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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

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
Bacterial Vaginosis HIV Drug: NuvaRing 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.


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Study Type : Interventional  (Clinical Trial)
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 2016
Actual Primary Completion Date : November 2018
Actual Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


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 Name: Contraceptive vaginal ring

Experimental: Continuous NuvaRing CVR Use
CVR use for 4 weeks, then replace
Drug: NuvaRing
Provide NuvaRing to women seeking contraception
Other Name: Contraceptive vaginal ring




Primary Outcome Measures :
  1. Quantity of L. crispatus determined by species-specific qPCR assay [ Time Frame: Up to 8 months ]

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


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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02445989


Locations
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Kenya
Thika Clinic
Thika, Kenya
Sponsors and Collaborators
University of Washington
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
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Principal Investigator: Jeanne M Marrazzo, MD, MPH University of Washington

Additional Information:
Publications:

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Responsible Party: Jeanne Marrazzo, Professor of Medicine, University of Washington
ClinicalTrials.gov Identifier: NCT02445989     History of Changes
Other Study ID Numbers: 48663
R01HD077872 ( U.S. NIH Grant/Contract )
First Posted: May 15, 2015    Key Record Dates
Last Update Posted: December 10, 2018
Last Verified: December 2018
Keywords provided by Jeanne Marrazzo, University of Washington:
HIV
Contraceptive Vaginal Ring
Bacterial Vaginosis
Additional relevant MeSH terms:
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Vaginosis, Bacterial
Vaginal Diseases
Genital Diseases, Female
Bacterial Infections
Vaginitis
Contraceptive Agents
Desogestrel
Ethinyl Estradiol
Reproductive Control Agents
Physiological Effects of Drugs
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Progestins