, Hillier SL, Deal C, Fredricks DN. Bacterial vaginosis: identifying research gaps proceedings of a workshop sponsored by DHHS/NIH/NIAID. Sex Transm Dis. 2010 Dec;37(12):732-44. doi: 10.1097/OLQ.0b013e3181fbbc95.
Results Reference
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PubMed Identifier
18614873
Citation
Atashili J, Poole C, Ndumbe PM, Adimora AA, Smith JS. Bacterial vaginosis and HIV acquisition: a meta-analysis of published studies. AIDS. 2008 Jul 31;22(12):1493-501. doi: 10.1097/QAD.0b013e3283021a37.
Results Reference
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PubMed Identifier
22745608
Citation
Cohen CR, Lingappa JR, Baeten JM, Ngayo MO, Spiegel CA, Hong T, Donnell D, Celum C, Kapiga S, Delany S, Bukusi EA. Bacterial vaginosis associated with increased risk of female-to-male HIV-1 transmission: a prospective cohort analysis among African couples. PLoS Med. 2012;9(6):e1001251. doi: 10.1371/journal.pmed.1001251. Epub 2012 Jun 26.
Results Reference
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PubMed Identifier
15339769
Citation
Veres S, Miller L, Burington B. A comparison between the vaginal ring and oral contraceptives. Obstet Gynecol. 2004 Sep;104(3):555-63. doi: 10.1097/01.AOG.0000136082.59644.13.
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PubMed Identifier
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Citation
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PubMed Identifier
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Citation
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Citation
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Citation
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Effects of Contraceptive Ring on Vaginal Microbiota, HIV Shedding and Local Immunity

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