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
About this trial
This is an interventional prevention trial for Bacterial Vaginosis focused on measuring HIV, Contraceptive Vaginal Ring, Bacterial Vaginosis
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
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
NCT ID
NCT02445989
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)
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.
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PubMed Identifier
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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.
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PubMed Identifier
21068695
Citation
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Effects of Contraceptive Ring on Vaginal Microbiota, HIV Shedding and Local Immunity
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