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OpenTrials
Completed

NCT Number: NCT02445989

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

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.

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Key information

Conditions

Bacterial Vaginosis Bacterial Infections Bacterial Infections and Mycoses Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female HIV Infections Urogenital Diseases Vaginal Diseases Vaginitis Vaginosis, Bacterial

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Thika Clinic

Thika, Kenya

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NuvaRing

Drug

Provide NuvaRing to women seeking contraception

Other names: Contraceptive vaginal ring

Primary outcomes

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

    Time frame: Up to 8 months

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

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

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
May 15, 2015
Registry last updated
Dec 10, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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